SUTURE LOCK

• K Number: K964935
• Device Name: SUTURE LOCK
• Manufacturer: SMITH & NEPHEW ENDOSCOPY, INC.
• Date Cleared: 1997-02-25 ( 77 days)
• Product Code: KGS
• Regulation Number: 878.4930

Intended Use

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.

Device Description

The Suture Lock is a sterile, single-use device manufactured from polyacetal.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for securing sutures and does not mention any software, algorithms, or AI/ML related terms.

Therapeutic

Yes
The device is described as being used to secure soft tissue to bone by securing sutures in Bankart and Rotator Cuff Repair procedures, which are therapeutic interventions.

Diagnostic

No
The document states that the Suture Lock is used to secure soft tissue to bone during surgical procedures, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "sterile, single-use device manufactured from polyacetal," indicating it is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The Suture Lock is intended for securing soft tissue to bone during surgical procedures. This is a direct surgical intervention on the patient's body.
• Device Description: It's a physical implantable device made of polyacetal.
• Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The Suture Lock does not perform any such analysis of biological samples.

Therefore, the Suture Lock falls under the category of a surgical implant or device used directly in a surgical procedure, not an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures.

Product codes

Not Found

Device Description

The Suture Lock is a sterile, single-use device manufactured from polyacetal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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 [phone] 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
Legally
Marketed
Devices	Smith and Nephew Endoscopy, Inc.
Mansfield, Ma.

8.6

ડાં

The Suture Lock is a sterile, single-use device manufactured from polyacetal. Device Description

1

| 8.7
Intended Use | The Suture Lock is intended to be use to secure soft tissue to bone, by securing
the placement of sutures used in surgical procedures. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8.8
Device
Indications | The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair
procedures. |
| 8.9
Substantial
Equivalence | The Suture Lock is substantially equivalent to the T-Fix Suture Bar which is
currently manufactured and distributed by Smith and Nephew Endoscopy, Inc.
(Mansfield, Ma.)
The table following summarizes the common features of the T-Fix suture Bar
and 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 securing
suture	Soft tissue fixation by securing
suture
Indications	Arthroscopic and open
shoulder lesion repair	Arthroscopic and open
shoulder lesion repair

Applicant Aus Zinn

Date 12/9/96