(147 days)
No
The device description and intended use clearly define a physical system for organizing and sterilizing surgical instruments and implants. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and sterilization effectiveness.
No.
This device is a sterilization tray system designed to organize, enclose, sterilize, transport, and store surgical instruments and implantable devices. It does not provide any therapeutic effect itself.
No
The device is a sterilization tray system designed to organize, enclose, sterilize, transport, and store other medical devices and instruments. Its function is to maintain the sterility and organize instruments, not to diagnose medical conditions.
No
The device is a physical sterilization tray system made of aluminum and stainless steel, designed to organize and sterilize surgical instruments and implants. It does not involve any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for organizing, enclosing, sterilizing, transporting, and storing implantable devices and surgical instruments. This is related to the preparation and handling of medical devices used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description details components for holding implants and instruments, and its function in sterilization and storage. This aligns with a device used in surgical settings, not a diagnostic test.
- Performance Studies: The performance studies focus on sterilization effectiveness, cleaning validation, design verification (containment, strength, stacking), and life cycle testing. These are all relevant to the functionality and safety of a device used to prepare surgical instruments and implants, not to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other characteristics typically associated with IVD devices.
Therefore, the Stryker Universal Select Sterilization Tray System is a medical device used in the preparation and handling of other medical devices, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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:
| Configuration1 | Maximum Validated Load Set Contents2,5 |
|---|---|
| 3-Level Rack - Qty. 2 (29-13910) in a Full DIN Rigid Sterilization Container3 | 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 DIN Rigid Sterilization Container4 | 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.
Product codes
KCT
Device Description
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.
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)
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 10^6 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 ANSI/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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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
1
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
2
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
"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."
3
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 Full | |
| DIN Rigid Sterilization | |
| Container3 | 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 DIN | |
| Rigid Sterilization | |
| Container4 | 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."
4
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 Medical
8 Matchett Drive
Pierceton, IN 46562 USA
Phone: 574-594-2140
Fax: 574-594-2154 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------|
| 2. Correspondent Contact Information: | Rebecca Walker
Regulatory 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.
5
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 Full | |
| DIN Rigid | |
| Sterilization | |
| Container3 | 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) | |
| 29-13905 Trocar Instrument Tray with Lid (29-13921) | |
| 3-Level Rack - Qty. | |
| 1 | |
| (29-13910) in a ½ | |
| DIN Rigid | |
| Sterilization | |
| Container4 | 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) |
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.
6
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/Sterilization | |
| Cassettes | Stryker Universal Select Sterilization Tray System | |
| 510(k) | ||
| Number | K163279 | K173615 |
| Product Code | KCT | KCT |
7
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.
| Indications
for Use | The Medtronic Transportation/Sterilization
Cassettes are intended for use in healthcare
facilities to organize, enclose, sterilize,
transport, and store medical devices and
other instrumentation between surgical and
other medical uses. The Medtronic
Transportation/Sterilization Cassettes are
not intended on their own to maintain
sterility; they are intended to be used in
conjunction with a legally marketed,
validated, FDA-cleared sterilization wrap.
Sterilization validations for the worst case
Medtronic Transportation/Sterilization
Cassette (22.75 x 11.26 x 5.5 inches)
included implants and common surgical
instruments such as rasps, drivers, trials,
handles, inserters, probes, drills, etc. The
validated total weight was 28.4lbs. The
validated worst case loading configurations
of the Medtronic Transportation/
Sterilization Cassette included the following
worst case lumen dimensions:
• 363 x 1.575 mm
• 247.5 x 4.1 mm | | | | | 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 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 SterilContainer
cleared for pre-vacuum steam sterilization under K792558: Full DIN
JK444 (base) and JK489 (lid) and ½ DIN JK346 (base) and JK389 (lid). | | | |
| | Cycle | Temp. | Exposure
Time
(min) | Dry
Time
(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 | | | | | |
8
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 a | |||
| Full DIN Rigid | |||
| Sterilization | |||
| Container3 | 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 DIN Rigid | |||
| Sterilization | |||
| Container4 | 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) |
9
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.
| Validated
Worst Case
Configuration | Cassette:
22.75 x 11.26 x 5.5 inches
Contents:
Implants, Common Surgical Instruments
such 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-case
configuration 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) in
a Full DIN
Rigid
Sterilization
Container | | 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-case
configuration in a ½ DIN rigid sterilization container: | | |
| | Configuration | Maximum Validated Load Set Contents | |
| | 3-Level Rack -
Qty. 1
(29-13910) in a
½ DIN Rigid
Sterilization
Container | 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) | |
| | 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.) | | |
| Percent
Perforation | Evenly distributed perforated steam hole
pattern. | Evenly distributed perforated steam hole pattern. | |
| Sterilization
Method | • 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 |
|---|---|---|
| Patient | ||
| Contact | No direct patient contact | No direct patient contact |
| Air | ||
| Permeance | Yes | Yes |
Table 2: Comparison of Performance Characteristics
| | Predicate Device (Medtronic
Transportation/Sterilization Cassettes) | Subject Device (Stryker Universal Select Sterilization Tray System) |
|---------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material
Compatibility
with
Sterilization
Process | Materials are compatible with sterilization
method | Materials are compatible with steam sterilization. Performance testing
demonstrated that the materials of construction are compatible with
repeated steam sterilization cycles. |
| Toxicological
Properties | 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.
-
- 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.
-
- 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.