(86 days)
Not Found
Not Found
No
The description focuses on the mechanical properties and materials of a suture anchor, with no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a suture anchor used for reattachment and repair of soft tissue and capsular structures, which are restorative actions rather than therapeutic.
No
The device description and intended use indicate it is an implantable medical device (suture anchor) used for reattachment and repair of soft tissue and capsules, not for diagnosing conditions.
No
The device description clearly describes a physical implant (PLLA cortical screw with suture) and associated hardware (driver), not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "soft tissue reattachment and capsular repair" in the shoulder. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (suture anchor) used to secure tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device is a surgical implant used for repair, not for diagnosis.
N/A
Intended Use / Indications for Use
The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue reattachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.
Product codes
79 JDR 87 MAI
Device Description
The Phantom Suture Anchor is a PLLA cortical screw with a flat tip and a rectangular head. Two holes run parallel to the axis of the screw. A #2 nonabsorbable polyester suture is prethreaded sequentially through these holes with a single loop at the tip of the screw. The suture anchors are available either pre-loaded on a driver or separately. The Phantom Suture Anchors are available in diameters of either 3.5 or 4.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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
Mechanical testing in cadaver bone showed that the pull-out loads for the Phantom Suture were comparable to the pull-out loads for the Statak anchors.
Key Metrics
Not Found
Predicate Device(s)
Zimmer Statak, Acufex Suretac
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
FEB - 6 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988 |
|----------------------|-----------------------------------------------------------|
| 510(k) CONTACT: | Vickie E. Arford, R.N.
Sr. Clinical Research Associate |
| TRADE NAME: | DePuy DuPont Phantom Suture
Anchor |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener |
| PRODUCT CODE: | 79 JDR 87 MAI |
SUBSTANTIALLY EQUIVALENT DEVICES:
Zimmer Statak Acufex Suretac Absorbable Tack
INTENDED USE AND DEVICE DESCRIPTION:
The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue reattachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.
The Phantom Suture Anchor is a PLLA cortical screw with a flat tip and a rectangular head. Two holes run parallel to the axis of the screw. A #2 nonabsorbable polyester suture is prethreaded sequentially through these holes with a single loop at the tip of the screw. The suture anchors are available either pre-loaded on a driver or separately. The Phantom Suture Anchors are available in diameters of either 3.5 or 4.5mm.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy DuPont Phantom Suture Anchors are substantially equivalent to the Zimmer Statak and the Acufex Suretac in that all of these devices are suture anchors which are intended for soft tissue re-attachment in the shoulder. The Phantom Suture Anchor is a resorbable anchor manufactured from PLLA. The Acufex Suretac is a resorbable tack manufactured from polyglyconate. The Zimmer Statak is non-resorbable and is manufactured from Ti-6Al-4V metal alloy. Both the Phantom suture anchors and the Stataks have a threaded design. Mechanical testing in cadaver bone showed that the pull-out loads for the Phantom Suture were comparable to the pull-out loads for the Statak anchors.