BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

K011967 · Bd · FOZ · Jan 23, 2002 · General Hospital

Device Facts

• Record ID: K011967
• Device Name: BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
• Applicant: Bd
• Product Code: FOZ · General Hospital
• Decision Date: Jan 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

Device Story

Pre-filled syringe containing Heparin Sodium (10u/mL or 100u/mL) in 0.9% Sodium Chloride solution; used to flush and maintain patency of vascular access devices (VADs). Device consists of three-piece piston design with polypropylene barrel; aseptically filled. Available in various volumes (2mL to 6mL) and configurations, including kits with saline syringes and blunt plastic cannulas. Operated by clinicians in healthcare settings to prevent occlusion of vascular access lines.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

Three-piece piston syringe; polypropylene barrel; sterile Heparin Sodium (10 or 100U/mL) and 0.9% Sodium Chloride solution; aseptically filled; manual operation; various fill volumes (2-6mL) in 3, 5, or 10mL syringe sizes.

Indications for Use

Indicated for maintaining patency of vascular access devices (VADs) in patients requiring such access.

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

• Vital Signs Heparin Lock Flush Device (K953120)
• BD Preefil™ Normal Saline Flush Syringe (K982558)
• Baxter Heparin Lock Flush Syringe (K003245)

Submission Summary (Full Text)

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1 Becton Drive Franklin Lakes, New Jersey 07417 tel: [phone] www.bd.com

K04967

JAN 2 3 2002

Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sun-like symbol on the left and the letters "BD" on the right. The sun-like symbol has a circle with rays emanating from the top and a stylized figure at the bottom. The letters "BD" are in a bold, sans-serif font.

Indispensable to human health

## Summary of Safety and Effectiveness for the Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe

1 BD Contact person:

Gregory W. Morgan Head of Regulatory BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone [phone] [phone] Fax

- 2 Device Name: Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe
- 3 Predicate Device(s):
- 3.1 Vital Signs Heparin Lock Flush Device K953120
- 3.2 BD Preefil™ Normal Saline Flush Syringe K982558
- 3.3 Baxter Heparin Lock Flush Syringe K003245
- 4 Product Description / Function:

Product sizes/reorder numbers: The following sizes/reorder numbers of the Heparin Lock Flush Solution, USP syringes to be offered are:

| BD | |
|--------|--------------------------------------------|
| Cat. # | Description |
| 306509 | Heparin, 10u/mL, 6mL Fill In 10mL Syringe |
| 306510 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe |
| 306511 | Heparin, 10u/mL, 5mL Fill In 5mL Syringe |
| 306521 | Heparin, 10u/mL, 3mL Fill In 10mL Syringe |
| 306512 | Heparin, 10u/mL, 3mL Fill In 3mL Syringe |
| 306527 | Heparin, 10u/mL, 2mL Fill In 3mL Syringe |
| 306513 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe |
| 306514 | Heparin, 100u/mL, 3mL Fill In 10mL Syringe |

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| BD<br>Cat. # | Description |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------|
| 306515 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe |
| 306516 | Heparin, 100u/mL, 3mL Fill In 5mL Syringe |
| 306517 | Heparin, 100u/mL, 3mL Fill In 3mL Syringe |
| 306528 | Heparin, 100u/mL, 2mL Fill In 3mL Syringe |
| 306525 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306531 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306529 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe With Blunt Plastic Cannula |
| 306537 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock<br>Flush Syringe), 5mL Fill In 10mL Syringe - 100u/mL Heparin |
| 306538 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 10u/mL Heparin Lock<br>Flush Syringe), 3mL Fill In 3mL Syringe - 10u/mL Heparin |
| 306539 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock<br>Flush Syringe), 3mL Fill In 5mL Syringe - 100u/mL Heparin |

Intended Uses: Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

- 5 Equivalence determination:
The elements of comparison between the Heparin Lock Flush Solution. USP syringes with the BD Preefil™ Normal Saline Flush syringe, the Baxter Heparin Lock Flush syringe and Vital Signs Heparin Lock Flush Device predicate devices are as follows:

- The Heparin Lock Flush Solution, USP syringe contains sterile flush (0.9% ● Sodium Chloride Injection, USP and Heparin Sodium 10 and 100U/mL solution as does the predicate devices).
- The Heparin Lock Flush Solution, USP syringe has a sterile solution contents . and fluid path as do the predicate devices.
- The Heparin Lock Flush Solution, USP syringe is aseptically filled as the . predicate device, BD Preefil TM.
- The Heparin Lock Flush Solution, USP syringe is a three-piece piston design . as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe.
- . The Heparin Lock Flush Solution, USP syringe barrel is molded from polypropylene as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe.
- . The Heparin Lock Flush Solution, USP syringe has a similar package unit design as the predicate device, BD Preefil ™.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three stylized human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2002

Mr. Gregory W. Morgan BD Medical Surgical BD Medical Injections Systems 1 Becton Drive, MC 226 Franklin Lakes, New Jersey 07417

Re: K011967

Trade/Device Name: BD Pre-Filled Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Heparin Lock Flush Syringe Regulatory Class: II Product Code: NGT Dated: November 7, 2001 Received: November 8, 2001

Dear Mr. Morgan:

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.

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.

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Page 2 - Mr. Morgan

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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) 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/adrh/dsma/dsmamain.html

Sincerely yours,

Timo 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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## Indications for Use

The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining
patency of vascular access devices (VAD'S).

Patricie Cucenate
Division Sign. Oto

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