Dynarex Three-Way Stopcock

K172266 · Dynarex Corporation · FMG · Mar 14, 2018 · General Hospital

Device Facts

• Record ID: K172266
• Device Name: Dynarex Three-Way Stopcock
• Applicant: Dynarex Corporation
• Product Code: FMG · General Hospital
• Decision Date: Mar 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Dynarex Three-Way Stopcock is a single-use, disposable, multiple-port, needless access device for infusion therapy. It attaches to intravascular administration sets at the point of use. Device features a polycarbonate body and high-density polyethylene handle/tap/rotator. Clinicians operate the device by rotating flow control taps to manage fluid flow, allowing for gravity feed, sampling, bolus injection, and fluid reflux into a patient's vascular system. It serves as a conduit for I.V. drug solutions or fluids. The device is used in clinical settings where I.V. access is required. It benefits patients by providing a controlled, accessible interface for medication and fluid delivery.

Clinical Evidence

Bench testing only. Testing included visual inspection, luer taper verification (6%), air/liquid leakage (up to 3.3 bar), tap rotation, gravity flow rate (435-465 mL/min), package integrity, and particulate testing. Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), intracutaneous reactivity (ISO 10993-10), acute systemic toxicity (ISO 10993-11), and hemocompatibility (ISO 10993-4/ASTM F756).

Technological Characteristics

Materials: Polycarbonate lexan body, high-density polyethylene handle/rotator. Dimensions: 2.125" x 1" x 0.8". Pressure rating: up to 3 bars (44 psi). Sterilization: Ethylene oxide (SAL 10^-6). Connectivity: Standalone, manual flow control via rotating tap. Standards: ISO 594-1, ISO 594-2.

Indications for Use

Indicated for patients requiring I.V. fluid delivery or drug administration via vascular access. Used for gravity feed, sampling, bolus injection, and fluid reflux. Limited contact duration (≤24 hours).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

| 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.<br>Orangeburg, NY 10962 |
| Phone Number: | [phone] |
| Contact Person: | Marc L. Somelofski<br>[e-mail] |
| 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:

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.

### Indications for Use:

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).

### Comparison to Predicate Device:

| Characteristic | Subject Device | Predicate Device | Equivalency |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Intended Use | Dynarex Three-Way<br>Stopcock is indicated to<br>serve as a flow control<br>and a conduit device for<br>I.V. fluid delivery to the<br>patient's vascular system.<br>The product is intended<br>for delivering of I.V. drugs<br>or fluids, allowing gravity<br>feed, sampling, bolus<br>injection and elimination<br>or reflux of fluid during<br>operation. | SafePort Manifold or<br>Stopcock is indicated to<br>serve as a flow control<br>and a conduit device for<br>I.V. fluid delivery to the<br>patient's vascular system.<br>The product is intended<br>for delivering of I.V. drugs<br>or fluids, allowing gravity<br>feed, sampling, bolus<br>injection and elimination<br>or reflux of fluid during<br>operation. | 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 |
| Sterility<br>Assurance<br>Level (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 maximum<br>3.3 bar | No leakage |
| Tap rotation | Rotates freely without<br>jerking | Rotates freely without<br>jerking |
| Fitment with receptive<br>component | Luers must fit securely<br>without any jerk or damage | Meets criteria |
| Gravity Flow rate | 435 to 465 mL/min | Average 451.5 mL, range<br>445mL/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<br><3 25µm particles/mL | 4.3 10µm particles/mL<br>0.5 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.