(147 days)
The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:
Pre-vacuum Steam
Enclosure: Rigid Container1
Temperature: 132°C (270°F), 135°C (275°F)
Sterilization Time: 4 minutes, 3 minutes
Minimum Dry Time: 30 minutes, 30 minutes
Maximum Weight: 25 lbs / 11.36 kg, 25 lbs / 11.36 kg
1 Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid).
The maximum validated product loads for the trays in containers are as follows:
Configuration: 3-Level Rack - Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container3
Maximum Validated Load Set Contents: 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941), 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941), 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941), 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941), 29-17903 1.7 Orthognathic Plates Inlay, 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941), 29-23905 2.0/2.3 Mini Plates Inlay, Large, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)
Configuration: 3-Level Rack – Qty. 1 (29-13910) in a ½ DIN Rigid Sterilization Container4
Maximum Validated Load Set Contents: 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941), 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941), 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay, 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921), 29-13905 Trocar Instrument Tray with Lid (29-13921), 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921), 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)
1 Model numbers shown in table are Stryker® model numbers
2 Contents in the validated Tray System inplants (plates, meshes, bone screws, etc.), single-use instruments (drills), and revable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.)
3 Tray system components part of the worst-case configuration Container validation in an Aesculap SterilContainer Base (K446) and Lid (JK489) cleared under K792558
4 Tray system components part of the worst-case configuration in a 1/2 DN Rigid Sterilization in an Aesculap SteriliContainer Base (K346) and Lid (JK389) cleared under K792558
5 No lumened devices were validated within the tray system as part of the Stryker Universal Select Sterilization Tray System does not have any lumen claims.
The Stryker Universal Select Sterilization Tray System consists of anodized aluminum implant modules and inlays to store single-use titanium implants and stainless steel instrument and accessory trays for surgical instrumentation. The implant modules and trays have stainless steel lids which have a slide latch feature. Instrument trays are specific to a set configuration and have stainless steel and silicone brackets, removable screw caddy (for the 90° screwdriver instrument tray), and silkscreened artwork to assist the end user in correct placement of the instruments. Accessory trays are not specific to a set configuration, and have an open area designed for placement of commonly used instruments such as cutters, benders and forceps. The individual components of the system can be organized and stored in a 2-level or a 3-level stainless steel rack. The rack is designed to fit in an Aesculap rigid sterilization container (K792558). The tray system is reusable and provided in a non-sterile condition.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Effectiveness (Biological Indicators) | Worst-case configuration: 10^6 Geobacillus stearothermophilus spores killed after 132°C pre-vacuum steam autoclave half cycle exposures. | Verified effective, with reduction of 10^6 Geobacillus stearothermophilus spores. |
| Dry Time | Defined minimum dry time based on validated sterilization configurations (e.g., 30 minutes for 132°C/4 min and 135°C/3 min cycles). | Achieved and maintained sterility following minimum dry times. |
| Cleaning Validation | Effectiveness in removing soil from all designated surfaces. | Effective in removing soil using recommended cleaning methods and neutral pH detergent. |
| Containment Verification | Ability to contain devices during transport and simulated use. | Verified to contain devices. |
| Handle Strength | Met ASTM F2111 (K163279, P.) and EN 868-8:2009 standards. | Met handle strength requirements per AAMI ST77:2013 and EN 868-8:2009. |
| Stacking Verification | Ability of trays to stack securely. | Verified to stack. |
| Edge Sharpness | No sharp edges impacting user safety. | Met edge sharpness requirements. |
| Maximum Weight | Sustained maximum validated weight (25 lbs / 11.36 kg). | Verified for maximum weight. |
| Life Cycle Testing | Maintained functional quality, material integrity, and traceability (artwork, UDI legibility) after repeated sterilization, washing, and simulated functional use. | Maintained functional quality, material integrity, and traceability. |
| Biocompatibility (Cytotoxicity) | Grade 2 or less cell lysis and reactivity (non-cytotoxic) per ISO 10993-5. | Test article extracts showed Grade 2 or less cell lysis and reactivity, indicating non-cytotoxic materials post-sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set in terms of individual devices or sterilization cycles. Instead, it refers to "worst case configured tray system" and "Both full size and ½ size rigid sterilization containers." This implies a representative selection of configurations rather than a large statistical sample.
