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 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 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 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 FDA 510(k) summary for the troCarWash™ System focuses on a device that removes visual obstructions from laparoscope lenses during surgery. The submission describes various non-clinical tests (packaging, sterilization, biocompatibility, electrical safety/EMC, software verification/validation, and bench performance testing) to demonstrate substantial equivalence to a predicate device.

However, the provided text does not contain the specific information required to answer many parts of your request, particularly regarding:

Acceptance criteria values for performance (e.g., target accuracy, sensitivity, specificity, or specific cleaning efficacy metrics). The text states "the troCarWash™ system was able to achieve acceptable cleans" but doesn't quantify what "acceptable" means.
Detailed study design for performance evaluation beyond "Bench Performance Testing." While it mentions "wash efficacy," it doesn't provide specific metrics.
Sample size and data provenance for a "test set" in the context of AI/ML or comparative studies with human readers.
Details on expert ground truth establishment, adjudication methods, or MRMC studies.
Information about a training set for an AI/ML model or how its ground truth was established. This device is a mechanical cleaning system, not an AI/ML diagnostic or therapeutic device, so these concepts (training set, experts for ground truth) likely don't apply in the way you're asking.
Standalone performance metrics (e.g., Sensitivity, Specificity, AUC) typical of AI/ML devices.

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

Device Description: The troCarWash™ system is a laparoscopic lens cleaning device consisting of a reusable control unit and a disposable, sterile, single-use trocar. It removes visual obstructions (condensation, blood, tissue particulates) from the distal lens of a laparoscope to maintain a clear image during surgery. It uses medical-grade CO2 and saline for cleaning.

Nature of Device: This is primarily a mechanical/electromechanical device, not an AI/ML-driven diagnostic or therapeutic device. Therefore, many of your questions related to AI/ML specific performance metrics (e.g., human reader improvement with AI assistance, training data, ground truth establishment by experts for AI models) do not directly apply to the described device and the information provided. The "Software Verification and Validation Testing" section explicitly states the software was considered "minor" level of concern, implying it's not performing complex diagnostic or decision-making functions typically associated with AI.

Table of Acceptance Criteria and Reported Device Performance

As the document does not specify quantitative acceptance criteria or performance metrics for wash efficacy (e.g., percentage of debris removed, clarity score), a table as requested cannot be fully populated. The closest statement is:

Acceptance Criteria Category	Acceptance Criteria (Quantified)	Reported Device Performance
Wash Efficacy	(Not specified in document)	"achieve acceptable cleans"
Packaging Validation	Passed standards (ASTM, ISO)	Passed all listed tests
Sterilization Validation	Passed standards (ANSI AAMI ISO)	Passed all listed tests
Biocompatibility	Passed standards (ISO)	Passed all listed tests
Electrical Safety & EMC	Complies with IEC 60601-1, -2	Complies with all listed standards

Study Information (Based on available text):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Wash Efficacy: Not explicitly quantified in the provided text. It states "acceptable cleans."
- Reported Device Performance for Wash Efficacy: "The study demonstrated that with various scope angles and brands, the troCarWash™ system was able to achieve acceptable cleans." (No quantitative metrics provided).
Sample sized used for the test set and the data provenance:
- Sample Size: "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." This totals 37 disposable sets.
- Data Provenance: The document does not specify the country of origin. The study was a "benchtop model" performance test, implying controlled laboratory conditions rather than retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is evaluated for its mechanical cleaning performance, not for diagnostic accuracy requiring expert interpretation or ground truth labeling in the context of an AI/ML model. The "acceptable cleans" would likely have been determined against pre-defined visual or technical criteria, not expert consensus on medical images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements and establish ground truth for image-based diagnostic systems. It is not relevant for a mechanical cleaning efficacy test.
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, an MRMC study was not done. The document explicitly states: "No clinical data was necessary to support a claim of substantial equivalence." This type of study is typically performed for AI/ML diagnostic aids to show improvement in human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Bench Performance Testing" section describes testing the system's ability to clean without direct human intervention in the cleaning process itself (though human operation initiates the cycle). However, this is not "standalone algorithm performance" in the context of AI/ML, but rather the performance of the device's mechanical function. No specific quantitative diagnostic metrics (like sensitivity, specificity, AUC) are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For wash efficacy: The ground truth would likely be defined by pre-established physical/visual criteria for lens cleanliness after contamination, rather than expert consensus on medical images or pathology. The document doesn't detail these criteria, only that "acceptable cleans" were achieved.
- For other tests (packaging, sterilization, biocompatibility, electrical safety): Ground truth is established by compliance with recognized industry standards and test methods.
The sample size for the training set:
- Not applicable / Not specified. This device is not an AI/ML model that requires a "training set" in the computational sense. Its design and operation are based on engineering principles, and its software is "minor" in terms of risk, suggesting it's primarily for control, not learning.
How the ground truth for the training set was established:
- Not applicable. As no AI/ML training set is mentioned or implied, this question does not apply.

Summary of Gaps: The provided text is a 510(k) summary for a mechanical device, emphasizing its substantial equivalence through non-clinical performance and safety testing. It lacks the quantitative performance metrics, study design details, and specific AI/ML related information (training sets, expert ground truth, adjudication, MRMC studies) that your questions are designed to uncover for AI/ML medical devices.

Summary

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February 17, 2023

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

Re: K222695

Trade/Device Name: troCarWash™ System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCX, FEQ Dated: September 2, 2022 Received: January 18, 2023

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,

Digitally signed by Mark ________ Mark Trumbore -S Trumbore -S Date: 2023.02.17 09:01:18 -05'00' On behalf of Long Chen. Ph.D. Assisstant 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

Submission Number (if known)

K222695

Device Name

troCarWash TM 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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510(k) #:	K222695	510(k) Summary	Prepared on: 2023-01-17
-----------	---------	----------------	-------------------------

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

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	21 CFR 807.92(a)(2)
-------------	---------------------

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	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K171637	OpClear System	OCX
K190029	Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable	GCJ

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

Intended Use/Indications for Use

Indications for Use Comparison

21 CFR 807.92(a)(5)

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

Technological Comparison

21 CFR 807.92(a)(6)

The troCarWash™ System is substantially equivalent to the OpClear System. Both the subject 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 laparocope during surgery and therefore maintaining a clear image of the surgical site. In addition, both the subject device use medical grade CO2 and saline to clear the lens of debris. The technical differences between the subject device and the predicate device consist of the following:

• The subject device only has one mode to clean. It does not incorporate a foot pedal but instead uses 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.

· The subject device utilizes a trocar-based wash apparatus in lieu of a sheath which is designed to fit all 10mm scopes regardless of brand or angle.

· Having the wash apparatus built into the need to potentially upsize the trocar due to an increased diameter of the laparoscope when used with a sheath and potentially obstruct visualization from the sheath.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

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 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.

Sterilization Validation

Sterilization validation testing was completed per the listed standards:

· ANSI AAMI ISO 11137-1:2006/(R)2010: Sterilization of health care products – Radiation – part 1: Requirement, validation and routine control of a sterilization process for medical devices

· ANSI AAMI ISO 11137-2:2013: Sterilization of health care products – Radiation – Part 2: Establishing the Sterilization Dose

· AAMI/ISO 11737-1:2018: Sterilization of medical devices – Microbiological methods – Part 1: Determination of population of microorganisms on products

· AAM/ISO 11737-2:2019: 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 cycle, 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, 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 cytoxicity, sensitization, acute systemic toxicity, and material-mediated Pyrogenicity. All testing was conducted in accordance with the following standards and guidance 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 Toxicity

· ISO 10993-12 Biological Evaluation of Medical Devices – Part 12: Sample Preparation and Reference Materials

·FDA Guidance Document "Use of international SO 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 set (trocar, obturator, and tubing set). The system complies with the IEC 60601-1-6, and IEC 60601-2-18 for EST and IEC 60601-1-2 for EMC.

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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 on Medical Devices." The software for this device 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.