Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector

K232004 · Medivators (A Subsidiary of Steris Corporation) · ODC · Mar 6, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232004
• Device Name: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
• Applicant: Medivators (A Subsidiary of Steris Corporation)
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Mar 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure. The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

Device Story

Family of sterile, single-use valves/connectors for Pentax endoscopes; includes Air/Water valve, Suction valve, Biopsy valve, and Irrigation connector. Air/Water valve controls insufflation and lens washing; Suction valve manages fluid aspiration; Biopsy valve allows instrument passage while maintaining insufflation/minimizing leakage; Connector facilitates irrigation via auxiliary water channel. Used in clinical GI endoscopy settings by physicians/technicians. Manual actuation by user. Output is mechanical control of endoscope functions; benefits include reduced cross-contamination risk via single-use design and maintained procedural integrity.

Clinical Evidence

Bench testing only. Performance testing included gas/water flow rates, backflow prevention, mechanical depression/application/removal forces, sonic weld integrity, leak testing, and procedure duration testing. Packaging validated per ISO 11607/ASTM 4169. Biocompatibility assessed per ISO 10993-1.

Technological Characteristics

Materials: Polycarbonate, stainless steel, thermoplastic elastomer, rubber, colorant. Manual actuation; no energy source. Dimensions: ~15-41mm length. Sterile, EtO-sterilized (SAL 10^-6), single-use. Packaging: PETG tray with Tyvek lid.

Indications for Use

Indicated for patients undergoing GI endoscopic procedures requiring air/water control, suction control, biopsy port access, or irrigation.

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

• Defendo Disposable Air/Water Valve Model 100304 (K102409)
• Defendo Disposable Suction Valve Model 100305 (K102581)
• Defendo Biopsy Valves (K090851)
• Endogator Endoscopy Irrigation Tubing (K220395)

Reference Devices

• Endogator Connector (K092429)

Submission Summary (Full Text)

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March 6, 2024

Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303

Re: K232004

Trade/Device Name: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 2, 2024 Received: February 2, 2024

Dear Nick Wang:

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"

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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.

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).

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Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number (if known) K232004

### Device Name

Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Valve, Endogator Pentax Single Use Connector

### Indications for Use (Describe)

The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

# Defendo Pentax Single Use Valves Set

| Manufacturer: | Medivators<br>3150 Pollok Drive<br>Conroe, TX 77303 |
|---------------|-----------------------------------------------------------------------------------|
| Submitter: | Nick Wang, Ph.D. RAC<br>Senior Manager, Regulatory Affairs<br>Phone: [phone] |

- 29 February 2024 Summary Date:

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#### 1. Device Name

| Trade Name: | Defendo Pentax Single Use Valves Set |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Defendo Pentax Single Use Biopsy Valve,<br>Defendo Pentax Single Use Air/Water Valve,<br>Defendo Pentax Single Use Suction Valve,<br>Endogator Pentax Single Use Connector |
| Classification Name: | Endoscope and Accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | ODC |

#### 2. Predicate Device(s)

Primary predicate is listed first:

K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing

#### 3. Description of Device

The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.

- . The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel and control the water used to wash the lens of the endoscope during an endoscopic procedure.
- The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
- . The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.

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- . The Connector allows attachment between the irrigation tubset via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.

#### 4. Intended Use

The Defendo Pentax Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The Defendo Pentax Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The single use Biopsy Valve provides access for endoscopic device passage and exchange, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).

#### 5. Technological Characteristic Comparison Table

Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table - Air / Water Valve

| Feature | Defendo Pentax<br>Single Use<br>Air/Water Valve<br>(Subject Device) | Defendo<br>Disposable<br>Air/Water Valve<br>(Predicate<br>K102409) | Comparison |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | The Defendo Pentax<br>Single Use Air/Water<br>Valve is intended to<br>be used to control<br>the air/water function<br>on an endoscope<br>during a Gl<br>endoscopic<br>procedure. | The Defendo<br>Disposable Air/Water<br>Valve is intended to<br>be used to control<br>the air/water function<br>on an endoscope<br>during a GI<br>endoscopic<br>procedure. | Same |

