(192 days)
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment.
The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
The request asks for details about the acceptance criteria and study that proves a device meets the acceptance criteria. However, the provided document is a 510(k) summary for a sterilization tray, which is a medical device for sterilizing other instruments, not a diagnostic AI device. Therefore, the information typically requested (e.g., sample sizes for training/test sets, ground truth methodology, expert qualifications, MRMC studies) is not applicable to this type of device.
This document describes the performance testing (bench testing) performed for the OsteoMed MMF Sterilization Tray to demonstrate its substantial equivalence to a predicate device.
Here's a summary of the available information relevant to acceptance criteria and performance, as best as can be extrapolated from the provided text for a non-AI device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Description | Acceptance Criteria (Inferred from "Summary of Test Results") | Reported Device Performance |
|---|---|---|
| Design Validation | Met all requirements for functionality | Pass; met all requirements |
| Ship Testing | No damage to package contents after shipping | Pass |
| Cleaning Validation | Reusable instruments can be cleaned per instructions to achieve standard requirements per AAMI TIR 30 | Pass |
| Sterilization Validation | Validated sterilization parameters with 3 consecutive tests | Passed for both sterile wrap and rigid container configurations |
| Sterilization Cycles Validation | Met pre-determined acceptance criteria for functional and visual aspects after 100 cycles | Passed functional and visual criteria after 100 cycles |
2. Sample size used for the test set and the data provenance: Not applicable to a sterilization tray. The "test set" here refers to the physical devices undergoing bench testing. The origin of the "data" is the manufacturing site / testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the traditional sense. For Design Validation, "Surgeons evaluated the functionality of the tray." The number and qualifications of these surgeons are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used:
* Design Validation: "Surgeons evaluated the functionality of the tray." The "ground truth" was likely subjective expert opinion on usability and functionality.
* Ship Testing: Visual inspection for damage.
* Cleaning Validation: Adherence to AAMI TIR 30 standards.
* Sterilization Validation: Successful sterilization parameters (demonstrated by, for example, biological indicators, chemical indicators, or other validated methods, though not explicitly detailed here).
* Sterilization Cycles Validation: Functional and visual criteria.
8. The sample size for the training set: Not applicable, as this is not an AI device that undergoes training.
9. How the ground truth for the training set was established: Not applicable.
Summary of the study that proves the device meets the acceptance criteria:
The study proving the OsteoMed MMF Sterilization Tray meets its acceptance criteria is a series of bench tests (non-clinical tests) on production-equivalent devices. These tests evaluated various aspects of the tray's performance and durability:
- Design Validation: Surgeons provided feedback on the tray's functionality.
- Ship Testing: Evaluated the integrity of the packaged tray after simulated shipping conditions (ASTM D-4169).
- Cleaning Validation: Used a "worst-case device" (ratchet handle) to ensure reusable instruments could be cleaned according to instructions and AAMI TIR 30 standards.
- Sterilization Validation: Conducted three consecutive tests to validate the specified sterilization parameters (Steam Cycle Pre-Vacuum, 270°F (132°C), 4 minutes exposure, 30 minutes dry time) for both sterile wrap and rigid container configurations. This likely involved verifying the ability of the tray to allow sterilant penetration and achieve sterility of the contents.
- Sterilization Cycles Validation: The device underwent 100 steam sterilization cycles to assess its long-term functionality and visual integrity.
All these bench tests "passed," indicating the device met its pre-determined acceptance criteria for each test. The conclusion drawn is that based on these non-clinical tests, the device is substantially equivalent to the predicate device and is safe and effective for its intended use.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2018
OsteoMed, LLC Kathryn Jayne Manager, Regulatory Affairs 3885 Arapaho Rd. Addison, TX 75001
Re: K173391
Trade/Device Name: OsteoMed MMF Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: Class II Product Code: KCT Dated: April 09, 2018 Received: April 10, 2018
Dear Kathryn Jayne:
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
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Geeta K. Pamidimukkala -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
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Indications for Use
510(k) Number (if known) K173391
Device Name OsteoMed MMF Sterilization Tray
Indications for Use (Describe)
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Sterilization validation was performed on MMF implants and as surgical instrumentation. Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a stylized font. The logo is surrounded by an oval shape, with the top half of the oval in blue and the bottom half in gray. The logo is clean and professional, and it is likely used to represent a medical company.
