The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to mount onto a trocar and 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.
Device Story
Sterile, single-use, disposable laparoscopic accessory; mounts to distal end of trocar. Input: laparoscopic camera inserted through trocar. Operation: mechanical jaws house thermoplastic elastomer squeegee; insertion of camera triggers jaws to automatically wipe lens; removes blood, tissue, fog, grease, debris. Used in OR during minimally invasive abdominal surgery; operated by surgical staff. Output: clear optical view for surgeon. Benefit: maintains visualization without requiring repeated removal/reinsertion of laparoscope from surgical site.
Clinical Evidence
No clinical studies performed. Evidence based on bench testing (mechanical force assessment in wet/dry conditions) and porcine animal model simulation to verify device robustness, retention, and cleaning efficacy. Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity).
Technological Characteristics
Materials: biocompatible polymers, stainless steel, titanium alloy. Principle: mechanical squeegee (thermoplastic elastomer). Form factor: sheath-like device for trocar mounting. Sterilization: EO gas. Connectivity: none (mechanical).
Indications for Use
Indicated for patients undergoing minimally invasive surgery requiring laparoscopic visualization; device mounts to a trocar to clean the laparoscope lens intraoperatively.
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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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 4, 2026
TroCare, LLC
% Kenneth Kleinhenz
Regulatory Affairs Consultant
QSR Consulting
4141 Elm Rd.
Hudson, Michigan 49247
Re: K253994
Trade/Device Name: TroKit Laparoscope Lens Wiper
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: December 12, 2025
Received: December 12, 2025
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 (the 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/cdrh/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.
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K253994 - Kenneth Kleinhenz
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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" (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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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 bear a unique 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K253994 - Kenneth Kleinhenz
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assistance/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).
Sincerely,
JAMES H. JANG-S
Digitally signed by
JAMES H. JANG-S
Date: 2026.06.04
16:46:52 -04'00'
For
Colin Kejing Chen
Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
# Indications for Use
510(k) Number (if known)
K253994
Device Name
TroKit Laparoscope Lens Wiper
Indications for Use (Describe)
The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to mount onto a trocar and 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.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Page 1 of 1
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510(k) SUMMARY (K253994)
TroCare TroKit Laparoscope Lens Wiper
Page 1 of 4
Date Prepared: 03 June 2026
### I. SUBMITTER
Manufacturer Name: TroCare, LLC
1000 Louisiana Street
Fifty-Third Floor
Houston, TX 77002
Mfg. Establishment Registration Number: No existing devices placed on the market commercially. Company to register with FDA within 30 days of first commercialization.
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
### III. PREDICATE DEVICE
TroCare TroKit Laparoscope Lens Wiper, K241796
### IV. DEVICE DESCRIPTION
#### Design Characteristics
The TroKit Laparoscope Lens Wiper is a sterile, single-use and disposable laparoscopic accessory device that is provided in various sizes and is designed to fit 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 (K253994)
TroCare TroKit Laparoscope Lens Wiper
Page 2 of 4
# **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 mount onto a trocar and 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.
# **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 device: TroCare TroKit Laparoscope Lens Wiper; a Class II medical device that was cleared for marketing in the United States under K241796.
# **Indications For Use**
The TroKit Laparoscope Lens Wiper and the TroCare TroKit Laparoscope Lens Wiper (K241796) predicate device are substantially equivalent with respect to their indications for use as they are both indicated for the same intended use of protecting laparoscope devices during intra-abdominal procedures and/or wiping the laparoscope lens intraoperatively to avoid repeated egress and ingress into the surgical space for solely for purposes of wiping the lens.
# **Design and Materials**
The design principles of the TroCare TroKit and the TroCare TroKit Laparoscope Lens Wiper (K241796) predicate device are substantially equivalent as they are identical in every way and only differ by their indications for use. The TroCare TroKit Laparoscope Lens Wiper and the TroCare TroKit Laparoscope Lens Wiper (K241796) predicate device are fabricated from the identical materials, consist of the identical constructs, packaged in the identical packaging materials, sterilized with the identical sterilization method and sterilization dose, contain and consist of the identical mechanical features and mechanical specifications, and are provided in the identical shapes and sizes.
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510(k) SUMMARY (K253994)
TroCare TroKit Laparoscope Lens Wiper
Page 3 of 4
# SUMMARY : TABLE OF SUBSTANTIAL EQUIVALENCE
The TroCare TroKit device is substantially equivalent to the TroCare TroKit Laparoscope Lens Wiper (K241796) in the following respects:
| Criteria | Subject Device | | Predicate Device | |
| --- | --- | --- | --- | --- |
| | TroKit Laparoscope Lens Wiper | | TroKit Laparoscope Lens Wiper | |
| | | | **K241796** | |
| | | | | |
| **Device Description** | Clear polymer sheath to protect the laparoscope and facilitate cleaning of the optical lens in vivo through the use of an elastomer squeegee | | Clear polymer sheath to protect the laparoscope and facilitate cleaning of the optical lens in vivo through the use of an elastomer squeegee | |
| **Indications for Use** | The TroKit Laparoscope Lens Wiper is a laparoscopic accessory lens cleaning device intended to mount onto a trocar and 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 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 Xi Surgical System. | |
| **Design and Materials** | Clear polymer that fits around the end of an endoscope with elastomer squeegee that wipes laparoscope lens. | | Clear polymer that fits around the end of an endoscope with elastomer squeegee that wipes laparoscope lens. | |
| **Inner Diameter (ID)** | 5mm Device | 10mm Device | 10mm | |
| **Length** | 85.70mm | 77.09 | 77.09mm | |
| **Height** | 11.80mm | 14.50 | 14.50mm | |
| **Anatomical Regions of Use** | Abdominal | | Abdominal | |
| **Single Use** | Yes | | Yes | |
| **Materials** | Clear Polymer | | Clear Polymer | |
| **Sterilization Methodology** | EO Gas | | EO Gas | |
| **Regulation** | 21 CFR 876.1500 | | 21 CFR 876.1500 | |
| **Product Code** | GCJ | | GCJ | |
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510(k) SUMMARY (K253994)
TroCare TroKit Laparoscope Lens Wiper
Page 4 of 4
## 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. Mechanical testing of the TroKit devices included push-on and pull-off forces to install and remove the TroKit device from appropriately sized trocars fabricated from various materials to demonstrate substantial equivalence. Push-on and pull-off forces were measured in both a wet and dry environment. Furthermore, the absence of damage and / or deformity of both the trocar and the TroKit device were assessed after maximum push-on and pull-off manipulations were performed. All bench top mechanical testing was repeated on each shape and size of TroKit devices. A porcine animal model was used to simulate in vivo use of the TroKit device as a means to demonstrate that the device is safe (does not dislodge during in vivo manipulations), is robust when used under simulated-use conditions (device does not break and remains fully functional during in vivo manipulations) and performs as intended (device efficiently clears/cleans the optical camera).
### Clinical Studies
No clinical studies were performed to support safety or effectiveness of the subject device.
## VIII. CONCLUSIONS
The nonclinical testing demonstrates that the subject device is as safe and effective, and performs as well as the legally marketed predicate device.