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| Feature | Defendo Pentax<br>Single Use<br>Air/Water Valve<br>(Subject Device) | Defendo<br>Disposable<br>Air/Water Valve<br>(Predicate<br>K102409) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------|
| Sterile/Non-<br>sterile | Sterile | Sterile | Same |
| Sterilization<br>Method | EtO | EtO | Same |
| Sterilization<br>Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device<br>Dimensions<br>(lengths/widths) | Air/Water Valve:<br>Length: ~41 mm<br>Diameter: ~17mm | Air/Water Valve:<br>Length: ~46 mm<br>Diameter: ~17 mm | Similar |
| Target Population | Patients undergoing<br>an endoscopic<br>procedure | Patients undergoing<br>an endoscopic<br>procedure | Same |
| Energy<br>Used/Delivered | None | None | Same |
| Method of<br>Application | Manual actuation | Manual actuation | Same |
| Compatible<br>Endoscopes | Pentax endoscope | Olympus endoscope | Reason for<br>this 510(k) |
| Packaging | Supplied as a kit in<br>PETG Tray with<br>Tyvek Lid | Supplied individually<br>in<br>Tyvek Pouch | Package<br>systems all<br>maintain<br>sterile barrier |

Table 2. Proposed/Predicate Device Technological Characteristics Comparison Table – Suction Valve

| Feature | Defendo Pentax<br>Single Use Suction<br>Valve<br>(Subject Device) | Defendo Disposable<br>Suction Valve<br>(Predicate K102581) | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Defendo Pentax<br>Single Use Suction<br>Valve is intended to<br>be used to control<br>the suction function<br>on an endoscope<br>during a Gl<br>endoscopic<br>procedure. | The Defendo<br>Disposable Suction<br>Valve is intended to<br>be used to control the<br>suction function on<br>an endoscope during<br>a GI endoscopic<br>procedure. | Same |
| Sterile/Non-sterile | Sterile | Sterile | Same |

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| Feature | Defendo Pentax<br>Single Use Suction<br>Valve<br>(Subject Device) | Defendo Disposable<br>Suction Valve<br>(Predicate K102581) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------|
| Sterilization<br>Method | EtO | EtO | Same |
| Sterilization<br>Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device<br>Dimensions<br>(lengths/widths) | Suction Valve:<br>Length: ~35 mm<br>Diameter: ~17 mm | Suction Valve:<br>Length: ~27 mm<br>Diameter: ~18 mm | Similar |
| Materials | Polycarbonate,<br>Stainless Steel,<br>Thermoplastic<br>Elastomer, Colorant,<br>and Rubber | Polycarbonate,<br>Stainless Steel, and<br>Thermoplastic<br>Elastomer | Similar |
| Target Population | Patients undergoing<br>an endoscopic<br>procedure | Patients undergoing<br>an endoscopic<br>procedure | Same |
| Energy<br>Used/Delivered | None | None | Same |
| Method of<br>Application | Manual actuation | Manual actuation | Same |
| Compatible<br>Endoscopes | Pentax endoscope | Olympus endoscope | Reason for<br>this 510(k) |
| Packaging | Supplied as a kit in<br>PETG Tray with<br>Tyvek Lid | Supplied individually<br>in<br>Tyvek Pouch | Package<br>systems all<br>maintain<br>sterile barrier |

Table 3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve

| Feature | Defendo Pentax<br>Single Use Biopsy<br>Valve<br>(Subject Device) | Defendo Biopsy<br>Valve for Pentax<br>Valves<br>(Predicate<br>K090851) | Comparison |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Defendo Pentax<br>Biopsy Valve is<br>intended for covering<br>the endoscope biopsy<br>port during an<br>endoscopy procedure.<br>The single use Biopsy<br>Valve provides access | The Defendo Biopsy<br>Valve is intended for<br>covering the<br>endoscope biopsy<br>port during an<br>endoscopy<br>procedure. The<br>valve provides | Same |

