(77 days)
The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures.
The Suture Lock is a sterile, single-use device manufactured from polyacetal.
This is a medical device 510(k) summary for a "Suture Retention Device" called Suture-Lock. It is a physical device, and therefore the request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance metrics is not applicable. The provided document does not contain information about an AI/algorithm-based device or its performance studies.
Therefore, I cannot answer the questions regarding acceptance criteria and performance studies in the requested format. This document describes a traditional medical device and its substantial equivalence to a predicate device based on characteristics like materials, intended use, and indications.
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964935
FEB 25 1997
Section 8: 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in
to and of 510(k) safety and 1990 and CEP 807 02 8.1 I his summary of 510(x) salety and c2000. I 1990 and CFR 807.92. Statement
Smith and Nephew Endoscopy, Inc. 8.2 130 Forbes Blvd. Submitter Mansfield, Ma. 02048
Susan Finneran 8.3 Clinical/Regulatory Affairs Company (508) 261-3772 Contact
| 8.4 | Proprietary Name: Suture-Lock |
|---|---|
| Device Name | Common Name: Suture Retention Device/ Accessory to Suture |
| Classification Name: Suture Retention Device |
| 8.5 | |
|---|---|
| Predicate | T-Fix Suture Bar |
| LegallyMarketedDevices | Smith and Nephew Endoscopy, Inc.Mansfield, Ma. |
8.6
ડાં
The Suture Lock is a sterile, single-use device manufactured from polyacetal. Device Description
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| 8.7Intended Use | The Suture Lock is intended to be use to secure soft tissue to bone, by securingthe placement of sutures used in surgical procedures. |
|---|---|
| 8.8DeviceIndications | The Suture Lock is indicated for use in Bankart and Rotator Cuff Repairprocedures. |
| 8.9SubstantialEquivalence | The Suture Lock is substantially equivalent to the T-Fix Suture Bar which iscurrently manufactured and distributed by Smith and Nephew Endoscopy, Inc.(Mansfield, Ma.)The table following summarizes the common features of the T-Fix suture Barand the Suture Lock. |
Table 4: Substantial Equivalence
| Product Name | Suture Lock | T-Fix |
|---|---|---|
| Product Labeling | Sterile (EtO), Single Use | Sterile (EtO), Single Use |
| Materials | Polyacetal | Polyacetal |
| Intended use | Soft tissue fixation by securingsuture | Soft tissue fixation by securingsuture |
| Indications | Arthroscopic and openshoulder lesion repair | Arthroscopic and openshoulder lesion repair |
Applicant Aus Zinn
Date 12/9/96
§ 878.4930 Suture retention device.
(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.