GESCO PER-Q-CATH PICC CATHETERS

K971990 · Bard Access Systems, Inc. · FOZ · Nov 7, 1997 · General Hospital

Device Facts

• Record ID: K971990
• Device Name: GESCO PER-Q-CATH PICC CATHETERS
• Applicant: Bard Access Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Nov 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For long term central venous catheterization for intravenous or blood therapy.

Device Story

Per-Q-Cath PICCs are silicone or polyurethane open-ended catheters available in single or dual lumen configurations. They provide peripheral access to the central venous system for intravenous therapy and blood sampling. The device is used in clinical settings for patients requiring long-term venous access. This specific submission involved no changes to the catheter design or materials, but updated the instructions for use regarding tip trimming.

Clinical Evidence

No clinical data or performance testing was conducted for this submission. Support for the labeling change was provided via a literature bibliography and a comparison of catheter tip trimming instructions from various competitors.

Technological Characteristics

Silicone or polyurethane open-ended catheters; single or dual lumen configurations. No changes to materials or design were made in this submission.

Indications for Use

Indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Per-Q-Cath® PICCs (Peripherally Inserted Central Catheters) (K971990)

Submission Summary (Full Text)

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NUV UJ DI 10.41 NO. U11 F.U4

K971990

510 (x) SUPPORTY OF SAFETY AND EFFECTIVENESS INFORMATION K971990

ート アンバー レディー コーナー

.

NOV - 7 1997

- Submitter Information: A.
・・・・・・・・・・・・・

Bard Access Systems, Inc. (Division of C.R. Submitter Name: Bard, Inc.) 5425 W. Amelia Earhart Drive Address: Salt Lake City, UT 84116 Telephone Number: [phone] Fax Number: Jane Ann Martin Contact Person: Date of Preparation: 5 November 1997

## Device Name: B.

| Common/Usual Name: | Per-Q-Cath® PICCs (Peripherally Inserted Central Catheters) |
|--------------------|-------------------------------------------------------------|
|--------------------|-------------------------------------------------------------|

Long-term Intravascular catheter (LJS) Classification Name:

#### C. Predicate Device Name:

Per-Q-Cath® PICCs (Peripherally Inserted Central Trade Name: Catheters

#### D. Device Dascription:

Per-Q-Cath PICCs are silicone or polyurethane open-ended catheters in single or dual lumen configurations.

#### B. Intended Use:

For long term central venous catheterization for intravenous or blood therapy .

### י . Technological Characteristics Summary

This 510(k) does not involve any technological characteristic changes. This submission was to change the tip trimming instructions in the Instructions For Use only. No changes were made to the catheters.

## હં. Performance Data (if applicable)

No performance teating was done. A comparison of catheter tip trimming instructions from various competitors and a literature bibligraphy were sent to FDA to support the change in tip trimming instructions.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jane Ann Martin ·Regulatory Affairs Manager Bard Access Systems, Incorporated 5425 West Amelia Earnhart Drive Salt Lake City, Utah 84116

K971990 Re : Gesco Per-O-Cath® Picc Catheters Trade Name: Requlatory Class: II Product Code: FOZ Dated: Auqust 7, 1997 Received: August 11, 1997

Dear Ms. Martin:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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

NOV - 7 1997

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Page 2 - Ms. Martin

through 542 of 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 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;

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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# INDICATION(S) STATEMENT* K971990

I state in my capacity as Regulatory Affairs Manager of Bard Access Systems, that this notification (510(k)) for the following devices, Per-Q-Cath® PICCs, are indicated for the following:

Per-Q-Cath PICCs are indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Amertus

Signature of 510(k) Submitter

Jane Ann Martin Printed Name of Submitter

6 Nov 97

Date

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

Paharia Cucente

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use . (Per 21 CFR 801.109)