(80 days)
Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsulo repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction. Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction. Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction. Knee Indications -- Medial collateral ligament repair, lateral collateral ligament repair, Ande indications - Medial Sollatora. neems. If intibial band tenodesis, and patellar ligament/tendon repair.
The Metal Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured out of theuile for ucasioning con is available in two sizes, 3.0 mm. The screw anchor consists of a screw portion and a head portion. The 3.0 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.0 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Metal Scrow Anchor will be packaged sterile and will be preloaded on a driver with suture.
The presented document is a 510(k) premarket notification for a medical device called the "Metal Screw Anchor." This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance.
Therefore, many of the requested elements (like acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and how ground truth was established for training sets) are not applicable or not explicitly detailed in this type of regulatory document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Typically for Clinical Performance) | Reported Device Performance (from submission) |
|---|---|
| Not explicitly stated/defined in the K012503 submission | Substantially equivalent to predicate devices |
- Explanation: The 510(k) process for this device relies on demonstrating substantial equivalence, primarily through non-clinical testing comparing it to legally marketed predicate devices. The document explicitly states: "Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there are no "acceptance criteria" for clinical performance in the sense of a clinical trial with pre-defined thresholds. The unstated "acceptance criterion" is that the device performs at least as well as the predicate in relevant mechanical tests and has similar technological characteristics.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical "test set" was used as clinical testing was not performed for substantial equivalence. For non-clinical (mechanical) testing, sample sizes are not provided in this document.
- Data Provenance: Not applicable. Clinical data was not used. For non-clinical testing, the testing was performed by the applicant (Arthrotek, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No clinical "test set" requiring expert ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. No clinical "test set" requiring adjudication 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
- MRMC Comparative Effectiveness Study: No. This device is a physical medical implant (Metal Screw Anchor), not an AI-powered diagnostic or decision-support tool. It does not involve human readers interpreting output from the device, so MRMC studies are not relevant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical implant, not an algorithm. Standalone performance studies are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for clinical performance. For the mechanical non-clinical testing, the "ground truth" would be the measured physical properties (e.g., pull-out strength, stiffness) of the device and the predicate devices, established through standard engineering/mechanical testing protocols.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. Clinical data was not used. No AI/machine learning model was trained for this device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. No training set was used.
Summary of Device Rationale from Document:
The Metal Screw Anchor establishes substantial equivalence based on:
- Similar Technological Characteristics: "The Metal Screw Anchor's technological characteristics (materials, design, sizes, and indications) are similar to the predicate device."
- Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
- No Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."
The predicate devices are the Harpoon Suture Anchor (Biomet, Inc., K943806/K973775). The regulatory pathway for this device (510(k)) focuses on demonstrating that the new device is as safe and effective as a legally marketed predecessor, primarily through comparison of design, materials, and mechanical performance, rather than new clinical trials with specified acceptance criteria on clinical outcomes.
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OCT 22 2001
Image /page/0/Picture/2 description: The image shows the words "BIOMET" in a stylized, bold font. Below this, the words "CORPORATE HEADQUARTERS" are printed in a smaller, less bold font. The text appears to be part of a logo or heading.
SUMMMARY OF SAFETY AND EFFECTIVENESS
Applicant or Sponsor:
Arthrotek, Inc. (A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Establishment Registration No .: 1825034
Contact Person:
Sara B. Shultz Biomet Manufacturing, Corp. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (219) 267-6639 FAX: (219) 372-1683
Proprietary Name:
Metal Screw Anchor
screw anchor Common or Usual Name:
Fastener. Fixation. Non-degradable, Soft Tissue Classification Name:
87MBI and 87HWC Device Product Code:
Legally Marketed Devices To Which Substantial Equivalence is Clalmed: Harpoon Suture Anchor (Biomet, Inc., K943806/K973775)
Indications for Use: Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows:
Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsulo repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand Indications - Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 II. Bell Drive Warsaw, IN 46582
OFFICIE 219.267.6639
l'Ax 219.267.8137
E-MAIL biomet@biomet.com
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2 OF 2
Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, black letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, black letters.
Elbow Indications – Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee Indications -- Medial collateral ligament repair, lateral collateral ligament repair, Ande indications - Medial Sollatora. neems. If intibial band tenodesis, and patellar ligament/tendon repair.
Device Description: The Metal Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured out of theuile for ucasioning con is available in two sizes, 3.0 mm. The screw anchor consists of a screw portion and a head portion.
The 3.0 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.0 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Metal Scrow Anchor will be packaged sterile and will be preloaded on a driver with suture.
Summary of Technologies: The Metal Screw Anchor's technological characteristics (materials, design, sizes, and indications) are similar to the predicate device.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SIXIPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
1:4X 219.267.8137
E-MAIL blomet@blomet.com
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the snakes intertwined around a staff. The caduceus is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
OCT 22 2001
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. P. O. Box 587 Warsaw, Indiana 46581-0587
Re: K012503
ﺑ
Trade Name: Metal Screw Anchor
Regulation Number: 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: MBI Dated: August 2, 2001 Received: August 3, 2001
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, 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. Sara 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 N. Millerson
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kol 2503 510(k) NUMBER (IF KNOWN):
DEVICE NAME: Metal Screw Anchor
INDICATIONS FOR USE: Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee.
Specific indications are as follows:
Shoulder Indications - Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule repair, or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.
Wrist/Hand Indications - Scapholunate ligament reconstruction, and ulnar/radial collateral ligament reconstruction.
Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow Indications - Ulnar or radial collateral ligament reconstruction, and biceps tendon reconstruction.
Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, liiotibial band tenodesis, and patellar ligament/tendon repair.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Ov
(Per 21 CFR 801.109) (O
Ma Mink Milk
(Division Sign-Off)
Dіvоn foeneral, Restorative
Over-The-Counter-Use (Optional Format 1-2-96)
and Neurological Devices
510kk) Number
§ 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.