UroLift System Procedure Kit Sterilization Tray

K192781 · Neotract, Inc. · KCT · Apr 14, 2020 · General Hospital

Device Facts

• Record ID: K192781
• Device Name: UroLift System Procedure Kit Sterilization Tray
• Applicant: Neotract, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Apr 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The UroLift System Procedure Kit Sterilization Tray is intended to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray: - UL-SCOPE / UL-SCOPE-FE Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view - · UL-SHEATH / UL-SHEATH-FE Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock) - · UL-VO / UL-VO-FE Visual obturator, 20 Fr. The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed. validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following pre-vacuum steam sterilization cycles: 132 °C Pre-vacuum Steam Cycle Exposure temperature: 270 °F (132 °C) Exposure time: 4 minutes Vacuum dry time: 30 minutes 134 ℃ Pre-vacuum Steam Cycle Exposure temperature: 273 °F (134 °C) Exposure time: 3 minutes Vacuum dry time: 20 minutes The maximum weight of the tray is 1.8kg / 4lbs.

Device Story

Rigid containment device (base and lid) for UroLift System surgical instruments; enables reprocessing via pre-vacuum steam sterilization. Instruments (cystoscope, sheath, visual obturator) secured by silicone retainers. Used in hospital environments; operated by sterile processing staff. Tray requires external FDA-cleared sterilization wrap to maintain sterility post-cycle. Benefits include organized, protected storage and validated sterilization of reusable instruments, ensuring patient safety during subsequent procedures.

Clinical Evidence

Bench testing only. No clinical data. Validation included usability testing, biocompatibility (ISO 10993-1, -5, -10), cleaning validation (AAMI TIR30), and sterilization validation (ANSI/AAMI ST77). Tray passed 100-cycle useful life testing. Cleaning validation met protein (<6.4µg/cm²) and hemoglobin (<2.2µg/cm²) residual benchmarks. Sterilization validation confirmed SAL of 10⁻⁶.

Technological Characteristics

Rigid containment tray; materials: stainless steel, silicone, Radel. Dimensions: 4.5" x 20" x 2.125". Perforated design for steam penetration. Reusable; validated for 100 pre-vacuum steam sterilization cycles (132°C/4min or 134°C/3min). Compliant with ANSI/AAMI ST77:2013.

Indications for Use

Indicated for storage and sterilization of specific UroLift System surgical instruments (cystoscope, sheath, visual obturator) in a pre-vacuum steam sterilizer. Used in clinical settings by healthcare personnel. No specific patient population contraindications.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Signia™ Sterilization Tray (K161347)

Submission Summary (Full Text)

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April 14, 2020

NeoTract, Inc. Brian Gall Regulatory Affairs Manager 4155 Hopyard Rd. Pleasanton, California 94588

Re: K192781

Trade/Device Name: UroLift® System Procedure Kit Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 11, 2020 Received: March 13, 2020

Dear Brian Gall:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Christopher K. Dugard, M.S. Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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

510(k) Number (if known) K192781

Device Name

UroLift® System Procedure Kit Sterilization Tray

Indications for Use (Describe)

The UroLift System Procedure Kit Sterilization Tray is intended to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer.

The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray:

- UL-SCOPE / UL-SCOPE-FE Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view
- · UL-SHEATH / UL-SHEATH-FE Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock)
- · UL-VO / UL-VO-FE Visual obturator, 20 Fr.

The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed. validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following pre-vacuum steam sterilization cycles:

132 °C Pre-vacuum Steam Cycle Exposure temperature: 270 °F (132 °C) Exposure time: 4 minutes Vacuum dry time: 30 minutes

134 ℃ Pre-vacuum Steam Cycle Exposure temperature: 273 °F (134 °C) Exposure time: 3 minutes Vacuum dry time: 20 minutes

The maximum weight of the tray is 1.8kg / 4lbs.

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

| | Research Use (Part 1, SER 901, Select Primary) |
|--|------------------------------------------------|
| | Service Tier Support (2+, SER 911, Select 2+) |

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) SUMMARY

### COMPANY INFORMATION

NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 Registration Number: 3015181082

### SUBMISSION CORRESPONDENT

Brian Gall Regulatory Affairs Manager, Interventional Urology NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588

Telephone - 925,329,6547 E-mail - [e-mail]

## DATE PREPARED

13 April 2020

#### DEVICE INFORMATION

| Trade Name: | UroLift® System Procedure Kit Sterilization Tray (UL-PKTRAY) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories |
| Classification Name: | Sterilization Wrap |
| Product Code: | KCT |
| Regulation Number: | 880.6850 |
| Classification: | II |
| Classification Panel: | Surgical and Infection Control Devices (OHT4)<br>Infection Control and Plastic and Reconstructive Surgery (DHT4B) |

### DEVICE DESCRIPTION

The UroLift System Procedure Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of the surgical instruments used in the UroLift System Procedure.

