The BD Posiflow Positive Displacement Valve is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids. The BD Positive Displacement Valve can be used by itself or as a component on an extension/infusion set, a vial adapter, or as a connector to convert a standard access site to a needleless access site.

Device Description

The BD Posiflow Positive Displacement Valve is a needleless alternative to an IV set injection port. It is accessed by a standard luer taper connection for continuous or intermittent infusion or withdrawal of fluids. The positive displacement feature is intended to eliminate fluid retrograde, which normally results when disconnecting a connector from an IV injection site.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, specific details about study methodology for clinical performance (like expert consensus, sample sizes for training sets in AI, etc.) are unlikely to be present.

It's important to note that this document concerns a physical medical device (a valve), not an AI/software device. Therefore, many of the questions related to AI-specific study details (like multi-reader multi-case studies, AI model performance metrics, training set details) are not applicable in this context. The "acceptance criteria" here refer to the performance standards for the physical device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from Nonclinical Tests)
Flow Rate	The current and modified devices were compared.
Backpressure Leakage	The current and modified devices were compared.
Vacuum Leakage	The current and modified devices were compared.

Overall Conclusion: Based on the nonclinical tests for flow rate, backpressure leakage, and vacuum leakage, the current and modified BD Posiflow Positive Displacement Valves are substantially equivalent. This implies that the modified device met the performance standards demonstrated by the predicate device for these parameters. The document does not specify quantitative acceptance thresholds for these categories, but rather indicates that the modified device performed equivalently to the predicate.

Study Details (for a physical medical device)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "the current and modified devices" being compared, implying a number of units of each were tested, but no specific sample size (N) is provided for these nonclinical tests.
- Data Provenance: Not explicitly stated, but these would be laboratory-based nonclinical tests, likely conducted at Becton Dickinson's facilities in the USA (based on their address).
- Context: These are nonclinical (bench) tests, not clinical trials involving patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As these are nonclinical physical device performance tests (flow rate, leakage), there's no "ground truth" established by human experts in the way it would be for an AI diagnostic device. The ground truth here would be derived from physical measurements against scientific principles and engineering standards.
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1) are typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiologists diagnosing images). These nonclinical tests involve objective physical measurements, not subjective interpretations requiring adjudication.
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:
- No. This is a physical medical device (a valve), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device. The concept of an "algorithm only" or "human-in-the-loop" performance is not applicable to a physical valve.
The type of ground truth used:
- For the nonclinical tests (flow rate, backpressure leakage, vacuum leakage), the "ground truth" is established through physical measurements and engineering standards/specifications. The comparison is against the performance of the predicate device, which itself would have met certain engineering and safety standards.
The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, this question is not relevant.

Summary

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K050207

page 1 of 2

BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com

APR 7 2005

Image /page/0/Picture/3 description: The image shows the BD logo. The logo consists of a circular emblem on the left and the letters "BD" on the right. The emblem features a stylized human figure with arms raised, surrounded by radiating lines, all enclosed within a circle. The letters "BD" are in a bold, sans-serif font.

Helping all people live healthy lives

Premarket Notification [510(k)] Summary

Submitter:Address:	Becton Dickinson Infusion Therapy Systems Inc.9450 South State StreetSandy, UT 84070
Contact Person:	Leslie WoodManager, Regulatory Affairs
Telephone Number:FAX Number:	(801) 565-2504(801) 565-2749
Date Summary Prepared:	January 18, 2005
Trade Name:	BD Posiflow™ Positive Displacement Valve
Common Name:	Luer Activated Valve
Classification Name:	Accessory to an Intravascular Administration Set
Predicate Device:	BD Posiflow Positive Displacement Valve

Description of the BD Posiflow Positive Displacement Valve:

shiption of the BB
The BD Posifilow Positive Displacement Valve is a needleless alternative in The BD Position Positive Displacement Farle standard luer taper
to an IV set injection port. It is accessed by a standard luer taper to an IV set injection port. It is accessed by a commotion connection for continuous of intent misten ded to eliminate fluids.
fluids. The positive displacement feature is intended to eliminate fluid fluids. The positive displacement reature is internative to the many of the prom
retrograde, which normally results when disconnecting a connector from an IV injection site.

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K050207
Page 292

Intended Use of the BD Posifiow Positive Displacement Valve:

The BD Posiflow Positive Displacement Valve is an accessory to an The BD Position I ostitive Bioplaben on mits injection, gravity flow on intravascular administration sol that pointify in the can be used
withdrawal of fluids. The BD Positive Displacement exist and as a vial adaptor withdrawal of liulus. The DD Fositive Displacemsion set, a vial adapter,
by itself or as a component on an extension/infusion as a possibless by itsell of as a component on an exismations site to a needleless access site.

