(186 days)
Not Found
No
The summary describes a mechanical instrument set for surgical fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the fixation of soft tissue to bone, specifically for rotator cuff repair in the shoulder, which is a therapeutic intervention.
No
The device is described as an "Anchor and Instrument Set" intended for fixation of soft tissue to bone (e.g., Rotator Cuff Repair). This indicates a surgical tool used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an "Instrument Set" consisting of a "squeeze handle tool with a stainless steel nosepiece," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of soft tissue to bone" during surgical procedures (specifically Rotator Cuff Repair in the shoulder). This is a surgical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a surgical instrument set (inserter tool, nosepiece). This aligns with a surgical device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, the Opus Magnum® Anchor and Instrument Set is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Opus Magnum® Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications: - (1) SHOULDER 1.) Rotator Cuff Repair
Product codes
MBI
Device Description
The Opus Magnum Instrument Set consists of an Inserter squeeze handle tool with a stainless steel nosepiece. The Instrument Set is supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 2 2 2002
Summary of Safety and Effectiveness
K030172
page 1 of 1
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The claim of substantial equivalence is based upon Opus Medical's prior submission for the same device K012125.
COMPANY AND CONTACT PERSON
Opus Medical, Inc. 27127 Calle Arrovo. Suite 1924 San Juan Capistrano, CA 92675 Tel. (949) 234-0400 FAX (949) 234-0493
Contact Person: Mr. Jim Hart Tel. 949-234-0400
DEVICE NAME
Opus Magnum® Instrument Set
DESCRIPTION OF DEVICE
The Opus Magnum Instrument Set consists of an Inserter squeeze handle tool with a stainless steel nosepiece.
The Instrument Set is supplied non-sterile.
STATEMENT OF INTENDED USE
The Opus Magnum Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications:
- (II) SHOULDER 1.) Rotator Cuff Repair
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICE
The predicate device is used for fixation of soft tissue to bone for shoulder rotator cuff repair.
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The Opus Magnum Instrument Set has the same technological characteristics as the predicate device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing right, with a stylized eagle wing above them.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2002
Mr. Jim Hart Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675
Re: K020172 Trade/Device Name: Opus Magnum® Anchor & Instrument Set Regulatory Class: Unclassified Product Code: MBI Dated: April 18, 2002 Received: April 24, 2002
Dear Mr. Hart:
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.
2
Page 2 - Mr. Jim Hart
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 A. Millmann
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 1 of 1
510(k) Number (if known): K Od Ol 7Q
Device Name: Opus Magnum® Anchor & Instrument Set
Indications For Use: The Opus Magnum® Anchor and Instrument Set is intended for the fixation of soft tissue to bone for the following indications:
- (1) SHOULDER 1.) Rotator Cuff Repair
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR Over-The-Counter Use
Mark N Milkman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -
510 (k) Notification
Opus Medical
January 14, 2002