The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.
Device Story
Sterile, single-use, disposable laparoscopic accessory; fits onto distal end of trocar. Device features clear polymer sheath and mechanical jaws housing thermoplastic elastomer squeegee. Upon insertion of laparoscopic camera through trocar into TroKit, mechanical jaws open; wiping occurs automatically as camera passes through jaws. Used in abdominal surgery; operated by surgical staff. Device shields lens from debris, grease, blood, and bodily fluids; maintains clear intra-operative view. Eliminates need for repeated egress/ingress of laparoscope for manual cleaning; improves surgical efficiency and visualization.
Clinical Evidence
No clinical studies were performed. Safety and effectiveness supported by non-clinical mechanical testing and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).
Technological Characteristics
Materials: biocompatible polymers, stainless steel, titanium alloy. Sensing/Actuation: mechanical jaw activation upon camera insertion. Form factor: clear polymer sheath for 10mm laparoscope. Connectivity: none. Sterilization: EO gas.
Indications for Use
Indicated for use as a laparoscopic accessory lens cleaning device to maintain intra-operative visualization during minimally invasive surgery by shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. Compatible with the da Vinci Si Surgical System.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2024
TroCare, LLC % Kenneth Kleinhenz Regulatory Affairs Consultant OSR Consulting 4141 Elm Rd. Hudson, Michigan 49247
Re: K241796
Trade/Device Name: TroCare TroKit Laparoscope Lens Wiper (CP000626) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 14, 2024 Received: June 21, 2024
Dear Kenneth Kleinhenz:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Long H. Chen -S-5
Digitally signed by Long H. Chen
Date: 2024.10.04 10:51:31 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K241796
Device Name TroCare, LLC TroKit Laparoscope Lens Wiper
Indications for Use (Describe)
The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.
| 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> </div> |
|-----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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### 510(k) SUMMARY TroCare TroKit Laparoscope Lens Wiper
## Date Prepared: 03 October 2024
#### I. SUBMITTER
Manufacturer Name:
TroCare, LLC 1000 Louisiana Street Fifty-Third Floor Houston, TX 77002
Mfg. Establishment Registration Number: First premarket notification. Company to register with FDA within 30 days of 510(k) clearance.
Official Contact:
Kenneth K. Kleinhenz Regulatory Affairs Telephone (619) 244-9573 Kleinhenz64@gmail.com
### II. DEVICE
| Name of Device: | TroCare TroKit Laparoscope Lens Wiper |
|------------------------|---------------------------------------------|
| Common or Usual | Laparoscope, General and Plastic Surgery |
| Name: Classification | Endoscope and Accessories (21 CFR 876.1500) |
| Name Regulatory Class: | II |
| Product Code: | GCJ |
| 510(K) Identification: | To be assigned |
### PREDICATE DEVICE III.
Medeon ClickClean, K192891
### DEVICE DESCRIPTION IV.
## Design Characteristics
The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that fits onto the distal end of a trocar and with its lens wiper serves to clean the camera lens from blood, tissue, fog, grease, and other surgical debris. The lens wiper itself is a mechanical device within the TroKit that employs a thermoplastic elastomer squeegee. The TroKit is translucent. When the laparoscopic camera is inserted through the trocar into the TroKit its insertion opens the mechanical jaws that house the lens wiper. The wiping is done automatically upon the passage of the laparoscopic camera through the TroKit jaws. The TroKit can be activated and used multiple times during surgery. One device is adequate for one surgery.
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#### 510(k) SUMMARY TroCare TroKit Laparoscope Lens Wiper
## Material Composition
The TroCare TroKit Laparoscope Lens Wiper device is fabricated with biocompatible polymers, stainless steel, and titanium alloy.
### V. INDICATIONS FOR USE
The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding and wiping the laparoscope lens from debris, grease, blood, and bodily fluids. The access device is compatible with the da Vinci Si Surgical System.
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The TroKit Laparoscope Lens Wiper shares indications for use and design principles with the following predicate devices: Medeon ClickClean (K192891), FlowShield (K150705) and the ClearCam System (K200228); all Class II medical device that was cleared for marketing in the United States under K192891, K150705, and K200228.
## Indications For Use
The TroKit Laparoscope Lens Wiper and the Medeon ClickClean (K192891), FlowShield (K150705) and the ClearCam System (K200228) predicate device are substantially equivalent with respect to their indications for use as they are all indicated for the same intended use of protecting laparoscope devices during intraabdominal procedures and/or wiping the lens intraoperatively to avoid repeated egress and ingress into the surgical space for purposes of wiping the lens.
