(81 days)
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: · UL-SCOPE4-0 / UL-SCOPE4-0-FE* - Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle - · UL-GRASP-R Optical Graspers, double action jaws - · UL-SCI-R Optical Scissors, double action jaws * Factory Exchange: Devices with a part number ending in "FE" have been repaired to meet product specifications. 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: Prevacuum Steam Temperature: 132°C (270°F) Sterilization time: 4 minutes Minimum dry time: 30 minutes Maximum weight: 5 lbs (2.7 kg)
The UroLift System Rigid Retrieval Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of surgical instruments that are optionally used in the UroLift System Procedure.
The document describes the acceptance criteria and the results of non-clinical studies for the UroLift® System Rigid Retrieval Kit Sterilization Tray.
1. Table of Acceptance Criteria and Reported Device Performance:
| Title of Test | Purpose of Test | Acceptance Criteria / Source of References | Reported Device Performance |
|---|---|---|---|
| Usability Testing | Assured that the user could perform the steps of the Instructions for Use (IFU) 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 | Evaluate 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 | Evaluate 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 | Evaluate 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 | Determine the serviceable life span of the tray after being subject to 100 cleaning and sterilization cycles per the IFU reprocessing directions. | 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 | Validate that the cleaning instructions listed in the IFU 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, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices revised 15 December 2016 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 | Validate that the sterilization instructions listed in the IFU 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 document does not explicitly state the sample sizes for each test in terms of the number of devices or data points beyond "100 cleaning and sterilization cycles" for Useful Life Testing. The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (NeoTract, Inc.), so the data provenance would be from internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in a way that is applicable to typical "ground truth" establishment for AI/ML devices. The tests described are engineering/performance validations, not clinical studies requiring expert interpretation of results for ground truth. The "acceptance criteria" themselves serve as the standard by which the device's performance is judged.
4. Adjudication Method for the Test Set:
Not applicable to these non-clinical performance and biocompatibility tests. The "Pass" results are based on meeting predefined quantitative and qualitative acceptance criteria specified by relevant standards (e.g., ISO, AAMI).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a non-clinical device (sterilization tray) and does not involve AI or human readers for diagnostic purposes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a non-AI medical device.
7. Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on:
- Predefined performance specifications and acceptance criteria derived from established industry standards (e.g., ANSI/AAMI ST77:2013, ISO 10993 series, AAMI TIR30: 2011/(R)2016).
- Laboratory measurements (e.g., protein and hemoglobin residuals, biological responses in cell cultures/animals).
- Visual inspection criteria.
8. Sample Size for the Training Set:
Not applicable. This is a non-AI medical device and does not involve machine learning models with training sets.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, this is a non-AI device.
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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.
October 22, 2021
NeoTract, Inc. Brian Gall Senior Manager of Regulatory Affairs 4155 Hopvard Road Pleasanton, California 94588
Re: K212396
Trade/Device Name: UroLift System Rigid Retrieval Kit Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 22, 2021 Received: September 23, 2021
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
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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 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 (OS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, Ph.D. 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) K212396
Device Name
UroLift® System Rigid Retrieval Kit Sterilization Tray
Indications for Use (Describe)
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: · UL-SCOPE4-0 / UL-SCOPE4-0-FE* - Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle
- · UL-GRASP-R Optical Graspers, double action jaws
- · UL-SCI-R Optical Scissors, double action jaws
- Factory Exchange: Devices with a part number ending in "FE" have been repaired to meet product specifications.
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:
Prevacuum Steam Temperature: 132°C (270°F) Sterilization time: 4 minutes Minimum dry time: 30 minutes Maximum weight: 5 lbs (2.7 kg)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K212396
COMPANY INFORMATION
NeoTract, Inc. 4155 Hopyard Road Pleasanton, CA 94588 Registration Number: 3015181082
SUBMISSION CORRESPONDENT
Brian Gall Senior 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
20 October 2021
DEVICE INFORMATION
| Trade Name: | UroLift® System Rigid Retrieval Kit Sterilization Tray (UL-RRKTRAY) |
|---|---|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 Rigid Retrieval Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of surgical instruments that are optionally used in the UroLift System Procedure.
