troCarWash™ System

K233442 · Biotex, Inc. · OCX · May 21, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K233442
• Device Name: troCarWash™ System
• Applicant: Biotex, Inc.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: May 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

System comprises mains-powered reusable control unit and disposable sterile trocar/obturator/tubing set. Used in hospital settings by medical professionals during laparoscopic procedures. Device detects laparoscope position via light sensor when surgeon retracts scope into trocar. Upon detection, system initiates automated <250ms wash/dry cycle using CO2 and saline/surfactant mix to clear distal lens. Output is a clean lens, restoring surgical vision. Benefits include reduced need to remove scope for manual cleaning, maintaining continuous surgical site visualization.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated using 37 disposable sets (preconditioned with sterilization, accelerated aging, and simulated transport/distribution) to verify wash efficacy across multiple scope brands and angles.

Technological Characteristics

Materials: ABS, polycarbonate, PVC. Sensing: Light sensor for scope position detection. Energy: Mains-powered. Cleaning: CO2 and saline/surfactant mix. Form factor: Reusable control unit with disposable trocar/obturator/tubing. Sterilization: Irradiation (VDmax25). Software: Minor level of concern. Standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-1-2, ISO 10993, ISO 11137, ISO 11607.

Indications for Use

Indicated for patients undergoing laparoscopic surgery to maintain clear visualization by removing lens contaminants including condensation, blood, peritoneal fluid, smoke, fat, and tissue smears.

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.

Predicate Devices

• troCarWash™ System (K222695)

Reference Devices

• Defogging and cleaning solution – Flo-X (K102452)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 | [e-mail] |

#### 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

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.

#### Intended Use/Indications for Use

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.

#### 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.