JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN

K973703 · Allegiance Healthcare Corp. · GBX · Dec 4, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973703
• Device Name: JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
• Applicant: Allegiance Healthcare Corp.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.

Device Story

Jackson-Pratt Hemaduct and Jackson-Pratt Gold Hemaduct are flexible, silicone, multilumen surgical wound drains. Available in flat and round configurations. Used to facilitate drainage of exudate from body cavities post-surgery. Operated by clinicians in clinical settings. Device functions via passive drainage through the lumen structure. Benefits include effective fluid removal from surgical sites to aid healing.

Clinical Evidence

Bench testing only. Testing included cytotoxicity, intracutaneous reactivity, hemocompatibility, systemic toxicity, sensitization, and pyrogenicity. Results demonstrated no toxic reactions, no reactivity, no lysis, and no pyrogenic response.

Technological Characteristics

Silicone material; flexible, multilumen tube design; flat and round configurations; sterile; passive drainage mechanism.

Indications for Use

Indicated for drainage of fluids (exudate) from body cavities in patients requiring surgical wound drainage.

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
• Johnson & Johnson Blake Drain
• Zimmer Quad-Lumen Drain

Submission Summary (Full Text)

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k 973703

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

DEC - 4 1997

## XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Jackson-Pratt® Hemaduct™ Jackson-Pratt Gold™ Hemaduct™ Wound Drains

| Manufacturer: | Allegiance Healthcare Corporation<br>MediVac<br>1500 Waukegan Road<br>McGaw Park, Illinois 60085 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Joseph A. Mertis<br>Allegiance Healthcare Corporation<br>1500 Waukegan Road<br>McGaw Park, IL 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | September 11. 1997 |
| Product Trade Name: | Jackson-Pratt® Hemaduct™ Wound Drain<br>Jackson-Pratt Gold™ Hemaduct™ Wound Drains |
| Common Name: | Surgical Wound Drain |
| Classification: | Catheter, Irrigation (79GBX) |
| Predicate Devices: | Jackson-Pratt® Wound Drains<br>Johnson & Johnson Blake™ Drain<br>Zimmer Quad-Lumen™ Drain |
| Description: | The Jackson-Pratt® Hemaduct and the Jackson-Pratt Gold™<br>Hemaduct™ Wound Drains are made of silicone in a variety of sizes<br>and are offered sterile in both flat and round configurations, |
| Intended Use: | These wound drains are flexible, multilumen tubes, intended to be<br>used to drain fluids (exudate) from body cavities. |
| CFR Citation: | 21CFR 878.4200 |

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The Jackson-Pratt® Hemaduct™ and the Jackson-Pratt Gold™ Equivalence: Hemaduct™ Wound Drains are substantially equivalent to Jackson-Pratt Wound Drains, the J&J Blake™ Drain and the Zimmer Quad-Lumen™ Drain in that they provide the following characteristics:

- intended use
- size, configuration, packaging
- made of silicone

Summary of Testing:

| Test | Result |
|---------------------------|-----------------------------------------------------------------------|
| Cytotoxicity Test | Drain does not elicit any<br>toxic reactions to acute<br>application. |
| Intracutaneous Reactivity | No reactivity was observed. |
| Hemocompatibility | Drains are hemocompatible<br>exhibiting no lysis. |
| Systemic Toxicity | Drain does not display<br>potential for irritation. |
| Sensitization | Drain does not display any<br>potential for irritation. |
| Pyrogen | Drain does not illicit a pyrogenic<br>response. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 1997

Mr. Joseph A. Mertis Director, Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787

Re: K973703

> Trade Name: Jackson-Pratt® Hemaduct™ Wound Drains and Gold™ Hemaduct™ Wound Drains Regulatory Class: I Product Code: GBX Dated: September 24, 1997 Received: September 26, 1997

Dear Mr. Mertis:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 regulation (21 CFR Part 820) and that, through periodic (OS) 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 devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Joseph A. Mertis

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your devices on our labeling 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 devices, 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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Jackson-Pratt® Hemaduct™ Wound Drain Device Name: Jackson-Pratt Gold™ Hemaduct™Wound Drain

Indications For Use: These wound drains are flexible, multilumen tubes, intended to be used to drain fluids (exudate) from body cavities.

CFR Citation - 21CFR 878.4200

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> | or | Over-The Counter Use | <span style="text-decoration: overline;"></span> |
|---------------------------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|
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(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | <span style="text-decoration: overline;">K973703</span> |
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