(158 days)
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
- Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
- Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time
- The kits are intended for sterilization of non-porous loads
- The tested kit represents the worst-case validated load of 497.1 grams
Paragon sterilization trays are divided into the following types:
- Complete Surgical Kit
- Standard Surgical Kit
- Drill Stop Kit
- Prosthetic Kit
The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon implant/prosthetic placement protocols, as well as hold various dental instruments such as: Surgical Drills, Drill Stops, Paralleling Tools, Implant Drivers, Drill Extender, Prosthetic Drivers and Torque Wrenches. The insert contains markings and colors to indicate either the surgical workflow or the position of the instruments within the cassette.
The Standard Surgical Kit includes a removable stainless-steel pan, which functions as a storage receptacle for used surgical instruments.
N/A
FDA 510(k) Clearance Letter - Sterilization Trays
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
November 14, 2025
Paragon Implant Mfg., LLC
Renee Bennett
Regulatory Affairs Manager
27030 Malibu Hills Road
Calabasas, California 91301
Re: K251756
Trade/Device Name: Sterilization Trays
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization Wrap
Regulatory Class: Class II
Product Code: KCT
Dated: October 15, 2025
Received: October 16, 2025
Dear Renee Bennett:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251756 - Renee Bennett Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K251756 - Renee Bennett Page 3
Sincerely,
STEPHEN A. ANISKO -S Digitally signed by STEPHEN A. ANISKO -S Date: 2025.11.14 16:27:56 -05'00'
Stephen Anisko
Acting Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K251756
Device Name
Sterilization Trays
Indications for Use (Describe)
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
- Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
- Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time
- The kits are intended for sterilization of non-porous loads
- The tested kit represents the worst-case validated load of 497.1 grams
| Model Name | Model (Catalog) Number | Max # of Instruments | Total Mass (g) | Vent to Volume Ratio (cm-1) |
|---|---|---|---|---|
| Complete Surgical Kit | CSK | 55 | 497.1 | 0.01043 |
| Standard Surgical Kit | SSK | N/A | 372.1 | 0.01043 |
| Drill Stop Kit | DSK | 20 | 37.5 | 0.9009 |
| Drill Stop Kit Empty | Not available | N/A | 31.2 | 0.9009 |
| Prosthetic Kit Empty | PKE | N/A | 120.3 | 0.03324 |
| Prosthetic Kit | Not available | 20 | 497.1 | 0.03324 |
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
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"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."
FORM FDA 3881 (8/23) Page 1 of 1
Page 5
510(k) Summary Sterilization Tray
K251756 Page 1 of 7
510(k) Summary
Paragon Implant Mfg., LLC
Sterilization Tray
November 13, 2025
Manufacturer Name
Paragon Implant Mfg., LLC
27030 Malibu Hills Road
Calabasas, CA 91301, U.S.A.
Telephone: (818) 475-4675
Official Contact
Renee Bennett, Manager of Regulatory Affairs
Paragon Implant Mfg., LLC
27030 Malibu Hills Road
Calabasas, CA 91301, U.S.A.
Telephone: (818) 475-4675
Email: rbennett@paragon-implant.com
Device Name and Classification
Trade/Proprietary Name: Sterilization Tray
Common Name: Sterilization Wrap
Regulation Number: 21 CFR § 880.6850
Regulation Name: Sterilization wrap (pack, sterilization wrapper, bag, or accessories)
Regulatory Class: Class II
Product Code(s): KCT
Legally Marketed Predicate Device
Predicate Device Name: Standard Sterilizable Tray
510(k) Number: K202524
Product Code: KCT
Regulation Number: 21 CFR § 880.6850
Device Description
Paragon sterilization trays are divided into the following types:
- Complete Surgical Kit
- Standard Surgical Kit
- Drill Stop Kit
- Prosthetic Kit
The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon
Page 6
510(k) Summary Sterilization Tray
K251756 Page 1 of 7
510(k) Summary
Paragon Implant Mfg., LLC
Sterilization Tray
November 13, 2025
Manufacturer Name
Paragon Implant Mfg., LLC
27030 Malibu Hills Road
Calabasas, CA 91301, U.S.A.
Telephone: (818) 475-4675
Official Contact
Renee Bennett, Manager of Regulatory Affairs
Paragon Implant Mfg., LLC
27030 Malibu Hills Road
Calabasas, CA 91301, U.S.A.
