FLAT CLOSED WOUND DRAIN WITH TROCAR

K965146 · Axiom Medical, Inc. · GBX · Mar 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965146
• Device Name: FLAT CLOSED WOUND DRAIN WITH TROCAR
• Applicant: Axiom Medical, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Mar 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To drainage excessive body fluid away from the wound site in the Surgery or after Surgery

Device Story

Closed wound vacuum drainage apparatus; used in surgery or post-operatively to remove excess body fluids. Components: radiopaque silicone flat drain with interlocking supports; silicone round drain with radiopaque line; stainless steel trocar. Trocar creates stab wound for drain placement. Drain perforations facilitate fluid collection. Single-patient use; sterile. Physician/clinician operated. Benefits: effective fluid removal, reduced trauma via sharp trocar, unhindered flow via lumen supports.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: radiopaque silicone (drains), stainless steel (trocars). Design: flat drain with interlocking lumen supports; round drain with alternate 90-degree plane perforations. Sizes: 4mm-13mm (flat), 7Fr-19Fr (round). Non-powered suction/drainage. Sterile, single-patient use.

Indications for Use

Indicated for patients requiring drainage of excessive body fluids from surgical wound sites.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• Davol silicone wound drain system
• Johnson & Johnson silicone wound drain system
• Baxter silicone wound drain system

Submission Summary (Full Text)

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AXIOM MEDICAL, INC.
555 West Victoria
Rancho Dominguez, California 90220
Telephone [phone] • Facsimile 310-632-1326
K965146
MAR 10 1997

In compliance with the requirements of section 510(k) of the Food, Drug, and Cosmetic Act as amended, and 21 CFR Section 807.92(a)(1), This "510(k) Summary" is on a product we intends to market in 90 days.

Company name: Axiom Medical Inc.
Address: 555 W. Victoria Street
Rancho Dominguez, Ca. 90220
Phone number: (310) 898 - 1779
Fax number: (310) 632 - 1326
Contact person: Ridwan Hardy
Date of Submission: 12/20/1996

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K965146

## 1.0 DEVICE NAMES

1.1 Trade Name: Axiom Closed Wound Drain With Trocar

1.2 Common Name: Closed Wound Vacuum Drainage Apparatus

1.3 Classification Name: Suction and Drainage Apparatus and Accessories, single patient use, Nonpowered (per 21 CFR section 878.4680)

## 2.0 PRODUCT DESCRIPTION

This Axiom Closed Wound Drain with Trocar is simplicity of design assures effective operation with added convenience. The sterile single-patient-use component includes the following:

2.1 Radiopaque silicone flat drain with multiple perforations. These perforations are located at the end of the drain. Unique interlocking supports run the full length of the flat drain to maintain ample lumen and ensure unhindered flow. Various sizes starting from 4 mm up to 13 mm for flat drain with Trocars will be offered.

2.2 Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. An evenly spaced perforations are created to enhance drainage from several directions, these perforations are positioned in alternate 90 degree planes. Various sizes starting from 7 French up to 19 French gauge with Trocars will be offered.

2.3 Trocar are manufactured from stainless steel. The one end of the trocar is razor sharp to able to make a stab wound with less trauma and the opposite end has barb type fitting or beads blasted surface on small size trocars for silicone wound drain attachment. Trocars will be offered in different length and various matching diameters to silicone wound drain.

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03/05/97 15:28 FAX [phone]
AXIOM MEDICAL
K965146
004

## 3.0 SUBSTANTIAL EQUIVALENCE COMPARISON

This device is substantially equivalent in design, indications for use and sterility to silicone flat and round wound drain system marketed by Davol, Johnson & Johnson and Baxter. These companies offer silicone wound drains system with or without trocars.

## 4.0 INTENDED USE OF THE DEVICE

Typical applications include:

- To drainage excessive body fluid away from the wound site in the Surgery or after Surgery

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