The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

Device Description

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the lens of the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.

AI/ML Overview

The provided document describes the troCarWash™ System, a device intended to remove visual obstructions from the distal lens of a laparoscope during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it details various validation and testing activities with implied acceptance criteria being successful completion of these tests according to specified standards.

Acceptance Criteria Category	Reported Device Performance
Packaging Validation	The troCarWash™ system passed seal strength and package integrity testing for environmental conditioning, simulated T&D, and Accelerated Aging, complying with ASTM F88/F88M, ASTM F2096, ASTM F1980, ASTM D4332, ASTM D4169, ISO 11607-1, and ISO 16269-6.
Sterilization Validation	The troCarWash™ system, sterilized via irradiation, successfully validated its sterilization cycle using VDmax25. This included bioburden testing, bioburden recovery, verification dose testing, product sterility testing, and method suitability testing, complying with ANSI AAMI ISO 11137-1, ANSI AAMI ISO 11137-2, AAMI/ISO 11737-1, and AAMI/ISO 11737-2.
Biocompatibility Testing	For its limited (<24 hours) patient contact components (trocar, obturator, wash solution, and tubing set), the system passed evaluations for cytotoxicity, sensitization, acute systemic toxicity, and material-mediated Pyrogenicity, in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and FDA Guidance Document "Use of international Standard ISO 10993-1".
Electrical Safety & EMC	The troCarWash™ system (reusable controller and disposable set) complies with IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-18 for EST and IEC 60601-1-2 for EMC.
Software V&V Testing	Software verification and validation testing was conducted, and documentation shows the software, considered a "minor" level of concern, meets the requirements and would not result in injury or damage to health in case of a failure or latent flaw.
Bench Performance Testing (Wash Efficacy)	The study demonstrated that the troCarWash™ system was able to achieve acceptable cleans with various scope angles and brands.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Packaging Validation: The sample sizes are not explicitly stated for each test within the packaging validation.
Sterilization Validation: The sample sizes are not explicitly stated for each test within the sterilization validation.
Biocompatibility Testing: The sample sizes for these tests are not explicitly stated.
Electrical Safety & EMC: The sample sizes for these tests are not explicitly stated.
Software V&V Testing: Not applicable for a sample size in this context.
Bench Performance Testing:
- Test Set Size: 29 disposable sets (preconditioned with sterilization and accelerated aging) and 8 disposable sets (preconditioned with sterilization and simulated transportation and distribution) were tested.
- Data Provenance: The document does not specify the country of origin of the data. It is a benchtop model study, implying it was conducted in a controlled laboratory environment. The tests involved preconditioned (sterilized, aged, and simulating transport) devices, indicating a prospective testing approach on manufactured devices.

3. 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)

Not applicable. The ground truth for the performance of this device (e.g., wash efficacy, sterilization, biocompatibility) is established through objective physical, biological, and electrical measurements against established international and industry standards, not by expert interpretation in the sense of medical image analysis or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is relevant for studies involving human interpretation of data (e.g., medical images). The studies described here are primarily objective validation and bench performance tests against predefined standards.

5. 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

No MRMC comparative effectiveness study was done. The device is a physical cleaning system for laparoscope lenses, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation was indeed done for the device's functional aspects:

Bench Performance Testing: This test specifically evaluated the "system performance" and its "wash efficacy" using various scope angles and brands in a "benchtop model." This implies an algorithm-only or device-only performance evaluation without direct human intervention in the cleaning process itself beyond initiating the cycle. The device "utilizes a light sensor to detect the position of the scope as the user pulls the scope back within the trocar to deliver a cleaning cycle," and "incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism." This confirms the automated, standalone operation for its core function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the various tests outlined is based on:

Bench Performance Testing: The ground truth for "acceptable cleans" is implied to be visually clear lenses after the cleaning cycle, as determined by direct observation in the benchtop model. The document states "the troCarWash™ system was able to achieve acceptable cleans." While not explicitly defined as a quantified "ground truth" metric (like µg/cm² of residue), the pass/fail nature against visual clarity is the de facto ground truth.
Packaging, Sterilization, Biocompatibility, Electrical Safety & EMC, Software V&V: The ground truth for these validations is compliance with specific international and national standards (e.g., ASTM, ISO, ANSI AAMI, IEC, FDA guidance documents). Successful completion according to the parameters and thresholds defined in these standards constitutes the ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. Its function is mechanical cleaning and physical/chemical interaction, governed by established engineering principles and materials science. While "software" is mentioned as having undergone V&V, it is for controlling the physical cleaning mechanism.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 21, 2024

Biotex, Inc. Wade Munsch Regulatory Affairs Manager 114 Holmes Rd. Houston, Texas 77045

Re: K233442

Trade/Device Name: troCarWash™ System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX, OCT Dated: April 23, 2024 Received: April 23, 2024

Dear Wade Munsch:

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.

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).

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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 QS 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.

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).

