(260 days)
Intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only.
This submission describes the OsteoMed Cranial Flap Fixation System intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only. The OsteoMed Cranial Flap Fixation System is a clamping device which has a threaded post attached to an inferior disk and a threading superior disk that threads down the post to secure a sandwich fit of the Cranial Flap and cranium between the inferior and superior plate. The device locks into place once the desired fixation is achieved by the surgeon. The OsteoMed Cranial Flap Fixation devices are available in a range of 10mm to 22mm disk diameters.
The provided text describes a medical device, the "OsteoMed Cranial Flap Fixation System," and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a study that proves the device meets specific performance criteria.
The document focuses on:
- Device Description: What the device is and how it works.
- Intended Use: For re-attachment of the bone flap after craniotomy.
- Predicate Devices: Identifying similar devices already on the market (MacroPore CraniLoc, Aesculap Craniofix Titanium Clamp System, Lorenz Rapidflap Cranial Clamp).
- Substantial Equivalence: The claim that the device is substantially equivalent to existing devices and raises no new safety or effectiveness issues due to similar materials and design.
- FDA Clearance: The 510(k) clearance letter from the FDA.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a detailed study as this information is not present in the provided text. The submission relies on "substantial equivalence" to predicate devices rather than presenting a performance study with detailed acceptance criteria.
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APR 0 1 2003
K022277
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510(k) Summary
| Device Proprietary Name: | OsteoMed Cranial Flap FixationSystem |
|---|---|
| Device Common Name: | Intraoral Distractor |
| Classification Name: | GXN, Plate, Cranioplasty,Preformed, Non-Alterable |
| Name of Submitter: | OsteoMed Corporation3750 Realty RoadAddison, Texas 75001Phone: (972) 241-3401Fax: (972) 241-3507 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | July 12, 2001 |
Summary:
This submission describes the OsteoMed Cranial Flap Fixation System intended for the re-attachment of the bone flap after a craniotomy. The OsteoMed Cranial Flap Fixation System is intended for single patient use only.
The OsteoMed Cranial Flap Fixation System is a clamping device which has a threaded post attached to an inferior disk and a threading superior disk that threads down the post to secure a sandwich fit of the Cranial Flap and cranium between the inferior and superior plate. The device locks into place once the desired fixation is achieved by the surgeon. The OsteoMed Cranial Flap Fixation devices are available in a range of 10mm to 22mm disk diameters.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the MacroPore CraniLoc (K002334), Aesculap Craniofix Titanium Clamp System (K972332) and the Lorenz Rapidflap Cranial Clamp (K991029).
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Cranial Flap Fixation does not raise any new safety or effectiveness issues. System
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 1 2003
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control Osteomed Corp. 3885 Arapaho Road Addison, TX 75001
Re: K022277
Trade/Device Name: Cranial Flap Fixation System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: II Product Code: GXN Dated: January 9, 2003 Received: January 10, 2003
Dear Ms. Holdeman:
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.
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 (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.
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Page 2 - Ms. Dawn T. Holdeman
This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at (301) 594-4679. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html .
Sincerely yours,
Mark H. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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OsteoMed "Indications for Use" Submission
510(k) Number:
| Device Name: | Osteomed Cranial Flap FixationSystem |
|---|---|
| Indication for Use: | Intended for the re-attachment of thebone flap after a craniotomy. |
| The OsteoMed Cranial Flap FixationSystem is intended for single patientuse only. |
Mark A. Milkman
(Division Sign-Off) Division General, Restorative and Neure rogical Devices
510(k) Number K022277
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).