← Product Code [GAM](/productcode/GAM) · K970317

# MODIFIED E-PACK PROCEDURE KIT (K970317)

_ETHICON, Inc. · GAM · Apr 25, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K970317

## Device Facts

- **Applicant:** ETHICON, Inc.
- **Product Code:** [GAM](/productcode/GAM.md)
- **Decision Date:** Apr 25, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4493
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Indications for Use

There is no change in the approved intended use of the device when provided in the procedure kit

## Device Story

E-PACK Procedural Kit; collection of legally marketed individual medical devices manufactured by or for ETHICON, Inc.; packaged together in thermoformed blister tray or sealed pouch for surgeon convenience; intended for use in surgical procedures; components retain original approved indications; sterilization via ethylene oxide.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Kit containing legally marketed individual medical devices; sterilization via ethylene oxide (SAL 10^-6); packaging in thermoformed blister tray or flexible sealed pouch.

## Regulatory Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

- Predicate Device E-PACK Procedural Kit

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

APR 25 1997 K970317

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

### 510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

**MODIFIED DEVICE NAME:** E-PACK Procedural Kit

**PREDICATE DEVICE NAME:** Predicate Device E-PACK Procedural Kit

### 510(k) SUMMARY

#### Device Description

All components of E-PACK procedural kit are legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses.

These products are packaged together in the form of a "kit" for the convenience of the surgeon.

#### Intended Use

There is no change in the approved intended use of the device when provided in the procedure kit

Continued on next page

Modified E-PACK Procedure Kit
ETHICON, Inc.

{1}

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(k) SUMMARY, Continued

Sterilization
E-Pack procedural kits are sterilized by ethylene oxide for minimum sterility level of 10/6.

Packaging
The component devices in the E-PACK procedure kit may be packaged in their current individual package or paper folders into one large thermoformed blister tray or in a flexible configuration consisting of a sealed pouch.

Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act.

Contact
John D. Paulson, Ph.D.
Vice President, Regulatory Affairs and Quality Assurance
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151

Date
January 24, 1997

Modified E-PACK Procedure Kit
ETHICON, Inc.

---

**Source:** [https://fda.innolitics.com/device/K970317](https://fda.innolitics.com/device/K970317)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com