MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS

K971208 · Medline Industries, Inc. · GAM · May 13, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971208
• Device Name: MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
• Applicant: Medline Industries, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2

Intended Use

Medline Orthopedic Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’s original intended use.

Device Story

Medline Orthopedic Trays/Kits/Packs consist of assemblages of medical devices, drugs, and non-medical materials (packaging/labels) customized by customers for specific orthopedic procedures. Used by licensed physicians in clinical settings. Contents are standard medical items; quantities and brands vary per customer specification. Assembled in class 10,000 clean room/controlled environment. Sterilized via EtO or gamma radiation at contracted facilities. Device maintains original intended use of individual components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assemblage of medical devices, drugs, and non-medical materials. Sterilization via EtO or gamma radiation. Assembled in class 10,000 clean room environment.

Indications for Use

Indicated for use by licensed physicians during orthopedic procedures, including total hip replacement, upper or lower extremity surgery, podiatry, and total knee replacement.

Regulatory Classification

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.

Reference Devices

• Baxter Healthcare procedure specific kits
• Sterile Concepts procedure specific kits

Submission Summary (Full Text)

{0}

MEDLINE
Medline Industries, Inc.
K971208
One Medline Place
Mundelein, Illinois 60060.4486
1.847.949.3109
1.800.950.0128
Fax [phone]
13

Corporate Quality Assurance/Regulatory Affairs

# SUMMARY OF SAFETY AND EFFECTIVENESS

MAY 13 1997

Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Registration #: 1417592
Phone: [phone]
Fax: [phone]
Lara N. Simmons
Corporate Regulatory Affairs Manager

March 31, 1997

**DEVICE NAME:** Orthopedic Trays/Kits/Packs
**PROPRIETARY NAME:** Medline Orthopedic Trays/Kits/Packs
**COMMON NAME:** Orthopedic Trays/Kits/Packs
**PERFORMANCE STANDARDS:** None per Section 514.

## CLASSIFICATION NAME:

We have been unable to locate specific classifications for these devices. The contents of each tray are either Class I or Class II medical devices, drugs or non-medical materials (i.e. packaging, cartons and labels).

## PRODUCT SPECIFICATIONS

Medline Orthopedic Trays/Kits/Packs are an assemblage of medical materials to be used by medical professionals during orthopedic procedures such as total hip replacement, upper or lower extremity surgery, podiatry, and total knee replacement procedures. These packs may be produced for other procedures that are considered orthopedic surgery. The trays will be assembled using Medline and other manufacturer’s materials, medical devices and/or drugs.

The devices are custom to our customers who specify the contents, quantity and placement of the individual items in the tray, kit, or pack. Attached is a list of individual components that are likely to be in any of these devices. These items are standard for Orthopedic procedures and we expect that only quantities will change from one tray to another. The customer may also specify a specific brand of similar items or minor variations of items.

Medline intends to assemble these kits in a class 10,000 clean room or controlled environment and to sterilize using either EtO or gamma radiation at a contracted sterilization facility.

## INTENDED USE/INDICATIONS FOR USE

Medline Orthopedic Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’s original intended use.

{1}

K971208
14

# SUMMARY - CONTINUED

## SUBSTANTIAL EQUIVALENCE

We certify that components or individual items of the assembled device have been on the market prior to May 28, 1976, or have been shown by their manufacturer to be substantially equivalent to pre-amendment devices, or to be exempt from 510(k) notification requirements.

Many companies assemble various medical devices into a kit or tray for specific medical procedures. Similar procedure specific kits are in commercial distribution and are marketed by Baxter Healthcare, located in Waukegan, Illinios, and Sterile Concepts located in Richmond, VA.

We are unable to locate 510(k)s for this category of kits for Baxter.