The Dynarex Three-Way Stopcock multiple port device is indicated to serve as a flow control and a conduit for I.V. fluid delivery to a patient's vascular system. This device is intended for delivering I.V. drug solutions or fluids, allowing gravity feed, sampling, bolus injection, and elimination or reflux of solutions and fluids during operation. The device may be used for a limited contact duration (24 hours or less).

Device Description

The Dynarex Three-Way Stopcock is a multiple port and needless access device that can be attached to other intravascular administration set devices by the user at the point of use during infusion therapy or sampling. The single-use disposable device intended for use on continuous or intermittent fluid administration or withdrawal of fluids. An in-line access site and can be connected to female luer adapters to allow needless access to fluid or vascular fluid path, and can control fluid flow by rotating flow control taps. The multiple access sites can be used for administration of drugs and solutions to a common fluid path or patient vascular system through a needle or catheter inserted into a vein.

AI/ML Overview

The provided text describes the submission of a medical device, the Dynarex Three-Way Stopcock, for FDA 510(k) clearance, indicating its substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Visual inspection (debris)	Free from foreign particles	Free from particles
Visual inspection (molding)	No molding defects	No defects
Male luer	6% taper	Meets criteria
Female luer (main port)	6% taper	Meets criteria
Female luer (side port)	6% taper	Meets criteria
Air leakage from tap	No leakage	No leakage
Liquid leakage	No leakage at maximum 3.3 bar	No leakage
Tap rotation	Rotates freely without jerking	Rotates freely without jerking
Fitment with receptive component	Luers must fit securely without any jerk or damage	Meets criteria
Gravity Flow rate	435 to 465 mL/min	Average 451.5 mL, range 445mL/min to 462 mL/min
Bisphenol A content	None	Undetectable (<10ppb)
Pouch open force	NLT 1.5N	(Performance not explicitly stated, but implies met)
Package integrity	200 mmHg	Meets criteria
Residual testing	ISO 10993-7; Residuals undetectable	Residuals undetectable
Particulate testing	<25 10µm particles/mL, <3 25µm particles/mL	4.3 10µm particles/mL, 0.5 25µm particles/mL
Hemocompatibility	ISO 10993-4/ASTM F756; Non-hemolytic	Non-hemolytic
Cytotoxicity	ISO 10993-5; Non-cytotoxic	Non-cytotoxic
Sensitization	ISO 10993-10; Non-sensitizer	Non-sensitizer
Intracutaneous Reactivity	ISO 10993-10; Non-irritant	Non-irritant
Acute Systemic Toxicity	ISO 10993-11; Non-toxic	Non-toxic

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes (number of devices tested) for each non-clinical test. It also does not provide information on the country of origin of the data or whether the tests were retrospective or prospective. These are typically details found in the full test reports, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This document describes non-clinical bench testing and material biocompatibility testing for a physical medical device (stopcock), not a diagnostic algorithm or image analysis tool. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists) in the context of diagnostic interpretation is not applicable here. The "ground truth" for these tests would be established by validated measurement standards and laboratory procedures, performed by trained technicians or engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or adjudication.

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

Not applicable. This is a non-clinical bench test report for a physical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a non-clinical bench test report for a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" (or reference standard) for these tests is based on established industry standards and regulatory requirements for medical devices, such as:

Physical measurements and engineering specifications: e.g., 6% taper for luers, specified flow rates, pressure ratings.
Absence/Presence of defects: as defined by visual inspection criteria.
Chemical analysis: e.g., Bisphenol A content, residual testing.
Biological safety standards: e.g., ISO 10993 series and ASTM F756 for hemocompatibility, cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity. These standards define the methods and criteria for evaluating biological responses.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 14, 2018

Dynarex Corporation Pablo Martinez Regulatory Affairs Manager 10 Glenshaw Street Orangeburg, New York 10962

Re: K172266

Trade/Device Name: Dynarex Three-Wav Stopcock Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FMG Dated: February 8, 2018 Received: February 12, 2018

Dear Pablo Martinez:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Tina

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K172266

Device Name Dynarex Three-Way Stopcock

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K172266

Section 5: Summary [As Required by 21 CFR 807.92]

Submitter's Information:

Name:	Dynarex Corp.
Address:	10 Glenshaw St.Orangeburg, NY 10962
Phone Number:	(845) 365-8200
Contact Person:	Marc L. SomelofskiM.Somelofski@Dynarex.com
Date Prepared:	March 9th, 2018

Subject Device:

Trade/Proprietary Name:	Dynarex Three-Way Stopcock
Common/Usual Name:	Three-Way Stopcock
Classification Name:	Stopcock, I.v. Set
Classification Panel:	General Hospital
Regulation Number:	21 CFR 880.5440
Product Code:	FMG
Device Class:	2

Predicate Device:

K111016 Elcam Medical's SafePort Manifold™ (or Stopcock).

