(89 days)
The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization.
The LactoSorb® Mini Interference Screw is a resorbable screw that is preloaded on a driver much like those used with suture anchors. The screw is made out of LactoSorb®. The screw will be available in one size only.
This document, K021254, is a 510(k) premarket notification for the "LactoSorb® Mini Interference Screw." It claims substantial equivalence to a predicate device and does not involve clinical testing. Therefore, there are no specific acceptance criteria or a study proving the device meets them as would be found in a clinical trial or performance study.
Based on the provided text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) relies on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria through clinical testing. The primary "performance" reported is related to its mechanical properties being similar to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific criteria were defined or tested clinically. | Device's technological characteristics (materials, design, sizing, indications) are similar to or identical to the predicate devices. |
| Mechanical equivalency to predicate device | Mechanical testing was performed to establish substantial equivalence. (Specific results are not provided in this summary document.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used. "Mechanical testing was performed" but details about sample size or data provenance for this testing are not provided in this summary. These would typically be included in a more detailed testing report, not usually summarized in the 510(k) letter itself.
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)
Not applicable. No clinical test set or ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
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
Not applicable. This is a medical device (interference screw), not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (interference screw), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established or used for this 510(k). The "ground truth" for substantial equivalence was based on mechanical testing and comparison to an existing predicate device's design and materials.
8. The sample size for the training set
Not applicable. No training set was used as there was no clinical testing or machine learning involved.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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K01/254
JUL 1 7 2002
Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, block letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, thinner letters.
SUMMMARY OF SAFETY AND EFFECTIVENESS
Biomet Orthopedics, Inc. Applicant or Sponsor: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Sara B. Shultz Contact Person: Telephone: (574) 267-6639 Fax: (574) 372-1683
Proprietary Name: LactoSorb® Mini Interference Screw
Arthrodesis screw Common or Usual Name:
Fastener, Fixation, Biodegradable, Soft Tissue Classification Name:
Device Product Code: 87MAI
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: LactoSorb® Suture Anchor, K954443, Biomet, Inc.
Indications for Use: The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization.
Device Description: The LactoSorb® Mini Interference Screw is a resorbable screw that is preloaded on a driver much like those used with suture anchors. The screw is made out of LactoSorb®. The screw will be available in one size only.
Summary of Technologies: The device's technological characteristics (materials, design, sizing, indications) are similar to or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
m
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2002
Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K021254
Trade/Device Name: LactoSorb® Mini Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 18, 2002 Received: April 19, 2002
Dear Ms. Shultz:
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. Iisting 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. Sara B. Shultz
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 and additionally 21 CFR Part 809,10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 M. Wilkerson
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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Page _/ of _/
510(k) NUMBER (IF KNOWN): K021554
DEVICE NAME: LactoSorb® Mini Interference Screw
INDICATIONS FOR USE:
The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization.
Mark N Millenor
Division of General, Restorative and Neurological Devices
KO21259 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use you (Per 21 CFR 801.109)
OR
Over-The-Counter-Use No
(Optional Format 1-2-96)
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.