(83 days)
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The Opus MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone. The purpose of this 510(K) is to notify the FDA of the clearance of a new Opus product, the Opus MiniMagnum™ Bone Anchor. The Opus MiniMagnum™ is substantially equivalent to Opus Magnum™ originally cleared under 510(k) 012125, but is smaller in size. The intended use and indications for use are the same as the predicate device, the Mitek BioKnotless Bone Anchor. The fundamental technology of the Opus MiniMagnum™ Bone Anchor System is substantially equivalent to the Opus Magnum™ Bone Anchor.
The provided text is a 510(k) premarket notification for a medical device (Opus MiniMagnum™ Bone Anchor with Inserter). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics. Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a new clinical trial.
Instead, the document asserts substantial equivalence based on:
- Identical intended use and indications for use to the predicate devices (Opus Magnum™ Anchor with Inserter and Mitek BioKnotless Anchor).
- Similar fundamental technology to the Opus Magnum™ Bone Anchor.
- The MiniMagnum™ is described as being "smaller in size" than its predicate.
To directly answer your specific questions in the context of this 510(k) submission, the following would be the response:
1. Table of acceptance criteria and the reported device performance:
This 510(k) submission does not include a table of acceptance criteria and reported device performance based on a new clinical study. The device's performance is implicit in its substantial equivalence to predicate devices, meaning it is expected to perform similarly to devices already on the market for the same intended use.
2. Sample size used for the test set and the data provenance:
No test set sample size or data provenance is reported, as a new clinical study demonstrating specific performance metrics was not conducted. The submission relies on the established safety and effectiveness of its predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for a test set is mentioned, as no new clinical study was performed.
4. Adjudication method for the test set:
Not applicable. Since there was no test set or expert ground truth establishment, no adjudication method is described.
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 device is a bone anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study involving human readers improving with AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical bone anchor, not a software algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used:
Not applicable. Given that no new clinical study with performance metrics was conducted, there is no mention of ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is a physical medical device seeking substantial equivalence, not an AI/ML device requiring a training set for algorithm development.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an algorithm, the method of establishing ground truth for it is not discussed.
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Opus Medical, Inc.
510(k) Notification
MiniMagnum™ Bone Anchor and Instrument Set Page 9 of Sin
DEC 1 4 2004
Section 4: 510(k) Summary
510(k) Number:
page 1 of 2
Substantial Equivalence
Substantial Equitements of 21 CFR 807.93, this summary is formatted with the In accordance with the requirements and 510(k) Statements... " and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer: | Opus Medical, 27127 Calle Arroyo, Suite 1924San Juan Capistrano, CA. 92675 |
|---|---|
| Contact Person: | Laura Kasperowicz, Ph: (949) 234-0400, Fax: 234-0493E-Mail: Lkasperowicz@opusmedical.com |
| Date Prepared: | September 20, 2004 |
Device Information
| Trade Name: | Opus MiniMagnum™ Anchor with Inserter |
|---|---|
| Common Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Classification: | Class II per 21 CFR 888.3040; Product Code: HTY |
Substantial Equivalence
The Opus MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone.
Indications For Use
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
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Opus Medical, Inc.
510(k) Notification
Section 4: 510(k) Summary
510(k) Number: K045584
page 2 of 2
Executive Summary and Reason for 510(k) Notification
Executive Sullimary and Reason ior erra of a new Opus product, the Opus I he purpose of this STU(K) is to nothy the PDF of the " substantially equivalent to Opus MiniMagnum™ originally cleared under 510(k) 012125, but is smallers in size. The intended use and Magnum !™ originally cleared under 310(x) 012125, oat be Mick BioKnotless Bone Anchor.
indications for use are the same as the predicate device, the Michaetially indications for use are the same as the predicate do november System is substantially I he rundaniental technology of the Opus Magnum™ Bone Anchor.
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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 eagle with three horizontal lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Ms. Laura N. Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arrovo, Suite 1924 San Juan Capistrano, California 92675
Re: K042584
Trade/Device Name: Opus MiniMagnum™ Bone Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 21, 2004 Received: September 22, 2004
Dear Ms. Kasperowicz:
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. Laura N. Kasperowicz
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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 A. Mcllussen
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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Opus Medical, Inc.
510(k) Notification
SECTION 3: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K042584
Device Name: Opus MiniMagnum™ Bone Anchor with Inserter
Indications for Use:
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Ελαπίριο στ such proved. SLAP Iesion repair, acromio-clavicular separation, rotator cuff Onounter - Banklift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair 1 count, expons sinfe bappen one in instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique I's ligament or joint capsule co anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Prescription Use X (Per CFR 801.109)
OR
Over-The-Counter Use No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) 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.