Telephone: (818) 475-4675
Email: rbennett@paragon-implant.com
Device Name and Classification
Trade/Proprietary Name: Sterilization Tray
Common Name: Sterilization Wrap
Regulation Number: 21 CFR § 880.6850
Regulation Name: Sterilization wrap (pack, sterilization wrapper, bag, or accessories)
Regulatory Class: Class II
Product Code(s): KCT
Legally Marketed Predicate Device
Predicate Device Name: Standard Sterilizable Tray
510(k) Number: K202524
Product Code: KCT
Regulation Number: 21 CFR § 880.6850
Device Description
Paragon sterilization trays are divided into the following types:
- Complete Surgical Kit
- Standard Surgical Kit
- Drill Stop Kit
- Prosthetic Kit
The Surgical, Drill Stop, and Prosthetic Kits are reusable perforated instrument cassette systems, composed of an outer case (base), cover (lid), and insert, that is designed to hold dental instruments in place during transport, steam sterilization, and storage. The Surgical Kits are designed to support Paragon
Page 7
510(k) Summary Sterilization Tray
K251756 Page 2 of 7
implant/prosthetic placement protocols, as well as hold various dental instruments such as: Surgical Drills, Drill Stops, Paralleling Tools, Implant Drivers, Drill Extender, Prosthetic Drivers and Torque Wrenches. The insert contains markings and colors to indicate either the surgical workflow or the position of the instruments within the cassette.
The Standard Surgical Kit includes a removable stainless-steel pan, which functions as a storage receptacle for used surgical instruments.
Indications for Use Statement
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:
- Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time
- Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time
- The kits are intended for sterilization of non-porous loads
- The tested kit represents the worst-case validated load of 497.1 grams
| Model Name | Model (Catalog) Number | Max # of Instruments | Total Mass (g) | Vent to Volume Ratio (cm-1) |
|---|---|---|---|---|
| Complete Surgical Kit | CSK | 55 | 497.1 | 0.01043 |
| Standard Surgical Kit | SSK | N/A | 372.1 | 0.01043 |
| Drill Stop Kit | DSK | 20 | 37.5 | 0.9009 |
| Drill Stop Kit Empty | Not available | N/A | 31.2 | 0.9009 |
| Prosthetic Kit Empty | PKE | N/A | 120.3 | 0.03324 |
| Prosthetic Kit | Not available | 20 | 497.1 | 0.03324 |
Comparison of Technological Characteristics:
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K251756 Page 3 of 7
Table 1. Technological Characteristics Comparison Table
| Characteristic | Subject Device (K251756) | Predicate Device K202524 (Standard Sterilizable Tray) | Comparison |
|---|---|---|---|
| Manufacturer/ Device Applicant | Paragon Implant Mfg, LLC27030 Malibu Hills RoadCalabasas, CA 91301-5332 | Implant Direct Sybron Manufacturing, LLC3050 East Hillcrest DriveThousand Oaks, CA 91362 | Different |
| Trade/Device Name | Sterilization Trays | Standard Sterilizable Tray | Different |
| Regulation Number | 880.6850 (Sterilization Wrap) | 880.6850 (Sterilization Wrap) | Same |
| Classification | 2 | 2 | Same |
| Primary Product Code | KCT | KCT | Same |
| Indications for Use | The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles:3. Gravity Steam Cycle – At 132°C for 15 minutes with a 30-minute dry time4. Pre-vacuum Steam Cycle – At 132°C for 4 minutes with a 20-minute dry time• The kits are intended for sterilization of non-porous loads• The tested kit represents the worst-case validated load of 497.1 grams | The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles:(1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time.(2) Gravity Steam – At 132°C for 15 minutes with a 30 minutes dry time.- The tray is intended for sterilization of non-porous loads.- Do not stack trays during sterilization.- The tested Tray represents the worst case validated load of 667.52 grams.- Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray. | SameDifferences:• Maximum number instruments, total mass, vent to volume ratio information itemized in separate columns below. |
