(83 days)
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:
| No | Method | Cycle |
|---|---|---|
| 1 | Ethylene Oxide (EtO) | Preconditioning Parameters |
| Temperature (°C) | ||
| 55°C (131°F) | ||
| Chamber Humidity | ||
| 70% RH | ||
| Vacuum Set Points | ||
| 1.3 psia | ||
| Time | ||
| 30 minutes | ||
| Exposure | ||
| Concentration | ||
| 725 mg/L, 100% EO | ||
| Temperature (°C) | ||
| 55°C ±2°C (131°F ±5°F) | ||
| Time | ||
| 1 hour | ||
| Chamber Humidity (%) | ||
| 70% RH (50-80%) ±5% | ||
| Aeration | ||
| Aeration Time | ||
| 12 hours | ||
| Temperature | ||
| 35°C - 54°C (95°F - 129°F) | ||
| 2 | Prevacuum Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 4 minutes | ||
| 3 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 3 | Gravity Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 15 minutes | ||
| 10 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 4 | STERIS® V-PRO® 1 | Standard |
| 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen |
| 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen |
| 7 | STERRAD® 100S | Standard |
| 8 | STERRAD® NX® | Standard |
| 9 | STERRAD® 100NX® | Standard |
In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.
| Method | Cycle | Cycle 1 | Cycle 2 |
|---|---|---|---|
| Immediate Use SteamSterilization (“Flash”)Prevacuum Steam | Wrapping | None | None |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | None | None |
The maximum product loads for the trays are as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Total LoadedTray Weight |
|---|---|---|---|
| Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1) | 8.83 lbs |
- Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods:
- Ethylene Oxide (EtO)
- Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam .
- Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles)
- STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) .
The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.
This document describes the premarket notification for sterilization trays and does not concern a medical device that relies on algorithms or AI for its function. Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truthing, MRMC studies, or standalone algorithm performance is not applicable in the context of this submission.
The document focuses on demonstrating substantial equivalence of the sterilization trays to a predicate device through physical and chemical performance testing related to sterilization cycles and material biocompatibility.
Here's an overview of the information that is available in the provided text:
Acceptance Criteria and Reported Device Performance:
The document broadly states that "All results met acceptance criteria" for non-clinical testing and that "Performance testing demonstrated the subject device met pre-set acceptance criteria." However, it does not explicitly define specific numerical acceptance criteria for each test or detail the quantitative results beyond stating they were met.
For example, for biocompatibility:
- Cytotoxicity (pre-sterilization and post-sterilization): "no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic" and "grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization."
- ISO intracutaneous reactivity: "overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating."
The key performance aspect relates to the efficacy of various sterilization methods when used with the trays and the physical integrity/biocompatibility of the trays themselves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Not explicitly defined with quantitative metrics, but implicitly: devices enclosed in the tray must be sterile after designated cycles. Compatibility with specific cycles is the main criterion. | The trays are compatible with and were validated for a range of sterilization methods and cycles, including: - Ethylene Oxide (EtO) - Prevacuum Steam (Cycle 1: 132°C/4min/30min dry; Cycle 2: 134°C/3min/30min dry) - Gravity Steam (Cycle 1: 132°C/15min/30min dry; Cycle 2: 134°C/10min/30min dry) - Immediate Use Steam Sterilization ("Flash")/Prevacuum Steam (Cycle 1: 132°C/4min/no dry; Cycle 2: 134°C/3min/no dry) - STERIS® V-PRO® (1 Standard, 1 Plus Non-Lumen/Lumen, maX Non-Lumen/Lumen) - STERRAD® (100S Standard, NX Standard, 100NX Standard) "Performance testing demonstrated the subject device met pre-set acceptance criteria." This implies successful sterilization outcomes using these methods with the trays. |
| Cleaning Validation | Not explicitly defined, but implicitly: trays must be effectively cleaned. | "cleaning validations (automated and manual)" were conducted. "All results met acceptance criteria." |
| Life Cycle Evaluation | Not explicitly defined, but implicitly: material and mechanical functionality must endure. | Life cycle evaluations of materials and mechanical functionality of the latch were performed. "All results met acceptance criteria." |
| Strength Testing of Tray Handles | Not explicitly defined, but implicitly: handles must withstand typical use without failure. | "strength testing of tray handles" was conducted. "All results met acceptance criteria." |
| Latch Force Testing | Not explicitly defined, but implicitly: latches must function correctly. | "latch force testing" was conducted. "All results met acceptance criteria." |
| Biocompatibility: | ||
| * Pre-sterilization Cytotoxicity* | No cytotoxicity or cell lysis (ISO 10993-5 grading system). | "test article extracts showed no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic." |
| * ISO Intracutaneous Reactivity* | Mean difference in erythema and edema scores between control and test articles must be minimal (based on ISO 10993-10). | "the overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating." |
| * Post-sterilization Cytotoxicity* | Acceptable cytotoxicity levels (grade 2 or less cell lysis). | "test article extracts showed grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization." |
Regarding the other questions:
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified in the document. These are physical product tests, not data-driven AI performance evaluations.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests would be objective measurements (e.g., sterility indicators, strength measurements, chemical analyses for biocompatibility).