#### INTENDED USE

The UroLift System Procedure Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer.

The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray:

- UL-SCOPE / UL-SCOPE-FE Cystoscope, 2.9 mm diameter x 365 mm length, ● 0° angle of view, 85° field of view
- UL-SHEATH / UL-SHEATH-FE Sheath, 20 Fr., with 2 tube connectors (Luer . lock and Luer lock with stopcock)

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- . UL-VO / UL-VO-FE – Visual obturator, 20 Fr.
The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following prevacuum steam sterilization cycles:

| Pre-Vacuum Steam | | |
|--------------------|------------------|---------------|
| Temperature | 132°C (270°F) | 134°C (273°F) |
| Sterilization Time | 4 minutes | 3 minutes |
| Minimum Dry Time | 30 minutes | 20 minutes |
| Maximum Weight | 1.8 kg / 4.0 lbs | |

## CONTRAINDICATIONS

There are no known contraindications.

## PREDICATE DEVICE

The predicate device is the Signia™ Sterilization Tray from Medtronic® (formerly Covidien®) (K161347). Trade Name: Signia Sterilization Tray Common Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Product Code: КСТ Regulation Number: 880.6850 Classification: = Classification Panel: Surgical and Infection Control Devices (OHT4) Infection Control and Plastic and Reconstructive Surgery (DHT4B)

#### Technological Comparison Table:

| Characteristic | Predicate<br>Device<br>Signia™<br>Sterilization<br>Tray K161347 | Subject Device<br>UroLift System Procedure Kit Sterilization Tray<br>[K192781] | Comparison |
|----------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------|------------|
| Device Name | Signia™ Sterilization Tray | UroLift System Procedure Kit Sterilization Tray | N/A |
| 510(k) Number | K161347 | TBD | N/A |
| Product Code | KCT | KCT | Same |
| Product Class | Class II | Class II | Same |
| Regulation<br>Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |

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| Indications<br>for Use | The Signia™ sterilization tray is<br>intended to provide storage for<br>the Signia™ adapters, Signia™<br>reusable insertion guide and<br>Signia™ manual retraction tool<br>during sterilization, storage and<br>transportation within the<br>hospital environment. The<br>Signia™ sterilization tray is only<br>intended to maintain sterility of<br>the enclosed devices if it is<br>used in conjunction with an<br>FDA cleared sterilization wrap<br>and has only been evaluated<br>for a non- stacked<br>configuration. The tray can<br>contain at a maximum: | The UroLift System Procedure Kit Sterilization<br>Tray is intended to be used to enclose and<br>protect surgical instruments used for the UroLift<br>System Procedure for storage and sterilization<br>in a pre-vacuum steam sterilizer.<br>The following instruments are intended to be<br>loaded into the UroLift System Procedure Kit<br>Sterilization Tray:<br>• UL-SCOPE / UL-SCOPE-FE – Cystoscope,<br>2.9 mm diameter x 365 mm length, 0° angle of<br>view, 85° field of view<br>• UL-SHEATH / UL-SHEATH-FE - Sheath,<br>20 Fr., with 2 tube connectors | Similar |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|

| one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide<br>and one (1) Signia™ manual retraction tool. The tray is intended to allow steam<br>sterilization of the enclosed medical devices. The validated<br>sterilization cycle parameters are as follows: | | | (Luer lock and Luer lock with stopcock)<br>• UL-VO / UL-VO-FE - Visual<br>obturator, 20 Fr.<br>The tray by itself is not intended to maintain<br>sterility; it is intended to be used in conjunction<br>with a legally marketed, validated, 510(k) cleared<br>sterilization wrap to maintain sterility of the<br>enclosed instruments when sterilized using the<br>following pre-vacuum steam<br>sterilization cycles: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STEAM STERILIZATION<br>Pre-vacuum (HiVac) Steam Cycles | | Pre-Vacuum Steam | |
| Item: Tray with components<br>wrapped or in sterilization<br>container system | 132 °C Pre-vacuum (HiVac)<br>Steam Cycles | Value<br>for the<br>United<br>States | Value for Other<br>Countries |
| Exposure temperature | 270 °F (132 °C) | 132°C<br>(270°F) | 134°C (273°F) |
| Exposure time | 4 minutes | 4 minutes | 3 minutes |
| Vacuum dry time | 20 - 40 minutes | 30 minutes | 20 minutes |
| Reusability | Reusable | Reusable | Same |
| Patient<br>Contact | No direct patient contact | No direct patient contact | Same |
| Design | Rigid containment device<br>consisting of a base with lid<br>which can be fastened by a<br>latching mechanism. The device<br>is perforated in order to enable<br>reprocessing of enclosed<br>medical devices held in place by<br>silicone<br>retainers. | Rigid containment device consisting of a base<br>with lid which can be fastened by a latching<br>mechanism. The device is perforated in order to<br>enable reprocessing of enclosed medical devices<br>held in place by silicone<br>retainers. | Same |
| Device Image | Image: Device image | Image: Device image | N/A |

