K Number
K011982
Device Name
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
Manufacturer
Date Cleared
2001-07-17

(21 days)

Product Code
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe and the existential BD Preefil Normal Saline Flush Syringe is provided 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 |
More Information

No
The device is a pre-filled syringe containing saline solution, and the description focuses on the materials and process, with no mention of AI or ML.

No.
The device is a pre-filled syringe containing 0.9% Sodium Chloride Injection, USP, intended for maintaining the patency of vascular access devices, not for therapeutic administration.

No

Explanation: The device is a pre-filled syringe containing sodium chloride solution, used for maintaining the patency of vascular access devices. Its intended use is therapeutic (maintaining device function), not diagnostic (identifying or characterizing a disease or condition).

No

The device description clearly outlines physical components (barrel, plunger rod, tip cap, lubricant, plunger tip, syringe tip) and a saline solution, indicating it is a hardware device with a drug component (saline).

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "maintaining patency of vascular access devices (VAD'S)." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
  • Device Description: The device is a pre-filled syringe containing saline solution. This is a medical device used for flushing, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of the device being used with biological specimens, performing tests on samples, or providing diagnostic information.

Therefore, this device falls under the category of a general medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for 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).

Product codes

FOZ

Device Description

A comparison between the new 0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush Syringe and the existential BD Preefil Normal Saline Flush Syringe is provided in the table below:

Component/Characteristic0.9% Sodium Chloride Injection, USP BD Pre-Filled Flush SyringeBD Preefil Normal Saline Flush Syringe
Barrel, Plunger Rod, Tip capPolypropylenePolypropylene
LubricantMedical Grade SiliconeMedical Grade Silicone
Plunger Tip (stopper)Latex Free Synthetic RubberLatex Free Synthetic Rubber
Syringe TipLuer LokLuer Lok
Saline Solution0.9% Sodium Chloride Injection, USP0.9% Sodium Chloride Injection, USP
ProcessAseptic FillAseptic Fill

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

BD Preefil™ Normal Saline Flush Syringe K982558

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).

0

human health

Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun and a person inside a circle, followed by the letters "BD" in bold. Below the letters, the words "Indispensable to" are printed in a smaller font. The logo is black and white and appears to be a company logo.

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 (201) 847-4344 (201) 847-4855 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/
Characteristic | 0.9% Sodium Chloride
Injection, USP BD Pre-
Filled Flush Syringe | BD Preefil Normal
Saline Flush Syringe |
|------------------------------|------------------------------------------------------------------------|-------------------------------------------|
| Barrel, Plunger Rod, Tip cap | Polypropylene | Polypropylene |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone |
| Plunger Tip (stopper) | Latex Free Synthetic
Rubber | Latex Free Synthetic
Rubber |
| Syringe Tip | Luer Lok | Luer Lok |
| Saline Solution | 0.9% Sodium Chloride
Injection, USP | 0.9% Sodium Chloride
Injection, USP |
| Process | Aseptic Fill | Aseptic Fill |

1

  • 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.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle. The text is in all capital letters and is evenly spaced around the circle.

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

3

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 (301) 594-4622. Additionally, for questions on Compliance at (301) 594-4622. "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 (800) 638-2041 or (301) 443-6597 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

4

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