(77 days)
Not Found
No
The device description and intended use are purely mechanical, describing a suture anchor for soft tissue attachment to bone. There is no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device, a suture anchor, is used to attach soft tissue to bone, which is a supportive and restorative function rather than a direct therapeutic treatment of a disease or condition.
No
Explanation: The device is a suture anchor used for attaching soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a "suture anchor, with polyester suture attached," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attachment of soft tissue to bone in shoulder, wrist and hand procedures." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "suture anchor... placed into a predrilled bone hole for anchorage of soft tissue." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for mechanical fixation.
N/A
Intended Use / Indications for Use
attachment of soft tissue to bone in shoulder, wrist and hand procedures
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, wrist and hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
arthroscopic procedures
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.
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
§ 888.3030 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
United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Suture Anchor**
JUL 1 0 1996
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
As is evident in the submitted information on indications, design, materials, manufacturing, sterilization, packaging and method of use, the Surgical Dynamics™ Suture Anchor** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Suture Anchor (K954443) and other currently market devices by United States Surgical Corporation.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
- Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
- . Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® Suture Anchor (K954443) are comprised of biosafe materials.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are manufactured in the same facilities, using the same materials and process methods and controls.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are packaged in similar facilities, with the same materials and with the same process methods and controls.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are sterilized in the same facilities, with the same materials and with the same process methods and controls.