BD CAREFLOW CENTRAL VENOUS CATHETER

K033500 · Becton, Dickinson & CO · FOZ · Jan 29, 2004 · General Hospital

Device Facts

• Record ID: K033500
• Device Name: BD CAREFLOW CENTRAL VENOUS CATHETER
• Applicant: Becton, Dickinson & CO
• Product Code: FOZ · General Hospital
• Decision Date: Jan 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The BD Careflow™ Central Venous Catheter is an intravascular catheter that is introduced into a patient's vascular system for short-term use (less than 30 days) using an introducer and guidewire. The catheter is used to sample blood, monitor blood pressure, or administer fluids.

Device Story

BD Careflow Central Venous Catheter (CVC) is a polyurethane, radiopaque intravascular catheter; used for short-term (less than 30 days) vascular access. Device facilitates blood sampling, blood pressure monitoring, and fluid administration. Sold in convenience kits including guidewire, introducer needle, introducer catheter, vessel dilator, syringe, injection caps, slide clamps, and movable suture wing. Operated by clinicians in clinical settings. Device functions by insertion into patient's vascular system via introducer and guidewire. Substantially equivalent to BD Hydrocath CVC, differing only by absence of hydrophilic coating.

Clinical Evidence

Bench testing only. Side-by-side testing of modified (BD Careflow) and unmodified (BD Hydrocath) devices compared tensile strength, leakage potential, and catheter stiffness to support substantial equivalence.

Technological Characteristics

Polyurethane, radiopaque intravascular catheter; 60-300mm lengths, 2.5-9.5 French sizes, 1-5 lumens. Non-coated (lacks hydrophilic coating). Supplied in convenience kits with standard placement accessories.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration via central venous catheterization.

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

• BD Hydrocath™ Central Venous Catheter

Submission Summary (Full Text)

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BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: [phone] fax: [phone] www.bd.com

# JAN 2 9 2004

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# Premarket Notification [510(k)] Summary of Safety and Effectiveness for BD Careflow™ Central Venous Catheters

| Submitter: | Becton Dickinson Infusion Therapy Systems Inc |
|------------------------|-----------------------------------------------|
| Address: | 9450 South State Street<br>Sandy, UT 84070 |
| Contact Person: | Leslie Wood, Manager, Regulatory Affairs |
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | October 27, 2003 |
| Trade Name: | BD CareflowTM Central Venous Catheter |
| Common Name: | Central Venous Catheter |
| Classification Name: | Intravascular Catheter |
| Predicate Device: | BD HydrocathTM Central Venous Catheter |

### Product Description:

The BD Careflow™ Central Venous Catheter (CVC) is a polyurethane, radiopaque catheter. It is identical to the BD Hydrocath™ CVC except that the BD Careflow product does not have a hydrophilic coating.

The BD Careflow product line includes the same range of product offerings as the BD Hydrocath product line: 60-300mm lengths, 2.5-9.5 French sizes, and 1 – 5 lumens.

BD Careflow catheters are sold in convenience kit form containing components to facilitate catheter placement, such as a guidewire, introducer needle, introducer catheter, vessel dilator, syringe, injection caps, slide clamps, and movable suture wing. The kit components are identical to those that were provided in the BD Hydrocath CVC convenience kits.

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## Intended Use:

The BD Careflow™ Central Venous Catheter is an intravascular catheter that is introduced into a patient's vascular system for short-term use (less than 30 days) using an introducer and guidewire. The catheter is used to sample blood, monitor blood pressure, or administer fluids.

# Technological Characteristics Comparison:

The design and technological characteristics are the same as those of the BD Hydrocath CVC product except that there is no hydrophilic coating on the BD Careflow CVC products.

# Nonclinical Tests Support Substantial Equivalence:

Side-by-side testing of BD Careflow (modified) and BD Hydrocath (unmodified) devices was conducted to compare tensile strength, potential for leakage, and catheter stiffness.

## Conclusions from Nonclinical Tests:

Data have been provided to demonstrate that product attributes are substantially equivalent between the modified and unmodified devices.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2004

Becton Dickinson & Corporation Ms Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems Incorporated 9450 South State Street Sandy, Utah 84070

Re: K033500

Trade/Device Name: BD Careflow™ Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 4, 2003 Received: November 5, 2003

Dear Ms. Wood

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed yoursed the device is substantially equivalent (for the It it it do a ve use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to de rises and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppression (1) the Act. The general controls provisions of the Act include controls provinces of an 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 If your device is classified (obs acc additional controls. Existing major regulations affecting (I Mry, it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Wood

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast to advised that I Dr. determination that your device complies with other requirements Incall that I DA mas made a aves and regulations administered by other Federal agencies. or the receded any I ederal time Act's requirements, including, but not limited to: registration 1 od linest compt 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadistion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This teter whilanon your be of a finding of substantial equivalence of your device to a premainer notification - I sults 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), If you desire specifice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K03560

#### BD Careflow™ Central Venous Catheter DEVICE NAME

#### INDICATIONS FOR USE

The BD Careflow™ Central Venous Catheter is an intravascular catheter that is introduced into a patient's vascular system for short-term use (less than 30 days) using an introducer and guidewire. The catheter is used to sample blood, monitor blood pressure, or administer fluids.

Vile Hibbard, Interim Branch Chief

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

510(k) Number: Ko 33 500

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: × (per 21 CFR 801.109)

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Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________

510(k) Indications