Regulation Number:	21 CFR 880.5440
Product Code:	FPA
Device Class:	2

The predicate device has not been subject to a design related recall.

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Description of the Device:

Indications for Use:

Comparison to Predicate Device:

Characteristic	Subject Device	Predicate Device	Equivalency
Intended Use	Dynarex Three-WayStopcock is indicated toserve as a flow controland a conduit device forI.V. fluid delivery to thepatient's vascular system.The product is intendedfor delivering of I.V. drugsor fluids, allowing gravityfeed, sampling, bolusinjection and eliminationor reflux of fluid duringoperation.	SafePort Manifold orStopcock is indicated toserve as a flow controland a conduit device forI.V. fluid delivery to thepatient's vascular system.The product is intendedfor delivering of I.V. drugsor fluids, allowing gravityfeed, sampling, bolusinjection and eliminationor reflux of fluid duringoperation.	Same
Body	Polycarbonate lexan	Polycarbonate	Equivalent
Handle/Tap	High density polyethylene	High density polyethylene	Same
Rotator	High density polyethylene	High density polyethylene	Same
Single Use	Yes	Yes	Same
Body Color	Clear	Clear	Same
Dimensions	2.125" X 1" X .8"	Similar	Equivalent
Sterilant	Ethylene oxide	Ethylene oxide	Same
SterilityAssuranceLevel (SAL)	$10^{-6}$	$10^{-6}$	Same

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Characteristic	Subject Device	Predicate Device	Equivalency
Pressure rating	Pressure up to 3 bars (44 psi)	Pressure up to 3 bars (44 psi)	Same
Performance parameters	Not designed to withstand high pressure injections	Not designed to withstand high pressure injections	Same
Performance standards	ISO 594-1, ISO 594-2	ISO 80369-7	Equivalent
Pouch Packaging	Blister pack with medical grade paper cover	Similar	Equivalent
Biocompatibility endpoints	External communicating device with indirect blood contact for a limited duration (24 hours or less)	Similar	Equivalent

Table 5-1: Equivalency of subject device and predicate device

Non-clinical Testing:

Test	Criteria	Conclusion
Visual inspection (debris)	Free from foreign particles	Free from particles
Visual inspection (molding)	No molding defects	No defects
Male luer	6% taper	Meets criteria
Female luer (main port)	6% taper	Meets criteria
Female luer (side port)	6% taper	Meets criteria
Air leakage from tap	No leakage	No leakage
Liquid leakage	No leakage at maximum3.3 bar	No leakage
Tap rotation	Rotates freely withoutjerking	Rotates freely withoutjerking
Fitment with receptivecomponent	Luers must fit securelywithout any jerk or damage	Meets criteria
Gravity Flow rate	435 to 465 mL/min	Average 451.5 mL, range445mL/min to 462 mL/min
Bisphenol A content	None	Undetectable (<10ppb)
Pouch open force	NLT 1.5N
Package integrity	200 mmHg	Meets criteria
Residual testing	ISO 10993-7	Residuals undetectable
Particulate testing	<25 10µm particles/mL<3 25µm particles/mL	4.3 10µm particles/mL0.5 25µm particles/mL
Hemocompatibility	ISO 10993-4/ASTM F756	Non-hemolytic
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Sensitization	ISO 10993-10	Non-sensitizer
Intracutaneous Reactivity	ISO 10993-10	Non-irritant
Acute Systemic Toxicity	ISO 10993-11	Non-toxic

Table 5-2: Summary of nonclinical testing

Conclusions Drawn from Testing:

Through performance bench testing and device labeling the subject device has demonstrated to be substantial equivalent to the predicate device.

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.