The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.

Device Description

B. Braun Medical's Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury. The Ultrasite Valve is designed to provide needle-free access on I.V. pump sets, gravity sets, and extension sets. The Ultrasite Valve is a needle-free, capless positive displacement valve to be used in place of needles for the administration of fluids. The Ultrasite Valve may be accessed with standard male luer connectors and requires no special accessory devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ultrasite® Valve" and its substantial equivalence to a previously marketed device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in the way typically expected for an AI/ML medical device.

The document is a regulatory submission for a physical medical device (needle-free injection site), not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance, training sets, ground truth establishment, expert adjudication, and multi-reader multi-case studies are not applicable to this submission.

The "study" mentioned is a "Functional testing" which was performed to support that there are "no new issues of safety or effectiveness raised by the expanded indications for use for power injectors." The document does not provide details of this functional testing, such as specific acceptance criteria or performance metrics.

Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the provided text. The submission focuses on substantial equivalence to a predicate device.
Reported Device Performance: The document states that "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for power injectors." However, specific performance metrics from this testing are not provided.

Acceptance Criteria	Reported Device Performance
Not specified	Functional testing indicated no new safety/effectiveness issues for expanded indications (power injectors).

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

Sample Size: Not specified for any functional testing.
Data Provenance: Not applicable as it's a physical device and not relying on a dataset from specific countries for analysis. The testing would have been conducted on the device itself.
Retrospective/Prospective: Not specified, but likely refers to lab/bench testing of the physical device.

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

This question is not applicable. The device is a physical medical device (needle-free injection site), not an AI/ML algorithm requiring expert ground truth for a test set.

4. Adjudication method for the test set

This question is not applicable. As above, it's a physical device, not an AI/ML algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a physical medical device and does not involve AI assistance or human readers in an MRMC study context.

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

This question is not applicable. The device is a physical medical device.

7. The type of ground truth used

This question is not applicable in the context of AI/ML ground truth (expert consensus, pathology, outcomes data). For a physical device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks for the physical device. The document implies comparison to the predicate device's performance and standard safety/effectiveness as per regulatory requirements.

8. The sample size for the training set

This question is not applicable. The device is a physical medical device and AI/ML training sets are not relevant.

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

This question is not applicable. The device is a physical medical device and AI/ML training sets are not relevant.

Summary

{0}------------------------------------------------

$\mathcal{K}_{0}31923$

AUG 1 1 2003

510(k) Summary
SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 596-2375Contact: Sheri L. Musgnung, Manager, Regulatory Affairs
DEVICE NAME:	Ultrasite® Valve
COMMON OR USUALNAME:	Needle free Injection Site
DEVICECLASSIFICATION:	Class II per Code of Federal Regulations,Title 21, § 880.5440, Intravascular AdministrationSets, product code FPA
PREDICATE DEVICE:	B. Braun Medical Inc.'s Ultrasite Valve (previouslyknown as V2 Injection Site (K955585)
DESCRIPTION:	B. Braun Medical's Ultrasite® Valve is intendedfor aspiration, injection or gravity/pump flow offluids upon insertion of a male luer fitting.
	The Ultrasite Valve may also be used with powerinjectors for which the maximum pressure setting is300 psi. When used with a power injector, theUltrasite Valve must be secured to other deviceswith a luer lock connection; other devices must alsobe rated for 300 psi. The Ultrasite Valve isdesigned to aid in the prevention of needlestickinjury. For more information of the principles ofoperation, please refer to Attachment I - ProposedDevice Labeling and Instructions for Use.
B. Braun Medical Inc.510(k) Premarket Notification	The Ultrasite Valve is designed to provide needle-free access on I.V. pump sets, gravity sets, andextension sets. The Ultrasite Valve is a needle-free,

510(k) Premarket Notification
Ultrasite® Valve SIO(k)

00001 :

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capless positive displacement valve to be used in place of needles for the administration of fluids. The Ultrasite Valve may be accessed with standard male luer connectors and requires no special accessory devices.

INTENDED USE:

The subject Ultrasite Valve is similar in materials and design to B. Braun Medical's premarket notification, Ultrasite Valve (previously known as V2 Injection site), K955585. Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for power injectors.

SUBSTANTIAL EQUIVALENCE:

Braun Mudical Inc. 510(2) Premarket Notification Ultrailas Valve 51000

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo contains the words "HEALTH & HUMAN SERVICES USA" around the top half of the circle and "DEPARTMENT OF" around the bottom half of the circle. In the center of the circle are three curved lines that are stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

Ms. Sheri L. Musgnung Regulatory Affairs Manager B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K031923

Trade/Device Name: Ultrasite® Valve Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 20, 2003 Received: June 23, 2003

Dear Ms. Musgnung:

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. Musgnung

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. 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 (QS) 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), please contact the Office of Compliance at (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Patricia Cucenitffa

Susan Runner, DDS, MA Interim 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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031923

Indications for Use Statement of ______________________________________________________________________________________________________________________________________________________________________ Page Page Ca 510(k) Number (if known):

Device Name: Ultrasite® Valve

Indications For Use:

Palaux Cucenite

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031923

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

B. Braun Modical Inc. 510(k) Premarket Notification Ultrasited Valva 510(k)

000004

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

INTENDED USE:

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Page 2 - Ms. Musgnung

Enclosure

Indications for Use Statement __ of ________________________________________________________________________________________________________________________________________________________________________ Page Page Ca 510(k) Number (if known):

§ 880.5440 Intravascular administration set.

Indications for Use Statement of ______________________________________________________________________________________________________________________________________________________________________ Page Page Ca 510(k) Number (if known):