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. These are physical product tests, not subjective expert reviews.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI-powered diagnostic/interpretive device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI-powered device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests (sterilization, cleaning, lifespan, strength, latch force), the ground truth would be established by objective, verifiable measurements according to validated test protocols and industry standards (e.g., AAMI standards for sterilization, ISO standards for biocompatibility).
- 8. The sample size for the training set: Not applicable. This refers to an AI/machine learning context, which is not relevant here.
- 9. How the ground truth for the training set was established: Not applicable. This refers to an AI/machine learning context, which is not relevant here.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2015
Paragon Medical, Inc. c/o Mr. Dave Yungvirt, CEO Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 1011
Re: K152951
Trade/Device Name: Advanced Imaging Modality (AIM) Sterilization Tray Endoscope and Camera Sterilization Tray Camera Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: KCT Dated: November 20, 2015 Received: December 14, 2015
Dear Mr. Yungvirt:
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. 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.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K152951
Device Name
Advanced Imaging Modality (AIM) Sterilization Tray Endoscope and Camera Sterilization Tray Camera Sterilization Tray
Indications for Use (Describe)
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker Endoscopy instruments for which they are not intended to mantain sterlity; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:
| No | Method | Cycle |
|---|---|---|
| 1 | Ethylene Oxide (EtO) | Preconditioning Parameters |
| Temperature (°C) | ||
| 55°C (131°F) | ||
| Chamber Humidity | ||
| 70% RH | ||
| Vacuum Set Points | ||
| 1.3 psia | ||
| Time | ||
| 30 minutes | ||
| Exposure | ||
| Concentration | ||
| 725 mg/L, 100% EO | ||
| Temperature (°C) | ||
| 55°C ±2°C (131°F ±5°F) | ||
| Time | ||
| 1 hour | ||
| Chamber Humidity (%) | ||
| 70% RH (50-80%) ±5% | ||
| Aeration | ||
| Aeration Time | ||
| 12 hours | ||
| Temperature | ||
| 35°C - 54°C (95°F - 129°F) | ||
| 2 | Prevacuum Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 4 minutes | ||
| 3 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 3 | Gravity Steam | Cycle 1 |
| Cycle 2 | ||
| Wrapping | ||
| Double | ||
| Double | ||
| Temperature | ||
| 132°C (270°F) | ||
| 134°C (273°F) | ||
| Sterilization Time | ||
| 15 minutes | ||
| 10 minutes | ||
| Dry Time | ||
| 30 minutes | ||
| 30 minutes | ||
| 4 | STERIS® V-PRO® 1 | Standard |
| 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen |
| 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen |
| 7 | STERRAD® 100S | Standard |
| 8 | STERRAD® NX® | Standard |
| 9 | STERRAD® 100NX® | Standard |
{3}------------------------------------------------
In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.
| Method | Cycle | Cycle 1 | Cycle 2 |
|---|---|---|---|
| Immediate Use SteamSterilization (“Flash”)Prevacuum Steam | Wrapping | None | None |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | None | None |
The maximum product loads for the trays are as follows:
| Tray Description | Catalog Number | Maximum TrayProduct Load | Total LoadedTray Weight |
|---|---|---|---|
| Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1) | 8.83 lbs |
- Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).
Type of Use (Select one or both, as applicable)
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.
