da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm)
Applicant
Intuitive Surgical, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
Sep 11, 2017
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Device Story
The da Vinci S/Si Surgical Systems are robotic-assisted platforms used in operating rooms by trained surgeons. The system consists of a surgeon console and patient-side instruments/accessories. The surgeon controls the movement of end-effectors (e.g., scissors, dissectors, stabilizers) via the console, which translates hand movements into precise instrument tip articulation. The Harmonic ACE Curved Shears use ultrasonic energy for tissue transection and coagulation. Accessories include cannulae for port access and alignment targets for stereo endoscope setup. This submission specifically updates the reprocessing instructions for these reusable instruments and accessories to ensure effective cleaning and thermal disinfection. The device benefits patients by enabling minimally invasive surgical procedures with high precision, potentially reducing trauma and recovery time.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including cleaning validation and thermal disinfection validation. Cleaning efficacy was verified using qualitative visual inspection and quantitative endpoints. Thermal disinfection efficacy was confirmed by achieving a 6-log10 reduction of vegetative organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and Klebsiella-Enterobacter). Human factors validation was performed to ensure the usability and safety of the updated reprocessing instructions.
Technological Characteristics
Reusable surgical instruments and accessories for da Vinci S/Si systems. Materials and design are identical to predicates. Includes articulating EndoWrist instruments, ultrasonic shears (with disposable inserts), cannulae (stainless steel), and various accessories. Connectivity is system-specific. Sterilization/reprocessing involves cleaning and thermal disinfection. No software algorithm changes; device is mechanical/electromechanical.
Indications for Use
Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures; also indicated for transoral otolaryngology procedures (benign/malignant T1/T2 tumors and base of tongue resection) and coronary anastomosis via adjunctive mediastinotomy. Contraindicated for transoral otolaryngology in pediatric patients.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2017
Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086
Re: K170644
Trade/Device Name: Da Vinci S/Si Endowrist Instruments and Accessories, Harmonic Ace Curved Shears (5mm & 8mm) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 14, 2017 Received: August 15, 2017
Dear Kunal Gunjal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# 7 510(k) Summary (K170644)
This 510(k) applies to multiple instruments and accessories that have been cleared through a number of 510(k) Premarket Notifications. It concerns the Reprocessing Instructions provided to users for reprocessing of instruments and accessories intended for multiple usage. For ease of review, the subject devices have been listed in Tables 7.1 and 7.2 (which is structured based on the device and the da Vinci Surgical System with which it is used). No changes have been made in the design or materials of the subject devices.
| 510(k) Owner | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Regulatory Affairs Specialist, Regulatory Affairs<br>Phone Number: 408-523-8017<br>Fax Number: 408-523-8907<br>Email: Kunal.Gunjal@intusurg.com | | |
| Date Summary Prepared | August 14, 2017 | | |
| Trade Name | <i>da Vinci S/ Si</i><br><i>EndoWrist</i><br>Instruments<br>(5mm & 8mm) | Harmonic ACE<br>Curved Shears<br>(5mm & 8mm) | Endowrist<br>Stabilizer |
| Common Name | Endoscope and<br>accessories | Endoscope and<br>accessories | Cardiovascular Surgical<br>Instrument |
| Classification | Class II,<br>21 CFR<br>876.1500 | Class II,<br>21 CFR<br>876.1500 | Class II,<br>21 CFR 876.1500 |
| Product Codes | NAY | NAY | NAY |
| Classification<br>Advisory<br>Committee: | General and<br>Plastic Surgery | General and<br>Plastic Surgery | General and Plastic Surgery |
| Predicate<br>Devices | K050369 (use<br>with IS2000<br>Surgical<br>System), with<br>additional<br>indications<br>under K081137<br>(use with<br>IS3000<br>System),<br>K090993<br>(TORS<br>indication) and<br>K123329<br>(updated TORS<br>indication) | K093217 (use<br>with IS2000 and<br>IS3000 Surgical<br>Systems) | K060391 (use with IS2000<br>Surgical System<br><br>K081137 (use with IS3000<br>System) |
| Table 7.1: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System | | |
|------------------------------------------------------------------------------------|--|--|
| | | |
Image /page/2/Picture/8 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
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# Changes to Reprocessing Instructions
K170644
| 510(k) Owner | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Kunal Gunjal<br>Regulatory Affairs Specialist, Regulatory Affairs<br>Phone Number: 408-523-8017<br>Fax Number: 408-523-8907<br>Email: Kunal.Gunjal@intusurg.com | | |
| Date Summary Prepared | August 14, 2017 | | |
| Trade Name | da Vinci S/ Si Accessories | Flared Cannula (5mm & 8mm) | 8.5 mm Endoscope Cannula<br>and 8.5 mm Endoscope<br>Alignment Target |
| Common Name | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories |
| Classification | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 | Class II, 21 CFR 876.1500 |
| Product Codes | NAY | NAY | NAY |
| Classification Advisory Committee: | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery |
| Predicate Devices | K050369 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication) | K101743 (use with IS2000 and IS3000 Surgical Systems) | K080155 (use with IS2000 Surgical System), with additional indications under K081137 (use with IS3000 System), K090993 (TORS indication) and K123329 (updated TORS indication) |
Table 7.2: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System
# Device Description
The da Vinci IS2000 (S) and IS3000 (Si) Surgical Systems are used in conjunction with reusable Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci S and da Vinci Si Instruments and Accessories. Tables 7.3 and 7.4 list the device descriptions for the subject devices impacted by the changes to the reprocessing instructions.
