The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.

Device Description

B. Braun Medical. Inc. intends to introduce into interstate commerce the Braun Prefilled Syringes. The syringes are aseptically filled with sterile 0.9% saline solutions intended solely for use in flushing intravascular catheters and maintain the patency of indwelling intravascular catheters. The syringes and solutions are not intended for use as anticoagulant therapy. The aseptic filling of these syringes with these solutions does not alter the intended use of the svringes or the solutions. The svringes have been cleared for marketing under K760392. The solutions meet the specifications of the applicable USP monograph for sodium chloride.

AI/ML Overview

The provided text is a 510(k) Summary for B. Braun Prefilled Syringes (K970736), which are described as being aseptically filled with sterile 0.9% saline solutions for flushing intravascular catheters. This document primarily focuses on establishing substantial equivalence to previously cleared devices under FDA regulations.

Based on the content, there is no information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device. This 510(k) is for a physical medical device (prefilled syringes) and relies on demonstrating substantial equivalence to predicate devices and adherence to manufacturing guidelines, rather than performance metrics from a clinical study.

Therefore, most of the requested information regarding AI/ML device performance is not applicable or cannot be extracted from this document.

Here's a breakdown of why and what information can be inferred:

1. A table of acceptance criteria and the reported device performance:

Not Applicable in the traditional sense. The "acceptance criteria" for this device are implicitly tied to meeting the specifications of the U.S. Pharmacopeia (USP) monograph for 0.9% sodium chloride, and the substantial equivalence to predicate syringes regarding materials, manufacturing processes, intended use, design, and labeling.
Reported Device Performance: The document states that the "solutions meet the specifications of the applicable USP monograph for sodium chloride" and that "the materials use to manufacture the syringes, as well as, the solutions used to fill the syringes have previously been reviewed by the FDA and determined to be suitable for the intended use of this product." This indicates that the performance is tied to material safety and chemical composition meeting established standards, not a specific measurable clinical outcome from a quantitative study.

2. Sample size used for the test set and the data provenance:

Not Applicable. This is not an AI/ML device or a device that underwent a clinical performance study with a test set of data points in the customary sense. The "testing" involved demonstrating that the materials and solution meet standards, and asserting equivalence to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of an AI/ML device, refers to verified labels or outcomes used to evaluate an algorithm. For this physical device, "ground truth" would be the established chemical composition standards of USP and safety profiles of the materials, which are defined by regulatory bodies and scientific consensus, not a specific set of experts for a single study.

4. Adjudication method for the test set:

Not Applicable. As there is no test set in the AI/ML context, there's no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This type of study is for evaluating human performance with and without an AI assistant, which is not relevant for a prefilled saline syringe.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device does not have an "algorithm."

7. The type of ground truth used:

Regulatory/Standard Compliance. The ground truth is the established U.S. Pharmacopeia (USP) monograph for 0.9% sodium chloride and the FDA's prior clearances and safety assessments of the syringe materials (K760392) and saline solutions. This is not "expert consensus, pathology, or outcomes data" in the AI/ML sense but rather established scientific and regulatory benchmarks.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

Not Applicable.

In summary, the provided K970736 document is a regulatory submission for a physical medical device (prefilled syringes) and not for an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, ground truth establishment for training/test sets, expert adjudication, and MRMC studies are not applicable to this document. The "study" referenced in the document is implicitly the demonstration that the components (syringes, saline solution) meet existing FDA clearances, USP standards, and manufacturing guidelines, leading to a finding of "substantial equivalence" to predicate devices.

Summary

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DEC 1 6 1998

K970736

510(k) Summary

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 (610)691-5400

August 31, 1998

CONTACT: Mark S. Alsberge, Regulatory Affairs Director

PRODUCT NAME: Braun Prefilled Syringes

Prefilled Intravascular Catheter TRADE NAME: Flush Syringes

CLASSIFICATION NAME:

Class: Il Panel: 80 General Hospital Devices Procode: FMF Piston Syringe

These devices have also been reviewed by the FDA as Accessory items to:

Class: II Panel: 80 General Hospital Devices Procode: FOZ Intravascular Catheters

DEVICE DESCRIPTION:

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MATERIALS:

The materials use to manufacture the syringes, as well as, the solutions used to fill the syringes have previously been reviewed by the FDA and determined to be suitable for the intended use of this product. The processes used to aseptically fill these syringes do not alter the properties or intended use of these materials.

510(k) number	Name	Applicant
K760392	Syringes	B. Braun Instruments, Inc.
K952645	Vital Signs SalineVascular Access FlushDevice	Vital Signs, Inc.
Unknown	SolopakTM0.9% Sodium Chloride	Solopak Medical Products,Inc.

SUBSTANTIAL EQUIVALENCE TO:

SUBSTANTIAL EQUIVALENCE:

B.Braun has marketed the syringes used in this device since their clearance by the FDA in 1976 (K760392). The solutions used in this device have also been cleared for their intended use by FDA review. The solutions meet the specifications of the applicable USP monograph for 0.9% sodium chloride USP. The processes used to aseptically fill these syringes do not alter the properties or intended use of these materials. The intended use, design, and labeling (warnings and claims) are substantially equivalent to the above listed devices. There are no new issues regarding safety and effectiveness raised by B. Braun Medical, Inc.'s intent to introduce into interstate commerce the Braun Prefilled Syringes.

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1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from a FDA -requlatory point of view under the Federal Food. Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

SAFETY AND EFFECTIVENESS:

The aseptic filling of these syringes with the solution does not alter the intended use of the svringe or the solution. The manufacturing processes and controls adhere to currently accepted quidelines and standards of practice.

Currently marketed prefilled syringes incorporate similar features and are available from a number of manufacturers for the same intended use. A review of the current literature and MDRs indicate that there are no additional risks or concerns associated with the use of prefilled syringes solely for use in flushing intravascular catheters or in preventing blood clots in these catheters.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an abstract symbol that resembles a human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 1998

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue 18018-0027 Bethlehem, Pennsylvania

Re : K970736 Trade Name: Braun Prefilled Syringes Requlatory Class: II Product Code: FOZ September 11, 1998 Dated: September 21, 1998 Received:

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoty A. Ulatowski 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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SIO(k) Number (if known): K9707 36

Normal Saline Prefilled Syringes Device Name:

Indications For Use:

The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.

The following table lists the available fill volumes and syringe sizes. .

DESCRIPTION	FillVol	ml	SyrSize	ml	CAPSProduct#	WSN#
0.9% Sodium Chloride PF	1	ml	3	ml	000-NS-0103	8193-9101-11
	2	ml	3	ml	000-NS-0203	8193-9101-12
	3	ml	6	ml	000-NS-0306	8193-9101-23
	3	ml	12	ml	000-NS-0312	8193-9101-33
	5	ml	6	ml	000-NS-0508	8193-9101-24
	5	ml	12	ml	000-NS-0512	8193-9101-34
	10	ml	12	ml	000-NS-1012	8193-9101-35

CAPS FLUSH SYRINGE PRODUCT LISTING TABLE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cusack

(Division Sign-Off) Division of Dental, Infor and General Hospit 510(k) Number

Prescription Use_X (Pcr 21 CFR 801.109) .. OR

Over-The-Counter Use

(Optional Formal 1-2-90)

Regulation Number and Section

§ 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).