Who is the manufacturer of ACUFEX DOUBLE ARMED SUTURE NEEDLE?

Smith & Nephew Endoscopy, Inc. filed the 510(k) submission for ACUFEX DOUBLE ARMED SUTURE NEEDLE (K970416).

What is the FDA product code for ACUFEX DOUBLE ARMED SUTURE NEEDLE?

GAT. It is classified under 21 CFR 878.5000 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ACUFEX DOUBLE ARMED SUTURE NEEDLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ACUFEX DOUBLE ARMED SUTURE NEEDLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACUFEX DOUBLE ARMED SUTURE NEEDLE

Q: What are the predicate devices for ACUFEX DOUBLE ARMED SUTURE NEEDLE?

Fast Pass Suture Needle (K961853).

K970416 · Smith & Nephew Endoscopy, Inc. · GAT · Apr 21, 1997 · General, Plastic Surgery

Device Facts

Record ID	K970416
Device Name	ACUFEX DOUBLE ARMED SUTURE NEEDLE
Applicant	Smith & Nephew Endoscopy, Inc.
Product Code	GAT · General, Plastic Surgery
Decision Date	Apr 21, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5000
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch.

Device Story

Sterile, single-use surgical needle; manufactured from braided polyester and stainless steel; used to pass suture through soft tissue during open or arthroscopic Rotator Cuff and Bankart repairs. Device functions exclusively with Fast Pass Suture Punch. Used by surgeons in clinical/OR settings to facilitate tissue fixation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: braided polyester and stainless steel. Form factor: double-armed needle. Sterilization: Ethylene Oxide (EtO).

Indications for Use

Indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

Fast Pass Suture Needle (K961853)

Related Devices

K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER · Acufex Microsurgical, Inc. · Jun 21, 1996
K231278 — Knotless Suture Anchor · Riverpoint Medical, LLC · Aug 1, 2023
K042233 — PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE · Depuy Mitek, A Johnson & Johnson Company · Sep 28, 2004
K231113 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · May 18, 2023
K041713 — SUPER REVO HERCULINE SUTURE ANCHOR · Linvatec Corp. · Jul 22, 2004

Submission Summary (Full Text)

{0} APR 21 1997 # Section 6: 510(k) Summary of Safety and Effectiveness | 6.1 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. | | --- | --- | | 6.2 Submitter | Smith & Nephew, Inc., Endoscopy Division 130 Forbes Blvd. Mansfield, Ma. 02048 | | 6.3 Company Contact | Susan Finneran Clinical/Regulatory Affairs (508) 261-3772 | | 6.4 Device Name | Proprietary Name: Acufex Double Armed Suture Needle Common Name: Suture Needle Classification Name: Nonabsorbable polyester surgical suture | | 6.5 Predicate Legally Marketed Devices | Fast Pass Suture Needle (K961853) Smith and Nephew Endoscopy, Inc. Mansfield, Ma. | | 6.6 Device Description | The Acufex Double Armed Suture Needle is a sterile, single-use device manufactured from braided polyester and stainless steel. | 039 {1} 040 6.7 Intended Use The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch. 6.8 Device Indications The Acufex Double Armed Suture Needle is indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs. 6.9 Substantial Equivalence The Acufex Double Armed Suture Needle is substantially equivalent to the recently cleared Fast Pass Suture Needle. (K961853) Table of Substantial Equivalence | Product Name | Fast Pass Suture Needle | Acufex Double Armed Suture Needle | | --- | --- | --- | | Product Labeling | Sterile (EtO), Single Use | Sterile (EtO), Single Use | | Materials | polyester/stainless steel | polyester/stainless steel | | Intended use | Soft tissue fixation | Soft tissue fixation | | Indications | Arthroscopic and open shoulder lesion repair | Arthroscopic and open shoulder lesion repair | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Applicant A. G. Jann Date 1/31/97