(154 days)
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Not Found
No
The summary describes simple mechanical fixation devices (K-Wires and Steinmann Pins) and makes no mention of AI or ML technology.
Yes
The device is designed to facilitate healing of bone fragments by drawing them together, which aligns with the definition of a therapeutic device aimed at treating a condition.
No
The device is described as a fixation device used to draw bone fragments together to facilitate healing. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly states the devices are "stainless steel fixation devices" which are physical implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "draw two or more bone fragments together in order to facilitate healing." This is a mechanical function performed directly on the patient's body.
- Device Description: The device is described as "stainless steel fixation devices" (K-Wires and Steinmann Pins) used to "draw bone fragments together." This further reinforces its mechanical, non-diagnostic function.
- 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 treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body to provide structural support for healing.
N/A
Intended Use / Indications for Use
The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.
Product codes
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Device Description
The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.
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
bone fragments
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Key Metrics
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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
SEP 2 3 1996
ATTACHMENT 11
510(k) SUMMARY
| Submitting Company: | SYNVASIVE Technology, Inc.
4925 Robert J. Matthews Pkwy.
El Dorado Hills, CA 95762 |
|----------------------|------------------------------------------------------------------------------------------|
| Telephone: | 916-939-3913 |
| Fax: | 916-939-3919 |
| Contact Person: | Michael G. Fisher
Vice President |
| Date Prepared: | April 8, 1996 |
| Common Product Name: | Kirschner Wires (K-Wires) and Steinmann Pins |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation
Fastener (per 21 CFR 888 .3040) |
Product Description: The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.
Intended Use: The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.
Substantial Equivalence: The fixation devices are substantially equivalent to standard K-Wires and Steinmann Pins legally marketed by many companies including DePuy, Howmedica, MicroAire, and Zimmer.
Technological Characteristics: The fixation devices have the same technological characteristics as all of the predicate devices.
Safety and Effectiveness Testing: All materials used in the fixation devices conform with ASTM specifications for medical device use. Material specifications are tested on a design basis and certificates of conformance to specifications are supplied with each material batch.