The data provenance is from non-clinical performance testing conducted by Paragon Medical (the manufacturer) in the United States, as indicated by the company information and the FDA submission. This would be considered prospective for the device's validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The validation for sterilization, cleaning, and design verification appears to be based on adherence to established standards and scientific testing protocols (e.g., ANSI/AAMI/ISO 17665-1:2006, AAMI TIR 30:2011, ISO 10993-5, AAMI ST77:2013, EN 868-8:2009) rather than expert consensus on observational data.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, laboratory-based evaluations against predetermined criteria and standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the testing for a medical device (sterilization tray system), not an AI algorithm for diagnostic imaging. Therefore, MRMC studies are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests is derived from:
- Microbiological standards: For sterilization effectiveness, the ground truth is the complete inactivation of a specified challenge organism (Geobacillus stearothermophilus spores) as defined by biological indicator testing (ANSI/AAMI/ISO 17665-1:2006).
- Chemical/Physical standards: For cleaning validation, the ground truth involves objective measurements of soil removal based on AAMI TIR 30:2011.
- Engineering and material standards: For design verification (handle strength, stacking, edge sharpness, maximum weight) and material compatibility/biocompatibility, the ground truth is adherence to established industry standards and test methods (e.g., AAMI ST77:2013, EN 868-8:2009, ISO 10993-5).
- Functional performance: For life cycle testing, the ground truth is the continued functional operation and integrity of the device after simulated use and repeated processing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set. The device is a physical product, and its performance is validated through non-clinical laboratory testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device validation.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and consists of a stylized caduceus symbol. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
June 20, 2018
Paragon Medical % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K173615
Trade/Device Name: Stryker Universal Select Sterilization Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: April 5, 2018 Received: April 9, 2018
Dear Dave Yungvirt:
This letter corrects our substantially equivalent letter of April 18, 2018.
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K173615
Device Name
Stryker Universal Select Sterilization Tray System
Indications for Use (Describe)
The Stryker Universal Select Sterilization Tray System is intended to organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:
| Pre-vacuum Steam | ||
|---|---|---|
| Enclosure | Rigid Container1 | Rigid Container1 |
| Temperature | 132°C (270°F) | 135°C (275°F) |
| Sterilization Time | 4 minutes | 3 minutes |
| Minimum Dry Time | 30 minutes | 30 minutes |
| Maximum Weight | 25 lbs / 11.36 kg | 25 lbs / 11.36 kg |
1 Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid).
The maximum validated product loads for the trays in containers are as follows:
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X 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
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Indications for Use
510(k) Number (if known)
K173615
Device Name
Stryker Universal Select Sterilization Tray System
| Indications for Use (Describe) | |
|---|---|
| Configuration1 | Maximum Validated Load Set Contents2,5 |
| 3-Level Rack - Qty. 2(29-13910) in a FullDIN Rigid SterilizationContainer3 | 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941) |
| 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941) | |
| 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941) | |
| 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941) | |
| 29-17903 1.7 Orthognathic Plates Inlay | |
| 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921) | |
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) | |
| 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | |
| 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941) | |
| 29-23905 2.0/2.3 Mini Plates Inlay, Large | |
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |
| 3-Level Rack – Qty. 1(29-13910) in a ½ DINRigid SterilizationContainer4 | 29-13905 Trocar Instrument Tray with Lid (29-13921) |
| 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | |
| 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941) | |
| 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay | |
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |
| 29-13905 Trocar Instrument Tray with Lid (29-13921) | |
| 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921) | |
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) |
1 Model numbers shown in table are Stryker® model numbers
2 Contents in the validated Tray System inplants (plates, meshes, bone screws, etc.), single-use instruments (drills), and revable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.)
් Tray system components part of the worst-case configuration Container validation in an Aesculap SterilContainer Base (K446) and Lid (JK489) cleared under K792558
" Tray system components part of the worst-case configuration in a 1/2 DN Rigid Sterilization in an Aesculap SteriliContainer Base (K346) and Lid (JK389) cleared under K792558
f No lumened devices were validated within the tray system as part of the Stryker Universal Select Sterilization Tray System does not have any lumen claims.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| X | 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."
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Image /page/4/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center, and the words "PARAGON MEDICAL" in black text to the right of the pentagon. There are two black lines above and below the text.
510(k) Summary for Stryker Universal Select Sterilization Tray System
In accordance with 21 CFR 807.92, the following 510(k) summary is provided:
| 1. Applicant Information: | Paragon Medical8 Matchett DrivePierceton, IN 46562 USAPhone: 574-594-2140Fax: 574-594-2154 |
|---|---|
| 2. Correspondent Contact Information: | Rebecca WalkerRegulatory Affairs Manager |
Regulatory Affairs Manager Rebecca.walker@paragonmedical.com Phone: 574-594-2140 ext. 10384
-
- Date Prepared: April 16, 2018
-
- Trade Name: Stryker Universal Select Sterilization Tray System
- Common Name: Sterilization Tray ട്.
-
- Classification Name: Sterilization wrap (21 CFR 880.6850, Product Code KCT)
-
- Predicate Device: The Stryker Universal Select Sterilization Tray System is substantially equivalent to the following 510(k) cleared device:
- . Medtronic Transportation/Sterilization Cassettes, K163279
- The Stryker Universal Select Sterilization Tray System consists of 8. Device Description: anodized aluminum implant modules and inlays to store single-use titanium implants and stainless steel instrument and accessory trays for surgical instrumentation. The implant modules and trays have stainless steel lids which have a slide latch feature. Instrument trays are specific to a set configuration and have stainless steel and silicone brackets, removable screw caddy (for the 90° screwdriver instrument tray), and silkscreened artwork to assist the end user in correct placement of the instruments. Accessory trays are not specific to a set configuration, and have an open area designed for placement of commonly used instruments such as cutters, benders and forceps. The individual components of the system can be organized and stored in a 2-level or a 3-level stainless steel rack. The rack is designed to fit in an Aesculap rigid sterilization container (K792558). The tray system is reusable and provided in a non-sterile condition.
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Image /page/5/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center, and the words "PARAGON MEDICAL" in black text to the right of the pentagon. There are two black lines above and below the text.
- The Stryker Universal Select Sterilization Tray System is intended to 9. Indications for Use: organize, enclose, sterilize, transport and store Stryker implantable devices and surgical instruments within a healthcare facility when used in conjunction with a validated, FDA cleared rigid sterilization container in order to maintain sterility of the enclosed devices. The Stryker Universal Select Sterilization Tray System has been validated for use in the following sterilization cycles:
| Pre-Vacuum Steam | ||
|---|---|---|
| Enclosure | Rigid Container² | Rigid Container² |
| Temperature | 132°C (270°F) | 135°C (275°F) |
| Sterilization Time | 4 minutes | 3 minutes |
| Minimum Dry Time | 30 minutes | 30 minutes |
| Maximum Weight¹ | 25 lbs / 11.36 kgs | 25 lbs / 11.36 kgs |
I Tray System has been validated in the following Aesculap SterilContainer cleared for pre-vacuum steam sterilization under K792558: Full DIN JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid)
| Configuration1 | Maximum Validated Load Set Contents2,5 |
|---|---|
| 3-Level Rack - Qty.2(29-13910) in a FullDIN RigidSterilizationContainer3 | 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941)29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941)29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941)29-17901 1.7 Mid-Face Plates Module with Lid (29-13941)29-17903 1.7 Orthognathic Plates Inlay29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921)29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921)29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941)29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941)29-23905 2.0/2.3 Mini Plates Inlay, Large29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)29-13905 Trocar Instrument Tray with Lid (29-13921) |
| 3-Level Rack - Qty.1(29-13910) in a ½DIN RigidSterilizationContainer4 | 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941)29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941)29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay29-13904 Mandible Fracture Instrument Tray with Lid (29-13921)29-13905 Trocar Instrument Tray with Lid (29-13921)29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921)29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) |
The maximum validated product loads for the trays in containers are as follows:
1 Model numbers shown in table are Stryker® model numbers
2 Contents in the validated Tray System included: Single-use implants (plates, meshes, etc.), single-use instruments (drills), and reusable surgical instruments (benders, forceps, handles, depth gauges, trocars, etc.)
3 Tray system components part of the worst-case configuration in a full DIN Rigid Sterilization Container validation in an Aesculap SterilContainer Base (JK446) and Lid (JK489) cleared under K792558
Tray system components part of the worst-case configuration in a 1/2 DIN Rigid Sterilization in an Aesculap SterilContainer Base (JK346) and Lid (JK389) cleared under K792558
' No lumened devices were validated within the tray system as part of the product load. The Stryker Universal Select Sterilization Tray System does have any lumen claims.
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Image /page/6/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star inside of it. To the right of the pentagon is the text "PARAGON MEDICAL" with a line above and below the text.
-
- Technological Comparison: A detailed comparison of the subject device to the predicate device demonstrates the similarities and differences in intended use, design, principles of operation, and materials of composition. The following pages contain a comparison of the technological (Table 1) and performance (Table 2) characteristics of the subject and predicate device.
Table 1: Comparison of Technological Characteristics
| Predicate Device | Subject Device | |
|---|---|---|
| Device Name | Medtronic Transportation/SterilizationCassettes | Stryker Universal Select Sterilization Tray System |
| 510(k)Number | K163279 | K173615 |
| Product Code | KCT | KCT |
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Image /page/7/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the logo, the words "PARAGON" and "MEDICAL" are stacked on top of each other, with a black line above and below the words.
| Indicationsfor Use | The Medtronic Transportation/SterilizationCassettes are intended for use in healthcarefacilities to organize, enclose, sterilize,transport, and store medical devices andother instrumentation between surgical andother medical uses. The MedtronicTransportation/Sterilization Cassettes arenot intended on their own to maintainsterility; they are intended to be used inconjunction with a legally marketed,validated, FDA-cleared sterilization wrap.Sterilization validations for the worst caseMedtronic Transportation/SterilizationCassette (22.75 x 11.26 x 5.5 inches)included implants and common surgicalinstruments such as rasps, drivers, trials,handles, inserters, probes, drills, etc. Thevalidated total weight was 28.4lbs. Thevalidated worst case loading configurationsof the Medtronic Transportation/Sterilization Cassette included the followingworst case lumen dimensions:• 363 x 1.575 mm• 247.5 x 4.1 mm | The Stryker Universal Select Sterilization Tray System is intended toorganize, enclose, sterilize, transport and store Stryker implantable devicesand surgical instruments within a healthcare facility when used inconjunction with a validated, FDA cleared rigid sterilization container inorder to maintain sterility of the enclosed devices.The Stryker Universal Select Sterilization Tray System has been validatedfor use in the following sterilization cycles: | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Pre-vacuum Steam Cycles | |||||||||
| Enclosure | Rigid Container1 | Rigid Container1 | |||||||
| Temperature | 132°C (270°F) | 135°C (275°F) | |||||||
| Sterilization Time | 4 minutes | 3 minutes | |||||||
| Minimum Dry Time | 30 minutes | 30 minutes | |||||||
| Maximum Weight | 25 lbs / 11.36 kg | 25 lbs / 11.36 kg | |||||||
| 1Tray System has been validated in the following Aesculap SterilContainercleared for pre-vacuum steam sterilization under K792558: Full DINJK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid). | |||||||||
| Cycle | Temp. | ExposureTime(min) | DryTime(min) | ||||||
| Gravity | 121°C | 30 | 30 | ||||||
| Gravity | 132 °C | 15 | 30 | ||||||
| Gravity | 135 °C | 10 | 30 | ||||||
| Pre-vacuum | 132 °C | 4 | 30 | ||||||
| Pre-vacuum | 135 °C | 3 | 30 |
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Image /page/8/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center, followed by the words "PARAGON" and "MEDICAL" stacked on top of each other. There are two black lines above and below the words.
| The maximum validated product loads for the tray system in containers are as follows: | |||
|---|---|---|---|
| Configuration1 | Maximum Validated Load Set Contents2,5 | ||
| 3-Level Rack –Qty. 2(29-13910) in aFull DIN RigidSterilizationContainer3 | 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941) | ||
| 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941) | |||
| 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941) | |||
| 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941) | |||
| 29-17903 1.7 Orthognathic Plates Inlay | |||
| 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921) | |||
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) | |||
| 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | |||
| 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941) | |||
| 29-23905 2.0/2.3 Mini Plates Inlay, Large | |||
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |||
| 3-Level Rack –Qty. 1(29-13910) in a½ DIN RigidSterilizationContainer4 | 29-13905 Trocar Instrument Tray with Lid (29-13921) | ||
| 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | |||
| 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid (29-13941) | |||
| 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay | |||
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |||
| 29-13905 Trocar Instrument Tray with Lid (29-13921) | |||
| 29-13906 Mandible Reconstruction Instrument Tray with Lid (29-13921) | |||
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) |
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Image /page/9/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star inside of it. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other, with a black line above and below the words.
| Design | Base, Lid with a locking latch, Individual Inserts | The Stryker Universal Select Sterilization Tray System platform is designed to be compatible with Stryker implantable devices and surgical instrumentation. Individual components were designed to slide in to 2- and 3-level storage racks. Racks have handles on the side to facilitate carrying. Module and tray lids have sliding latch mechanism to facilitate containment. | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Materials of Construction | Thermoplastic Polymers, Aluminum, Stainless Steel | Stainless Steel, Anodized Aluminum, USP Class VI Silicone, PPSU, Polypropylux | |||||||
| Perforated Bases, Lids, Inserts | Perforated 2-level and 3-level Racks that house the following tray components: | ||||||||
| Configuration and Dimensions | Case - Triple Generic Outer Base Lid - Generic Outer Lid Tray Lid Tray 1 Tray 2 Tray 3 Large Caddy Large Lid Small Caddy Small Lid | 22.74 x 11.260 x 5.040 inches 22.75 x 11.260 x 0.470 inches 21 x 10.13 x 0.075 inches 20.75 x 9.79 x 1.32 inches 21 x 10.13 x 1.69 inches 21 x 10.13 x 1.38 inches 9.47 x 6.37 x 1.3 inches 5.85 x 4.725 x 0.095 inches 2 x 1.5 x 1.025 inches 2 x 1.29 x 0.095 inches | 2-level Rack 3-level Rack 1/4 DIN Instrument/Accessory Tray 1/4 DIN Instrument/Accessory Tray Lid 1/2 DIN Instrument/Accessory Tray 1/2 DIN Instrument/Accessory Tray Lid 1/4 DIN Implant/Screw Modules ¼ DIN Screw Module ¼ DIN Implant Module Lid Inlay Inlay, large Drill Caddy 1/4 DIN Instrument/Accessory Tray Silicone Mat | 9.80 x 9.70 x 5.27 inches 9.80 x 9.70 x 7.57 inches 9.31 x 4.09 x 1.54 inches 9.29 x 4.30 x 0.51 inches 9.31 x 8.55 x 1.54 inches 9.29 x 8.71 x 0.55 inches 9.31 x 4.25 x 1.05 inches 9.31 x 4.25 x 1.75 inches 9.33 x 4.23 x 0.44 inches 4.34 x 3.85 x 0.53 inches 8.91 x 3.85 x 0.34 inches 3.30 x 1.33 x 1.47 inches 8.95 x 3.67 x 0.63 inches | |||||
| 1/2 DIN Instrument/Accessory 8.95 x 8.14 x 0.63 inches Tray Silicone Mat | |||||||||
| Sterilization Parameters (Pre-Vacuum) | Cycle | Temp | Exposure | Min Dry Time | Cycle | Temp | Exposure | Min Dry Time | |
| Pre-Vacuum | 132° C (270°F) 135°C (275°F) | 4 Min 3 Min | 30 Min 30 Min | Pre-Vacuum | 132° C (270°F) 135°C (275°F) | 4 Min 3 Min | 30 Min 30 Min |
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Image /page/10/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star inside of it. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other, with a black line above and below the words.
| ValidatedWorst CaseConfiguration | Cassette:22.75 x 11.26 x 5.5 inchesContents:Implants, Common Surgical Instrumentssuch as rasps, drivers, trials, handles,inserters, probes, drills, etc.Lumen Dimensions:• 363 x 1.575 mm• 247.5 x 4.1 mm | The following set configurations were validates as the worst-caseconfiguration in a full DIN rigid sterilization container: | |
|---|---|---|---|
| Configuration | Maximum Validated Load Set Contents | ||
| 29-12900 1.2 Upper-Face Plates/Screws Module with Lid (29-13941) | |||
| 29-12901 1.2 Orbital Plates/Mesh Module with Lid (29-13941) | |||
| 29-17900 1.7 Mid-Face Plates/Screws Module with Lid (29-13941) | |||
| 29-17901 1.7 Mid-Face Plates Module with Lid (29-13941) | |||
| 3-Level Rack -Qty. 2(29-13910) ina Full DINRigidSterilizationContainer | 29-17903 1.7 Orthognathic Plates Inlay | ||
| 29-13901 Upper-/Mid-Face Instrument Tray with Lid (29-13921) | |||
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) | |||
| 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | |||
| 29-23901 2.0/2.3 Mandible Plates Module with Lid (29-13941) | |||
| 29-23905 2.0/2.3 Mini Plates Inlay, Large | |||
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |||
| 29-13905 Trocar Instrument Tray with Lid (29-13921) | |||
| The following set configurations were validated as the worst-caseconfiguration in a ½ DIN rigid sterilization container: | |||
| Configuration | Maximum Validated Load Set Contents | ||
| 3-Level Rack -Qty. 1(29-13910) in a½ DIN RigidSterilizationContainer | 29-23900 2.0/2.3 Mandible Screws Module with Lid (29-13941) | ||
| 29-23903 2.0/2.3 Mandible Recon Plates Module with Lid(29-13941) | |||
| 29-23904 2.0/2.3 Mandible Recon Primary Plates Inlay | |||
| 29-13904 Mandible Fracture Instrument Tray with Lid (29-13921) | |||
| 29-13905 Trocar Instrument Tray with Lid (29-13921) | |||
| 29-13906 Mandible Reconstruction Instrument Tray withLid (29-13921) | |||
| 29-13920 ¼ DIN Instrument/Accessory Tray with Lid (29-13921) | |||
| Contents include Stryker single-use implants (plates, meshes, bone screws,etc.) single-use reprocessed instruments (drills), and reusable instruments(Such as benders, forceps, handles, depth gauge, trocar, etc.) | |||
| PercentPerforation | Evenly distributed perforated steam holepattern. | Evenly distributed perforated steam hole pattern. | |
| SterilizationMethod | • Pre-vacuum• Gravity | • Pre-vacuum |
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Image /page/11/Picture/0 description: The image shows the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other, with a black line above and below the words.
