(197 days)
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.
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.
The UroLift® System Procedure Kit Sterilization Tray is a rigid containment device for surgical instruments, intended for storage and sterilization in a pre-vacuum steam sterilizer. The device was evaluated through non-clinical testing including usability, biocompatibility, cleaning, and sterilization testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of test | Purpose of test | Acceptance Criteria / Source of references | Results |
|---|---|---|---|
| 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 that the tray performed as intended to securely store and sterilize the instruments. | The user is able to load and unload the tray, perform the reprocessing workflow (clean the tray, inspect the tray, clean and inspect the instruments, and load the tray and sterilize), and determine the end of the serviceable life of the tray. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cytotoxicity Testing | Evaluated the cytotoxicity of a test article extract using an in vitro mammalian cell culture test. | The test sample meets the requirements of the test if the biological response is less than or equal to grade 2 (mild). Cytotoxicity testing per ISO 10993-5:2009 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. | Pass |
| Sensitization Testing | Evaluated the potential of the test article to cause delayed dermal contact sensitization in the guinea pig maximization test. | Grades of 1 or greater observed in the test group generally indicate sensitization, provided that grades of less than 1 are observed on the control animals. If grades of 1 or greater are noted on control animals, then the reactions of test animals that exceeded the most severe control reaction will be considered to be due to sensitization. Sensitization testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Intracutaneous Reactivity Testing | Evaluated the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | The difference of overall mean of the test group to the control group on erythema and edema score must be less than 1. Intracutaneous Reactivity testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Useful Life Testing | Determined the serviceable lifespan of the tray by subjecting it to 100 cleaning and sterilization cycles. | The tray must pass the inspection criteria on the IFU after 100 reprocessing cycles. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cleaning Validation | Validated that the cleaning instructions in the Instructions for Use appropriately clean the tray to ensure the sterilization cycle will be effective. | Per the protocol, there were three acceptance criteria: protein residual analysis, hemoglobin residual analysis, and visual inspection. The protein residual benchmark level was 6.4µg/cm², and the hemoglobin benchmark level was 2.2µg/cm². The tray must pass the visual inspection in the IFU. AAMI TIR30: 2011/(R)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. | Pass |
| Sterilization Validation | Validated that the sterilization instructions in the Instructions for Use appropriately sterilize the tray and contents. | The minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the IFU were followed. ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the exact sample sizes for each test in the test set (e.g., number of units tested for usability, number of samples for biocompatibility). The testing is described as non-clinical in nature. The provenance of the data is manufacturer-generated (NeoTract, Inc.) through non-clinical design verification testing. It is retrospective in the sense that the testing was conducted on the device to demonstrate conformance to pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not explicitly provided. Non-clinical studies like these generally rely on established scientific protocols and standards (e.g., ISO, AAMI) rather than expert consensus on interpretation for ground truth. For "Usability Testing," the evaluation would typically involve trained users or human factors engineers, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
The document does not detail specific adjudication methods as would be typical for clinical studies involving multiple reviewers or subjective assessments. The results are reported as "Pass" or "Fail" based on whether the acceptance criteria were met according to established laboratory methods and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This device is a sterilization tray, not a diagnostic or therapeutic device evaluated for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical device (sterilization tray), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was based on:
- Established scientific and regulatory standards: e.g., ISO 10993 for biocompatibility, AAMI ST77 and TIR30 for sterilization and cleaning.
- Predefined acceptance criteria: Specific quantitative (e.g., protein residual levels, SAL) and qualitative (e.g., visual inspection, user performance steps) benchmarks derived from these standards and industry best practices.
- Performance of the device itself through repeated cycles (for useful life testing).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 - brian.gall@teleflex.com
DATE PREPARED
13 April 2020
DEVICE INFORMATION
| Trade Name: | UroLift® System Procedure Kit Sterilization Tray (UL-PKTRAY) |
|---|---|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories |
| Classification Name: | Sterilization Wrap |
| Product Code: | KCT |
| Regulation Number: | 880.6850 |
| Classification: | II |
| Classification Panel: | Surgical and Infection Control Devices (OHT4)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 | PredicateDeviceSignia™SterilizationTray K161347 | Subject DeviceUroLift System Procedure Kit Sterilization Tray[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 |
| RegulationNumber | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
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| Indicationsfor Use | The Signia™ sterilization tray isintended to provide storage forthe Signia™ adapters, Signia™reusable insertion guide andSignia™ manual retraction toolduring sterilization, storage andtransportation within thehospital environment. TheSignia™ sterilization tray is onlyintended to maintain sterility ofthe enclosed devices if it isused in conjunction with anFDA cleared sterilization wrapand has only been evaluatedfor a non- stackedconfiguration. The tray cancontain at a maximum: | The UroLift System Procedure Kit SterilizationTray is intended to be used to enclose andprotect surgical instruments used for the UroLiftSystem Procedure for storage and sterilizationin a pre-vacuum steam sterilizer.The following instruments are intended to beloaded into the UroLift System Procedure KitSterilization Tray:• UL-SCOPE / UL-SCOPE-FE – Cystoscope,2.9 mm diameter x 365 mm length, 0° angle ofview, 85° field of view• UL-SHEATH / UL-SHEATH-FE - Sheath,20 Fr., with 2 tube connectors | Similar |
|---|
| one (1) Signia™ adapter, one (1) Signia™ reusable insertion guideand one (1) Signia™ manual retraction tool. The tray is intended to allow steamsterilization of the enclosed medical devices. The validatedsterilization cycle parameters are as follows: | (Luer lock and Luer lock with stopcock)• UL-VO / UL-VO-FE - Visualobturator, 20 Fr.The tray by itself is not intended to maintainsterility; it is intended to be used in conjunctionwith a legally marketed, validated, 510(k) clearedsterilization wrap to maintain sterility of theenclosed instruments when sterilized using thefollowing pre-vacuum steamsterilization cycles: | ||
|---|---|---|---|
| STEAM STERILIZATIONPre-vacuum (HiVac) Steam Cycles | Pre-Vacuum Steam | ||
| Item: Tray with componentswrapped or in sterilizationcontainer system | 132 °C Pre-vacuum (HiVac)Steam Cycles | Valuefor theUnitedStates | Value for OtherCountries |
| Exposure temperature | 270 °F (132 °C) | 132°C(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 |
| PatientContact | No direct patient contact | No direct patient contact | Same |
| Design | Rigid containment deviceconsisting of a base with lidwhich can be fastened by alatching mechanism. The deviceis perforated in order to enablereprocessing of enclosedmedical devices held in place bysiliconeretainers. | Rigid containment device consisting of a basewith lid which can be fastened by a latchingmechanism. The device is perforated in order toenable reprocessing of enclosed medical devicesheld in place by siliconeretainers. | Same |
| Device Image | Image: Device image | Image: Device image | N/A |
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| Materials ofConstruction | 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 | |
| MaterialBiocompatibility | Cytotoxicity | Materials are biocompatible. Tested per ISO10993-1 and Use of International Standard ISO10993-1, "Biological evaluation of medical devices- Part 1: Evaluation and testing within a riskmanagement process" - Guidance for Industryand Food and Drug Administration Staff issued 16June 2016 | Similar |
| SterilizationMethod | Pre-vacuum Steam Sterilization | Pre-vacuum Steam Sterilization | |
| SterilizationParameters | 132 °C Pre-vacuum (Hi Vac)Steam CycleExposure temperature: 270 °F(132 °C) Exposure time: 4minutesVacuum dry time: 20 - 40minutes 134 °C Pre-vacuum(Hi Vac) Steam CycleExposure temperature: 273 °F(134 °C) | 132 °C Pre-vacuum Steam Cycle Exposuretemperature: 270 °F (132 °C) Exposure time: 4minutesVacuum dry time: 30 minutes134 °C Pre-vacuum Steam Cycle Exposuretemperature: 273 °F (134 °C) Exposure time: 3minutesVacuum 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 ofreferences | Results |
|---|---|---|---|
| UsabilityTesting | Usability testing assured that theuser could perform the steps of theInstructions for Use to meet theintended use of the sterilization trayand assured that the sterilization trayperformed as intended to securelystore and sterilize the instruments | The user is able to load andunload the tray, perform thereprocessing workflow (Clean thetray, inspect the tray, clean andinspect the instruments, and loadthe tray and sterilize), anddetermine the end of theserviceable life of the tray.ANSI/AAMI ST77:2013 -Containment devices for reusablemedical device sterilization | Pass |
| CytotoxicityTesting | The purpose of this study is toevaluate the cytotoxicity of a testarticle extract using an in vitromammalian cell culture test. | The test sample meets therequirements of the test if thebiological response is less than orequal to grade 2 (mild).Cytotoxicity testing per ISO10993-5:2009 – Biologicalevaluation of medical devices Part5: Tests for in vitro cytotoxicity | Pass |
| SensitizationTesting | The purpose of this study is toevaluate the potential of the testarticle to cause delayed dermalcontact sensitization in the guineapig maximization test. | Grades of 1 or greater observed inthe test group generally indicatesensitization, provided that gradesof less than 1 are observed on thecontrol animals. If grades of 1 orgreater are noted on controlanimals, then the reactions of testanimals that exceeded the mostsevere control reaction will beconsidered to be due tosensitization.Sensitization testing per ISO10993-10:2010 – Biologicalevaluation of medical devices Part10: Tests for irritation and skinsensitization | Pass |
| IntracutaneousReactivityTesting | The purpose of this study is toevaluate the local dermal irritation ofa test article extract followingintracutaneous injection in rabbits. | The difference of overall mean ofthe test group to the control groupon erythema and edema scoremust be less than 1.Intracutaneous Reactivity testingper ISO 10993-10:2010 –Biological evaluation of medicaldevices Part 10: Tests for irritationand skin sensitization | Pass |
| Title of test | Purpose of test | Acceptance Criteria / Source ofreferences | Results |
| Useful LifeTesting | The tray was subject to 100 cleaningand sterilization cycles per theInstructions for Use reprocessingdirections. The purpose of the testwas to determine the serviceable lifespan of the tray. | The tray must pass the inspectioncriteria on the IFU after 100reprocessing cycles.ANSI/AAMI ST77:2013-Containment devices for reusablemedical device sterilization | Pass |
| CleaningValidation | The purpose of this test is to validatethat the cleaning instructions listed inthe Instructions for Use appropriatelyclean the tray to ensure thesterilization cycle will be effective. | Per the protocol, there were threeacceptance criteria; proteinresidual analysis, hemoglobinresidual analysis, and visualinspection. The protein residualbenchmark level was 6.4µg/cm²and the hemoglobin benchmarklevel was 2.2µg/cm². The traymust pass the visual inspection inthe IFU.AAMI TIR30: 2011/(R)2016, Acompendium of processes,materials, test methods, andacceptance criteria for cleaningreusable medical devices revised15 December 2016 andReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling Guidancefor Industry and Food and DrugAdministration Staff issued 17March 2015 | Pass |
| SterilizationValidation | The purpose of this test is to validatethat the sterilization instructions listedin the Instructions for useappropriately sterilize the tray andcontents. | The minimum sterility assurancelevel (SAL) of 10-6 can beachieved if the sterilizationinstructions in the IFU werefollowed.ANSI/AAMI ST77:2013,Containment devices for reusablemedical 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.
§ 880.6850 Sterilization wrap.
(a)
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.(b)
Classification. Class II (performance standards).