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}------------------------------------------------
7 510(k) Summarv
| Submitter | Paragon Medical8 Matchett Industrial Park DrivePierceton, IN 46562 |
|---|---|
| Contact Person | Mike GosmeyerVP, Quality and RegulatoryParagon Medical, Inc.8 Matchett Industrial Park DrivePierceton, IN 46562Email: mike.gosmeyer@paragonmedical.comPhone: 574-594-2140 ext. 10381 |
| Date Prepared | December 23, 2015 |
| Trade Names | Advanced Imaging Modality (AIM) Sterilization TrayEndoscope and Camera Sterilization TrayCamera Sterilization Tray |
| Common Name | Sterilization Tray |
| Classification | 21 CFR 880.6850, Sterilization wrap containers, trays, cassettes and otheraccessories, Class II |
| Product Code | KCT |
| Product Design | Sterilization cassette by Oticon Medical AB, K141616 |
Device Description: The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are stainless steel, perforated sterilization trays to allow sterilization gases to penetrate the tray and sterilize the enclosed devices. They are used to enclose and protect particular Stryker endoscopy products during sterilization. The tray is compatible with the following sterilization methods:
- Ethylene Oxide (EtO)
- Prevacuum Steam, Immediate Use Prevacuum Steam, and Gravity Steam .
- Steris V-PRO 1 (Standard Cycle), Steris V-PRO 1 Plus (Non-Lumen or Lumen Cycles), Steris V-. PRO maX (Non-Lumen or Lumen Cycles)
- STERRAD 100S, STERRAD NX, and STERRAD 100NX (all with Standard Cycle) .
The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The trays are comprised of a stainless steel base and removable stainless steel lid. The base includes silicone brackets for Stryker endoscopy device fixation within the tray and two (2) latches to affix the lid to the base. Handles on the sides of the base facilitate carrying of the trays are reusable and provided in a non-sterile condition.
Intended Use
The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended to enclose and organize Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility. The trays are optional accessories to the Stryker
{5}------------------------------------------------
Endoscopy instruments for which they are designed. The trays are not intended to maintain sterility; they are intended to be used in conjunction with legally marketed, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are intended for use in any of the following standard sterilization machines / cycles:
| No | Method | Cycle | ||
|---|---|---|---|---|
| 1 | Ethylene Oxide (EtO) | Preconditioning Parameters | ||
| Temperature (°C) | 55°C (131°F) | |||
| Chamber Humidity | 70% RH | |||
| Vacuum Set Points | 1.3 psia | |||
| Time | 30 minutes | |||
| Exposure | ||||
| Concentration | 725 mg/L, 100% EO | |||
| Temperature (°C) | 55°C +2°C (131°F +5°F) | |||
| Time | 1 hour | |||
| Chamber Humidity (%) | 70% RH (50-80%) +5% | |||
| Aeration | ||||
| Aeration Time | 12 hours | |||
| Temperature | 35°C - 54°C (95°F - 129°F) | |||
| 2 | Prevacuum Steam | Cycle 1 | Cycle 2 | |
| Wrapping | Double | Double | ||
| Temperature | 132°C(270°F) | 134°C(273°F) | ||
| Sterilization Time | 4 minutes | 3 minutes | ||
| Dry Time | 30 minutes | 30 minutes | ||
| 3 | Gravity Steam | Cycle 1 | Cycle 2 | |
| Wrapping | Double | Double | ||
| Temperature | 132°C(270°F) | 134°C(273°F) | ||
| Sterilization Time | 15 minutes | 10 minutes | ||
| Dry Time | 30 minutes | 30 minutes | ||
| 4 | STERIS® V-PRO® 1 | Standard | ||
| 5 | STERIS® V-PRO® 1 Plus | Non-Lumen or Lumen | ||
| 6 | STERIS® V-PRO® maX | Non-Lumen or Lumen | ||
| 7 | STERRAD® 100S | Standard | ||
| 8 | STERRAD® NX® | Standard | ||
| 9 | STERRAD® 100NX® | Standard |
{6}------------------------------------------------
In addition, the Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are validated for the following Immediate Use Steam Sterilization cycles for emergency situations ONLY.
| Method | Cycle | Cycle 1 | Cycle 2 |
|---|---|---|---|
| Immediate Use SteamSterilization (“Flash”)Prevacuum Steam | Wrapping | None | None |
| Temperature | 132°C(270°F) | 134°C(273°F) | |
| Sterilization Time | 4 minutes | 3 minutes | |
| Dry Time | None | None |
The maximum product loads for the trays are as follows:
| Tray Description | CatalogNumber | Maximum TrayProduct Load | Total LoadedTray Weight |
|---|---|---|---|
| Advanced Imaging Modality (AIM) Sterilization Tray | 0233-032-301 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Endoscope and Camera Sterilization Tray | 233-032-302 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1)Scope (Qty. 2)Adapter (Qty. 2) | 10.58 lbs |
| Camera Sterilization Tray | 0233-410-002 | Camera (Qty. 1)Light Cable (Qty. 1)Coupler (Qty. 1) | 8.83 lbs |
- Validated worst case loading configuration included the Advanced Imaging Modality (AIM) Sterilization Tray containing a camera (Qty. 1), light cable (Qty. 1), coupler (Qty. 2), scope (Qty. 3) and adapter (Qty. 3).