510(k) SUMMARY-K173391
SUBMITTER I.
OsteoMed 3885 Arapaho Rd. Addison, TX 75001
| Phone: | 972-677-4766 |
|---|---|
| Fax: | 800-390-2620 |
| Email: | kjayne@osteomed.com |
Contact: Phone: Fax: Email:
Kathryn Jayne 972-677-4766 800-390-2620 kjayne@osteomed.com
Alternate Contact: Alicia Hemphill Phone: 972-677-4783 Email: ahemphill@osteomed.com
Date Prepared:
May 08, 2018
II. DEVICE
| Name of the Device: | OsteoMed MMF Sterilization Tray |
|---|---|
| Common or Usual Name: | Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes &Other Accessories |
| Regulation: | 21 CFR 880.6850 |
| Regulatory Class: | II |
| Product Code: | KCT |
III. PREDICATE DEVICE
Primary Predicate: NuVasive® Sterilization Trays (K143579)
IV. DEVICE DESCRIPTION
The OsteoMed MMF Sterilization Tray is composed from a material commonly used (anodized and non-anodized Aluminum) to enclose, protect, and organize
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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The logo has a swoosh design that goes around the word "OsteoMed". The swoosh is blue on top and gray on the bottom.
OsteoMed's dental non-sterile devices, which meet national or international standards. The OsteoMed MMF Sterilization Tray is intended to provide storage for appropriate dental (MMF) devices and accessories during sterilization, storage, and transportation within the hospital environment.
The tray is composed of a base, a lid, and locking latch that secure the device and accessories. The tray is perforated to allow for steam sterilization. An FDAcleared wrap or FDA-cleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed MMF Sterilization Tray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed MMF Sterilization Tray is effective for containing devices during sterilization and have been designed to withstand repeated steam sterilization cycles.
V. INDICATIONS FOR USE
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The sterilization tray may also be used in conjunction with a legally marketed rigid container.
Do not exceed a maximum load of 2.3 lbs. in the sterilization tray.
Validated sterilization parameters for OsteoMed MMF Sterilization Tray:
Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are substantially equivalent based on the following same technological elements as demonstrated below.
| Characteristics | OsteoMed MMF SterilizationTraySubject Device | NuVasive Sterilization TraysPredicate Device (K143579) | Comparison |
|---|---|---|---|
| Product Code | KCT | KCT | Same |
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Image /page/5/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold, blue letters. The logo is surrounded by a gray and blue swoosh design. The logo is clean and professional, and it is likely used on the company's website and marketing materials.
| 21 CFR | 880.6850 | 880.6850 | Same |
|---|---|---|---|
| SystemComponents | Base, lid, locking latch | Base, lid, insert trays, brackets,caddies | Similar |
| MaterialComposition | Aluminum | Aluminum, Nylon, Silicone,Stainless Steel, Polypropylene,Polyphenylsulfone | Similar |
| PhysicalProperties | Evenly distributed perforatedhole | Evenly distributed perforatedhole | Same |
| Configurations/Dimensions(Lx W x H) in. | Rectangle base with lid(9.5 x 5.0 x 1.5) | Rectangle base with lid, inserts,brackets and caddies; Multipledimensions to accommodatedifferent product configurations(9.8 x 6.3 x 3.6) | Similar |
| SterilantPenetration | Sterilant (steam) penetrationthrough perforations in tray | Sterilant (steam) penetrationthrough perforations in tray | Same |
| Sterilizationmethod | Steam | Steam | Same |
| Sterilization cycle | Pre-vacuum | Pre-vacuum | Same |
| Exposuretemperature | 270°F (132°C) | 270°F(132°C) | Same |
| Exposure time | 4 minutes | 4 minutes | Same |
| Dry time | 30 minutes | 30 minutes | Same |
| Vent to VolumeRatio | 0.050 in²/in³ | unknown | unknown |
| Reusable | Yes | Yes | Same |
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Image /page/6/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray oval shape. The blue part of the oval is on top, and the gray part is on the bottom.
