(360 days)
Resor-Pin is used in oral, dental and maxillofacial surgery for the fixation of resorbable and non-resorbable membranes in augmentation and guided bone regeneration.
Resor-Pin Resorbable Membrane Pin
This is a 510(k) premarket notification for a medical device (Resor-Pin Resorbable Membrane Pin) from 1998. This type of document establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding detailed study design, ground truth establishment, and sample sizes is not applicable or typically found in this kind of regulatory submission.
However, I can extract the following information that is present or can be inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) summary, specific numerical acceptance criteria and performance data from studies are not typically provided in this format. The "performance" being evaluated here is the substantial equivalence to a predicate device, meaning it performs similarly and has similar indications for use and safety profiles.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to legally marketed predicate devices. |
| Indications For Use | Resor-Pin is used in oral, dental, and maxillofacial surgery for fixation and guided bone regeneration. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. 510(k) submissions typically reference existing data or general scientific principles rather than detailing new large-scale clinical trials for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there is no mention of a "test set" and "ground truth" establishment in the context of an AI device. This document pertains to a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons above.
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
This information is not applicable as this document is for a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as there is no specific "ground truth" mentioned in the context of an AI device. The ground truth for a physical device like this would be its proven safety and effectiveness over time and through predicate device history.
8. The sample size for the training set
This information is not applicable as this document is for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this document is for a physical medical device, not an AI model.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JU 24 1998
Geistlich-Pharma C/O Mr. Peter S. Reichertz Attorneys at Law Arent Fox Kintner and Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339
K972817 Re : Resor-Pin Resorbable Membrane Pin Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: July 8, 1998 Received: July 9, 1998
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 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਦੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Reichertz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general 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.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Whetstone
iy A. Ulatowski Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure a se se se se se se se se
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7 510(k) Nunber (if known):
Device Name Resor-Pin Resorbable Membrane Pin
Indications For Use:
: -
Resor-Pin is used in oral, dental and maxillofacial aurgery Resor-Pin 18 used in oral, doncal and maximulation and guided bone regeneration.
(PLRASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDSED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K9712817 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Formst 1-2-96)
§ 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.