Sincerely,

Long H. Chen -S Digitally signed by Long H. Chen-S

Digitally signed Date: 2024.05.21 08:22:21 -0400'

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

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Indications for Use

Submission Number (if known)

K233442

Device Name

troCarWash™ System

Indications for Use (Describe)

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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Contact Details

Applicant Name	Biotex, Inc.
Applicant Address	114 Holmes Rd. Houston TX 77045 United States
Applicant Contact Telephone	7137410111 x208
Applicant Contact	Mr. Wade Munsch
Applicant Contact Email	wade.munsch@biotexmedical.com

Device Name

Device Trade Name	troCarWash™ System
Common Name	Endoscope and accessories
Classification Name	Endoscopic Irrigation/Suction System
Regulation Number	876.1500
Product Code	OCX

Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K222695	troCarWash™ System	OCX
K102452(Reference)	Defogging and cleaning solution – Flo-X	OCT

Device Description Summary

Intended Use/Indications for Use

Indications for Use Comparison

Indications for use between the predicate device and the subject device are the same.

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Technological Comparison

The troCarWash™ System is substantially equivalent to the troCarWash™ System. Both the subject device and the predicate device have the same intended use and are used for the same indications. Specifically, both devices are intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintaining a clear image of the surgical site. In addition, both the subject device and the predicate device use medical grade CO2 and saline to clear the lens of debris, have one mode to clean, have a light sensor to detect the position of the scope as the user pulls the scope back within the trocar to deliver a cleaning cycle, and utilize a trocar-based wash apparatus designed to fit all 10mm scopes regardless of brand or angle. Both the subject device and predicate device require the user to apply a drop of wash solution to the end of the scope. The technical differences between the subject device and the predicate device consist of the following:

The subject device utilizes a diluted mix of the same FDA-cleared surfactant and saline . as the wash solution to prevent re-fogging.
The reference device supports the scientific justification of the patient contacting type, with indication for use as follows:

"The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site", which is substantially equivalent to the subject device wash solution and supports the second half of the indications for use "… to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site" since both devices have similar working mechanisms.

Non-Clinical and/or Clinical Tests Summary & Conclusions

The following performance data is provided in support of the substantial equivalence determination.

Packaging Validation

Packaging validation testing was completed per the listed standards:

ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal . Pressurization (Bubble Test)
. ASTM F1980: Standard Guide for Accelerate Aging of Sterile Barrier Systems for Medical Devices
ASTM D4332: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
. ISO 11607-1: Packaging of Terminally Sterilized Medical Devices – Part 1 Requirements for Materials, Sterile Barrier Systems and Packaging Systems
. ISO 16269-6: Statistical Interpretation of Data - Part 6 Determination of Statistical Tolerance Intervals

The troCarWash™ system passed the seal strength and package integrity testing for environmental conditioning and simulated T&D, and Accelerating Aging.

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Sterilization Validation

Sterilization validation testing was completed per the listed standards:

ANSI AAMI ISO 11137-1: Sterilization of health care products Radiation part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices
. ANSI AAMI ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the Sterilization Dose
. AAMI/ISO 11737-1: Sterilization of medical devices – Microbiological methods – Part 1: Determination of population of microorganisms on products
. AAMI/ISO 11737-2: Sterilization of a medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation, maintenance of a sterilization process

The troCarWash™ system is sterilized via irradiation. To validate the sterilization cvcle, VDmax25 was used, which includes bioburden testing, bioburden recovery, verification dose testing, product sterility testing, and method suitability testing.

Biocompatibility Testing

The troCarWash™ system is a limited (<24 hours) patient contacting device. The trocar, obturator, wash solution, and tubing set are the only components that contact the patient, while the reusable controller does not have any contact with the patient. The biocompatibility evaluation for the troCarWash™ system included cytotoxicity, sensitization, acute systemic toxicity, and material-mediated Pyrogenicity. All testing was conducted in accordance with the following standards and quidance documents:

. ISO 10993-1: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
. ISO 10993-5: Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro Cytotoxicity
. ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation
and Skin Sensitization
. ISO 10993-11: Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicitv
. ISO 10993-12: Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials
. FDA Guidance Document: "Use of international Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing with a risk management process"

Electrical Safety and Electromagnetic Compatibility (EMC and EST)

Electrical safety and EMC testing were conducted on the troCarWash™ system, consisting of the reusable controller and disposable set (trocar, obturator, and tubing set). The system complies with the IEC 60601-1, IEC 60601-1-6, and IEC 60601-2-18 for EST and IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device

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was considered as a "minor" level of concern, since a failure or latent flaw in the system would not result in injury or damage to health.

Bench Performance Testing

Performance testing was conducting in a benchtop model to evaluate system performance. 29 disposable sets (trocar, obturator, and tubing set) preconditioned with sterilization and accelerated aging and 8 disposable sets preconditioned with sterilization and simulated transportation and distribution were tested for wash efficacy. The study demonstrated that with various scope angles and brands, the troCarWash™ system was able to achieve acceptable cleans.

No clinical data was necessary to support a claim of substantial equivalence.

The troCarWash System performance testing demonstrated a sufficient wash efficacy across scope angles tested. The risk controls and bench performance testing ensure the troCarWash system raises no new issues of safety or effectiveness. The descriptive information contained within the predicate 510(k) is sufficiently precise to ensure the substantial equivalence of the troCarWash™ System, and to determine that there are no new issues of safety or effectiveness. There is no need for comparative performance data as the effect of the device in terms of cleaning and defogging the lens is demonstrated through the bench performance testing.

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.