(273 days)
OSTEO-PIN is used to attach absorbable and non-absorbable membranes used for guided tissue regeneration and guided bone regeneration to underlying bone.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (OSTEO-PIN Membrane Fixation Pin). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.
The document does not contain any information about acceptance criteria for a study, reported device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone algorithm performance, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.
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Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 1999
Luitpold Pharmaceuticals, Inc. c/o Mr. Peter S. Reichertz Luitpold Pharmaceuticals, Inc. Arent Fox Kitner Plotkin & Kahn, PLLC 1050 Connecticut Avenue NW Washington, D.C. 20036-5339
Re : K990537 OSTEO-PIN® Membrane Fixation Pin Trade Name: Regulatory Class: Unclassified Product Code: LYC October 29, 1999 Dated: Received: October 29, 1999
Dear Mr. Reichertz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdg.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot A. Ulatowski Director Division of Dental, Infection Con and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
Center for Devices and Radiological Health
Page 1 of 1
510(k) Number (if known): K 990537
OSTEO-PIN Membrane Fixation Pin Device Name:
Indications for Use:
0STF0-PIN is used to attach absorbable and non-absorbable membranes used for guided tissue regeneration and guided bone regeneration to underlying bone.
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| (Division Sign-Off) | Sunain |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K990537 |
| (Posted July 1, 1998) | |
| Over-The-Counter Use | |
| (Optional Format 3-10-98) |
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.