DEUTSCH ANTI-BLOCKAGE WOUND DRAIN

K052286 · The Catheter Exchange, Inc. · GBX · Oct 21, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052286
• Device Name: DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
• Applicant: The Catheter Exchange, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Oct 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.

Device Story

Deutsch Anti-Blockage Wound Drain is a surgical wound drainage system designed to prevent post-operative occlusion. Device components include a silicone elastomer drain segment with distal side holes, an internal tubular mesh, a luer fitting adapter, a transition tube, and a stainless steel trocar. The trocar facilitates placement through tissue. The drain segment is elastic; applying pulling force reduces its cross-sectional area to minimize tissue gripping. The internal tubular mesh, connected to the luer fitting, serves as a mechanism to clear obstructions; if occlusion occurs, the luer adapter is removed and the mesh is pulled through the lumen to extract debris. The device connects to an external suction source to remove fluids (bloody, chylous, purulent, etc.) from the operative site. Used in clinical settings by surgeons to promote wound healing by preventing fluid buildup.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Silicone elastomer (drain and transition segments), stainless steel (trocar). Design: Multi-component assembly including drain segment, internal tubular mesh, luer fitting, and transition tube. Principle: Passive/active suction drainage with mechanical anti-clogging feature. Radiopacity provided by internal tubular mesh. Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing open surgical procedures (abdominal, thoracic, head/neck, gynecological, urological, spinal, orthopedic) to prevent post-operative fluid accumulation at the operative site.

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

• Jackson-Pratt Wound Drains (K973703)
• Axiom Multipurpose Wound Drain (K993592)

Submission Summary (Full Text)

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K052286.,/

Premaket Notification - The CEI Anti-Blockage Wound Drain Device

## OCT 2 1 2005

Image /page/0/Picture/3 description: The image contains a logo with the words "Catheter Exchange" written in bold, sans-serif font. Above the text is a stylized graphic of a circle with a swirl inside, set against a black square. The logo appears to be for a medical or healthcare-related service, given the reference to catheters.

16633 Ventura Blvd Suite 735 Encino, CA 91436 Phone: [phone] Fax: [phone]

## SUMMARY

| Submitter's name: | The Catheter Exchange, Inc. |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Address: | 16633 Ventura Blvd.<br>Suite 735<br>Encino, CA 91436 |
| Phone: | 323-442-2936 |
| Fax: | 323-442-2913 |
| Name of contact person: | George P. Teitelbaum, M.D. |
| Telephone: | 323-442-8948 |
| Fax: | 323-442-8969 |
| Date the summary was prepared: | August 12, 2005 |
| Name of the device: | Deutsch Anti-Blockage Wound Drain |
| Trade or proprietary name: | Deutsch Anti-Blockage Wound Drain |
| Common or usual name: | Surgical Wound Drain |
| Classification name: | Catheter, Irrigation |
| The legally marketed device to which we are claiming equivalence: | Jackson-Pratt Wound Drains. The clearance number K973703<br>Axiom Multipurpose Wound Drain. The clearance number K993592 |

## DEVICE DESCRIPTION

The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar. The final assembly of the Deutsch Anti-Blockage Wound Drain is illustrated as in the following figure:

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Image /page/1/Figure/2 description: The image shows a medical device with several labeled components. The device includes a curved transition tube connected to a drain tube. Other labeled parts are the trocar, male luer fitting, female luer fitting, and tubular mesh.

- 1. The drain segment has a uniform cross-sectional area and is made from a silicone elastomer having sufficient elasticity to permit the cross-sectional area of the drain decrease when a pulling force is applied to it, thereby reducing the gripping force of tissue surrounding the wound. The drain segment has distal side holes which are used to drain fluids and exudates during and after surgery.
- 2. The internal tubular mesh is permanently connected to the inner surface of the luer fitting adapter. In this subassembly, the luer fitting adapter acts as a handle. The tubular mesh is used to re-establish the drain patency when a post-operative occlusion occurs. To do this, the luer fitting adapter needs to be removed from the drain segment end and the luer fitting adapter and the mesh segment to be pulled from the drain lumen to remove the obstructing material. The tubular mesh also provides the catheter radiopacity.
- 3. The transition tube segment is made from a silicone elastomer with a sufficient elasticity, similar to the drain segment. This transition segment has an internal cavity opening. One end of this transition tube goes over one end of the luer fitting adapter and the other end to the source of suction. When necessary this end is used to insert a metal trocar.
- The trocar with a sharp distal tip is made from stainless steel. The trocar is used to pull 4. the drain through the surrounding tissue to the intended drainage site.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms.

Public Health Service

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

George P. Teitelbaum, M.D. CEO/President The Catheter Exchange, Inc. 16633 Ventura Boulevard, Suite 735 Encino, California 91436

Re: K052286

Trade/Device Name: Deutsch Anti-Blockage Wound Drain Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: I Product Code: GBX Dated: August 16, 2005 Received: August 22, 2005

Dear Dr. Teitelbaum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- George P. Teitelbaum, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maning of substantial equivalence of your device to a legally prematics notication: "The PDF intents sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spocitie acries 101 500 [phone]. Also, please note the regulation entitled, Comaci the Office of Compulation (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Bouckund

tor

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_

Device Name: Deutsch Anti-Blockage Wound Drain

The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.

The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures."

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brehm

(Division Sign-Division of General, Restorative. and Neurological Devices

Page 1 of __ 1 September 2004

**510(k) Number** K052286

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