ZYNO MEDICAL ADMINISTRATION SET

K120685 · Zyno Medical, LLC · FPA · Sep 7, 2012 · General Hospital

Device Facts

• Record ID: K120685
• Device Name: ZYNO MEDICAL ADMINISTRATION SET
• Applicant: Zyno Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

Device Story

Single-use, latex-free, non-DEHP intravenous administration set; delivers fluids from container to patient vascular system via needle or catheter. Components include tubing, drip chamber with spike, back check valves, needleless Y-sites, clamps (slide, roller, pinch), filters (0.22 or 1.2 micron), and male luer locks. Used in clinical settings for infusion therapy; compatible with Zyno Medical Z-800 family infusion pumps. Device facilitates controlled fluid delivery to patient.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing, sterilization testing, and biocompatibility testing.

Technological Characteristics

Constructed of high-grade extruded DEHP-free Polyvinyl Chloride (PVC). Components include tubing, drip chambers, valves, filters, and luer locks. Sterilized via Ethylene Oxide gas. Single-use, non-electronic, mechanical fluid delivery system.

Indications for Use

Indicated for patients requiring intravenous fluid administration via needle or catheter into a vein.

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

• Solution Administration Set, Baxter Healthcare Corporation (K981792)
• AMSURE I.V. Administration Set, Amsino International, Inc (K973107)
• IV Administration Set, Health Line International Corporation (K060352)

Submission Summary (Full Text)

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K120685

## 510(k) SUMMARY

SEP 7 2012

#### SUBMITTER INFORMATION: 1.

Zyno Medical, LLC 10 Tech Circle Natick, MA 01760, USA

Submitter Contact: Mei Zhang, PhD Engineering Manager Phone: [phone] Ext.205 Fax: [phone] Email: [e-mail]

#### 2. NAME of DEVICE:

Trade Name: Zyno Medical Administration Set Common Name: Intravascular Administration Set, Intravenous Administration Set, I.V. Administration Set, IV Set Classification Name: Intravascular Administration Set

#### DEVICE CLASSIFICATION: 3.

Device Class: II Regulation Number: 21 CFR 880.5440 Product Code: FPA Panel: General Hospital and Personal Use

#### 4. PREDICATE DEVICES:

The Zyno Medical's Administration Set is substantially equivalent to the following predicate devices:

-- Solution Administration Set, Baxter Healthcare Corporation (K981792) -- AMSURE I.V. Administration Set, Amsino International, Inc (K973107) -- IV Administration Set, Health Line International Corporation (K060352)

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#### 5. STATEMENT OF INTENDED USE:

The Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein.

#### DEVICE DESCRIPTION: 6.

The Zyno Medical's I.V. Administration Set is a single use, latex-free, non-DEHP device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein.

Depending on configuration, the device may include the following components: tubing, protective cap(s), drip chamber (s) with spike, tubing, back check valve(s), needleless Y-site(s), slide clamp(s), roller clamp(s), pinch clamp(s), 0.22 micron filter or 1.2 micron filter, male luer lock (with cap), and pressure activated valve(s). Seven (7) representative administration sets and one (1) representative extension set are described in the application package to illustrate the device confiqurations.

Zyno Administration Set is identical to the following predicate devices:

-- IV Administration Set manufactured by Health Line International Corporation (K060352). -- AMSURE I.V. Administration Set, Amsino International, Inc (K973107)

Zyno medical currently privately labels the above administration sets for use with Zyno Medical's Z-800 family infusion pump (K100705).

#### SUMMARY OF TECHNOLOGY CHARACTERISTICS 7.

Zyno Medical Administration Set is constructed of high grade extruded DEHP-free Polyvinyl Chloride (PVC). The primary components of Zyno Medical's Administration Set are manufactured to identical or similar specifications of the predicated devices listed above. The intended use, basic design, function and materials used are identical or similar to the predicate devices. The technical characteristic is substantially equivalent to the predicate devices. For details please refer to the Equivalency Table in the application package.

#### 8. SUMMARY NON-CLINICAL TESTING

The non-clinical testing consisted of evaluation studies of the Zyno Medical Administration Set to verify its ability to meet its intended use requirements. This testing also included testing to the relevant safety standards. When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results. The data obtained from bench testing, sterilization testing, and biocompatibility testing showed that the device is substantially equivalent to the predicated device and complies with the safety and effectiveness criteria.

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#### SUMMARY OF CLINICAL EVALUATION 9.

A summary of clinical data has been provided to support that the Zyno Medical Administration Set is substantially equivalent to the predicate devices.

:

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP

7 2012

Mr. Chaoyoung Lee
President
Zyno Medical Limited Liability Company
10 Tech Circle
Natick, Massachusetts 01760

Re: K120685

Trade/Device Name: Zyno Medical Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 26, 2012 Received: August 3, 2012

Dear Mr. Lee:

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. 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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### Page 2- Mr. Lee

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 (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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For

Anthony D. Watson, B.S., M.S., M.B.A. 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

K120685

510(k) Number (if known): _

Device Name: Zyno Medical Administration Set

Indications for Use:

The Zyno Medical 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.

י "

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C Chapman 8/30/12
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K120685