(74 days)
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No
The summary describes a mechanical implant (screw and washer) and its intended use and materials. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
Yes
The intended use describes the device as being used for "intra-articular fixation of small bones" and "fractures," which are therapeutic applications.
No
The device, Synthes 3.0 mm Cannulated Screw and Threaded Washer, is described as being used for intra-articular fixation of small bones in fractures and arthrodesis, which is a therapeutic and surgical purpose, not a diagnostic one.
No
The device description explicitly states it is a physical screw and washer made of stainless steel or titanium, and it undergoes sterilization. This indicates a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bones (fractures, arthrodesis). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a screw and washer made of metal, designed for physical implantation. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
- Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot).
- The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes 3.0 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel or Ti-6Al-7Nb. Synthes 3.0 mm Cannulated Screw and Threaded Washer are provided to the user sterile. Gamma Radiation will be used to sterilize the device.
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
Hand, wrist, forefoot (carpals, metacarpals, metatarsal - phalangeal)
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)
- Study type: Mechanical testing
- Key results: Synthes 3.0 mm Cannulated Screw and Threaded Washer are at least equivalent to Synthes 2.7 mm Cannulated Screw and Threaded Washer, based on mechanical testing of both devices.
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.
Synthes 2.7 mm Cannulated Screw and Threaded Washer.
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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§ 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/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person inside of a circle. A small registered trademark symbol is located to the right of the word.
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Attachment VI:
Summary of Safety and Effectiveness Information
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Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri July 1996
Synthes Sterile 3.0 mm Cannulated Screw and Threaded Washer is compared to Synthes 2.7 mm Cannulated Screw and Threaded Washer.
Synthes 3.0 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 3.0 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot. The 3.0 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel or Ti-6Al-7Nb.
Synthes 2.7 mm Cannulated Screw, used with the Threaded Washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist and forefoot. Specifically, it is intended for fractures of carpals and metacarpals, carpal and metacarpal arthrodesis; small fragments of the hand and wrist, and certain metatarsal - phalangeal applications (in foot). The 2.7 mm Cannulated Screw, by itself is intended for fixation of small bones, such as the hand, wrist and forefoot. The 2.7 mm Cannulated Screw and Threaded Washer are manufactured from 316L stainless steel.
Synthes 3.0 mm Cannulated Screw and Threaded Washer are provided to the user sterile. Gamma Radiation will be used to sterilize the device.
In our opinion, Synthes 3.0 mm Cannulated Screw and Threaded Washer are at least equivalent to Synthes 2.7 mm Cannulated Screw and Threaded Washer, based on mechanical testing of both devices.