(105 days)
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML or data processing.
No.
The device is described as a laparoscopic accessory lens cleaning device intended to maintain the intra-operative view of the surgical site by wiping the laparoscope lens. It does not exert a therapeutic effect on the patient.
No.
Explanation: The device is described as a "laparoscopic accessory lens cleaning device" which physically shields and wipes the laparoscope lens. Its purpose is to maintain the intra-operative view, not to diagnose a medical condition.
No
The device description clearly states it is a sterile, single-use, disposable laparoscopic accessory device with a mechanical lens wiper made of thermoplastic elastomer. This indicates it is a physical hardware device, not software.
Based on the provided information, the TroKit Laparoscope Lens Wiper is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TroKit Function: The TroKit Laparoscope Lens Wiper is a mechanical device designed to clean the lens of a laparoscope during surgery. It physically interacts with the surgical environment and the laparoscope itself, not with patient samples for diagnostic purposes.
- Intended Use: The intended use clearly states its purpose is to "maintain the intra-operative view of the surgical site" by cleaning the lens. This is a surgical accessory function, not a diagnostic one.
- Device Description: The description details a mechanical wiping mechanism and its interaction with the laparoscope, further reinforcing its role as a surgical tool.
- Lack of Diagnostic Information: The document does not mention any analysis of biological samples, diagnostic results, or any function related to identifying diseases or conditions.
Therefore, the TroKit Laparoscope Lens Wiper falls under the category of a surgical accessory or instrument, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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"
1
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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).
2
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
3
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) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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.
5
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 | |||
| Lens Wiper | Medeon | |||
| Click Clean | Minimally Invasive | |||
| Devices | ||||
| FlowShield | ClearCam LLC | |||
| ClearCam System | ||||
| Image: TroKit Laparoscope Lens Wiper | K192891 | |||
| Image: Medeon Click Clean | K150705 | |||
| Image: Minimally Invasive Devices FlowShield | K200228 | |||
| Image: ClearCam LLC ClearCam System | ||||
| FloShield Air | ||||
| 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 | Stainless steel laparoscope | |||
| provided with a clear | ||||
| polymer sheath to protect | ||||
| the laparoscope and | ||||
| facilitate cleaning of the | ||||
| lens in vivo | laparoscopic accessory lens | |||
| clearing device consisting of a | ||||
| sheath and handle that slides | ||||
| over the laparoscope. The | ||||
| handle contains a wire | ||||
| connected to a wiper at the | ||||
| distal end of the sheath that | ||||
| provides lens clearing when | ||||
| activated.Elastomer squeegee | ||||
| used to clean a laparoscope | ||||
| lens in vivo | ||||
| Criteria | Subject Device | Predicate Device | Related Device | |
| TroKit Laparoscope | ||||
| Lens Wiper | Medeon | |||
| ClickClean | ||||
| K192891 | Minimally Invasive | |||
| Devices | ||||
| FlowShield 10mm | ||||
| Endoscopic Cannula and | ||||
| Conical Blunt Obturator | ||||
| K150705 | ClearCam LLC | |||
| ClearCam System | ||||
| 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 | |||
| 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. | Laparoscope Lens Shield | |||
| Device (LENS), a sterile, | ||||
| single-use and disposable | ||||
| laparoscopic accessory | ||||
| lens shield device, for | ||||
| various sizes of | ||||
| laparoscopes including | ||||
| standard and bariatric | ||||
| laparoscope, intended to | ||||
| maintain the intra- | ||||
| operative view of the | ||||
| surgical site during | ||||
| minimally invasive | ||||
| surgery by physically | ||||
| shielding the laparoscope | ||||
| lens from debris, grease, | ||||
| blood, and bodily fluids. | The reusable FloShield | |||
| 10mm Endoscopic | ||||
| Cannula and Conical | ||||
| Blunt Obturator is an | ||||
| access device indicated | ||||
| for use with a disposable | ||||
| 8.5 – 13mm Cannula Seal | ||||
| manufactured by Applied | ||||
| Medical to provide a | ||||
| passageway for the | ||||
| introduction of | ||||
| endoscopic instruments in | ||||
| general laparoscopic | ||||
| procedures. The access | ||||
| device is compatible with | ||||
| the da Vinci si Surgical | ||||
| System. | The ClearCam System is | |||
| indicated to provide lens | ||||
| clearing during laparoscopic | ||||
| procedures | ||||
| Criteria | Subject Device | Predicate Device | Related Device | |
| TroKit Laparoscope | ||||
| Lens Wiper | Medeon | |||
| ClickClean | ClearCam LLC | |||
| 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 | ||||
| FlowShield 10mm | ||||
| Endoscopic Cannula and | ||||
| Conical Blunt Obturator | ||||
| K150705 | ||||
| Design and Materials | Clear polymer that fits | |||
| around the end of an | ||||
| endoscope | Clear polymer that fits | |||
| around the end of an | ||||
| endoscope | Clear polymer that fits | |||
| around the end of an | ||||
| endoscope | Clear polymer that fits around | |||
| the end of an endoscope | ||||
| Anatomical Regions of | ||||
| Use | Abdominal | Abdominal | Abdominal | Abdominal |
| Fits with Laparoscope | ||||
| 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 | ||||
| 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
8
9
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.