(214 days)
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No
The summary describes a mechanical staple system for bone fixation and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is described as a system for fixing fractures and securing bone sections, which are structural and mechanical functions, not therapeutic. A therapeutic device would typically involve treating a disease, restoring health, or alleviating symptoms through biological, pharmacological, or other non-mechanical means.
No
The device is described as a system for fixation of fractures and bone fixation after osteotomy, which are therapeutic interventions, not diagnostic ones.
No
The device description and intended use clearly describe a physical staple system for bone fixation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the fixation of fractures and bone sections within the body. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description refers to a "staples system," which is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is used directly on the bone during surgery.
N/A
Intended Use / Indications for Use
The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.
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 fracture.
Product codes
JDR
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
big toe, interphangeal, scaphoid
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
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Mr. Douglas W. Stuart Surgical Implants. Inc. 962 South Tamiami Trail Suite 203 Sarasota, Florida 34326
Re: K991962
Trade Name: EIS Dynamic Memory Staples System Regulatory Class: II Product Code: JDR 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 (QS) 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.
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.
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Page 2 - Mr. Douglas W. Stuart
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,
Russell Sage
Sa 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 6
A Statement of intended Use
K991962 not known 510(K) Number _ EIS Dynamic Staple System Device Name: _________________________________________________________________________________________________________________________________________________________________
Statement of Intended Use
Indications For Use:
The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.
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 fracture.
Signed: DWStuart
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Ser J712 |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991962 |
| Prescription Use | /ve | OR | Over The Counter Use | No |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |