(77 days)
No
The description focuses on the mechanical components of a surgical implant and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a pin and socket used for soft tissue to bone fixation, which is an implantable medical device, not typically classified as a therapeutic device in the sense of actively treating or alleviating a condition (like a drug or a therapy machine). It facilitates repair rather than directly providing therapy.
No
The device is described as a pin and socket for soft tissue to bone fixation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is comprised of a pin and a socket, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for soft tissue to bone fixation within the body during an arthroscopic procedure. It's a physical device used to repair a structural issue in the shoulder.
The device's function is entirely mechanical and surgical, not diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop . Rivet (K951658) are indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.
Product codes
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Device Description
Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are comprised of a pin. which widens distally, and a socket, which consists of a cannulated head with circumferential teeth on the underside, as well as four ribbed legs emanating from the underside of the head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Poly-Medics Lactosorb® Pop Rivet (K951658)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 Corporation 510(k) Premarket Notification Surgical Dynamics™ Pop Rivet*
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™ Pop Rivet** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Pop Rivet (K951658) and other currently market devices by United States Surgical Corporation.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop . Rivet (K951658) are indicated for use in soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with recurrent anterior dislocation or subluxation of the shoulder.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are comprised of a pin. which widens distally, and a socket, which consists of a cannulated head with circumferential teeth on the underside, as well as four ribbed legs emanating from the underside of the head.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop . Rivet (K951658) are comprised of biosafe materials.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop . Rivet (K951658) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop . Rivet (K951658) are manufactured in the same facilities, using the same materials and process methods and controls.
- . Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are packaged in similar facilities, with the same materials and with the same process methods and controls.
- Both the Surgical Dynamics™ Pop Rivet** and the Poly-Medics Lactosorb® Pop Rivet (K951658) are sterilized in the same facilities, with the same materials and with the same process methods and controls.