Technological Characteristics Comparison:

Modifications have been made to improve the reseal function of this Modifications have been made to improve and handes were made to any materials.

Nonclinical Tests Support Substantial Equivalence:

The current and modified devices were compared for flow rate, backpressure leakage, and vacuum leakage.

Conclusions from Nonclinical Tests:

The current and modified BD Posiflow Positive Displacement Valves are substantially equivalent.

The term "substantial equivalence" as used in this 510(k) notification is limited The term' substantial equivalorido 'ace found in the Federal Food, Drug, lo the delifilion of Substantial Squrvalento Franches 21 CFR 807, Subpart E and Obsinetic Aot, as ameriable that and without premarket approval or under which a device our be time of substantial equivalency under this reclasslication. A determination of Substanting whatsoever on the resolution nothication is not intended to have any bearing matters. No statements of patent initingentent suits of any other parence herein shall be construed as related to of in Support of Substantial oquivalent Laws or their application by the courts.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 APR 7

Ms. Leslie Wood Manager, Regulatory Affairs Manager, Regulatory Afrans
Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070

Re: K050207

K050207
Trade/Device Name: BD Posiflow Positive Displacement Valve
Trade/Device Name: 300 5440 Regulation Number: 880.5440 Regulation Number: 86015 Privation Administration Set
Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 26, 2005 Received: January 28, 2005

Dear Ms. Wood:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 10(K) pleitial is substantially equivalent (for the referenced above and have detemined the device Is substanted predicate devices marketed in
indications for use stated in the enclosure) to legally marketed in
the economic of indications for use stated in the enclosure to tegals manteded posice of the Medical Device
interstate commerce prior to May 28, 1976, the enactment with the provisio interstate commerce prior to May 23, 1976, the enable with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions of Amendments, or to devices that have been received in acteduction of approval of a premaired
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug, and Cosmetic Act (Act) that do hot of the device, subject to the general
approval application (PMA). Therefore, market the device, subject to the ge approval application (PMA). You may, thereves insnovisions of the Act include
controls provisions of the Act. The general controls provisions of the Active controls provisions of the Act. Ine general collines good manufacturing practice,
requirements for annual registration, listing of devices, good manufacturing . requirements for annual registration, noming and adulteration.
labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affect and control and controls. Existing major regulations affect If your device is classified (see above) into elibert of the major regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations T (PMA), it may be subject to such additional controls. Existing individual roganizations of SPS. In
your device can be found in the Code of Federal Regulations, Title 21, Pa your device can be found in the Code of rederal Regulations, The 24,
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Wood

Please be advised that FDA's issuance of a substantial equivalence determination does not
ement Please be advised that FDA's issuance of a substances with other requirements
mean that FDA has made a determination that your devices with other requires. mean that FDA has made a determinations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registration of the Act or any Federal statutes and regulations administered or registration
You must comply with all the Act 's requirements, including, but not limited to: registration You must comply with all the Act s' requirences on the manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); abeling (21 CFR Part 801); good include (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part requirements as set forth in the quality systems (QS) regulation (Sections 531-542 of the Act);
applicable, the electronic product radiation control provisions (Sections 531-21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 10(k)
Children and connecting TD informatial equivalence of your device to a This letter will allow you to begin marketing your device of your device to a
premarket notification. The FDA finaling of substantial equivalence of your device and thus, pe premarket notification. The FDA finding of substantial equirales by
legally marketed predicate device results in a classification for your device and thus, permits legally wice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device on on Tabeling regaments of the regulation
please contact the Office of Compliance at (240) 276-0115. Also, please not 807.97). please contact the Office of Compliance at (240) 270-1137 " (21CF) Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (11CFF) Part 807.97). Yo entitled, "Misbranding by reference to prehibities under the Act from the Act from the may obtain other general intornation on your responsibility.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free
State of Small Manufactur Division of Small Manufacturers, Incenters, nr. at its Internet address
number (800) 638-2041 or (301) 443-6597 or at its Internet address number (800) 056-2017 01 (5 %) {5 % = 1 % = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = = 1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =

Sincerely yours,

Chiu Lin, Ph.D.

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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Indications For Use

510(k) Number (if known):

Device Name:

Indications For Use:

The BD Posiflow Positive Displacement Valve is an accessory to an intravascular
The BD The BD Position Positive Displacement variet is and sees and of fluids. The BD
administration set that permits injection, gravity flow or withdrawal on an administration set that permits injection, glavity all n as a component on an
Positive Displacement Valve can be used by itself or as a component a standar Positive Displacement Valve can be used by itself of as a connector to convert a standard access site to a needleless access site.

× Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Intention D. hum
2010

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Number K050207

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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.