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

K011982 · Bd · FOZ · Jul 17, 2001 · General Hospital

Device Facts

• Record ID: K011982
• Device Name: 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
• Applicant: Bd
• Product Code: FOZ · General Hospital
• Decision Date: Jul 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

Device Story

The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe is a pre-filled, single-use device designed for flushing vascular access devices (VADs) to maintain patency. The device consists of a polypropylene barrel, plunger rod, and tip cap, with a latex-free synthetic rubber plunger tip and a Luer Lok tip. It is pre-filled with 0.9% Sodium Chloride Injection, USP. The device is used by clinicians in clinical settings to deliver saline solution into a VAD. By maintaining patency, the device helps ensure the functionality of the vascular access line, facilitating ongoing patient treatment. The device is manually operated by the clinician.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Materials: Polypropylene (barrel, plunger rod, tip cap), medical grade silicone (lubricant), latex-free synthetic rubber (plunger tip). Design: Luer Lok tip. Contents: 0.9% Sodium Chloride Injection, USP. Processing: Aseptic fill. Form factor: Pre-filled syringe.

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

• BD Preefil™ Normal Saline Flush Syringe (K982558)

Submission Summary (Full Text)

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human health

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## Summary of Safety and Effectiveness for the 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe

1 BD Contact person:

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

- Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe 2
- Predicate Device(s): 3
- 3.1 BD Preefil™ Normal Saline Flush Syringe K982558
- Intended Uses: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringes 4 Intended Uses: 0.9% Sodium Chionde Injection, OSF DB Parcellar access devices (VAD'S).
- Device Description and Comparison: (REVISED) ર

A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled
Incomparison Station Childer Flyer Election Elysh Syrings is provided in A comparison between the new 0.5% Boulum Shines injos in the existential in the table below:

| Component/<br>Characteristic | 0.9% Sodium Chloride<br>Injection, USP BD Pre-<br>Filled Flush Syringe | BD Preefil Normal<br>Saline Flush Syringe |
|------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Plunger Tip (stopper) | Latex Free Synthetic<br>Rubber | Latex Free Synthetic<br>Rubber |
| Syringe Tip | Luer Lok | Luer Lok |
| Saline Solution | 0.9% Sodium Chloride<br>Injection, USP | 0.9% Sodium Chloride<br>Injection, USP |
| Process | Aseptic Fill | Aseptic Fill |

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- Equivalence determination: 6
The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe has the following the The 0.9% Sodium Chionde Injection, OSF - BB Preefil Normal Saline Flush Syringe:
similarities to the predicate BD Preefil Normal Saline Flush Syringe:

- Same syringe components .
- Syringes have the same operating principle .
- Syringes have the same operating operformance specifications .
- Syringes have the similar design .
- Synngoo nave tion in each product is identical .
- THE Saline Solution in Sach producing shelf life .
- The syringes have the same packaging .

In summary, the 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringer In summary, the 0.9% Sodium Chionde injection, SCF-BB-140-118-11-2
described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2001

Mr. Gregory W. Morgan Head of Regulatory BD Medical Surgical One Becton Drive MC226 07417 Franklin Lakes, New Jersey

K011982 Re : K011982
Trade/Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe Regulation Number: 880.5200 Regulatory Class: II Product Code: FOZ June 25, 2001 Dated: June 26, 2001 Received:

Dear Mr. Morgan:

We have reviewed your Section 510(k) notification of intent to We have reviewed your section bronne have determined the market the device referenced above (for the indications for device is substancially ogarransis in marketed predicate use stated in interstate commerce prior to May 28, 1976, devices marketed in theer blace of mevice Amendments, or to the enactment date of the reclassified in accordance with the devices that have been recrassir and Cosmetic Act (Act).
provisions of the Federal Food, Irug, and Cosmetic the general provisions of the reachar room, subject to the general The general controls controls provisions of the Act. controls provisions of the necessor include requirements for annual provisions of the Act incraac requiremanufacturing practice, registration, firsting on a against misbranding and adulteration.

If your device is classified (see above) into either class II If your device is crability (Socialist (Socoval), it may (Special Controls) of Stimal controls. Existing major be subject to such addression be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, freic ar, farts on assumes compliance with substantlarly equivatence actor Practice requirements, as set the Current Good Manaractor (QS) for Medical Lorch in the Quarre] Bytoom (2) CFR Part 820) and that, Devices: General regarations, the Food and Drug through periodic go inspections as were in in regulatery Administracion (FBA) will versions in regulation may result in regulatory

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Page 2 – Mr. Morgan

In addition, FDA may publish further announcements action. action. In addition, ron may pagers. Register. Please note: concerning your device in the resimines intension does this response to your premarket hour under sections 531
not affect any obligation you might have under the Electronic not aftect any obligation you might under the Electronic through 542 of the Act for devices under eno 2000-1000
Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as the FDA This letter will allow you co begin maification. The FDA
described in your 510(k) premarket notification a leo described in your 51018) premarke as your device to a legally
finding of substantial equivalence of your device tor your finding of substantial equivatence of yourseification for your
marketed predicate device results in a classification for your marketed predicate device results in a crabbided. The market.

If you desire specific advice for your device on our labeling
If you desire and 201 and additionally 809 10 for in If you desire specific advice for your and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Parc 801 una acontact the Office of
yitro diagnostic devices), please contact the for questi vitro diagnostic devices), prease conculture on questions on
Compliance at [phone]. Additionally, for questions on Compliance at [phone]. "Addressederice, please contact
the promotion and advertising of your device, please no the promotion and advertising of your acs9300 planes note "Misbranding by reference to the regulation entitled, che regaration" (21CFR 807.97). Other general premarket notification (21ch 007.97). Jost be Act may be information on your responsibilities ands - careers Assistance
obtained from the Division of Small Manufacturers Assistance obtained from the Division of Smarr Manufaceae in
at its toll-free number [phone] or [phone] or at its internet address

its Theernet addrebb
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski Directbr 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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## Attachment 2

## Indications for Use Statement

510(k) Number: not known at this time

. Device Name: 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe

Indications for Use: The 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush
er and the first for the first and in maintaining patency of vascular access devices Indications for Use: The 0.9% Sodium Chilonde injection, OST 22.4%
Syringes are intended for use in maintaining patency of vascular access devices (VAD'S).

(Division Sign-Off) (Division of Dental, Infection Control, Division of Dental, ----------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number