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| Feature | Defendo Pentax<br>Single Use Biopsy<br>Valve<br>(Subject Device) | Defendo Biopsy<br>Valve for Pentax<br>Valves<br>(Predicate<br>K090851) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | for endoscopic device<br>passage and<br>exchange, help<br>maintain sufflation,<br>and minimize leakage<br>of biomaterial from the<br>biopsy port throughout<br>the endoscopic<br>procedure. | access for<br>endoscopic device<br>passage and<br>exchange, help<br>maintain sufflation,<br>and minimize<br>leakage of<br>biomaterial from the<br>biopsy port<br>throughout the<br>endoscopic<br>procedure. | |
| Sterile/Non-<br>sterile | Sterile | Sterile | Same |
| Sterilization<br>Method | EtO | EtO | Same |
| Sterilization<br>Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device<br>Dimensions<br>(lengths/widths) | Length: ~18 mm<br>Diameter: ~16 mm | Length: ~17 mm<br>Diameter: ~17 mm | Similar |
| Target Population | Patients undergoing an<br>endoscopic procedure | Patients undergoing<br>an endoscopic<br>procedure | Same |
| Energy Used/<br>Delivered | None | None | Same |
| Compatible<br>Endoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kit in<br>PETG Tray with Tyvek<br>Lid | Supplied individually<br>in<br>Tyvek Pouch | Package<br>systems all<br>maintain<br>sterile barrier |

Table 4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector

| Feature | Endogator Pentax<br>Single Use<br>Connector<br>(Subject Device) | Endogator<br>Connector<br>(K092429) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Endogator<br>Pentax Connector is<br>intended to be used in | The Endogator<br>system is intended | Similar |
| Feature | Endogator Pentax<br>Single Use<br>Connector<br>(Subject Device) | Endogator<br>Connector<br>(K092429) | Comparison |
| | conjunction with<br>Endogator Irrigation<br>Tubing (not included)<br>to provide irrigation<br>via sterile water<br>during GI endoscopic<br>procedures when<br>used with an irrigation<br>pump (or cautery<br>unit). | to provide irrigation<br>via sterile water<br>supply during GI<br>endoscopic<br>procedure when<br>sued in conjunction<br>with an irrigation<br>pump (or cautery<br>unit). | (Language<br>modified for<br>the subject<br>device to<br>reflect the<br>connector<br>provided does<br>not include the<br>Endogator<br>tubing) |
| Sterile/Non-<br>sterile | Sterile | Sterile | Same |
| Sterilization<br>Method | EtO | EtO | Same |
| Sterilization<br>Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device<br>Dimensions<br>(lengths/widths) | Length: ~32 mm<br>Diameter: ~15 mm | Length: ~32 mm<br>Diameter: ~15 mm | Same |
| Target Population | Patients undergoing<br>an endoscopic<br>procedure | Patients undergoing<br>an endoscopic<br>procedure | Same |
| Energy<br>Used/Delivered | None | None | Same |
| Compatible<br>Endoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kit<br>inPETG Tray with<br>Tyvek Lid | Supplied individually<br>in Tyvek Pouch | Package<br>systems all<br>maintain<br>sterile barrier |

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#### Non-Clinical Performance Testing 4.

Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination. The following tests were performed:

Air / Water Valve

- Gas (Air and CO2) flow rate testing .

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- Water flow rate testing ●
- Backflow prevention testing ●
- Mechanical testing ●
- Depression Force O
- Valve Application Force O
- Valve Removal Force O
- o Sonic Weld Break Testing
- Valve Operation / Procedure Duration Test ●

Suction Valve

- Suction Bypass
- Suction Rate (water and soil) ●
- Mechanical testing ●
- Depression Force O
- o Valve Application Force
- o Valve Removal Force
- o Sonic Weld Break Testing
- Valve Operation / Procedure Duration Test ●

Biopsy Valve

- Leak Testing ●
- Insufflation Testing .

Auxiliary Waterjet Valve (Connector)

- Flow Durability Testing ●
- Check Valve Functionality Testing (Back Flow Prevention Test) .
- Mechanical Strength Testing ●

In addition to performance testing, ISO 11607/ASTM 4169 testing was completed to ensure the packaging of the subject device kit maintained sterile barrier after shipping/transit.

#### 5. Biocompatibility

The biocompatibility of the subject devices was assessed in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing conducted on the patient-contacting portions of the subject device in accordance with the ISO 10993 standard. The test result shows that the subject devices are biocompatible.

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#### Conclusion 6.

Based on the intended use, technological characteristics, non-clinical performance testing, and biocompatibility assessment, the subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.