CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY

K080531 · Conmed Linvatec · KCT · Sep 5, 2008 · General Hospital

Device Facts

• Record ID: K080531
• Device Name: CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
• Applicant: Conmed Linvatec
• Product Code: KCT · General Hospital
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration. The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is intended for use with the following instruments: MFX-OLT Microfracture Awl, 0 degrees light; MFX-30LT Microfracture Awl, 30 degree light; MFX-45LT Microfracture Awl, 45 degrees light; MFX-90LT Microfracture Awl, 90 degrees light; MFX-0HV Microfracture Awl, 0 degrees heavy; MFX-30HV Microfracture Awl, 30 degrees heavy; MFX-45HV Microfracture Awl, 45 degrees heavy; MFX-90HV Microfracture Awl, 90 degrees heavy; MFX-30ANG Microfracture Awl, Angled, 30 Degrees Heavy; MFX-45CU Microfracture Awl Currette, 45 Degrees.

Device Story

The Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device designed to hold specific surgical instruments during steam sterilization. It is constructed from metal and plastic with perforations to allow steam penetration. The tray is used in clinical settings to organize and protect instruments during the sterilization process. It is compatible with pre-vacuum and gravity steam sterilization cycles. The device ensures that instruments are properly contained and exposed to sterilization conditions, facilitating safe instrument reprocessing for surgical use.

Clinical Evidence

Bench testing only. Sterilization validation was conducted in accordance with AAMI TIR 12 requirements using an FDA-cleared sterilization wrap with a maximum load of 8.1 lbs (3.67 kg).

Technological Characteristics

Constructed of metal and plastic with perforations for steam penetration. Designed for pre-vacuum and gravity steam sterilization cycles (270°F/132°C). Validation performed per AAMI TIR 12.

Indications for Use

Indicated for use as a containment device for the sterilization of specific ConMed Linvatec Microfracture surgical instruments in healthcare facilities.

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

• Paragon Medical Surgical Instrument Delivery Tray (K0032116)

Submission Summary (Full Text)

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## 510(k) SUMMARY of SAFETY And EFFECTIVENESS ConMed Linvatec

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number ير رادرد و 3

#### A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

SEP - 5 2008

#### B. Company Contact

Elizabeth M. Paul Manager, Regulatory Affairs [phone] Telephone [phone] FAX

#### ். Device Name

| Trade Name: | ConMed Linvatec Microfracture™ Instrument<br>Sterilization Tray |
|------------------------|-----------------------------------------------------------------|
| Common Name: | Instrument Sterilization Tray |
| Classification Name: | Sterilization Wrap Containers, Trays and other<br>Accessories |
| Proposed Class/Device: | Class II |

Product Code: KCT

Regulation Number: 21 CFR 880.6850

Panel: 880 General Hospital

### Predicate/Legally Marketed Devices D.

Paragon Medical Surgical Instrument Delivery Tray Paragon Medical 510(k) # K0032116

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, symbolizing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2008

Ms. Rebecca Roberts Regulatory Specialist ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773

Re: K080531

Trade/Device Name: Microfracture™ Instrument Sterilization Tray (MFX-TRAY) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: August 21, 2008 Received: August 22, 2008

Dear Ms. Roberts:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Roberts

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); 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. This letter will allow you to begin marketing your device as described in vour Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

M. Kamuli-Yendema
for //

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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)

K080531

Device Name

Microfracture™ Instrument Sterilization Tray (MFX-TRAY)

Indications for Use

The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration.

| Method | Cycle | Minimum Temperature | Minimum Exposure | Minimum Dry Cycle |
|----------------------------------------------------------------------------------------------------|------------|---------------------|------------------|-------------------|
| Steam (wrapped) | Pre-vacuum | 270°F(132°C) | 4 minutes | 8 minutes |
| Steam (wrapped) | Gravity | 270°F(132°C) | 10 minutes | 8 minutes |
| NOTES: | | | | |
| 1. Sterilization validation has been conducted in accordance with the requirements of AAMI TIR 12. | | | | |

2. Validation was conducted using an FDA cleared sterlization wrap with a maximum load of 8.1 Ibs. (3.67 kg).

The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is intended for use with the following instruments:

| REF | Description |
|-----------|---------------------------------------------|
| MFX-OLT | Microfracture Awl, 0 degrees light |
| MFX-30LT | Microfracture Awl, 30 degree light |
| MFX-45LT | Microfracture Awl, 45 degrees light |
| MFX-90LT | Microfracture Awl, 90 degrees light |
| MFX-0HV | Microfracture Awl, 0 degrees heavy |
| MFX-30HV | Microfracture Awl, 30 degrees heavy |
| MFX-45HV | Microfracture Awl, 45 degrees heavy |
| MFX-90HV | Microfracture Awl, 90 degrees heavy |
| MFX-30ANG | Microfracture Awl, Angled, 30 Degrees Heavy |
| MFX-45CU | Microfracture Awl Currette, 45 Degrees |

Sheila A. Murphy, R.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080531