Comparison of Intended Use: Relative to the predicate, the indications for use statement for the subject device recommends the following additional sterilization methods: ethylene oxide (EO), gravity steam. immediate use prevacuum steam. Steris V-PRO 1 Plus, Steris V-PRO maX, STERRAD 100S, STERRAD NX, and STERRAD 100NX. These new sterilization cycles do not raise new questions of safety and effectiveness and do not affect safety and effectiveness. Performance testing demonstrated the subject device met pre-set acceptance criteria and are substantially equivalent to the predicate. The subject device includes a 30 minute dry time for both the 132°C, 4 minute and 134°C, 3 minute prevacuum steam sterilization cycles. This dry time complies with the recommended 20 to 30 minutes dry times per ANSI/AAMI ST 79:2010 for wrapped instruments. The predicate indicates a shorter 20 minute (132°C, 4 minute) and 16 minute (134°C, 3 minute) prevacuum steam sterilization dry time. The longer dry time of the subject device does not raise new questions of safety and effectiveness and does not affect safety and effectiveness. Performance testing demonstrated the longer dry time of the subject device met pre-set acceptance criteria and is substantially equivalent to the predicate. The subject device has an aeration time of 12 hours at a temperature of 35°C - 54°C (95°F – 129°F) for ethylene oxide (EO) The predicate device does not have an aeration time, as it is not indicated for EO sterilization. sterilization. This aeration time does not raise new questions of safety and effectiveness and does not
{7}------------------------------------------------
affect safety and effectiveness. Performance testing demonstrated that the subject device met pre-set acceptance criteria and is substantially equivalent to the predicate.
The intended use of the subject device is prescription use as compared to over-the-counter (OTC) use for the predicate device. As the subject device is intended to be used with Stryker Endoscopy devices in a clinical setting, its indications for use statement specifies prescription use. This difference does not raise new questions of safety and effectiveness and does not affect safety and effectiveness.
Comparison of Technological Characteristics: Like the predicate device, the subject device is a perforated, stainless steel sterilization tray requiring the usage of an FDA cleared sterilization wrap.
Non-Clinical Testing: The following non-clinical testing was conducted: a) sterilizations (steam [prevacuum air removal and gravity air displacement cycles], STERRAD [100S, NX, and 100NX], Steris [V-PRO, V-PRO 1 Plus, and V-PRO 1 maX], and Ethylene Oxide (EO)], b) cleaning validations (automated and manual), c) life cycle evaluations of materials and mechanical functionality of latch, d) strength testing of tray handles, and e) latch force testing. All results met acceptance criteria.
Biocompatibility testing was conducted on indirect / secondary patient-contacting materials of the device. Three sets of testing were conducted: 1) presterilization cytotoxicity, 2) presterilization ISO intracutaneous reactivity, and 3) post-sterilization cytotoxicity. Under conditions of the each study, results were as follows: 1) test article extracts showed no cytotoxicity or cell lysis using the grading system of ISO 10993-5, indicating the materials are non-cytotoxic, 2) using the 8-point edema and 4-point erythema scoring system of ISO 10993-10, the overall mean difference in erythema and edema scores scores between control and test articles was 0.0 (0.9% sodium chloride extract) and 0.1 (sesame oil extract), indicating the materials are non-irritating, 3) test article extracts showed grade 2 or less cell lysis and none to mild reactivity, indicating the materials met acceptable cytotoxicity levels (grade 2 or less) post-sterilization.
Clinical Testing: No clinical testing was conducted.
Conclusions: The Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray have been validated to meet the established performance criteria. Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the subject devices Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, and Camera Sterilization Tray are substantially equivalent to, and are safe and as effective as, the legally marketed predicate device, Sterilization Cassette by Oticon Medical AB, under 510(K) K141616.
§ 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).