(189 days)
This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications.
The Polymer Cinch SB Anchor/Suture Combination is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.
Shoulder:
- Bankhart Repair
- SLAP Lesion Repair
- Acromio-clavicular separation
- Rotator Cuff Repair
- Capsule and Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair
Hand, Wrist, Elbow:
- Scapholunate ligament reconstruction
- Ulnar Collateral Ligament Reconstruction
- Lateral Collateral Ligament Reconstruction
- Biceps Tendon Reattachment
- Elbow Medial/Lateral Repair of Tendons in the Elbow
Foot:
- Hallux Valgus Reconstruction
- Mid and Forefoot Reconstruction
Knee:
- medial collateral ligament
- lateral collateral ligament
- posterior oblique ligament
- Joint capsule closure
- Illiotibial band tendonesis
- VMO Advancement
Urinary: Bladder Neck Suspension
The Polymer OBL SB Anchor is a simple modified polyacetal cylinder designed to be pushed through a hole in bone chosen by the surgeon as a site for anchoring soft tissue to bone. Each anchor is preloaded with suture and includes an insertion device.. These components are packaged together sterile in double mylar/tyvek pouches or formed trays. The device is single use. The device can be used for open and arthroscopic procedures.
The anchor is a modified cylinder made of polyacetal. From the end, the anchor is round with two grooves milled 180° apart. From the side, the anchor is a parallelogram with a hole through it. The anchors will be referred to by the diameter and the overall length, for example 2x8 means the diameter is 2.0 mm and the length is 8 mm. Refer to the drawing on page 12 for the dimensions "C" and "A".
The largest anticipated size of the anchor is 3 mm in diameter and 15 mm in length (3x15). The smallest anticipated size of the anchor is 2 mm in diameter and 8 mm in length (2x8). The purpose of the hole through the device is to hold suture. The smooth longitudinal grooves on each side of the device allow the suture to pass into the bone hole without pinching the suture. The ends of the device are designed to initiate rotation of the device as it is pushed and subsequently pulled into place. The ends are tapered at angles that range from 30° to 60°. The anchor is symmetric, allowing it to be inserted with regard to which end enters first. The shape of the device distributes the load over a large bone surface reducing the risk of bone breakage or pullout.
The Insertion Device is a manual surgical instrument comprised of a handle, sleeve, and piston. The handle is constructed from polypropylene and serves the functions of holding all pieces together and to interface between the surgeon's hand and the device. The sleeve houses the piston and the Anchor. The sleeve keeps the Anchor and piston in-line to allow the piston to push the Anchor into the implantation site.
The Suture is Braided Polyester Suture from Surgical Specialties (See Appendix 3 for Approval Letters. N80950). The largest anticipated diameter of the suture USP #2. The smallest anticipated diameter of suture is USP #2-0. The suture is preloaded in the anchor eyelet.
Materials
Anchor: Polyacetal Inserter: Piston and Sleeve: Stainless Steel, Handle: Polypropylene Suture: Braided Polyester from Surgical Specialties, See Appendix 3.
Use
To implant the Anchor, the surgeon must first create an implantation site in bone. OBL supplies accessory drills and awls to prepare these sites.
Once the implantation site is prepared, the surgeon simply aligns the Anchor to the hole, pushes the handle toward the bone, retracts, and disconnects the Suture from the Inserter. The Suture will be retained by the Anchor. Pulling back on the Suture further engages the Anchor into the walls of the hole. The surgeon is then left with an Anchor in the bone and Suture to attach to the soft tissue.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information about AI/ML specific acceptance criteria, study designs, and performance metrics (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable.
The document describes the device, its intended use, a comparison to predicate devices, and performance data related to its physical characteristics.
Here’s the available information presented in a format that aligns with the requested table, as much as possible for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Polymer OBL SB Anchor / Suture Combination) | Notes |
|---|---|---|
| Pullout Strength (smallest device: 2x8 mm) | 9.6 lbs | Compared to predicate Innovasive product (9 lbs). |
| Pullout Strength (largest device: 6x15 mm) | 14 lbs | Compared to predicate Innovasive product (9 lbs). |
| Suture Break Strength (smallest device) | 19.4 lbs | Compared to USP #2 synthetic suture knot break strength (14 lbs). This indicates the knot will fail before the suture at the anchor. |
| Suture Break Strength (largest device) | 23.2 lbs | Compared to USP #2 synthetic suture knot break strength (14 lbs). This indicates the knot will fail before the suture at the anchor. |
| Material (Polyacetal) | Used in device; also used in predicate Innovasive device. | The only difference between the OBL Polymer OBL SB Anchor and the OBL SB Bone Anchor (K950592) is the material (Polyacetal vs. Titanium Alloy). |
| Sterilization | EtO sterilized (as described for predicate Innovasive device). | Both devices can be EtO sterilized. |
Missing Information (Not applicable for this type of device submission):
The following points are specific to AI/ML device evaluations and are not present in this 510(k) submission for a non-AI surgical anchor:
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size
- Standalone (algorithm only) performance
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data)
- Sample size for the training set
- How the ground truth for the training set was established
§ 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.