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| Characteristic | Subject Device (K251756) | Predicate Device K202524 (Standard Sterilizable Tray) | Comparison |
|---|---|---|---|
| Model Information | |||
| Model Name: Complete Surgical KitModel (Catalog) Number: CSKMax # of Instruments: 55Total Mass (g): 497.1Vent to Volume Ratio (cm-1): 0.01043Model Name: Standard Surgical KitModel (Catalog) Number: SSKMax # of Instruments: N/ATotal Mass (g): 372.1Vent to Volume Ratio (cm-1): 0.01043Model Name: Drill Stop KitModel (Catalog) Number: DSKMax # of Instruments: 20Total Mass (g): 37.5Vent to Volume Ratio (cm-1): 0.9009Model Name: Drill Stop Kit EmptyModel (Catalog) Number: Not availableMax # of Instruments: N/ATotal Mass (g): 31.2Vent to Volume Ratio (cm-1): 0.9009Model Name: Prosthetic Kit EmptyModel (Catalog) Number: PKEMax # of Instruments: N/ATotal Mass (g): 120.3Vent to Volume Ratio (cm-1): 0.03324Model Name: Prosthetic KitModel (Catalog) Number: Not availableMax # of Instruments: 20Total Mass (g): 497.1Vent to Volume Ratio (cm-1): 0.03324 | Model Name: Standard Surgical KitModel Number: CSSKMax # of Instruments: 46Max Load (g): 667.52Vent to volume Ratio (in-1): 0.021Model Name: Standard Surgical Kit EmptyModel Number: SSKMax Load (g): 385.2Vent to volume Ratio (in-1): 0.021Model Name: InterActiveTM Surgical KitModel Number: CISKMax # of Instruments: 34Max Load (g): 662.70Vent to volume Ratio (in-1): 0.021Model Name: InterActiveTM Surgical Kit EmptyModel Number: ISKMax Load (g): 384.2Vent to volume Ratio (in-1): 0.021 | ||
| Materials | CSK: Base: Radel® R-5000 NTLid: Radel® R-5000 NTInner Tray: Radel® R-5000 NTTooling Support: SiliconeDSK: (see DSK)SSK: Base: Radel® R-5000 NTLid: Radel® R-5000 NTInner Tray: Radel® R-5000 NTTooling Support: SiliconePan: Stainless SteelDSK: Lid: Radel® R-5000 NTBase: PPHTPKE: Lid: Radel® R-5000 NTBase: Radel® R-5000 NT | Base – Radel 5000Lid – Radel 5000Inner tray – Radel 5000Tooling support - SiliconePan – Stainless steel | Same:• Radel® R-5000 NT, Silicone, and Stainless SteelDifferences:• The Drill Stop Kit (DSK) base is made from PPHT. |
| Maximum Number of Devices | CSK: 55DSK: 20 | CSSK: 46CISK: 34 | Differences:• Subject (55) maximum number of |
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510(k) Summary Sterilization Tray
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| Characteristic | Subject Device (K251756) | Predicate Device K202524 (Standard Sterilizable Tray) | Comparison |
|---|---|---|---|
| devices is more than the predicate (46) | |||
| Mass of Maximum Sterilization Load | CSK: 497.1gSSK: 372.1gDSK: 37.5gPKE: 497.1g | CSSK: 667.52gCISK:662.70g | Differences:• Subject (497.1g) mass of maximum sterilization load is less than the predicate (667.52g) |
| Vent to Volume Ratio | CSK: 0.01043cm-1 (0.004106in-1)SSK: 0.01043cm-1 (0.004106in-1)DSK: 0.9009cm-1 (0.3547in−1)PKE: 0.03324cm-1 (0.01309in−1) | CSSK: 0.021 in-1CISK: 0.021 in-1 | Differences:• Subject (0.004106in-1) is lower than the predicate (0.021 in-1) vent to volume ratio |
| Air Permeance | Yes | Yes | Same |
| Intended Use | Perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage | Perforated instrument cassette system to hold dental instruments in place during transport, steam sterilization, and storage | Same |
| General Design | Plastic tray with locking lid, silicone grommet supports, stainless steel pan (SSK only) | Plastic tray with locking lid co-molded silicone and silicone grommet supports and stainless steel component | Same |
| Dimensions | CSK & SSK: 185.1mm x 133.8mm x 59mm (7.29" x 5.27" x 2.32")DSK: 64mm x 43mm x 26.5mm (2.52" x 1.69" x 1.04")PKE: 145mm x 100mm x 18mm (5.71"x 3.94" x 0.71") | 7.3 in x 5.5 in x 2.4 in | Differences:• Predicate tray is slightly larger than the subject trays |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Sterilization Method | Moist heat gravity or pre-vacuum | Moist heat gravity or pre vacuum | Same |
| Usage | Reusable | Reusable | Same |
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510(k) Summary
K251756 Page 6 of 7
Indication for Use Comparison
The indications for use are the same as the predicate.