INDICATIONS FOR USE
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments optionally 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 Rigid Retrieval Kit Sterilization Tray:
- UL-SCOPE4-0 / UL-SCOPE4-0-FE Cystoscope, 4.0 mm diameter x 302 mm . length, 0° angle of view, wide angle
- UL-GRASP-R Optical Graspers, double action jaws ●
Image /page/3/Picture/16 description: The image shows the logos for "NeoTract" and "Teleflex" side by side, separated by a vertical line. Below the logos, the text "INTERVENTIONAL UROLOGY" is displayed in a smaller font size. The logos and text are likely associated with a medical company or division specializing in interventional urology.
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- UL-SCI-R Optical Scissors, double action jaws .
- Factory Exchange: Devices with a part number ending in "FE" have been repaired to meet product specifications.
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) |
| Sterilization Time | 4 minutes |
| Minimum Dry Time | 30 minutes |
| Maximum Weight | 2.27 kg / 5.0 lbs |
CONTRAINDICATIONS
There are no known contraindications.
PREDICATE DEVICE
The predicate device is the UroLift System Procedure Kit Sterilization Tray, NeoTract / Teleflex (K192781).
| Trade Name: | UroLift System Procedure Kit Sterilization Tray (UL-PKTRAY) |
|---|---|
| Common Name: | Sterilization Wrap Containers, Trays, Cassettes & OtherAccessories |
| 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) |
COMPARISON WITH THE PREDICATE DEVICE
The legally-marketed UroLift System Procedure Kit Sterilization Tray cleared via K192781 (14 April 2020) is the predicate for the UroLift System Rigid Retrieval Kit Sterilization Tray since both are metal sterilization trays with similar indications for use. Also, the predicate device and the proposed sterilization tray can undergo pre-vacuum steam sterilization with similar cycles. The primary differences are the size of the tray and the validated dry time. The differences do not affect the safety and effectiveness of the device as demonstrated through the cleaning and sterilization validation.
Technological Comparison Table:
| Characteristic | Subject DeviceUroLift® System Rigid Retrieval KitSterilization Tray [K212396] | Predicate DeviceUroLift System Procedure Kit SterilizationTray [K192781] | Comparison |
|---|---|---|---|
| Device Name | UroLift® System Rigid Retrieval KitSterilization Tray | UroLift System Procedure Kit SterilizationTray | N/A |
| 510(k)Number | K212396 | K192781 | N/A |
Image /page/4/Picture/13 description: The image features the logos of NeoTract and Teleflex, two companies in the interventional urology field. The NeoTract logo is on the left, and the Teleflex logo is on the right. Below the logos, the words "INTERVENTIONAL UROLOGY" are written in smaller letters.
