(83 days)
Not Found
No
The device is a passive sterilization tray made of stainless steel with silicone brackets. Its function is to hold instruments during sterilization cycles. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
Explanation: The device is a sterilization tray intended to enclose and organize reusable medical instruments during sterilization. It is not designed to directly treat or diagnose any medical condition.
No
This device is a sterilization tray intended to enclose and organize medical instruments during sterilization, not to diagnose medical conditions.
No
The device described is a physical sterilization tray made of stainless steel with silicone components. It is intended to enclose and organize medical instruments during sterilization. There is no mention of any software component in the description or intended use.
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 trays are for "enclos[ing] and organiz[ing] Stryker Endoscopy reusable medical instruments during sterilization at a healthcare facility." This is a function related to the processing and sterilization of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description details the physical characteristics of the trays (stainless steel, perforated, silicone brackets, latches, handles) and their purpose in facilitating sterilization. There is no mention of any components or functions related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
- Reagents, calibrators, or controls used in diagnostic tests
The device is a medical device used in the process of preparing other medical devices for use. It does not perform any diagnostic function.
N/A
Intended Use / Indications for 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 Endoscopy instruments for which they 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 Wrapping Double Temperature 132°C (270°F) Sterilization Time 4 minutes Dry Time 30 minutes |
| 3 | Gravity Steam | Cycle 1 Wrapping Double Temperature 132°C (270°F) Sterilization Time 15 minutes Dry Time 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 Steam Sterilization (“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 |
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
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
healthcare facility
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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 Steam | |||
| Sterilization (“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 Tray
Product Load | Total Loaded
Tray 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)
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4
7 510(k) Summarv
| Submitter | Paragon Medical
8 Matchett Industrial Park Drive
Pierceton, IN 46562 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mike Gosmeyer
VP, Quality and Regulatory
Paragon Medical, Inc.
8 Matchett Industrial Park Drive
Pierceton, IN 46562
Email: mike.gosmeyer@paragonmedical.com
Phone: 574-594-2140 ext. 10381 |
| Date Prepared | December 23, 2015 |
| Trade Names | Advanced Imaging Modality (AIM) Sterilization Tray
Endoscope and Camera Sterilization Tray
Camera Sterilization Tray |
| Common Name | Sterilization Tray |
| Classification | 21 CFR 880.6850, Sterilization wrap containers, trays, cassettes and other
accessories, 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 Steam | |||
| Sterilization (“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 Tray
Product Load | Total Loaded
Tray 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.