INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K090993 · Intuitive Surgical, Inc. · NAY · Dec 16, 2009 · Gastroenterology, Urology
Device Facts
Record ID
K090993
Device Name
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
Applicant
Intuitive Surgical, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
Dec 16, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K090993 · Dec 16, 2009
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
Intuitive Surgical, Inc.
Multicenter retrospective clinical study
A multicenter retrospective clinical study was conducted to assess the feasibility, efficacy, and safety of the da Vinci Surgical System for transoral otolaryngology surgical procedures, comparing outcomes against historical controls (open surgery, transoral surgery, and chemoradiation).
Retrospective study; Historical controls; Otolaryngology; Feasibility study
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Multicenter retrospective clinical study; Retrospective clinical study
Patients undergoing transoral otolaryngology surgical procedures; Number of Sites: Multicenter
Historical controls (Open surgery, transoral surgery and chemoradiation treatment)
Feasibility, efficacy, safety, and functional assessment
Indications for Use
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S, and da Vinci Si Surgical Systems Models IS1200, IS2000, IS3000) are intended to assist in the accurate control of Intuitive Surgical EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic 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, delivery and placement of microwave 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 T1 and T2, 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 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.
Device Story
Robotic-assisted surgical system comprising Surgeon Console and Patient Side Cart (PSC). Surgeon at console controls endoscopic instruments and camera via Master Tool Manipulators (MTM). PSC holds instruments and endoscope via Patient Side Manipulators (PSM) and Endoscope Camera Manipulator (ECM). Insite Vision System provides 3D or 2D stereo images to surgeon. System facilitates tissue manipulation (grasping, cutting, dissection, suturing, etc.) during minimally invasive procedures. Surgeon commands relayed via cables to PSC; assistant at PSC performs instrument/endoscope changes. Enables precise control of EndoWrist instruments, enhancing surgical dexterity and visualization. Used in OR by trained physicians.
Clinical Evidence
Multicenter retrospective clinical study conducted to assess feasibility, efficacy, and safety in transoral otolaryngology procedures. Historical controls used to demonstrate substantial equivalence of robotic-assisted transoral procedures to alternative methods including open surgery, transoral surgery, and chemoradiation.
Technological Characteristics
Computer-controlled endoscopic instrument system. Components: Surgeon Console, Patient Side Cart, stereo endoscope, endoscopic camera, light source, and EndoWrist instruments. Connectivity via cables between console and cart. No changes in materials or technology from predicate.
Indications for Use
Indicated for adult and pediatric patients (excluding transoral otolaryngology) undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures. Also indicated for transoral otolaryngology procedures restricted to T1 and T2 benign and malignant tumors. Used by trained physicians in operating rooms.
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.
{0}------------------------------------------------
K090993
## Section II - 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
## 510(k) Number:
| Date | December 14, 2009 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical, Inc.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Karen Uyesugi<br>VP, Clinical and Regulatory Affairs<br>Telephone: (408) 523 - 8918<br>Fax: (408) 523 - 1390<br>e-mail:karen.uyesugi@intusurg.com |
| Subject Device | Name: Intuitive Surgical® da Vinci, da Vinci S® and da Vinci Si®<br>Surgical Systems and EndoWrist Instruments and Accessories. |
| | Classification Name: System, Surgical, Computer Controlled<br>Instrument (21 CFR 876.1500). |
| | Common Name: Endoscopic Instrument Control System,<br>Endoscopic Instruments and Accessories |
| Predicate Devices | Intuitive Surgical da Vinci Surgical Systems (Models IS1200,<br>IS2000, IS3000) and EndoWrist Instruments and Accessories<br>(legally marketed under: K990144 / K002489 / K011002 / K011281<br>/ K012833 / K013416 / K021036 / K022574 / K040237 / K040948 /<br>K042855 / K043153 / K043288 / K050005 / K050369 / K050404 /<br>K050802 / K060391 / K061260 / K063220 / K081137). |
| Device Description | This 510(k) is being submitted to request an expansion of the<br>Indications for Use to include transoral otolaryngology surgical<br>procedures. There are no changes in the design, technology,<br>materials, manufacturing, performance, specifications, or method<br>of use for the da Vinci Surgical Systems, EndoWrist Instruments and Accessories associated with this pre-market notification.<br>The da Vinci Surgical Systems (Models IS1200, IS2000, IS3000) |
| | consists of two integrated sub-systems as follows: |
| Device | A Surgeon Console and a Patient Side Cart. While seated at the<br>Surgeon Console, the surgeon controls critical aspects of the |
\$\rho.1/3\$
{1}------------------------------------------------
