Predicate Devices

N83-509, N85-378, P810028

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on mechanical components for suture placement, with no mention of AI/ML or related concepts.

Therapeutic

No
The device is used for suture placement, which is a surgical procedure to repair tissue, not to treat or cure a disease or condition itself.

Diagnostic

No

Explanation: The device description and intended use clearly state that the Fast Pass Suture Punch System is for the placement of sutures during surgical procedures (Rotator Cuff and Bankart repair). It does not mention any function related to diagnosing medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly lists three physical components: a suture punch, a suture needle, and a cannula/obturator. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for the "placement of sutures in Rotator Cuff and Bankart repair procedures" during "arthroscopic and open procedures." This describes a surgical tool used directly on a patient's tissue.
Device Description: The components (suture punch, suture needle, cannula/obturator) are all instruments designed for physical manipulation of tissue and suture.
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 for diagnosis, monitoring, or screening.

IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical instrument used in vivo (within the body) for a therapeutic purpose (repairing tissue).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Fast Pass Suture Punch System is indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures. The Fast Pass Suture Punch System is intended to be used for the placement of sutures during arthroscopic and open procedures.

Product codes

Not Found

Device Description

The Fast Pass Suture Punch System comprises three components: the Fast pass Suture Punch, the Fast Pass Suture Needle, and the Fast Pass Cannula/Obturator.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Rotator Cuff and Bankart

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

Testing has shown the suitability of the Fast Pass Suture Punch System for its intended use and environment; the suture punch and suture needle successfully passed suture through a simulated tissue model.

Key Metrics

Not Found

Predicate Device(s)

Shutt Arthroscopic Suture Passer (Linvatec, Inc. Largo, Fl.), Ti-Cron Sutures (Davis & Geck., N83-509), Surgical Specialties Braided Polyester Suture (N85-378), Deknatel Silky II Polydek(P810028)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

Summary

0

K 961853 JUN 21 1000

Section 7 - 510(k) Summary of Safety and Effectiveness

| Statement | This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and CFR 807.92 | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Smith and Nephew Endoscopy
130 Forbes Boulevard
Mansfield, Ma. 02048 | |
| Company
Contact | Susan Finneran or Amy Walters
Clinical/Regulatory Affairs
(508) 339-9700 | |
| 1.2
Device Name:
Suture Punch | Proprietary Name: Fast Pass Suture Punch System
The Fast Pass Suture Punch System comprises of the following components:
Suture Punch:
Proprietary Name: Fast Pass Suture Punch
Common Name: Suture Punch
Classification Name: Arthroscopic Accessory
Suture Needle:
Proprietary Name: Fast Pass Suture Needle
Common Name: Suture Needle
Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical
suture
Cannula/Obturator:
Proprietary Name: Fast Pass Cannula/Obturator
Common Name: Cannula, Obturator
Classification Name: Arthroscopic Accessory | |
| | These components will be offered for sale individually, and also as a system.
The Fast Pass Suture Needle is a necessary component in the system. The use
of other sutures or needles with the Fast Pass Suture Punch System is
prohibited. | |
| Predicate
Legally
Marketed
Devices | Suture Punch:
Shutt Arthroscopic Suture Passer
Linvatec, Inc. (Largo, Fl.) | Suture Needle:
Ti-Cron Sutures (Davis & Geck., N83-509)
Surgical Specialties Braided Polyester Suture (N85-372)
Deknatel Silky II Polydek (P810028) |

(1)

1

The Fast Pass Suture Punch System is indicated for the placement of sutures in Device Indications Rotator Cuff and Bankart repair procedures.

Intended Use The Fast Pass Suture Punch System is intended to be used for the placement of sutures during arthroscopic and open procedures.

The Fast Pass Suture Punch System comprises three components: the Fast pass Substantial Equivalence Suture Punch, the Fast Pass Suture Needle, and the Fast Pass Cannula/Obturator. The Fast Pass Suture Punch is substantially equivalent to the Shutt Arthroscopic Suture Passer (Linvatec, Inc. Largo, Fl.) The Fast Pass Suture Needle is substantially equivalent to Ti-Cron Sutures (Davis & Geck., N83-509), Surgical Specialties Braided Polyester Suture (N85-378), and Deknatel Silky II Polydek(P810028). The Fast Pass Cannula/Obturator is exempt from premarket notification.

Testing has shown the suitability of the Fast Pass Suture Punch System for its intended use and environment; the suture punch and suture needle successfully passed suture through a simulated tissue model.

A summary of the features of the Fast Pass Suture Punch and the substantially equivalent product is presented on the following page:

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2

Table of Substantial Equivalent Device Similarities
	Subject Device System	Predicate Device(s)
Product Name	Fast Pass Suture Punch System	Suture Punch:
Shutt Suture Punch

Applicant Amy Mattek

Date 6/13/96

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