INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS

K971339 · Becton Dickinson Vascular Access, Inc. · FOZ · Dec 24, 1997 · General Hospital

Device Facts

• Record ID: K971339
• Device Name: INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS
• Applicant: Becton Dickinson Vascular Access, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide access to the vascular system to monitor blood pressure, to sample blood or introduce substances into the heart and vessels.. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Device Story

INSYTE, INSYTE-W, and INSYTE AUTOGUARD catheters are short-term, single-use, radiopaque VIALON intravascular catheters. Designed for vascular access; used to monitor blood pressure, sample blood, or infuse substances. Operated by clinicians in clinical settings. Key feature is compatibility with power injectors up to 300 psi. Output is vascular access for diagnostic or therapeutic purposes. Benefits include reliable vascular access for fluid/drug delivery and hemodynamic monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque VIALON catheter; short-term, single-use; various gauges and lengths. Designed for vascular access. Compatible with power injectors up to 300 psi.

Indications for Use

Indicated for sampling blood, monitoring blood pressure, or introducing substances into the heart and vessels. Applicable to any patient population, considering patient size, solution appropriateness, and therapy duration. Compatible with power injectors up to 300 psi.

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

• INSYTE, INSYTE-W, and INSYTE AUTOGUARD brand catheters

Submission Summary (Full Text)

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DEC 2 4 1997

#### SUMMARY OF SAFETY AND EFFICACY

- A. The submitter's name, address, telephone number, contact person, and date of preparation.
Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070. Contact: C. J. Welle. Telephone: [phone]. Prepared:April 10, 1997.

- B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.
Name: Diagnostic Intravascular Catheter Brand: INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ II Catheters Common Name: I.V. Catheter Classification Name: Diagnostic Intravascular Catheter (74DQQ)

- C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:
Predicate Device: The Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters.

- D. A description of the device that is the subject of the Premarket Notification submission.
The subject catheter is a short term, single use, diagnostic intravascular catheter of various gauges and lengths which is designed to provide access to the vascular system. It is a radiopaque, VIALON® catheter for which the labeling sets forth the conditions of use with power injectors.

- E. Statement of intended use of the device.
The intended use is to provide access to the vascular system to monitor blood pressure, to sample blood or introduce substances into the heart and vessels.. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

- F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.
The proposed catheter differs from the INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters currently marketed in that the labeling clarifies the suitability of the catheters for use with power injectors.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three faces in profile, stacked on top of each other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 1997

Mr. Charles J. Welle Manager, Regulatory Affairs Manager, Rogano Vascular Access, Incorporated 9450 South State Street Sandy, Utah 84070

K971339 Re: INSYTE®, INSYTE-W® and INSYTE® AUTOGUARD™ Trade Name: Catheters II Requlatory Class: Product Code: FOZ Dated: September 22, 1997 Received: September 30, 1997

Dear Mr. Welle:

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, Drug, 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 Regulations, 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 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

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Page 2 - Mr. Welle

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 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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

Ulatows Timothy A. 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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April 10, 1997-

### INDICATIONS FOR USE

# 510(k) Number: K 97|339

## Device Name: INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ Catheters

Indications for Use: As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels . These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use: (Per 21 CFR 801.109) | X |
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| OR | Over-The -Counter Use: |

| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices |
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| 510(k) Number | K971339 |
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