OsteoMed QuickFix Hybrid MMF Sterilization Tray

K173391 · Osteomed, LLC · KCT · May 10, 2018 · General Hospital

Device Facts

• Record ID: K173391
• Device Name: OsteoMed QuickFix Hybrid MMF Sterilization Tray
• Applicant: Osteomed, LLC
• Product Code: KCT · General Hospital
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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.

Device Story

Device consists of anodized/non-anodized aluminum base, lid, and locking latch; perforated design allows steam penetration. Used in hospital environments to organize, protect, and transport dental MMF implants and surgical instruments during steam sterilization cycles. Operated by hospital staff; requires placement within FDA-cleared sterilization wrap or rigid container to maintain sterility post-process. Benefits include organized, protected, and effective sterilization of surgical instrumentation. Device withstands repeated steam sterilization cycles.

Clinical Evidence

No clinical data. Bench testing only: design validation, ship testing (ASTM D-4169), cleaning validation (AAMI TIR 30), and sterilization validation (3 consecutive tests in wrap and rigid container). Durability confirmed via 100-cycle steam sterilization testing.

Technological Characteristics

Materials: Anodized and non-anodized aluminum. Form factor: Rectangular base with lid and locking latch (9.5 x 5.0 x 1.5 inches). Sterilization: Pre-vacuum steam (270°F/132°C for 4 minutes). Perforated design for steam penetration. Reusable. Maximum load capacity: 2.3 lbs.

Indications for Use

Indicated for containing MMF implants and surgical instruments during sterilization, storage, and handling in hospital environments. Suitable for use with dynamic air removal (pre-vacuum) steam sterilization. Not intended to maintain sterility independently; requires use with FDA-cleared sterilization wrap or rigid container. Maximum load: 2.3 lbs.

Regulatory Classification

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.

Predicate Devices

• NuVasive® Sterilization Trays (K143579)

Submission Summary (Full Text)

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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 [phone] or [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |
| <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |

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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: | [e-mail] |

Contact: Phone: Fax: Email:

Kathryn Jayne 972-677-4766 800-390-2620 [e-mail]

Alternate Contact: Alicia Hemphill Phone: [phone] Email: [e-mail]

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 &<br>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 Sterilization<br>Tray<br>Subject Device | NuVasive Sterilization Trays<br>Predicate 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 |
|-----------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| System<br>Components | Base, lid, locking latch | Base, lid, insert trays, brackets,<br>caddies | Similar |
| Material<br>Composition | Aluminum | Aluminum, Nylon, Silicone,<br>Stainless Steel, Polypropylene,<br>Polyphenylsulfone | Similar |
| Physical<br>Properties | Evenly distributed perforated<br>hole | Evenly distributed perforated<br>hole | Same |
| Configurations/<br>Dimensions<br>(L<br>x W x H) in. | Rectangle base with lid<br>(9.5 x 5.0 x 1.5) | Rectangle base with lid, inserts,<br>brackets and caddies; Multiple<br>dimensions to accommodate<br>different product configurations<br>(9.8 x 6.3 x 3.6) | Similar |
| Sterilant<br>Penetration | Sterilant (steam) penetration<br>through perforations in tray | Sterilant (steam) penetration<br>through perforations in tray | Same |
| Sterilization<br>method | Steam | Steam | Same |
| Sterilization cycle | Pre-vacuum | Pre-vacuum | Same |
| Exposure<br>temperature | 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 Volume<br>Ratio | 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 Hybrid<br>MMF Sterilization Tray | NuVasive Sterilization Trays | Comparison |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | The OsteoMed MMF Sterilization<br>Tray is intended to contain MMF<br>implants and surgical instruments<br>for sterilization, storage and<br>handling. The OsteoMed MMF<br>Sterilization Tray is suitable for<br>dynamic air removal (pre-vacuum)<br>steam sterilization methods. The<br>tray is not intended to maintain | The NuVasive Sterilization Trays<br>are intended to contain NuVasive<br>implants and surgical instruments<br>for sterilization, storage and<br>handling. The NuVasive<br>Sterilization Trays are suitable for<br>dynamic air removal (pre-vacuum)<br>steam sterilization methods. The<br>trays are not intended to maintain | |
| | sterility; it is intended to be used in<br>conjunction with a validated,<br>FDA-cleared sterilization wrap in<br>order to maintain sterility of the<br>enclosed devices. The sterilization<br>tray may also be used in | sterility; they are intended to be<br>used in conjunction with a<br>validated, FDA-cleared sterilization<br>wrap in order to maintain sterility<br>of the enclosed devices. | |
| | conjunction with a legally<br>marketed rigid container. | Sterilization validations for three<br>level worst case tray (20.5" x 10" x<br>7.375") included three different<br>loading configurations: implant<br>only content (26.4 lbs.), instrument | |
| Indications of Use | Sterilization validation was<br>performed on MMF implants and<br>accessories such as surgical<br>instrumentation. Do not exceed a | only content (39.95 lbs.) and mixed<br>instruments and implants content<br>(30.45 lbs.) | Similar |
| | maximum load of 2.3 lbs. in the<br>sterilization tray. | Validated worst case loading<br>configurations included 23<br>instruments with lumens including<br>the following worst case lumen | |
| | Validated sterilization parameters<br>for OsteoMed MMF Sterilization<br>Tray: | dimensions: - 1.6 mm x 306.8 mm -<br>1.1 mm x 166.4 mm - 7.2 mm x<br>331.9 mm - 5.5 mm x 356.9 mm | |
| | Method: Steam Cycle<br>Pre-Vacuum Temperature: 270°F<br>(132°C)<br>Exposure Time: 4 minutes | Do not exceed a maximum load of<br>25 lbs in the sterilization tray.<br>Validated sterilization parameters<br>for NuVasive Sterilization Trays: | |
| | Minimum Dry Time: 30 minutes | Method: Steam Cycle: Pre-Vacuum<br>Temperature: 270°F (132°C)<br>Exposure Time: 4 minutes<br>Minimum Dry Time: 30 minutes<br>Minimum Cool Down Time: 40<br>minutes | |

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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.

| Test<br>Description | Test Method Description | Summary of Test<br>Results |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Design<br>Validation | Surgeons evaluated the<br>functionality of the tray. | Pass; met all<br>requirements |
| Ship Testing | Ship packaged plate per ASTM<br>D-4169 and evaluate package<br>contents for damage upon return | Pass |
| Cleaning<br>Validation<br>(reusable<br>instruments) | Use the ratchet handle as worst-<br>case device to verify that re-<br>useable instruments can be cleaned<br>per instructions to achieve<br>standard requirements for reusable<br>devices per AAMI TIR 30. | Pass |
| Sterilization<br>Validation | Validate sterilization parameters<br>with 3 consecutive tests. Conduct<br>test for both system wrapped in<br>polypropylene sterile wrap and<br>system enclosed in rigid container. | Passed for both sterile<br>wrap and rigid container<br>configurations |
| Sterilization<br>Cycles<br>Validation | The device was steam sterilized<br>for 100 cycles with the<br>sterilization parameters described<br>in the IFU The subject device was<br>then evaluated to determine if it<br>met pre-determined acceptance<br>criteria. | Passed functional and<br>visual criteria after 100<br>cycles |

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.