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| Materials of<br>Construction | | | Same |
|------------------------------|----------------------------------|--|------|
| Stainless steel, silicone | Stainless steel, silicone, Radel | | |

| | | | Similar |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensions | 10.0 (W) x 21.4 (L) x 3.0 (H) inches | 4.5 (W) x 20 (L) x 2.125 (H) inches | |
| Air Permeance | Yes | Yes | |
| Material<br>Biocompatibility | Cytotoxicity | Materials are biocompatible. Tested per ISO<br>10993-1 and Use of International Standard ISO<br>10993-1, "Biological evaluation of medical devices<br>- Part 1: Evaluation and testing within a risk<br>management process" - Guidance for Industry<br>and Food and Drug Administration Staff issued 16<br>June 2016 | Similar |
| Sterilization<br>Method | Pre-vacuum Steam Sterilization | Pre-vacuum Steam Sterilization | |
| Sterilization<br>Parameters | 132 °C Pre-vacuum (Hi Vac)<br>Steam Cycle<br>Exposure temperature: 270 °F<br>(132 °C) Exposure time: 4<br>minutes<br>Vacuum dry time: 20 - 40<br>minutes 134 °C Pre-vacuum<br>(Hi Vac) Steam Cycle<br>Exposure temperature: 273 °F<br>(134 °C) | 132 °C Pre-vacuum Steam Cycle Exposure<br>temperature: 270 °F (132 °C) Exposure time: 4<br>minutes<br>Vacuum dry time: 30 minutes<br>134 °C Pre-vacuum Steam Cycle Exposure<br>temperature: 273 °F (134 °C) Exposure time: 3<br>minutes<br>Vacuum dry time: 20 minutes | Similar |

## SUMMARY OF NON-CLINICAL TESTING

The design requirements for the UroLift Procedure Kit Sterilization Tray were reviewed and non-clinical design verification testing was required to assure that the device met the intended use. Non-clinical testing included usability testing, biocompatibility testing, and cleaning / sterilization testing. The usability testing assured that the user could perform the steps of the Instructions for Use to meet the intended use of the sterilization tray and assured that the sterilization tray performed as intended to securely store and sterilize the instruments. A summary of the non-clinical testing is below:

