INTERPLEURAL ANESTHESIA CATHETER

K971851 · Axiom Medical, Inc. · BSO · Jan 22, 1998 · Anesthesiology

Device Facts

• Record ID: K971851
• Device Name: INTERPLEURAL ANESTHESIA CATHETER
• Applicant: Axiom Medical, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Typical applications include: For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.

Device Story

Axiom Interpleural Anesthesia Catheter is a sterile, single-patient-use, two-lumen silicone catheter. The device functions as a chest tube for draining fluids and exudates during or after surgery. The first lumen features a series of port openings (eyes) for fluid drainage. The second lumen serves as an irrigation channel, connected to a funnel with a three-way or four-way stopcock for the administration of topical/local anesthetic to manage postoperative pain. The catheter includes a radiopaque line to facilitate placement assessment via imaging. Used in clinical settings by healthcare professionals. The device provides a dual-purpose solution for pleural drainage and localized pain management, potentially reducing patient discomfort post-surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-lumen silicone catheter; radiopaque line for visualization; sizes 18 Fr. to 28 Fr.; includes three-way or four-way stopcock for irrigation lumen. Sterile, single-patient-use device.

Indications for Use

Indicated for patients requiring chest tube drainage of fluids and exudates during or after surgery, and for the delivery of local anesthetic to relieve postoperative pain for a duration of less than 72 hours.

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

• Mills Filtered Mediastinal Sump
• Interpleural Anesthesia Kit with Polyurethane Catheter (Arrow International)
• Interpleural Anesthesia Kit (Medical Disposable Inc.)
• Interpleural Anesthesia Kit (Baxter Pharmaseal)

Submission Summary (Full Text)

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K471851

# AXIOM MEDICAL, INC.

555 West Victoria Rancho Dominguez, California 90220 Telephone [phone] • Facsimile 310-632-1326

JAN 2 2 1998

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.

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

Date of Submission: 05/16/1997

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#### DEVICE NAMES 1.0

- 1.1 Trade Name: Axiom Interpleural Anesthesia Catheter
- 1.2 Common Name: Anesthesia Catheter
- 1.3 Classification Name: Anesthesia Conduction Catheter (Per 21 CFR section 868.5120)

#### 2.0 PRODUCT DESCRIPTION

This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. (see Exhibit A: Photograph and Exhibit B: Engineering Drawing) The sterile single patient use component includes the following:

- 2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered.
- 2.2 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 Funnel as a fluid outlet (Drainage function).
- 2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.

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## 3.0 SUBSTANTIAL EQUIVALENCE COMPARISON

This device is substantially equivalent in sterility, material and drainage function with our Mills Filtered Mediastinal Sump, also is substantially equivalent in indications for use to Interpleural Anesthesia Kit with Polyurethane Catheter marketed by Arrow International, Medical Disposable Inc. and Baxter Pharmaseal. These companies offer Interpleural Anesthesia Kit and teflon epidural catheter.

## 4.0 INTENDED USE OF THE DEVICE

Typical applications include:

- For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of topical anaesthetic to relieve pleural pain.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three parallel lines curving upwards and to the right, resembling a stylized human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Mr. Ridwan Hardy Axiom Medical, Inc. 555 West Victoria Street Rancho Dominguez, CA 90220

K971851 Re : Interpleural Anesthesia Catheter Regulatory Class: II (two) Product Code: 73 BSO Dated: November 3, 1997 November 5, 1997 Received:

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 of the Act. The general controls provisions 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodio (QS) --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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ridwan Hardy

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 leqally 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 labeling requlation (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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours,
Thomas Y. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if Known): K971851

Device Name: Axiom Interpleural Anesthesia Catheter

Indications For Use:

Typical applications include:

- For use where a routine chest tube is required to drain fluids and exudates . during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971851 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

Revised: 01/16/98