PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER

K961853 · Acufex Microsurgical, Inc. · HRX · Jun 21, 1996 · Orthopedic

Device Facts

• Record ID: K961853
• Device Name: PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER
• Applicant: Acufex Microsurgical, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Fast Pass Suture Punch System is a surgical instrument set used by orthopedic surgeons during arthroscopic or open procedures. The system consists of a suture punch, a nonabsorbable poly(ethylene terephthalate) surgical suture needle, and a cannula/obturator. The device is used to facilitate the placement of sutures into soft tissue for repair, specifically targeting rotator cuff and Bankart lesions. The surgeon operates the punch to pass the suture through tissue; the system is designed to streamline the suture placement process compared to manual methods. The use of other sutures or needles with the system is prohibited. The device is provided non-sterile and is reusable.

Clinical Evidence

Bench testing only. The system was evaluated using a simulated tissue model to demonstrate the ability of the suture punch and needle to successfully pass suture through tissue, confirming suitability for the intended use.

Technological Characteristics

Materials: stainless steel (punch), USP #1 and #2 polyester (suture). Components: suture punch, suture needle, cannula/obturator. Form factor: manual surgical instrument. Reusable, non-sterile. No electronic or software components.

Indications for Use

Indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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JUN 21 1998
K 961853

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

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| Device
Indications | The Fast Pass Suture Punch System is indicated for the placement of sutures in 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. |
| Substantial
Equivalence | 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. 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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| Table of Substantial Equivalent Device Similarities | | |
| --- | --- | --- |
| | Subject Device System | Predicate Device(s) |
| Product Name | Fast Pass Suture Punch System | Suture Punch: Shutt Suture Punch
Suture Needle: Ti-Cron Suture
Deknatel Silky Polydek
Surgical Specialties Braided Polyester Suture |
| Product Labeling | Non-sterile, Reusable | Non-sterile, Reusable |
| Materials
Suture Punch
Suture Needle | stainless steel
USP #1,#2 polyester | stainless steel
USP #1,#2 polyester |
| Intended Use | placement of sutures | placement of sutures |
| Indications
Suture Punch
Suture Needle | Arthroscopic shoulder lesion repair
Orthopaedic soft tissue fixation | Arthroscopic shoulder lesion repair
Orthopaedic soft tissue fixation |

Applicant _Amy Wetter_ Date 6/13/96

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