Image /page/3/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol.
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| Trade Name | da Vinci S/ Si EndoWrist<br>Instruments (5mm & 8mm) | Harmonic ACE Curved Shears<br>(5mm & 8mm) | Endowrist Stabilizer |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | S2000/IS3000 5mm and 8mm<br>Instruments can be used only<br>with the da Vinci S (IS2000)<br>and Si (IS3000) Surgical<br>Systems. Most instruments<br>have a unique articulating<br>design at their distal tips that<br>mimics the human wrist.<br>While seated at the Surgeon<br>Console of the Surgical<br>System, the surgeon can<br>precisely control movements<br>of the end<br>effectors/instrument tips. | The Harmonic ACE Curved<br>Shears Instrument (5mm/8mm)<br>consists of a proximal reusable<br>instrument housing and a distal<br>disposable insert. The reusable<br>instrument housing, when<br>assembled with the disposable<br>insert, is attached to the da<br>Vinci IS2000/IS3000 System<br>and delivers ultrasonic energy<br>for transection (cutting) and<br>coagulation of tissue. | The Endowrist Stabilizer is a<br>reusable instrument similar to the<br>da Vinci S/ Si EndoWrist<br>Instruments. It is mounted on a<br>PSM arm and is positioned,<br>controlled, and held in place by the<br>da Vinci IS2000/IS3000 System. |
Table 7.3: Reusable Instruments used with the da Vinci S/Si (IS2000/IS3000) System
| Table 7.4: Reusable Accessories used with the da Vinci S/Si (IS2000/IS3000) System | | |
|------------------------------------------------------------------------------------|--|--|
| | | |
| Trade<br>Name | da Vinci S/ Si Accessories | Flared Cannula (5mm &<br>8mm) | 8.5 mm Endoscope Cannula and 8.5 mm<br>Endoscope Alignment Target |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | da Vinci S/ Si Accessories mainly consist of:<br>Cannulae, which are essentially hollow tubes<br>that provide a path for instruments to access the<br>surgical site<br><br>Obturators, which provide a means of initially<br>inserting the seal and cannula assemblies<br>through the body wall by providing a fitted tip<br>that extends beyond the cannula's most distal<br>point.<br><br>"Other" Accessories include PK Cables,<br>instrument release kit (IRK), Blade Protectors<br>and Insertion tools (used with the Snap-FitTM<br>Scalpel Instrument), a Blank Cartridge (used<br>with the Endopass Delivery instrument),<br>cannula mounts, light guide cable and cannula<br>gage pins. These accessories have simple<br>geometries with no long narrow lumens. | The Flared Cannula<br>consists of a tapered<br>hollow tubular shaft with<br>a flared distal tip and a<br>bowl with an integral<br>electrical receptacle. The<br>hollow shaft serves as the<br>port of entry, the bowl is<br>used to attach the cannula<br>to the da Vinci S/Si<br>Surgical System and the<br>receptacle allows for<br>attachment of<br>commercially available<br>dispersive electrode<br>grounding pad via a 2-pin<br>grounding connector. | The 8.5 mm Endoscope Cannula is made<br>of stainless steel components and is used to<br>establish a port of entry for the 8.5mm<br>Endoscope and provide an outlet for<br>insufflation and/or smoke evacuation.<br><br>The Endoscope Alignment Target is used<br>during stereo endoscope set-up to align the<br>left and right images from the endoscope to<br>provide a stereo image to the console<br>surgeon. It does not have any long narrow<br>lumens. |
# Indications for Use:
Tables 7.5 through 7.7 list the Indications for Use for the devices impacted by the changes to the reprocessing instructions. There is no change in the Indications for Use between the subject and predicate devices.
