(197 days)
Not Found
No
The document describes a sterilization tray for surgical instruments and its validation for cleaning and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a sterilization tray for surgical instruments and does not directly provide therapy to a patient.
No
Explanation: The device is a sterilization tray used to enclose and protect surgical instruments for storage and sterilization. Its function is to facilitate the reprocessing of instruments, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical sterilization tray designed to hold and protect surgical instruments during sterilization. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a sterilization tray designed to enclose and protect surgical instruments for storage and sterilization. It is used in conjunction with a sterilization wrap to maintain sterility.
- Device Description: The description reinforces that it's a rigid containment device for reprocessing surgical instruments.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests. It is a tool for preparing and maintaining the sterility of surgical instruments.
The information provided focuses on the physical properties, sterilization capabilities, and usability of the tray, which are all relevant to a device used in a surgical setting, but not to an in vitro diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of Non-Clinical 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 that the sterilization tray performed as intended to securely store and sterilize the instruments.
- Acceptance Criteria: 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. Based on ANSI/AAMI ST77:2013.
- Results: Pass.
- Cytotoxicity Testing: Evaluated the cytotoxicity of a test article extract using an in vitro mammalian cell culture test.
- Acceptance Criteria: Biological response less than or equal to grade 2 (mild). Per ISO 10993-5:2009.
- Results: Pass.
- Sensitization Testing: Evaluated the potential of the test article to cause delayed dermal contact sensitization in the guinea pig maximization test.
- Acceptance Criteria: 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. Per ISO 10993-10:2010.
- Results: Pass.
- Intracutaneous Reactivity Testing: Evaluated the local dermal irritation of a test article extract following intracutaneous injection in rabbits.
- Acceptance Criteria: The difference of overall mean of the test group to the control group on erythema and edema score must be less than 1. Per ISO 10993-10:2010.
- Results: Pass.
- Useful Life Testing: The tray was subject to 100 cleaning and sterilization cycles per the Instructions for Use reprocessing directions. The purpose of the test was to determine the serviceable life span of the tray.
- Acceptance Criteria: The tray must pass the inspection criteria on the IFU after 100 reprocessing cycles. Per ANSI/AAMI ST77:2013.
- Results: Pass.
- Cleaning Validation: Validated that the cleaning instructions listed in the Instructions for Use appropriately clean the tray to ensure the sterilization cycle will be effective.
- Acceptance Criteria: Protein residual analysis (benchmark 6.4µg/cm²), hemoglobin residual analysis (benchmark 2.2µg/cm²), and visual inspection (tray must pass visual inspection in the IFU). Per AAMI TIR30: 2011/(R)2016 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance.
- Results: Pass.
- Sterilization Validation: Validated that the sterilization instructions listed in the Instructions for use appropriately sterilize the tray and contents.
- Acceptance Criteria: Minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the IFU were followed. Per ANSI/AAMI ST77:2013.
- Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 & 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 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)
5
- . 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
Device
Signia™
Sterilization
Tray K161347 | Subject Device
UroLift 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 |
| Regulation
Number | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
6
| Indications
for Use | The Signia™ sterilization tray is
intended to provide storage for
the Signia™ adapters, Signia™
reusable insertion guide and
Signia™ manual retraction tool
during sterilization, storage and
transportation within the
hospital environment. The
Signia™ sterilization tray is only
intended to maintain sterility of
the enclosed devices if it is
used in conjunction with an
FDA cleared sterilization wrap
and has only been evaluated
for a non- stacked
configuration. The tray can
contain at a maximum: | 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 | Similar |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide
and one (1) Signia™ manual retraction tool. The tray is intended to allow steam
sterilization of the enclosed medical devices. The validated
sterilization cycle parameters are as follows: | | | (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: |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STEAM STERILIZATION
Pre-vacuum (HiVac) Steam Cycles | | Pre-Vacuum Steam | |
| Item: Tray with components
wrapped or in sterilization
container system | 132 °C Pre-vacuum (HiVac)
Steam Cycles | Value
for the
United
States | Value for Other
Countries |
| 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 |
| Patient
Contact | No direct patient contact | No direct patient contact | Same |
| Design | Rigid containment device
consisting of a base with lid
which can be fastened by a
latching mechanism. The device
is perforated in order to enable
reprocessing of enclosed
medical devices held in place by
silicone
retainers. | Rigid containment device consisting of a base
with lid which can be fastened by a latching
mechanism. The device is perforated in order to
enable reprocessing of enclosed medical devices
held in place by silicone
retainers. | Same |
| Device Image | Image: Device image | Image: Device image | N/A |
7
| Materials of
| 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 | |||
| Biocompatibility | Cytotoxicity | Materials are biocompatible. Tested per ISO | |
| 10993-1 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 | Similar |
| Sterilization
Method | Pre-vacuum Steam Sterilization | Pre-vacuum Steam Sterilization | |
| Sterilization
Parameters | 132 °C Pre-vacuum (Hi Vac)
Steam Cycle
Exposure temperature: 270 °F
(132 °C) Exposure time: 4
minutes
Vacuum dry time: 20 - 40
minutes 134 °C Pre-vacuum
(Hi Vac) Steam Cycle
Exposure temperature: 273 °F
(134 °C) | 132 °C Pre-vacuum Steam Cycle Exposure
temperature: 270 °F (132 °C) Exposure time: 4
minutes
Vacuum dry time: 30 minutes
134 °C Pre-vacuum Steam Cycle Exposure
temperature: 273 °F (134 °C) Exposure time: 3
minutes
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:
8
| 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
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 | The purpose of this study is to
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 |
| Title of test | Purpose of test | Acceptance Criteria / Source of
references | Results |
| Useful Life
Testing | The tray was subject to 100 cleaning
and sterilization cycles per the
Instructions for Use reprocessing
directions. The purpose of the test
was to determine the serviceable life
span of the tray. | 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 | The purpose of this test is to validate
that the cleaning instructions listed 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, 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 | Pass |
| Sterilization
Validation | The purpose of this test is to validate
that the sterilization instructions listed
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 |
9
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.
10
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.