Comparison to Legally Marketed Predicate Device
The subject Sterilization Trays and the predicate K202524 (Standard Sterilizable Tray) are similar in general design composed of a plastic tray with a locking lid, Silicon overmolded accessories (co-molded Silicone and Silicone Grommet supports), and Stainless-Steel pan. The subject Sterilizable Tray (specifically the Complete Surgical Kit) has an inserted kit (container) for holding Drill Stops which the predicate K202524 (Standard Sterilizable Tray) does not.
The subject Sterilizable Trays and predicate K202524 (Standard Sterilizable Tray) device have the same intended use.
The subject Sterilizable Trays are slightly smaller in size than the predicate K202524 (Standard Sterilizable Tray) and are the same materials except for the Drill Stop container base. Although the materials are not intended to contact the patient, they are in contact with surgical and prosthetic instruments and handled by clinicians. Provided testing reports show the minimum biocompatibility endpoints for the subject devices have no risk of the materials migrating during containment and sterilization. The use of Sterilization Trays has been validated through sterilization testing.
The subject Sterilizable Trays and predicate K202524 (Standard Sterilizable Tray) devices are sold non-sterile are reusable devices. They require the same end user sterilization methods (most heat gravity or pre-vacuum) when using as intended as a sterilization wrap.
The vent to volume ratio for the subject Sterilization Trays is 0.01043 cm-1 (0.027 in-1) which is higher than the predicate (0.021 in-1) vent to volume ratio and this has been demonstrated to not present an issue through sterilization validation testing.
The subject Sterilization Tray loaded with the maximum number of devices can hold more instruments and has a smaller maximum sterilization load than the predicate K202524 (Standard Sterilizable Tray). The maximum sterilization load for the subject Sterilization Tray is 497.1g, while the predicate's maximum sterilization load is 667.52g. While the subject Sterilization Tray has a smaller weight and more instruments, this has been demonstrated to not be an issue through sterilization testing and has been validated.
Summary of Non-Clinical Testing
The proposed Surgical and Prosthetic Trays are reusable devices provided non-sterile which need to be end user sterilized. Sterilization of the proposed trays was validated according to the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
Non-clinical testing data submitted, referenced, or relied upon, including acceptance criteria and set specifications in test methodology and standards, are summarized below:
- Manual Cleaning Validation:
- Standards: AAMI TIR12:2020, AAMI ST98:2022, ISO 17664-1:2021, and 2015 FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
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510(k) Summary
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-
Purpose: Evaluate and validate the manual cleaning of the subject devices
-
Acceptance Criteria: No visible soil should remain on the test articles. Protein level should be <6.4 μg/cm2 for the processed test articles
-
Result: Pass
-
Automated Cleaning Validation:
- Standards: AAMI TIR12:2020, AAMI ST98:2022 and 2015 FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- Purpose: Evaluate and validate the automated cleaning of the subject devices
- Acceptance Criteria: No visible soil should remain on the test articles. Protein level should be <6.4 μg/cm2 for the processed test articles.
- Result: Pass
-
Gravity and Prevacuum Steam Sterilization Validation
- Standards: ISO 17665:2024, ANSI/AAMI/ISO 17665-1:2006/(R)2013, Annex D and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013, Annex D (Approach 3), and AAMI TIR12:2020
- Purpose: Validate a sterilization cycle and drying time of the subject devices
- Acceptance Criteria: SAL ≤10-6 using the biological indicator (BI) overkill method
- Result: Pass
-
Biocompatibility Testing
- Test Methodology/Standard: ISO 10993-5 and the FDA Guidance Use of International Standard ISO 10993-1
- Purpose: Cytotoxicity testing has been performed to validate the biocompatibility of the standard surgical, prosthetic, and drill stop kits which shows that the materials and manufacturing processes represented by the finished subassemblies are non-cytotoxic following cleaning and sterilization.
- Acceptance Criteria: Reagent control and the negative control must have a reactivity of none (grade 0), and the positive control must be a grade 3 or 4. The test sample must meet the requirements of the test if the biological response is less than or equal to grade 2 (mild).
- Result: Pass
Clinical Performance Data
Not applicable.
Conclusions
The conclusions drawn from the non-clinical test data and evaluation support that the proposed Sterilization Trays are as safe, as effective and perform as well as the legally marketed predicate device K202524 (Standard Sterilizable Tray).
§ 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).