(24 days)
No
The 510(k) summary describes a modification to an implant system involving a new suture material. There is no mention of AI or ML technology in the intended use, device description, or any of the other sections. The focus is on the physical components of the device.
Yes
The device is an implant indicated for rotator cuff repair in the shoulder, which is a therapeutic intervention.
No
The device is an implant for rotator cuff repair, not a diagnostic tool. Its purpose is treatment, not diagnosis.
No
The device description clearly states it is an "implant" and an "Implant System," which are hardware components. The modification involves adding a new "suture," also a hardware component. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "rotator cuff repair in the shoulder." This is a surgical procedure performed in vivo (within the living body), not a test performed in vitro (outside the living body) on biological samples to diagnose a condition.
- Device Description: The device is an implant and a suture used in a surgical repair. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Opus Magnum® implant is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.
Product codes
HTY, MBI, GAT
Device Description
The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Opus Magnum® Implant Set, K031083
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
Opus Medical, Inc.
K04/440
SECTION 4: 510(k) SUMMARY
JUN 2 5 2004
(Premarket Notification [510(k) Number]
| Manufacturer | Opus Medical, Inc.
27127 Calle Arroyo, Suite 1924
San Juan Capistrano, CA 92675 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Laura Kasperowicz, Regulatory Affairs
Phone: (949) 234-0400
Fax: (949) 234-0493
E-mail: Lkasperowicz@opusmedical.com |
| Date Prepared | May 28, 2004 |
Device Information
| Trade Name: | Opus Magnum® 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 Magnum® Anchor with Inserter is substantially equivalent to the existing Opus Magnum® Implant Set cleared by the Food and Drug Administration. The intended use of the Opus Magnum® Anchor with Inserter is substantially equivalent to the intended use of the existing Opus Magnum® Implant Set, for fixation of soft tissue to bone.
Indications For Use
The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.
Device Description and Reason for 510(k) Notification
The purpose of this 510(k) is to notify the FDA of a modification to the Opus Magnum® Implant System wherein a new suture, MagnumWire™, will be added as an option to provide convenience to the user. MagnumWire™ is substantially equivalent to FiberWire® USP braided polyester suture size #2 originally cleared under 510(k) 031083. The intended use and indications for use are the same as the predicate device. The addition of the use of MagnumWire™ with the Opus Magnum® Implant System does not alter the fundamental technology of the Opus Magnum® Implant System.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its wings and body.
JUN 2 5 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675
Re: K041440
Trade/Device Name: Opus Magnum® Anchor with Inserter Regulation Number: 21 CFR 888.3040, 21 CFR 878.5000 Regulation Name: Metallic bone fixation fastener, Nonabsorbable polyethylene surgical suture Regulatory Class: II Product Code: MBI, GAT Dated: May 28, 2004 Received: June 1, 2004
Dear Ms. Kasperowicz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premised is substantially equivalent (for the indications ferenced above and nave decemined the arredicate devices marketed in interstate for tise stated in the encrosule) to tegally manatise province Americal Device Amendments, or to commerce province way 26, 1978, the excordance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). allu Cosmetic Act (Act) that do not requence appent of the general controls provisions of the Act. The You may, merclove, market me device, excirements for annual registration, listing of general controls provisions of the fies 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 If your device is classified (500 abor of the Existing major regulations affecting your device can may be subject to such additional econsolors, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean FICASE oc advised that i DFF 3 localites over device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I cuttar statutes and regarations and admited to: registration and listing (21 comply with an the Act 3 requirements, merchang, and manufacturing practice requirements as set Crit Fatt 807), labeling (21 CFR Part 800); goods ionin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Laura Kasperowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manieting of substantial equivalence of your device to a legally premarket nothleadon: "The PDA mailing of basion 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 If you desire specific acvice for your as 1) 594-4659. Also, please note the regulation entitled, comact the Office of Comphanes at (so t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Obless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam l. Provost
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
3
Opus Medical, Inc.
510(k) Notification
Opus Magnum® Bone Anchor with Inserter Page 8 of 31
SECTION 3: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Opus Magnum® Bone Anchor with Inserter
Indications for Use:
The Opus Magnum® implant is indicated for use for rotator cuff repair in the shoulder.
Prescription Use X (Per CFR 801.109)
OR
Over-The-Counter Use -------
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________