(111 days)
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No
The summary describes a mechanical drill bit and makes no mention of AI or ML.
No
The device, a drill bit, is used to bore a hole in bone for insertion of other devices. It does not provide any therapeutic effect itself.
No
Explanation: The device, Synthes Sterile Drill Bits, is designed to bore holes into bone for inserting other medical devices like screws or pins. This is a surgical or mechanical function, not one that identifies or diagnoses a medical condition or disease.
No
The device description clearly states it is a physical drill bit, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical tool (drill bit) used for mechanical action on bone.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Synthes Sterile Drill Bits are available in various sizes and lengths, have a fluted design, and are either solid or cannulated, and may be calibrated. The Synthes Sterile Drill Bits have various coupling mechanisms. Synthes Drill Bits will be 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
bone
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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§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.
K96 2913
Attachment IV:
Summary of Safety and Effectiveness Information
Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647 - 9700 Contact: Angela J. Silvestri July 1996
NOV 1 4 1896
Synthes commercially available Drill Bits are being made available as sterile.
Synthes Sterile Drill Bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.
Synthes Sterile Drill Bits are available in various sizes and lengths, have a fluted design, and are either solid or cannulated, and may be calibrated. The Synthes Sterile Drill Bits have various coupling mechanisms.
Synthes Drill Bits will be provided to the user sterile. Gamma radiation will be used to sterilize the device.