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| Product Code | KCT | KCT | Same | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Product Class | Class II | Class II | Same | |||||||||||
| RegulationNumber | 21 CFR 880.6850 | 21 CFR 880.6850 | Same | |||||||||||
| Indications forUse | The UroLift System Rigid Retrieval KitSterilization Tray is intended to be used toenclose and protect surgical instrumentsoptionally used for the UroLift Systemprocedure for storage and sterilization in aprevacuum steam sterilizer. The followinginstruments are intended to be loaded intothe UroLift System Rigid Retrieval KitSterilization Tray:- UL-SCOPE4-0 / UL-SCOPE4-0-FE* -Cystoscope, 4.0 mm diameter x 302 mmlength, 0° angle of view, wide angle- UL-GRASP-R - Optical Graspers, doubleaction jaws- UL-SCI-R - Optical Scissors, doubleaction jaws* Factory Exchange: Devices with a partnumber ending in "FE” have been repairedto meet product specifications. | The UroLift System Procedure KitSterilization Tray is intended to be used toenclose and protect surgical instrumentsused for the UroLift System Procedure forstorage and sterilization in a pre-vacuumsteam sterilizer.The following instruments are intended tobe loaded into the UroLift SystemProcedure Kit Sterilization Tray:UL-SCOPE / UL-SCOPE-FE - Cystoscope,2.9 mm diameter x 365 mm length, 0° angleof view, 85° field of viewUL-SHEATH / UL-SHEATH-FE – Sheath,20 Fr., with 2 tube connectors (Luer lockand Luer lock with stopcock)UL-VO / UL-VO-FE – Visual obturator,20 Fr.The tray by itself is not intended to maintainsterility; it is intended to be used inconjunction with a legally marketed,validated, 510(k) cleared sterilization wrapto maintain sterility of the enclosedinstruments when sterilized using thefollowing pre-vacuum steam sterilizationcycles: | Different | |||||||||||
| The tray by itself is not intended to maintainsterility; it is intended to be used inconjunction with a legally marketed,validated, 510(k) cleared sterilization wrapto maintain sterility of the enclosedinstruments when sterilized using thefollowing pre-vacuum steam sterilizationcycles:Pre-vacuum SteamTemperature: 132°C (270°F)Sterilization time: 4 minutesMinimum dry time: 30 minutesMaximum weight: 5 lbs (2.7 kg) | 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 | |||||||||||||
| Reusability | Reusable | Reusable | Same | |||||||||||
| PatientContact | No direct patient contact | No direct patient contact | Same | |||||||||||
| Design | Rigid containment device consisting of abase with lid which can be fastened by alatching mechanism. The device isperforated in order to enable reprocessingof enclosed medical devices held in placeby silicone retainers. | Rigid containment device consisting of abase with lid which can be fastened by alatching mechanism. The device isperforated in order to enablereprocessing of enclosed medicaldevices held in place by siliconeretainers. | Same | |||||||||||
| Device Image | Image: Urolift Sterilization Tray | Image: Urolift Sterilization Tray | Similar |
Image /page/5/Picture/1 description: The image features the logos of "neotract" and "Teleflex" side by side, separated by a vertical line. Below the logos, the words "INTERVENTIONAL UROLOGY" are written in smaller, capitalized letters. The logos and text are presented in a clean and professional manner.
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| Materials ofConstruction | Stainless steel, silicone, Radel | Stainless steel, silicone, Radel | Same |
|---|---|---|---|
| Dimensions | 5.3 (W) x 20.7 (L) x 1.75 (H) inches | 4.5 (W) x 20 (L) x 2.125 (H) inches | Similar |
| AirPermeance | Yes | Yes | Same |
| MaterialBiocompatibility | Materials are biocompatible. Tested perISO 10993-1 and Use of InternationalStandard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement process" - Guidance forIndustry and Food and Drug AdministrationStaff issued 16 June 2016 | Materials are biocompatible. Tested perISO 10993-1 and Use of InternationalStandard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement process" – Guidance forIndustry and Food and Drug AdministrationStaff issued 16 June 2016 | Same |
| SterilizationMethod | Pre-vacuum Steam Sterilization | Pre-vacuum Steam Sterilization | Same |
| SterilizationParameters | 132 °C Pre-vacuum Steam CycleExposure temperature: 270 °F (132 °C)Exposure time: 4 minutesVacuum dry time: 30 minutes | 132 °C Pre-vacuum Steam CycleExposure temperature: 270 °F (132 °C)Exposure time: 4 minutesVacuum dry time: 30 minutes134 °C Pre-vacuum Steam CycleExposure temperature: 273 °F (134 °C)Exposure time: 3 minutes Vacuum dry time:20 minutes | Similar |
SUMMARY OF NON-CLINICAL TESTING
| Title of test | Purpose of test | Acceptance Criteria / Source of references | Results |
|---|---|---|---|
| Usability Testing | 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 | 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 | The purpose of this study is to evaluate 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 | The purpose of this study is to evaluate the potential of the test | Grades of 1 or greater observed in the test group generally indicate | Pass |
