BD ONECATH

K042862 · Becton Dickinson Infusion Therapy Systems, Inc. · FOZ · Dec 3, 2004 · General Hospital

Device Facts

• Record ID: K042862
• Device Name: BD ONECATH
• Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Device Story

BD OneCath is a 20 cm midline catheter designed for peripheral vascular insertion (basilic, cephalic, or median cubital veins). It functions as an intravascular conduit for blood sampling, blood pressure monitoring, and fluid administration. Used in clinical settings by healthcare professionals, the device provides a pathway for therapy delivery or diagnostic monitoring. The catheter is inserted via an introducer; it remains in place for short-term use (up to 30 days). By providing reliable venous access, it facilitates necessary medical interventions and patient monitoring.

Clinical Evidence

Bench testing only. Biocompatibility testing of the polyurethane tubing and physical testing of device junctions (pull strength and security) were performed to support substantial equivalence.

Technological Characteristics

Radiopaque polyurethane catheter tubing; 20 cm length; inserted via catheter introducer. Features improved radiopacity, alcohol resistance, and flex endurance compared to predicate. No software or electronic components.

Indications for Use

Indicated for any patient population requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration, contingent upon adequate vascular anatomy and procedural appropriateness.

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 L-Cath Midline Catheter

Submission Summary (Full Text)

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K042862
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## Attachment D

Image /page/0/Picture/2 description: The image shows the BD logo, which consists of a stylized sun-like graphic to the left and the letters "BD" in bold, sans-serif font to the right. Below the letters, there is the text "Helping all people live healthy lives" in a smaller font size. The logo is simple and conveys a sense of health and well-being.

## Premarket Notification [510(k)] Summary

| Submitter: | Becton Dickinson Infusion Therapy Systems Inc |
|------------------------|-----------------------------------------------|
| Address: | 9450 South State Street<br>Sandy, UT 84070 |
| Contact Person: | Leslie Wood<br>Manager, Regulatory Affairs |
| Telephone Number: | [phone] |
| FAX Number: | [phone] |
| Date Summary Prepared: | October 4, 2004 |
| Trade Name: | BD OneCath™ |
| Common Name: | Midline Catheter |
| Classification Name: | Intravascular catheter |
| Classification: | Class II<br>880.5200 FOZ |
| Predicate Device: | BD L-Cath Midline Catheter |

# Description of the BD OneCath Midline Catheter:

Desorrption of the Proponent of intravenous therapy. Some of the Device selection is an important confortient on the check (1) length and type of
patient considerations that are included in this decision and ectivity, and (5) setting in patient considerations that are included in this detivity, and (5) setting in
therapy, (3) adequacy of venous access, (4) lifestyle and (5) setting in therapy, (3) adequacy of venous access, (+) illestyn dina cathers are 20 cm long,
which therapy will be administered. BD OneCathers are 20 cm long, which therapy will be administered. DD One Outler blood pressure, or administer.
designed for peripheral use to sample blood prossure, The basili designed for peripheral tise to sample blood, montor brocher in the basilic, in the basilic,
fluids, and prescribed when IV therapy is expected to last for midline fluids, and prescribed when iv there is expected to factory.
cephalic and median cubital veins of the arm are the preferred locations for midline catheters are the cephalic and median cubital veins of the ann are the professor as a commended for midline catheters are the catheter insertion. The types of infaction peripheral IV catheters.

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

DEC - 3 2004

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The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.

## Intended Use of the BD OneCath Peripherally Inserted Central Catheter:

The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

#### Technological Characteristics Comparison:

The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. These improved characteristics will make the BD OneCath midline catheters more competitive in this market.

#### Nonclinical Tests Support Substantial Equivalence:

Biocompatibility testing of the new polyurethane tubing and physical testing on the areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted.

#### Conclusions from Nonclinical Tests:

The BD OneCath midline catheter is substantially equivalent to the BD L-Cath midline catheter.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 2004

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

Re: K042862

Trade/Device Name: BD OneCath™ Midline Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 13, 2004 Received: October 15, 2004

Dear Ms. Wood:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish 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 mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Fee of ally I vatinal the Act's requirements, including, but not limited to: registration r od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 es revior the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet resir product radiation 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) rms retet 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), n you dontact the Office 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 Division 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 yours,

Susan Burns
K. Chiu Lin, 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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K042862

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## Indications For Use

K042862__ 510(k) Number (if known):

__BD OneCath™ Midline Catheter__ Device Name:

Indications For Use:

The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ank D. h.

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection of Anesthesiology, Gene

519(k) Number:_

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