GESCO PER-Q-CATH MIDLINE CATHETERS

K971991 · Bard Access Systems, Inc. · FOZ · Nov 7, 1997 · General Hospital

Device Facts

• Record ID: K971991
• Device Name: GESCO PER-Q-CATH MIDLINE 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 midline venous catheterization of selected intravenous infusates ox blood therapy. A midline catheter placement is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.

Device Story

Per-Q-Cath Midline Catheters are silicone or polyurethane open-ended catheters available in single or dual lumen configurations. Used for peripheral venous access for intravenous therapy and blood sampling. Device is placed by healthcare professionals in clinical settings. This specific submission involves no changes to the device itself, only updates to tip trimming instructions in the labeling.

Clinical Evidence

No clinical data or performance testing was conducted. Support for the labeling change was provided via a comparison of competitor tip trimming instructions and a literature bibliography.

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 peripheral venous system for selected intravenous therapies and blood sampling. Contraindicated for patients requiring solutions with glucose >10%, protein >5%, or continuous infusion of vesicants.

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® Midline catheters (K971991)

Submission Summary (Full Text)

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KG71991

### 510 (x) BUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION K971991

# NOV - 7 1997

#### Submitter Information: 人。

D.H.J. FILLD Hosonning ID our Jos

Bard Access Systems, Inc. (Division of C.R. Submitter Name: Bard, Inc.) 5425 W. Amelia Earhart Drive Address : Salt Lake City, UT 84116 [phone] ex 4982 Telephone Number: [phone] Fax Number: Jane Ann Martin Contact Person: 5 November 1997 Date of Preparation:

#### Device Name: B.

Per-Q-Cath® Midline Catheters Common/Usual Name:

Classification Name: Long-term Intravascular catheter (LJS)

#### Predicate Device Name: c. Per-Q-Cath® Midline catheters Trade Name:

#### D. Device Description:

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

#### E . Intended Use:

For long term midline venous catheterization of selected intravenous infusates ox blood therapy. A midline catheter placement is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.

#### P. 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.

#### Performance Data (if applicable) G.

No performance testing was done. À 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/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines connecting them. The text "U.S.A" is located at the top right of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 199

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

Re : K971991 Gesco Per-O-Cath® Midline Catheters Trade Name: Regulatory Class: II Product Code: FOZ Dated: August 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 aqainst 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. A 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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

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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,

y A. Ulatowski Timot 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* K971991

I state in my capacity as Regulatory Affairs Manager of Bard Access Systems, that this I state in my capacity as regulatory interior . Per-Q-Cath® Midline Catheters, are indicated for the following:

Per-Q-Cath® Midline Catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. A midline catheter is contraindicated for patients requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and patients requiring continuous infusion of vesicants.

Amaster

Signature of 510(k) Submitter

Jane Ann Martin Printed Namc of Submitter

b 700 57

Datc

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

Patricio Cucurella

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

510(k) Number K971991

**Prescription Use**
(Per 21 CFR 801.109)