| article to cause delayed dermalcontact sensitization in the guineapig maximization test. | sensitization, 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 | ||
| IntracutaneousReactivityTesting | The purpose of this study is toevaluate the local dermal irritationof a 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 – Biologicalevaluation of medical devices Part10: Tests for irritation and skinsensitization | Pass |
| Useful LifeTesting | The tray was subject to 100cleaning and sterilization cycles perthe Instructions for Usereprocessing directions. Thepurpose of the test was todetermine the serviceable life spanof 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 tovalidate that the cleaninginstructions listed in the Instructionsfor Use appropriately clean the trayto ensure the sterilization cycle willbe effective. | Per the protocol, there were threeacceptance criteria; protein residualanalysis, hemoglobin residualanalysis, and visual inspection. Theprotein residual benchmark levelwas 6.4µg/cm² and the hemoglobinbenchmark level was 2.2µg/cm².The tray must pass the visualinspection in the 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 Guidance forIndustry and Food and Drug | Pass |
| Administration Staff issued 17March 2015 | |||
| SterilizationValidation | The purpose of this test is tovalidate that the sterilizationinstructions listed in the Instructionsfor use appropriately sterilize thetray and contents. | The minimum sterility assurancelevel (SAL) of 10-6 can be achieved ifthe sterilization instructions in theIFU were followed.ANSI/AAMI ST77:2013,Containment devices for reusablemedical device sterilization | Pass |
Image /page/6/Picture/3 description: The image features the logos of "neotract" and "Teleflex" side by side, separated by a vertical line. The "neotract" logo is in a sans-serif font with the "neo" part in black and the "tract" part in blue, underlined by a black line. The "Teleflex" logo is in a bold, sans-serif font, also in blue, with a registered trademark symbol. Below both logos, in smaller, all-caps letters, is the text "INTERVENTIONAL UROLOGY".
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nectract | ገfeleflex® INTERVENTIONAL UROLOGY
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PERFORMANCE TESTING
The design requirements for the UroLift System Rigid Retrieval 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, 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.
BIOCOMPATIBILITY TESTING
The biocompatibility of the UroLift System Rigid Retrieval Kit Sterilization tray is equivalent to the predicate. Both trays are manufactured using identical materials and equivalent processing methods. The type and duration of contact of the proposed and predicate tray are identical, and the instruments contained in both trays are identical duration and contact type. As such, the biocompatibility of the predicate is considered representative of the proposed tray and no additional biocompatibility testing was required.
The predicate device (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 September 2020. 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 System Rigid Retrieval Kit Sterilization Tray is intended to be sold non-sterile and used during the reprocessing of the surgical instruments that are optionally used in the UroLift System Procedure. As such, cleaning and sterilizations were performed to ensure the tray could withstand multiple reprocessing cycles without adverse reaction or
Image /page/8/Picture/11 description: The image features the logos of "neotract" and "Teleflex" side by side, separated by a vertical line. The "neotract" logo is in black and blue, with a horizontal line underneath. The "Teleflex" logo is in blue. Below the logos, the words "INTERVENTIONAL UROLOGY" are written in a smaller, gray font.
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degradation.
The cleaning validation was designed to simulate the worst case scenario conforming to several industry standards includinq 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 reuse life of the UroLift System Rigid Retrieval Kit Sterilization tray is equivalent to the predicate. Both trays are manufactured using identical materials and equivalent processing methods, and subject to equivalent cleaning and sterilization cycles. As such, the reuse life of the predicate (100 cycles) is considered adequate for the proposed tray and no additional reuse life testing was required. Inspection criteria are the same as the predicate and described in the instructions for use (IFU).
CONCLUSION
The conclusions drawn from the non-clinical tests demonstrate the UroLift System Rigid Retrieval Kit Sterilization Tray is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
Image /page/9/Picture/6 description: The image features the logos of two companies, "NeoTract" and "Teleflex", side by side. Below the logos, the words "Interventional Urology" are written in smaller font. The logos and text are all in a professional, corporate style.
§ 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).