| Description<br>(continued) | procedure, including movement of the endoscopic instruments and<br>endoscope within the operative field. The endoscopic instrument<br>and camera movements are controlled by the surgeon through use<br>of the Master Tool Manipulators (MTM); two hand-operated<br>mechanisms residing within the Surgeon Console. The endoscopic<br>instruments are held in a fixed position with respect to the patient<br>by either two (or optionally three) unique arms known as Patient<br>Side Manipulators (PSM), which are located on the Patient Side<br>Cart (PSC). The endoscope is also held in a fixed position (with<br>respect to the patient) by another arm, similar to the PSM, known<br>as the Endoscope Camera Manipulator (ECM), which is also<br>located on the PSC. Commands from the Surgeon Console are<br>relayed to the PSC, which is located immediately adjacent to the<br>patient, via cables. Instrument and endoscope changes are<br>performed by another individual positioned adjacent to the PSC. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intuitive Surgical Stereo View Endoscopic System: The | endoscopic vision system used with the da Vinci Surgical<br>Systems, also known as Intuitive Surgical Insite® Vision System,<br>consists of a stereo endoscope, endoscopic camera, and various<br>accessories, including a light source and light guides. The Insite<br>Vision System provides two independent images that are relayed<br>to the surgeon located at the Surgeon Console, where they are<br>fused to form a 3-D (or alternatively a 2-D image) image of the<br>surgical field. |
| Intended Use | The Intuitive Surgical Endoscopic Instrument Control Systems (da<br>Vinci, da Vinci S, and da Vinci Si Surgical Systems Models<br>IS1200, IS2000, IS3000) are intended to assist in the accurate<br>control of Intuitive Surgical EndoWrist Instruments and<br>Accessories including rigid endoscopes, blunt and sharp<br>endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic<br>shears, forceps/pick-ups, needle holders, endoscopic retractors,<br>stabilizers, electrocautery and accessories for endoscopic<br>manipulation of tissue, including grasping, cutting, blunt and sharp<br>dissection, approximation, ligation, electrocautery, suturing,<br>delivery and placement of microwave ablation probes and<br>accessories, during urologic surgical procedures, general<br>laparoscopic surgical procedures, gynecologic laparoscopic<br>surgical procedures, transoral otolaryngology surgical procedures<br>restricted to benign and malignant tumors classified as T1 and T2,<br>general thoracoscopic surgical procedures, and thoracoscopically<br>assisted cardiotomy procedures. The system can also be<br>employed with adjunctive mediastinotomy to perform coronary<br>anastomosis during cardiac revascularization. The system is<br>indicated for adult and pediatric use (except for transoral<br>otolaryngology surgical procedures). It is intended for use by |
- P. 2/3
{2}------------------------------------------------
trained physicians in an operating room environment Intended Use accordance with the representative, specific procedures set forth (continued) in the Professional Instructions for Use.
Comparison to Predicate Device
There are no changes in the design, technology, materials, manufacturing, performance, specifications, and method of use for the Intuitive Surgical Endoscopic Instrument Control Systems. The expansion of the labeling to include transoral otolaryngology surgical procedures is based on the da Vinci, da Vinci S Surgical Systems (Models IS1200, IS2000, IS3000) and EndoWrist instruments and accessories being currently cleared for performing a full array of surgical tasks across multidisciplinary surgical specialties, and on a comparison of surgical tasks performed in cleared procedures to those performed in transoral otolaryngology surgical procedures.
The technological characteristics of the subject device are the Technological same as for the predicate device cleared to performed similar Characteristics surgical tasks in other specialties. A list of surgical tasks involved in completing the typical array of transoral otolaryngology surgical procedures confirms there are no new tasks above and beyond those for which the da Vinci Surgical System (IS1200, IS2000, IS3000) is currently used.
A multicenter retrospective clinical study has been conducted to Clinical Data confirm the feasibility, efficacy, safety and functional assessment undergoing transoral otolaryngology surgical patients in Historical controls demonstrate substantial procedures. equivalence of robotic assisted transoral procedures to alternative methods of treatment (Open surgery, transoral surgery and chemoradiation treatment).
- upon the information provided in this pre-market Conclusion Based notification, the Intuitive Surgical Endoscopic Instrument Control Systems' (Models IS1200, IS2000, IS3000) use in transoral otolaryngology surgical procedures is substantially equivalent to existing treatment methods of otolaryngology procedures (Open and transoral surgery). The use of the da Vinci Surgical Systems do not raise any new issues of safety or effectiveness.
P. 3/3
in
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle with its wings spread, possibly representing freedom or protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Intuitive Surgical, Inc. % Ms. Usha S. Kreaden Senior Director, Clinical Affairs 1266 Kifer Road Sunnyvale, California 94086
## DEC 1 6 2009
Re: K090993
Trade/Device Name: Intuitive Surgical® Endoscopic Instrument Control Systems Regulation Number: 21 CFR 876-1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: December 01, 2009 Received: December 02, 2009
Dear Ms. Kreaden:
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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (reporting of medical
{4}------------------------------------------------
Page 2 - Ms. Usha S. Kreaden
device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
For
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## Section III - Indications for Use
510(k) Number (if known): K090993
Intuitive Surgical® Endoscopic Instrument Control Systems Device Name:
Indications for Use:
The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, IS3000) are intended to assist in the accurate control of Intuitive Surgiçal Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic 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 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 T1 and T2. 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 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.
Prescription Use × (Part 21 CFR ,801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Kldal for xxx
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090993
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.