| Characteristics | OsteoMed QuickFix HybridMMF Sterilization Tray | NuVasive Sterilization Trays | Comparison |
|---|---|---|---|
| The OsteoMed MMF SterilizationTray is intended to contain MMFimplants and surgical instrumentsfor sterilization, storage andhandling. The OsteoMed MMFSterilization Tray is suitable fordynamic air removal (pre-vacuum)steam sterilization methods. Thetray is not intended to maintain | The NuVasive Sterilization Traysare intended to contain NuVasiveimplants and surgical instrumentsfor sterilization, storage andhandling. The NuVasiveSterilization Trays are suitable fordynamic air removal (pre-vacuum)steam sterilization methods. Thetrays are not intended to maintain | ||
| sterility; it is intended to be used inconjunction with a validated,FDA-cleared sterilization wrap inorder to maintain sterility of theenclosed devices. The sterilizationtray may also be used in | sterility; they are intended to beused in conjunction with avalidated, FDA-cleared sterilizationwrap in order to maintain sterilityof the enclosed devices. | ||
| conjunction with a legallymarketed rigid container. | Sterilization validations for threelevel worst case tray (20.5" x 10" x7.375") included three differentloading configurations: implantonly content (26.4 lbs.), instrument | ||
| Indications of Use | Sterilization validation wasperformed on MMF implants andaccessories such as surgicalinstrumentation. Do not exceed a | only content (39.95 lbs.) and mixedinstruments and implants content(30.45 lbs.) | Similar |
| maximum load of 2.3 lbs. in thesterilization tray. | Validated worst case loadingconfigurations included 23instruments with lumens includingthe following worst case lumen | ||
| Validated sterilization parametersfor OsteoMed MMF SterilizationTray: | dimensions: - 1.6 mm x 306.8 mm -1.1 mm x 166.4 mm - 7.2 mm x331.9 mm - 5.5 mm x 356.9 mm | ||
| Method: Steam CyclePre-Vacuum Temperature: 270°F(132°C)Exposure Time: 4 minutes | Do not exceed a maximum load of25 lbs in the sterilization tray.Validated sterilization parametersfor NuVasive Sterilization Trays: | ||
| Minimum Dry Time: 30 minutes | Method: Steam Cycle: Pre-VacuumTemperature: 270°F (132°C)Exposure Time: 4 minutesMinimum Dry Time: 30 minutesMinimum Cool Down Time: 40minutes |
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Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The logo has a blue swoosh above the text and a gray swoosh below the text. The logo is simple and modern.
PERFORMANCE DATA VII.
Bench Testing
The following table provides a summary of the bench testing conducted.
| TestDescription | Test Method Description | Summary of TestResults |
|---|---|---|
| DesignValidation | Surgeons evaluated thefunctionality of the tray. | Pass; met allrequirements |
| Ship Testing | Ship packaged plate per ASTMD-4169 and evaluate packagecontents for damage upon return | Pass |
| CleaningValidation(reusableinstruments) | Use the ratchet handle as worst-case device to verify that re-useable instruments can be cleanedper instructions to achievestandard requirements for reusabledevices per AAMI TIR 30. | Pass |
| SterilizationValidation | Validate sterilization parameterswith 3 consecutive tests. Conducttest for both system wrapped inpolypropylene sterile wrap andsystem enclosed in rigid container. | Passed for both sterilewrap and rigid containerconfigurations |
| SterilizationCyclesValidation | The device was steam sterilizedfor 100 cycles with thesterilization parameters describedin the IFU The subject device wasthen evaluated to determine if itmet pre-determined acceptancecriteria. | Passed functional andvisual criteria after 100cycles |
Bench testing was conducted on production equivalent devices. The devices passed the pre-acceptance criteria.
A tolerance study was conducted for the lid and latch of the sterilization tray.
Animal Study
No animal studies were performed to demonstrate safety and efficacy.
Clinical Studies
No clinical studies were performed to demonstrate safety and efficacy.
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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in bold, sans-serif font. The word "Osteo" is in blue, and the word "Med" is in gray. The logo is surrounded by a blue and gray swoosh design.
VIII. CONCLUSIONS
Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, subject Instrument trays, are substantially equivalent to, and are as safe and as effective as, the legally marketed predicate device, NuVasive® Sterilization Trays cleared under K143579 under regulation 21 CFR 880.6850, product code KCT.
§ 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).