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| Title of test | Purpose of test | Acceptance Criteria / Source of<br>references | Results |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Usability<br>Testing | Usability testing assured that the<br>user could perform the steps of the<br>Instructions for Use to meet the<br>intended use of the sterilization tray<br>and assured that the sterilization tray<br>performed as intended to securely<br>store and sterilize the instruments | The user is able to load and<br>unload the tray, perform the<br>reprocessing workflow (Clean the<br>tray, inspect the tray, clean and<br>inspect the instruments, and load<br>the tray and sterilize), and<br>determine the end of the<br>serviceable life of the tray.<br>ANSI/AAMI ST77:2013 -<br>Containment devices for reusable<br>medical device sterilization | Pass |
| Cytotoxicity<br>Testing | The purpose of this study is to<br>evaluate the cytotoxicity of a test<br>article extract using an in vitro<br>mammalian cell culture test. | The test sample meets the<br>requirements of the test if the<br>biological response is less than or<br>equal to grade 2 (mild).<br>Cytotoxicity testing per ISO<br>10993-5:2009 – Biological<br>evaluation of medical devices Part<br>5: Tests for in vitro cytotoxicity | Pass |
| Sensitization<br>Testing | The purpose of this study is to<br>evaluate the potential of the test<br>article to cause delayed dermal<br>contact sensitization in the guinea<br>pig maximization test. | Grades of 1 or greater observed in<br>the test group generally indicate<br>sensitization, provided that grades<br>of less than 1 are observed on the<br>control animals. If grades of 1 or<br>greater are noted on control<br>animals, then the reactions of test<br>animals that exceeded the most<br>severe control reaction will be<br>considered to be due to<br>sensitization.<br>Sensitization testing per ISO<br>10993-10:2010 – Biological<br>evaluation of medical devices Part<br>10: Tests for irritation and skin<br>sensitization | Pass |
| Intracutaneous<br>Reactivity<br>Testing | The purpose of this study is to<br>evaluate the local dermal irritation of<br>a test article extract following<br>intracutaneous injection in rabbits. | The difference of overall mean of<br>the test group to the control group<br>on erythema and edema score<br>must be less than 1.<br>Intracutaneous Reactivity testing<br>per ISO 10993-10:2010 –<br>Biological evaluation of medical<br>devices Part 10: Tests for irritation<br>and skin sensitization | Pass |
| Title of test | Purpose of test | Acceptance Criteria / Source of<br>references | Results |
| Useful Life<br>Testing | The tray was subject to 100 cleaning<br>and sterilization cycles per the<br>Instructions for Use reprocessing<br>directions. The purpose of the test<br>was to determine the serviceable life<br>span of the tray. | The tray must pass the inspection<br>criteria on the IFU after 100<br>reprocessing cycles.<br>ANSI/AAMI ST77:2013-<br>Containment devices for reusable<br>medical device sterilization | Pass |
| Cleaning<br>Validation | The purpose of this test is to validate<br>that the cleaning instructions listed in<br>the Instructions for Use appropriately<br>clean the tray to ensure the<br>sterilization cycle will be effective. | Per the protocol, there were three<br>acceptance criteria; protein<br>residual analysis, hemoglobin<br>residual analysis, and visual<br>inspection. The protein residual<br>benchmark level was 6.4µg/cm²<br>and the hemoglobin benchmark<br>level was 2.2µg/cm². The tray<br>must pass the visual inspection in<br>the IFU.<br>AAMI TIR30: 2011/(R)2016, A<br>compendium of processes,<br>materials, test methods, and<br>acceptance criteria for cleaning<br>reusable medical devices revised<br>15 December 2016 and<br>Reprocessing Medical Devices in<br>Health Care Settings: Validation<br>Methods and Labeling Guidance<br>for Industry and Food and Drug<br>Administration Staff issued 17<br>March 2015 | Pass |
| Sterilization<br>Validation | The purpose of this test is to validate<br>that the sterilization instructions listed<br>in the Instructions for use<br>appropriately sterilize the tray and<br>contents. | The minimum sterility assurance<br>level (SAL) of 10-6 can be<br>achieved if the sterilization<br>instructions in the IFU were<br>followed.<br>ANSI/AAMI ST77:2013,<br>Containment devices for reusable<br>medical device sterilization | Pass |

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## BIOCOMPATIBILITY TESTING

The UroLift System Procedure Kit Sterilization Tray has been tested for biocompatibility and passed the relevant tests according to ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff issued 16 June 2016.

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Biocompatibility testing was performed on worst case sterilized devices and included:

- Cytotoxicity testing per ISO 10993-5:2009 Biological evaluation of medical ● devices Part 5: Tests for in vitro cytotoxicity
- Sensitization testing per ISO 10993-10:2010 Biological evaluation of medical ● devices Part 10: Tests for irritation and skin sensitization
- Intracutaneous Reactivity testing per ISO 10993-10:2010 Biological evaluation . of medical devices Part 10: Tests for irritation and skin sensitization

## CLEANING / STERILIZATION TESTING

The UroLift Procedure Kit Sterilization Tray is intended to be sold non-sterile and used during the reprocessing of the surgical instruments used in the UroLift System Procedure. As such, cleaning and sterilization validations were performed to ensure the tray could withstand multiple reprocessing cycles without adverse reaction or degradation.

The cleaning validation was designed to simulate the worst case scenario conforming to several industry standards including AAMI TIR30: 2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices revised 15 December 2016 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff issued 17 March 2015. The cleanliness of the tray was assessed by protein and hemoglobin residuals, and all residuals met predefined acceptance criteria demonstrating the adequate cleanliness of the tray using the cleaning instructions.

The sterilization validation, designed based on the FDA-recognized standard ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization, demonstrated the minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the instructions for use (IFU) were followed.

The tray was validated to be reused for up to 100 cleaning/sterilization cycles. Careful inspection is the best way to determine the end of serviceable life. Inspection criteria are described in the instructions for use (IFU).

## CONCLUSION

The conclusions drawn from the nonclinical tests that demonstrate that the NeoTract UroLift System Procedure Kit Sterilization Tray is as safe, as effective, and performs as well as or better than the legally marketed device.