K182421 · Transenterix, Inc. · NAY · Jan 11, 2019 · Gastroenterology, Urology
Device Facts
Record ID
K182421
Device Name
Senhance Ultrasonic System
Applicant
Transenterix, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
Jan 11, 2019
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.
Device Story
Senhance Ultrasonic System is an energized surgical instrument system for soft tissue incisions; used with Senhance Surgical System. Components: dissector, transducer, adapter, ultrasonic generator, footswitch. System converts electrical energy into torsional ultrasonic energy (35-37 kHz) to cut and coagulate tissue. Operated by surgeons in OR; robotic manipulation of laparoscopic instrument. Provides hemostasis with minimal thermal spread. Benefits: precise robotic control for soft tissue dissection; reduced thermal injury compared to traditional methods. Output: mechanical ultrasonic energy delivered to tissue via end effector. Healthcare providers use system to perform procedures like hysterectomy, cholecystectomy, and liver resection.
Clinical Evidence
No clinical data. Evidence consists of bench testing and a single-center, un-blinded, observational, simulated use design validation study. Four teams performed procedures (hysterectomy, salpingo-oophorectomy, cholecystectomy, liver resection) on a live porcine model. All pre-determined acceptance criteria met. Bench testing confirmed compatibility, force feedback, and tissue effects (burst pressure, lesion size) comparable to reference system.
Indicated for soft tissue surgical incisions requiring bleeding control and minimal thermal injury. For use with the Senhance Surgical System in surgical procedures.
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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## 510(k) SUMMARY
[In accordance with 21CFR 807.92]
#### Submitter l.
| 510(k) Sponsor: | TransEnterix, Inc. |
|------------------------|-------------------------------------------------------------------------------------|
| Address: | 635 Davis Drive, Suite 300<br>Morrisville, NC 27713 |
| Contact Person: | Stephanie M. Fitts, PhD<br>Vice President, Clinical, Quality and Regulatory Affairs |
| Contact Information: | Email: sfitts@transenterix.com<br>Phone: 919.765.8430<br>Facsimile: 919.765.8459 |
| Date Summary Prepared: | 12/21/2018 |
#### II. Device
| Proprietary (Trade) Name: | Senhance™ Ultrasonic System |
|---------------------------------------|--------------------------------------------------------|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification: | Class II |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
- Intuitive Surgical 5mm Harmonic ACE Curved Shears (K112584) lll. Predicate Device:
Reference Device
BOWA Lotus Ultrasonic System 4 (K151101)
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#### IV. Device Description:
The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery.
The Senhance Ultrasonic System is composed of five components:
- 1. The Dissector which interfaces with the tissue of interest
- 2. The Transducer which converts electrical energy into ultrasonic energy
- The Senhance Adapter which physically attaches the instrument to the Senhance Surgical 3. Robotic System manipulator arm
- The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 4.
- 5. The Footswitch
The system components are presented in Figure 1 below:
Image /page/1/Figure/11 description: The image shows a diagram of a Senhance surgical system. The diagram labels five components of the system: the dissector, transducer, Senhance adapter, ultrasonic generator, and footswitch. The distal portion of the Senhance manipulator arm is also labeled. The numbers 1 through 5 are used to label the components.
Figure 1: The Senhance Ultrasonic System Components
#### > Intended Use/ Indications for Use:
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.
# Comparison with Predicate Device Intended Use/ Indications for Use:
The Senhance Ultrasonic System has the same intended use as the predicate Intuitive Surgical 5mm Harmonic ACE Curved Shears as cleared in K112584. The da Vinci Harmonic ACE Curved Shears are 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 (Models IS1200, IS2000 and IS3000) and a compatible Ethicon Endo-Surgery Generator and Handpiece. Thus the intended use (soft tissue incisions when bleeding control and minimal thermal injury are important/desired) is the
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same and both systems reference the larger robotically assisted surgical device system with which they are intended to be used.
#### VI. Summary of Technological Characteristics:
The Senhance™ Ultrasonic System has the same basic technological characteristics as the predicate Intuitive Surgical 5mm Harmonic ACE curved Shears cleared under K112584. Both systems robotically manipulate a variant of a standard manual laparoscopic instrument that delivers ultrasonic energy to the tissue of interest. The Intuitive Surgical predicate adapted the Harmonic ACE manual laparoscopic instrument (K042777) and the Senhance Ultrasonic System is an adaptation of the BOWA Lotus manual laparoscopic system cleared under K151101.
The Senhance Ultrasonic system includes some technological characteristics that differ from the predicate device. The end effector design is different (12mm shear versus 14mm shear for the predicate) and there are different materials of construction. The wavelength of the ultrasonic energy differs between the systems as well as its mode (torsional for Senhance versus linear for Harmonic ACE). See the table below for a description of the technological differences among the subject, predicate and reference device systems.