Image /page/4/Picture/9 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a light gray color, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "INTUITIVE".
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| Trade Name | da Vinci S/ Si EndoWrist Instruments (5mm&<br>8mm) and Accessories | Harmonic ACE Curved Shears (5mm& 8mm) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical Endoscopic Instrument<br>Control System is intended to assist in the<br>accurate control of Intuitive Surgical Endoscopic<br>Instruments including rigid endoscopes, blunt and<br>sharp endoscopic dissectors, scissors, scalpels,<br>ultrasonic shears, forceps/pick-ups, needle<br>holders, endoscopic retractors, stabilizers,<br>electrocautery and accessories for endoscopic<br>manipulation of tissue, including grasping,<br>cutting, blunt and sharp dissection,<br>approximation, ligation, electrocautery, suturing,<br>and delivery and placement of microwave and<br>cryogenic ablation probes and accessories, during<br>urologic surgical procedures, general laparoscopic<br>surgical procedures, gynecologic laparoscopic<br>surgical procedures, transoral otolaryngology<br>surgical procedures restricted to benign and<br>malignant tumors classified as TI and T2, and for<br>benign base of tongue resection procedures,<br>general thoracoscopic surgical procedures, and<br>thoracoscopically assisted cardiotomy procedures.<br>The system can also be employed with adjunctive<br>mediastinotomy to perform coronary anastomosis<br>during cardiac revascularization. The system is<br>indicated for adult and pediatric use (except for<br>transoral otolaryngology surgical procedures). It<br>is intended to be used by trained physicians in an<br>operating room environment in accordance with<br>the representative, specific procedures set forth in<br>the Professional Instructions for Use. | The Intuitive Surgical da Vinci Harmonic ACE™<br>Device is intended for soft tissue incisions when<br>bleeding control and minimal thermal injury are<br>desired. It is designed to be used in conjunction with<br>the da Vinci Surgical Systems (Model IS1200, IS2000<br>and IS3000) and the Ethicon Endo-Surgery Generator<br>300 (Model GEN04) and Hand Piece (Model HP054). |
# Table 7.6: EndoWrist Stabilizer Instrument used with the da Vinci S/Si (IS2000/IS3000) System
| Trade Name | EndoWrist Stabilizer Instrument- For use with the da<br>Vinci S IS2000 System) | EndoWrist Stabilizer Instrument- For use with the da Vinci Si IS3000<br>System) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Intuitive Surgical Endoscopic Instrument Control<br>System is intended to assist in the accurate control of<br>Intuitive Surgical Endoscopic Instruments including<br>rigid endoscopes, blunt and sharp endoscopic dissectors,<br>scissors, scalpels, ultrasonic shears, forceps/pickups,<br>needle holders, endoscopic retractors, stabilizers,<br>electrocautery and accessories for endoscopic<br>manipulation of tissue, including grasping, cutting, blunt<br>and sharp dissection, approximation, ligation,<br>electrocautery, suturing, and delivery and placement of<br>microwave ablation probes and accessories during<br>urologic surgical procedures, general laparoscopic<br>surgical procedures, gynecologic laparoscopic surgical<br>procedures, general noncardiovascular thoracoscopic<br>surgical procedures and thoracoscopically assisted<br>cardiotomy procedures. The system can also be<br>employed, with adjunctive mediastinotomy to perform<br>coronary anastomosis during cardiac revascularization.<br>The system is indicated for adult and pediatric use. It is<br>intended for use by trained physicians in an operating<br>room environment in accordance with the representative<br>specific procedures set forth in the Professional<br>Instructions for Use. | The Intuitive Surgical Endoscopic Instrument Control System (Intuitive<br>Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist<br>in the accurate control of Intuitive Surgical Endoscopic Instruments<br>including rigid endoscopes, blunt and sharp endoscopic dissectors,<br>scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders,<br>endoscopic retractors, stabilizers, electrocautery and accessories for<br>endoscopic manipulation of tissue, including grasping, cutting, blunt and<br>sharp dissection, approximation, ligation, electrocautery, suturing, and<br>delivery and placement of microwave and cryogenic ablation probes and<br>accessories during urologic surgical procedures, general laparoscopic<br>surgical procedures, gynecological laparoscopic surgical procedures,<br>general cardiovascular and non-cardiovascular thoracoscopic surgical<br>procedures, and thoracoscopically assisted cardiotomy procedures. The<br>system is indicated for adult and pediatric use. The system can also be<br>employed, with adjunctive mediastinotomy to perform coronary<br>anastomosis during cardiac revascularization. It is intended for use by<br>trained physicians in an operating room environment in accordance with<br>the representative specific procedures set forth in the Professional<br>Instructions for Use. |
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| Trade Name | Flared Cannula (5mm & 8mm) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model<br>1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that<br>do not require maintenance of insufflation. |
Table 7.7: Flared Cannula (5mm & 8mm) used with the da Vinci S/Si (1S2000/IS3000) System
# Technological Characteristics:
The technological characteristics of the subject devices are identical to the predicate devices.
# Performance Data:
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Verification, design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices.
# Cleaning Validation
The cleaning validation testing summarized in this submission validates the efficacy of the cleaning process in the Reprocessing Instructions in accordance with the following standards and guidance documents:
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
- AAMI TIR 12:2010 Designing, testing, and labeling reusable medical devices for 0 reprocessing in health care facilities: A guide for medical device manufacturers
- AAMI TIR 30: 2011 A compendium of processes, materials, test methods, and ● acceptance criteria for cleaning reusable medical devices
Cleaning validation testing was performed using devices within the product family that represent the greatest challenge for the cleaning process. The Cleaning Efficacy test evaluated the cleaning process (as described in the Reprocessing Instructions) for the devices using qualitative visual inspection and quantitative endpoints.
# Thermal Disinfection Validation
The disinfection validation testing summarized in this submission validates the efficacy of the disinfection process in the Reprocessing Instructions in accordance with the following guidance documents:
Image /page/6/Picture/18 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a small yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
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- K170644
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation ● Methods and Labeling", document issued on: March 17, 2015
- FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and ● Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff", document issued on February 7, 2002.
Efficacy of the thermal disinfection process (as described in the Reprocessing Instructions) was performed using devices within the product family that represent significant challenges to the disinfection step within the scope of the intended use. The thermal disinfection efficacy testing evaluated the efficacy of the disinfection process in the Reprocessing Instructions using a quantitative endpoint i.e., 6-log10 reduction of typical vegetative organisms, such as Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group.
# Human Factors Testing
The Reprocessing Instructions underwent a rigorous Human Factors testing process. This process included:
- Preliminary Evaluation: A preliminary evaluation was completed to better understand . the users, uses, and use environment.
- . Usability Risk Analysis (URA): Task and Use Error analysis was conducted for Reprocessing. This analysis included the process and Reprocessing Instructions.
- Design Team Participation: Human Factors Engineers participated in design meetings 0 and played a significant role in the visual design and content development.
- 0 Formative Testing: Formative tests were completed during the development of the new Reprocessing Instructions.
- . Validation Testing: Validation test of representative Reprocessing Instructions was completed with representative end users.
This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions.
# Summary:
Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate devices listed in Tables 7.1 and 7.2.
Image /page/7/Picture/17 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
Page | 7-6
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## Changes to Reprocessing Instructions
## Traditional 510(k)
### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
### 510(k) Number (if known) K170644
Device Name
da Vinci S/Si EndoWrist Instruments (5mm & 8mm) and Accessories
#### Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, lisation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiae revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
FORM FDA 3881 (8/14)
Page 1 of 1
600000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Image /page/8/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Above the "I" in Intuitive is a yellow dot. Below the word "INTUITIVE" is the word "SURGICAL" in a smaller font and also in light gray.
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# Changes to Reprocessing Instructions
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 Indications for Use See PRA Statement below.
#### 510(k) Number (if known)
K170644
Device Name
Harmonic ACE Curved Shears Instrument (5mm & 8mm)
#### Indications for Use (Describe)
The Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS 1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publiching Sarvices (301)-403-4740 17
Image /page/9/Picture/23 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, light gray sans-serif font, with the registered trademark symbol next to it.
{10}------------------------------------------------
# Changes to Reprocessing Instructions
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
# 510(k) Number (if known)
K170644
Device Name Flared Cannula (5mm & 8mm)
#### Indications for Use (Describe)
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Image /page/10/Picture/23 description: The image contains the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" followed by the registered trademark symbol. The text is light gray against a white background.
{11}------------------------------------------------
# Changes to Reprocessing Instructions
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
#### 510(k) Number (if known) K170644
Device Name
EndoWrist Stabilizer Instrument
#### Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pickups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
Image /page/11/Picture/24 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a light gray sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.
{12}------------------------------------------------
# Changes to Reprocessing Instructions
# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K170644
Device Name
Endowrist Stabilizer Instrument
#### Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps(pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping. cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
EP PSC Publishing Services (301) 443-6740
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