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#### TroCare TroKit Laparoscope Lens Wiper 510(k) SUMMARY Page 3 of 6
## SUMMARY : TABLE OF SUBSTANTIAL EQUIVALENCE
The TroCare TroKit device is substantially equivalent to the Medeon ClickClean (K192891) predicate (K150705) and the ClearCam System (K200228) Related devices in the following respects:
| | Subject Device | Predicate Device | | Related Device |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Criteria | TroKit Laparoscope<br>Lens Wiper | Medeon<br>Click Clean | Minimally Invasive<br>Devices<br>FlowShield | ClearCam LLC<br>ClearCam System |
| | Image: TroKit Laparoscope Lens Wiper | K192891<br>Image: Medeon Click Clean | K150705<br>Image: Minimally Invasive Devices FlowShield | K200228<br>Image: ClearCam LLC ClearCam System |
| | | | FloShield Air | |
| Device Description | Clear polymer sheath to<br>protect the laparoscope<br>and facilitate cleaning of<br>the optical lens in vivo<br>through the use of an<br>elastomer squeegee | Clear polymer sheath to<br>protect the laparoscope<br>and facilitate cleaning of<br>the optical lens in vivo<br>through the use of an<br>elastomer squeegee | Stainless steel laparoscope<br>provided with a clear<br>polymer sheath to protect<br>the laparoscope and<br>facilitate cleaning of the<br>lens in vivo | laparoscopic accessory lens<br>clearing device consisting of a<br>sheath and handle that slides<br>over the laparoscope. The<br>handle contains a wire<br>connected to a wiper at the<br>distal end of the sheath that<br>provides lens clearing when<br>activated.Elastomer squeegee<br>used to clean a laparoscope<br>lens in vivo |
| Criteria | Subject Device | Predicate Device | Related Device | |
| | TroKit Laparoscope<br>Lens Wiper | Medeon<br>ClickClean<br>K192891 | Minimally Invasive<br>Devices<br>FlowShield 10mm<br>Endoscopic Cannula and<br>Conical Blunt Obturator<br>K150705 | ClearCam LLC<br>ClearCam System<br>K200228 |
| | Image: TroKit Laparoscope Lens Wiper | Image: Medeon ClickClean | Image: Minimally Invasive Devices FlowShield 10mm Endoscopic Cannula and Conical Blunt Obturator | Image: ClearCam LLC ClearCam System |
| Indications for Use | The TroKit Laparoscope<br>Lens Wiper is a<br>laparoscopic accessory<br>lens cleaning device<br>intended to maintain the<br>intra-operative view of<br>the surgical site during<br>minimally invasive<br>surgery by physically<br>shielding and wiping the<br>laparoscope lens from<br>debris, grease, blood, and<br>bodily fluids. The access<br>device is compatible with<br>the da Vinci Si Surgical<br>System. | Laparoscope Lens Shield<br>Device (LENS), a sterile,<br>single-use and disposable<br>laparoscopic accessory<br>lens shield device, for<br>various sizes of<br>laparoscopes including<br>standard and bariatric<br>laparoscope, intended to<br>maintain the intra-<br>operative view of the<br>surgical site during<br>minimally invasive<br>surgery by physically<br>shielding the laparoscope<br>lens from debris, grease,<br>blood, and bodily fluids. | The reusable FloShield<br>10mm Endoscopic<br>Cannula and Conical<br>Blunt Obturator is an<br>access device indicated<br>for use with a disposable<br>8.5 – 13mm Cannula Seal<br>manufactured by Applied<br>Medical to provide a<br>passageway for the<br>introduction of<br>endoscopic instruments in<br>general laparoscopic<br>procedures. The access<br>device is compatible with<br>the da Vinci si Surgical<br>System. | The ClearCam System is<br>indicated to provide lens<br>clearing during laparoscopic<br>procedures |
| Criteria | Subject Device | Predicate Device | Related Device | |
| | TroKit Laparoscope<br>Lens Wiper | Medeon<br>ClickClean | ClearCam LLC<br>ClearCam System | |
| | Image: TroKit Laparoscope Lens Wiper | Image: Medeon ClickClean | Image: ClearCam LLC ClearCam System | |
| | | K192891 | K200228 | |
| | | | | |
| | | Image: Minimally Invasive Devices FlowShield | | |
| | | Minimally Invasive Devices<br>FlowShield 10mm<br>Endoscopic Cannula and<br>Conical Blunt Obturator | | |
| | | K150705 | | |
| Design and Materials | Clear polymer that fits<br>around the end of an<br>endoscope | Clear polymer that fits<br>around the end of an<br>endoscope | Clear polymer that fits<br>around the end of an<br>endoscope | Clear polymer that fits around<br>the end of an endoscope |
| Anatomical Regions of<br>Use | Abdominal | Abdominal | Abdominal | Abdominal |
| Fits with Laparoscope<br>Size (O.D) | 10mm | 5mm - 7mm | 8.5mm - 13mm | 5mm |
| Single Use | Yes | Yes | Yes | Yes |
| Materials | Clear Polymer | Clear Polymer | Clear Polymer | Clear Polymer |
| Sterilization<br>Methodology | EO Gas | EO Gas | EO Gas | EO Gas |
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ | GCJ | GCJ | GCJ |
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## 510(k) SUMMARY
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## K241796
#### 510(k) SUMMARY TroCare TroKit Laparoscope Lens Wiper
## VII. PERFORMANCE DATA
## Biocompatibility Testing
The TroKit Laparoscope Lens Wiper was evaluated against the international standard ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Guidance Document entitled, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The battery of testing included.
Cytotoxicity Sensitization Irritation Acute System Toxicity Material Mediated Pyrogenicity
## Non-clinical Testing
The TroKit Laparoscope Lens Wiper was evaluated for mechanical characteristics to demonstrate that it is safe and performs as intended.
## Clinical Studies
No clinical studies were performed to support safety or effectiveness of the subject device.
## VII. CONCLUSIONS
The nonclinical testing demonstrates that the subject device is as safe and effective, and performs as well as the legally marketed predicate device.
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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.
