(81 days)
No
The summary describes a resorbable bone pin for fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for fixation of bone fragments, which is a therapeutic intervention.
No
The device is described as a fixation pin for small bone fragments, indicating it is a treatment or surgical device, not one that identifies a disease or condition.
No
The device description clearly states it is a "resorbable fixation pin," which is a physical 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 for the fixation of small bone fragments within the body. This is a surgical procedure performed in vivo (within a living organism).
- Device Description: The device is a resorbable fixation pin designed to be implanted in bone. This is a medical device used for treatment, not for testing samples in vitro (outside of a living organism).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone pin does not fit that description.
N/A
Intended Use / Indications for Use
Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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): 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.
Poly-Medics Lactosorb® Bone Pin (K953194)
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.
Not Found
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).
Not Found
§ 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
United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Bone Pin** MAR 2 5 1997 K9 +0036 510(k) SUMMARY OF INFORMATION: United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 CONTACT PERSON: Melissa Mazzoni December 31, 1996 DATE PREPARED: CLASSIFICATION NAME: Pin, Fixation, Smooth or threaded metallic bone fixation fastener COMMON NAME: Fixation Pin or Rod Trademark name not yet determined. PROPRIETARY NAME: The Surgical Dynamics™ Bone Pin** is a resorbable DEVICE DESCRIPTION: fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires. Poly-Medics Lactosorb® Bone Pin (K953194) PREDICATE DEVICE: Both the Surgical Dynamics™ Bone Pin** and the Poly-INTENDED USE: Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization. Both the Surgical Dynamics™ Bone Pin** and the Poly-MATERIALS: Medics Lactosorb® Bone Pin (K953194) are comprised of biosafe materials.
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