(193 days)
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Not Found
No
The summary describes a mechanical screw system for bone fixation and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML device submissions.
No
Explanation: The device is a fixation screw system used to secure bone sections after osteotomy or fractures, which aligns with the definition of a surgical implant rather than a therapeutic device that would treat or heal a condition.
No
The device is described as a fixation screw system used to secure bones after osteotomy or trauma, indicating it is a therapeutic or surgical device rather than one used for diagnosis.
No
The device description clearly states "EIS Threaded Compression Screw System," which is a hardware implant. The intended use also describes fixation of bones, which is a mechanical function performed by hardware. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device is a surgical implant (a screw system) used to fix bones within the body.
The intended use clearly describes a surgical procedure for bone fixation, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures. The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.
Product codes
HWC
Device Description
EIS Threaded Screws for Metatarsal Fixation
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
first metatarsal, small bones
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
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Image /page/0/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 three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 20 1999
Mr. Douglas W. Stuart Surgical Implants, Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326
Re: K991964
Trade Name: EIS Threaded Screws for Metatarsal Fixation Regulatory Class: II Product Code: HWC Dated: October 12, 1999 Received: October 15, 1999
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. A 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogdin
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT 5
STATEMENT of INTENDED USE
K991964 not known 510(K) Number ________________________________________________________________________________________________________________________________________________________________ EIS Threaded Compression Screw System Device Name: __
Statement of Intended Use
Indications For Use:
The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.
The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.
| Signed: | Dh Stuart |
|---|---|
| --------- | ----------- |
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NRO for
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991964 |
| Prescription Use (Per 21 CFR 801.109) | Yes | OR | Over The Counter Use | No |
|---|---|---|---|---|
| --------------------------------------- | ----- | ---- | ---------------------- | ---- |
(Optional Format 1-2-96)