(90 days)
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Not Found
No
The summary describes a physical implant (mesh cup/sheet) for acetabular reconstruction and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "scaffold" that creates a "sound foundation or base for the definitive load bearing acetabular cup replacement devise," indicating its role in the surgical reconstruction and restoration of the acetabular joint cavity for conditions like acetabular erosion, protrusio, failed implants, or trauma-induced fractures. This falls under the definition of a therapeutic device as it directly treats or manages a medical condition.
No
The device, a Link Acetabular Mesh Cup and Sheet, is described as a surgical reconstruction device used to restore the acetabular floor or defect, creating a foundation for an acetabular cup replacement. Its purpose is therapeutic/restorative, not to diagnose a condition.
No
The device description explicitly states "Link Acetabular Mesh Cup and Sheet," which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure to reconstruct the acetabulum (hip socket) using a mesh cup or sheet as a scaffold for a load-bearing implant. This is a surgical device used in vivo (within the body).
- Device Description: The device is described as an "Acetabular Mesh Cup and Sheet," which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly used in vivo for surgical reconstruction.
N/A
Intended Use / Indications for Use
Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise.
Product codes
JDJ
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
Acetabular
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 1997
Mr. Douglas W. Stuart Surqical Implants Incorporated for Link America, Inc. 962 South Tamiami Trail, Ste. 203 Sarasota, Florida 34326
Re: K972760 Acetabular Revision Mesh and Cup Trade Name: Regulatory Class: II Product Code: JDJ Dated: July 16, 1997 and the comments of the comments of Received: July 24, 1997
Dear Mr. Stuart:
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 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 (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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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.
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Page 2 - Mr. Douglas W. Stuart
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA association 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,
a M. Witten, Ph.D., M.D. 1Cell Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 - 1 - 1
Exhibit 8
STATEMENT OF INTENDED USE
not known 510(K) Number Device Name: Link Acetabular Mesh Cup and Sheet
Indications For Use:
Statement of Intended Use
Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise: ---------------------------
Signed: DW Stuart
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices |
| 510(k) Number | K972760 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over The Counter Use | _ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |