PARACENTESIS CATHETER DEVICE

K974146 · Allegiance Healthcare Corp. · GCB · Jan 28, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974146
• Device Name: PARACENTESIS CATHETER DEVICE
• Applicant: Allegiance Healthcare Corp.
• Product Code: GCB · General, Plastic Surgery
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.

Device Story

Paracentesis catheter is a 'catheter over the needle' device. Components include radiopaque polyurethane catheter, needle, stopcock, self-sealing valve, and 5 cc syringe. Used for therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity. Operated by healthcare professionals in clinical settings. Device facilitates fluid removal or sampling to aid in diagnosis or patient symptom relief.

Clinical Evidence

No clinical data. Safety established through bench testing and biocompatibility evaluation (cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility).

Technological Characteristics

Radiopaque polyurethane catheter over needle; includes stopcock, self-sealing valve, and 5 cc syringe. Biocompatibility verified per standard safety tests.

Indications for Use

Indicated for therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity in patients requiring such procedures.

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

• Paracentesis Catheter device (K870704)

Submission Summary (Full Text)

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# K974146

Allegian

JAN 2 8 1998

Allegiance Healthcare Corporation 500 Waukegan Road AcGaw Park, Illinois 60085-6787 47.473.1500 FAX: [phone]

#### SMDA REQUIREMENTS XII.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER

Manufacturer:

Allegiance Healthcare Corporation 400 East Foster Road Mannford, OK 74044

Regulatory Affairs Contact:

Sharon Robbins Allegiance Healthcare Corporation 1500 Waukegan Road MP-WM McGaw Park, IL 60085

Telephone:

Common Name:

Classification:

Description:

Predicate Device:

Date Summary Prepared: October, 1997

Paracentesis Catheter

[phone]

Class II per 21CFR § 878.4200, Needle, Catheter

Paracentesis Catheter device, K870704 owned by Allegiance Healthcare Corporation

The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.

14

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#### XII. SMDA REQUIREMENTS (continued)

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS PARACENTESIS CATHETER

Intended Use: The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity. Substantial

Equivalence:

The proposed Allegiance Paracentesis Catheter is substantially equivalent to the currently marketed Allegiance Paracentesis Catheter in that:

- intended use is the same
- performance attributes are the same

All materials used in the fabrication of this paracentesis Summary of testing: device were evaluated through biological qualification safety tests. The biocompatibility tests performed were cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute) and hemocompatibility as identified on the tests for each material. These materials have met the testing requirements and were found to be acceptable for the intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1998

Ms. Sharon Robbins 'Manager of Requlatory Affairs Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787

Re : K974146 Paracentesis Catheter Device Trade Name: Requlatory Class: II Product Code: GCB Dated: October 30, 1997 Received: November 3, 1997

### Dear Ms. Robbins:

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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (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 - Ms. Sharon Robbins

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 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 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,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974146

# Allegiance

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

## Indications for Use

510(k) Number (if known):

Device Name:

.

Paracentesis Catheter

Indications For Use:

The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

or

| Over-The Counter Use | |
|-----------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 2974146 |