| | Subject Device<br>Senhance<br>Ultrasonic System | Predicate Device<br>Intuitive Surgical 5mm<br>Harmonic ACE Curved<br>Shears (K112584) | Reference Device<br>BOWA Lotus Ultrasonic<br>System 4 (K151101) |
|--------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Manipulation<br>Method | Robotic | Robotic | Manual |
| Method of<br>Activation | Footswitch - not<br>integrated to robotic<br>system | Footpedal - integrated to<br>robotic system | Footswitch or handpiece<br>buttons |
| End Effector<br>Design | 12mm Curved Shear | 14mm Curved Shear | 12mm Curved Shear |
| End Effector<br>packaging and<br>Sterility | Single Use<br>Disposable (EO<br>Sterilization) SAL<br>10-6 | Single Use Disposable (EO<br>Sterilization) SAL 10-6 | Single Use Disposable<br>(EO Sterilization) SAL 10-6 |
| End Effector<br>Dimensions | Shaft Diameter:<br>5.5mm<br>Shaft Length: 349mm | Shaft Diameter: 5.5mm<br>Shaft Length: 360mm | Shaft Diameter: 5.5mm<br>Shaft Length: 340mm |
| Ultrasonic Mode | Torsional | Linear | Torsional |
| Ultrasonic<br>Wavelength | 35 to 37 kHz | 55.5 kHz | 35 to 37 kHz |
| Generator | Rebranded Lotus<br>Series 4 generator | Ethicon Harmonic ACE<br>generator | Lotus Series 4 generator |
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Performance testing demonstrated that the technological differences between the Senhance System and the predicate device did not raise any different questions of safety or effectiveness. The end effectors are both made of biocompatible materials that are either effectively provided sterile to the end user or can be effectively cleaned and sterilized by the end user. Both systems effectively create soft tissue incisions with effective hemostasis and minimal thermal damage to adjacent tissues.
#### VII. Performance Data
The following performance testing of the Senhance Ultrasonic System was conducted to support the substantial equivalence of the device.
Biocompatibility testing: The biocompatibility evaluation for the Senhance Ultrasonic System relied on testing for the manual reference device and newly performed testing. All patient contacting devices were assessed in accordance with the FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The dissector and transducer are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone.
Cleaning, Disinfection (Reprocessing) and Sterilization: The reusable transducer and adapter have cleaning instructions that have been validated based on the guidelines outlined in AAMI TIR12:2010 and ANSI/AAMI TIR30:2011. A steam sterilization study was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on: March 17, 2015 and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R) 2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. Both items were validated to a Sterlity Assurance Level of 10° using the Half Cycle Testing validation method.
The disposable dissector is provided sterile to the end user via ethylene oxide sterilant in a fixed rigid chamber (FDA Established Category A). Sterility validation established the Sterility Assurance Level of 106 per EN ISO 11135-1:2014 with EO and ECH residuals meeting the acceptance criteria per EN ISO 10993-7:2008.
Bench Testing: Bench testing included system integrations of the Ultrasonic System with the Surgical System as well as tests to determine any effects of the instrument to the ultrasonic energy delivered. The following tests confirmed compatibility of the systems and that the ultrasonic energy delivery to tissue is comparable to that provided by the reference system.
- Cantilever bend stiffness characterization
- Force Feedback Response Linearity, Sensitivity and Stability ●
- Fulcrum Accuracy
- . Jaw output force verification
- Mechanical reliability of the dissector ●
- . Thermal spread characterization of end effector and adjacent tissue
- Tissue effects vessel sealing burst pressure comparison ●
- Tissue effects lesion size comparison on soft tissues ●
As both the reference and predicate have demonstrated safe and effective use for soft tissue dissections, the subject device has demonstrated equivalence with the predicate.
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Electrical Safety and Compatibility: The Senhance Ultrasonic System components as well as the Senhance Surgical System comply with current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), and IEC 60601-2-2 (High frequency surgical equipment). Previous testing and analysis demonstrate electrical safety and electromagnetic compatibility of the Senhance Ultrasonic system in the operating room environment. Although the system does not contain an endoscopic vision system, the effects of the energy delivered on the vision system in use concurrently with the system was evaluated using IEC 60601-2-18 (Endoscopic Equipment). The testing verified that the devices when used concurrently do not cause interference in the vision system signal.
Software Verification and Validation Testing: Software verification were conducted on both the Senhance Surgical System software modification which supported the extension to incorporate the Senhance Ultrasonic System components and also the Senhance Ultrasonic Generator. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "major" level of concern
Pre-Clinical Design Validation: Design Validation of the Senhance Ultrasonic system was conducted to ensure that the system conforms to defined user needs and intended uses in a simulated use environment. A single-center, un-blinded, observational, simulated use design validation evaluation of the Senhance System was conducted with users who represented the intended primary user population.
Four (4) teams of trained subjects (one surgeon and one surgical assistant per team) performed surgical tasks and procedures on a live porcine model, which most closely represents the human anatomy for the given procedures were non-survival and did not include any animal endpoints. Users were divided into two surgical specialties: gynecological and general surgery. Two gynecological teams each performed a bilateral salpingo-oophorectomy, and a hysterectomy. Two general surqical teams each performed a cholecystectomy, dissection of short gastric vessels and a liver wedge resection. All pre-determined acceptance criteria were met.
#### Conclusions VIII.
The Senhance™ Ultrasonic System has the same intended use as the predicate device. There are technological differences between the subject device and the predicate device, but these raise no different questions of safety or effectiveness. Further, the device is an adaptation of the BOWA Lotus manual laparoscopic system cleared under K151101. The performance testing supported the safety and functionality of the device and demonstrate the device is substantially equivalent to the predicate device.
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# Indications for Use
510(k) Number (if known) K182121
Device Name Senhance Ultrasonic System
Indications for Use (Describe)
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic System are indicated for use with the Senhance Surgical System.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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January 11, 2019
TransEnterix, Inc. Stephanie Fitts VP, Clinical, Quality and Regulatory Affairs 635 Davis Drive, Suite 300 Morrisville, North Carolina 27650
Re: K182421
Trade/Device Name: Senhance Ultrasonic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: November 30, 2018 Received: December 4, 2018
Dear Stephanie Fitts:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R.
Stevenson -S 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
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.
