(63 days)
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No
The summary describes a suture anchor, a mechanical device for tissue fixation, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a suture anchor used for the fixation of soft tissue to bone, which is a structural or mechanical function, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as a 'Suture Anchor' intended for soft tissue to bone fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states "Anspach Suture Anchor," which is a physical implantable device used for surgical fixation, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a "Suture Anchor" used for the "Fixation of soft tissue to bone." This is a surgical implant used directly within the body during a procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, the Anspach Suture Anchor is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Fixation of soft tissue to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot.
Specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.
Product codes
MBI, HWC, GAT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TUL 1 3 1998
William E. Anspach, III, M.D. · Vice President, R&D Regulatory The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K981688 Anspach Suture Anchor Requlatory Class: II Product Codes: MBI, HWC, and GAT Dated: May 10, 1998 Received: May 11, 1998
Dear Dr. Anspach:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - William E. Anspach, III, M.D.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
G
Page of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Anspach Suture Anchor
Indications For Use:
15:33
Fixation of soft tissue to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot.
Specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K981688 |
| Prescription Use | X | OR | Over-The-Counter Use | / |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Form 1-2-9) |