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 Description

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.

AI/ML Overview

The provided FDA 510(k) summary for the TroCare TroKit Laparoscope Lens Wiper (K241796) focuses on demonstrating substantial equivalence to predicate devices through design characteristics, intended use, and non-clinical performance data. It does not contain information related to the acceptance criteria and study design elements specified in the request, such as a table of acceptance criteria with reported device performance, sample sizes for test sets, expert qualifications for ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or details about the training set.

Based on the document, here's what can be extracted and what information is missing:

Information available from the document:

Type of Ground Truth Used: Non-clinical testing demonstrates that the subject device "performs as well as the legally marketed predicate device." The performance data section specifies "mechanical characteristics" testing to show it is safe and performs as intended. Implied ground truth is the performance of the predicate device and established safety and performance benchmarks for such devices.
Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
How Ground Truth for Training Set was Established: Not applicable as this is a physical medical device, not an AI/ML algorithm.

Information NOT available from the document:

A table of acceptance criteria and the reported device performance: While the document states "The TroKit Laparoscope Lens Wiper was evaluated for mechanical characteristics to demonstrate that it is safe and performs as intended," it does not provide a table with specific acceptance criteria (e.g., in terms of cleaning effectiveness, durability, or ease of use) nor the reported quantitative device performance against those criteria.
Sample sized used for the test set and the data provenance: The document indicates that "non-clinical testing" was performed, but it does not specify the sample size of devices tested or any details about data provenance (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Since this is not an AI/ML device, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or diagnosis is not applicable here. The evaluation of mechanical characteristics would typically involve engineers or laboratory personnel following test protocols.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the non-clinical mechanical testing described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a physical laparoscopic lens wiper, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI/ML algorithm.

In summary, the provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence based on design, indications for use, and non-clinical mechanical and biocompatibility testing. The detailed information requested, particularly concerning performance metrics, test set specifics, and expert involvement for ground truth, is typically provided for AI/ML-driven devices or more complex diagnostic tools, which this device is not.

Summary

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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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(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)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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

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 LaparoscopeLens Wiper	MedeonClick Clean	Minimally InvasiveDevicesFlowShield	ClearCam LLCClearCam System
	Image: TroKit Laparoscope Lens Wiper	K192891Image: Medeon Click Clean	K150705Image: Minimally Invasive Devices FlowShield	K200228Image: ClearCam LLC ClearCam System
			FloShield Air
Device Description	Clear polymer sheath toprotect the laparoscopeand facilitate cleaning ofthe optical lens in vivothrough the use of anelastomer squeegee	Clear polymer sheath toprotect the laparoscopeand facilitate cleaning ofthe optical lens in vivothrough the use of anelastomer squeegee	Stainless steel laparoscopeprovided with a clearpolymer sheath to protectthe laparoscope andfacilitate cleaning of thelens in vivo	laparoscopic accessory lensclearing device consisting of asheath and handle that slidesover the laparoscope. Thehandle contains a wireconnected to a wiper at thedistal end of the sheath thatprovides lens clearing whenactivated.Elastomer squeegeeused to clean a laparoscopelens in vivo
Criteria	Subject Device	Predicate Device	Related Device
	TroKit LaparoscopeLens Wiper	MedeonClickCleanK192891	Minimally InvasiveDevicesFlowShield 10mmEndoscopic Cannula andConical Blunt ObturatorK150705	ClearCam LLCClearCam SystemK200228
	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 LaparoscopeLens Wiper is alaparoscopic accessorylens cleaning deviceintended to maintain theintra-operative view ofthe surgical site duringminimally invasivesurgery by physicallyshielding and wiping thelaparoscope lens fromdebris, grease, blood, andbodily fluids. The accessdevice is compatible withthe da Vinci Si SurgicalSystem.	Laparoscope Lens ShieldDevice (LENS), a sterile,single-use and disposablelaparoscopic accessorylens shield device, forvarious sizes oflaparoscopes includingstandard and bariatriclaparoscope, intended tomaintain the intra-operative view of thesurgical site duringminimally invasivesurgery by physicallyshielding the laparoscopelens from debris, grease,blood, and bodily fluids.	The reusable FloShield10mm EndoscopicCannula and ConicalBlunt Obturator is anaccess device indicatedfor use with a disposable8.5 – 13mm Cannula Sealmanufactured by AppliedMedical to provide apassageway for theintroduction ofendoscopic instruments ingeneral laparoscopicprocedures. The accessdevice is compatible withthe da Vinci si SurgicalSystem.	The ClearCam System isindicated to provide lensclearing during laparoscopicprocedures
Criteria	Subject Device	Predicate Device	Related Device
	TroKit LaparoscopeLens Wiper	MedeonClickClean	ClearCam LLCClearCam System
	Image: TroKit Laparoscope Lens Wiper	Image: Medeon ClickClean	Image: ClearCam LLC ClearCam System
		K192891	K200228

		Image: Minimally Invasive Devices FlowShield
		Minimally Invasive DevicesFlowShield 10mmEndoscopic Cannula andConical Blunt Obturator
		K150705
Design and Materials	Clear polymer that fitsaround the end of anendoscope	Clear polymer that fitsaround the end of anendoscope	Clear polymer that fitsaround the end of anendoscope	Clear polymer that fits aroundthe end of an endoscope
Anatomical Regions ofUse	Abdominal	Abdominal	Abdominal	Abdominal
Fits with LaparoscopeSize (O.D)	10mm	5mm - 7mm	8.5mm - 13mm	5mm
Single Use	Yes	Yes	Yes	Yes
Materials	Clear Polymer	Clear Polymer	Clear Polymer	Clear Polymer
SterilizationMethodology	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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.