| Reusable | Yes | Yes |
|---|---|---|
| PatientContact | No direct patient contact | No direct patient contact |
| AirPermeance | Yes | Yes |
Table 2: Comparison of Performance Characteristics
| Predicate Device (MedtronicTransportation/Sterilization Cassettes) | Subject Device (Stryker Universal Select Sterilization Tray System) | |
|---|---|---|
| MaterialCompatibilitywithSterilizationProcess | Materials are compatible with sterilizationmethod | Materials are compatible with steam sterilization. Performance testingdemonstrated that the materials of construction are compatible withrepeated steam sterilization cycles. |
| ToxicologicalProperties | Materials are biocompatible | Cytotoxicity testing demonstrated that the materials are non-cytotoxic. |
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Image /page/12/Picture/0 description: The image contains the logo for Paragon Medical. The logo consists of a red pentagon with a white star in the center. To the right of the pentagon are the words "PARAGON" and "MEDICAL" stacked on top of each other, with a black line above and below the words.
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- Performance Testing: The following non-clinical performance testing was conducted on the Stryker Universal Select Sterilization Tray System:
- Sterilization and Dry Time Validation .
Sterilization validations were performed to verify the effectiveness of steam sterilization of a fully loaded Stryker Universal Select Sterilization Tray System sterilized in a rigid sterilization container using an autoclave cycle with pre-vacuum air removal. The study evaluated the resistance of biological indicators (Bls) in the form of paper spore strips inoculated with 10° Geobacillus stearothermophilus spores to 132°C pre-vacuum steam autoclave half cycle exposures. Dry time was evaluated after sterilization. Both full size and ½ size rigid sterilization containers were validated per ANSV/AAMI/ISO 17665-1:2006.
. Cleaning Validation
A manual and automated cleaning validation was performed on the worst case configured tray system per AAMI TIR 30:2011 to validate the cleaning instructions. The results indicate that the recommended cleaning methods, using a neutral pH detergent were effective in removing soil from all designated surfaces of the Stryker Universal Select Sterilization Tray System that might be accessible to the end user.
. Design Verification
Design verification testing included containment verification during transport and simulated use, handle strength testing per AAMI ST77:2013 and EN 868-8:2009, verification of the tray system to stack, edge sharpness and verification of the maximum weight.
● Life Cycle Testing
Lifecycle testing was performed to verify that the Stryker Universal Select Sterilization Tray System maintained functional quality requirements, material integrity, and traceability (artwork and UDI legibility) after exposure to repeated pre-vacuum steam sterilization cycles and automated washing cycles, and simulated functional use of the components (latch and handle actuation).
. Biocompatibility
Biocompatibility testing was conducted on all materials used in construction of the Stryker Universal Select Sterilization Tray System per ISO 10993-5 using the MEM Elution method. Test article extracts showed grade 2 or less cell lysis and reactivity, indicating the materials met acceptable cytotoxicity levels post-sterilization.
All results of design verification testing met acceptance criteria.
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- Conclusion: The Stryker Universal Select Sterilization Tray System has been validated to meet the established performance criteria. Based on the intended use, technological characteristics, performance data, and nonclinical testing performed; the subject device is substantially equivalent to the legally marketed predicate device.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).