(88 days)
Not Found
Not Found
No
The 510(k) summary describes a physical suture anchor for surgical repair and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended for reattaching soft tissue to bone and is indicated for repairs and reconstructions, which are therapeutic interventions.
No
The device, a suture anchor, is used for reattaching soft tissue to bone, which is a therapeutic or reconstructive function, not a diagnostic one. Its indicated uses (Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions) are all surgical procedures rather than diagnostic assessments.
No
The intended use describes a physical suture anchor, which is a hardware device used in surgical procedures. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for reattaching soft tissue to bone in the shoulder during surgical procedures. This is a direct surgical intervention on the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or test kits.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical fixation.
N/A
Intended Use / Indications for Use
The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.
Product codes
MBI
Device Description
UltraFix® Knotless MiniMite® Suture Anchor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
glenoid bone in the 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)
Not Found
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
August 22, 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 22 2002
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the UltraFix® Knotless MiniMite® Suture Anchor 510(k) Number Ko222827.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
B. Company Contact
Laura D. Seneff, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
Trade Name: UltraFix® Knotless MiniMite® Suture Anchor
Common Name: Bone Anchor
Classification Names: Fastener, fixation, nondegradable, soft tissue
Proposed Class/Device: Class II Product Code MBI
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 an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K022827
Trade/Device Name: UltraFix® Knotless MiniMite® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 22, 2002 Received: August 26, 2002
Dear Ms. Seneff:
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 - Ms. Laura D. Seneff
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 (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" (21 CFR 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 Milken
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
August 22, 2002
510(k) Number (if known):
Device Name: UltraFix® Knotless MiniMite® Suture Anchor
Indications for Use:
The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
(Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
for Mark N Milkum
(Division Sign-Off)
Division of General, Restorative and Neurological De
510(k) Number .