AXIOM MULTIPURPOSE WOUND DRAIN

K993592 · Axiom Medical, Inc. · BSO · May 17, 2000 · Anesthesiology

Device Facts

• Record ID: K993592
• Device Name: AXIOM MULTIPURPOSE WOUND DRAIN
• Applicant: Axiom Medical, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: May 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain.

Device Story

Axiom Multipurpose Wound Drain is a double-lumen silicone catheter used for surgical fluid drainage. Device features radiopaque line for placement verification; suture ring for securement; polypropylene Christmas tree connector for fluid outlet. Primary lumen facilitates drainage; secondary lumen supports sump gravity, irrigation, or local anesthetic delivery. Used in clinical settings by healthcare providers to manage postoperative exudates and pain. Benefits include effective drainage and versatile functionality via dual-lumen design.

Clinical Evidence

Bench testing only.

Technological Characteristics

Double-lumen silicone catheter; radiopaque line; sizes 14 Fr. to 36 Fr.; coated or uncoated options; polypropylene Christmas tree connector; suture ring for securement. Non-electronic, mechanical device.

Indications for Use

Indicated for patients requiring routine drainage of fluids and exudates during or after surgery. Includes functionality for sump gravity, irrigation, or local anesthetic delivery for postoperative pain relief.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• Axiom Sump Drain with Filter
• Axiom Interpleural Anesthesia Catheter

Submission Summary (Full Text)

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K993592

## SUMMARY

## SAFETY AND EFFECTIVENESS for 510(K) OF AXIOM MULTIPURPOSE WOUND DRAIN

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 intend to market in 90 days.

- (1) Submitter's name, address, telephone number, contact person, date of preparation

| 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 preparation: 10/01/1999

- (2) Name of the device
Trade Name: Axiom Multipurpose Wound Drain Common Name: Irrigation Drainage Catheter Classification Name: Anesthesia Conduction Catheter (Per 21 CFR 868.5120)

- (3) ldentification of predicate devices
Axiom Sump Drain with Filter Axiom Interpleural Anesthesia Catheter

- (4) Description of the device
This Axiom Multipurpose Wound Drain is simplicity of design assures effective operation with added convenience. It is a conveniently sized double Lumens Catheter made of silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 14 Fr. up to 36 Fr. coated or no coated will be offered. The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first proximal end and connected with polypropylene Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.

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Christmas tree connector as a fluid outlet (Drainage function). The Catheter equips with suture ring to secure the catheter in the position.

- (5) Intended use of the device
For use where a routine drainage tube is required to drain fluids and exudates during or after surgery. The additional lumen allows for sump gravity, irrigation function or application of anesthetic to relieve postoperative pain.

- (6) Comparison to predicate devices
This device is substantially equivalent in material, indications for use, sterility, drainage and irrigation function with the predicate devices. The lumen of Axiom Multipurpose Wound Drain is designed with full internal diameter and various lengths for drainage and irrigation function. Suture Ring is provided on each catheter to secure the position of the catheter in the body.

- (7) Performance data
The test results demonstrate that the device is substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle.

Public Health Service

MAY 1 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ridwan Hardy Development Engineer Axiom Medical, Incorporated 555 West Victoria Street 90220 Rancho Dominquez, California

K993592 Re : Axiom Multipurpose Wound Drain Trade Name: Requlatory Class: II Product Code: FRN Dated: March 13, 2000 Received: March 14, 2000

Dear Mr. Hardy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Hardy

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## EXHIBIT F STATEMENT OF INDICATIONS FOR USE

warry 510(K) Number (if Known): NA

Device Name: Axiom Multipurpose Drain

Indications For Use:

Typical applications include:

- For use where a routine drainage tube is required to drain fluids and . exudates during surgery or after surgery. The additional lumen allows for sump gravity, irrigation function or application of local anaesthetic to relieve postoperative pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR Over-The-Counter Use

Patrice Crescent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number *K993597*