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.

Device Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Zyno Medical Administration Set (K120685).

Important Note: The provided text is a 510(k) summary for a medical device that is substantially equivalent to existing predicate devices. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving novel performance against specific, quantifiable acceptance criteria in a clinical study. Therefore, many of the typical "AI/software device" study questions (like MRMC, training sets, expert ground truth) are not applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices and meeting relevant safety standards. There aren't specific numerical performance metrics (like sensitivity/specificity for a diagnostic AI) listed in the summary.

Acceptance Criteria Category	Reported Device Performance	Comments
Intended Use	"administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein."	This is met by the device's design and intended function, as described. The study demonstrated functional equivalence to predicate devices.
Material Composition	Constructed of high-grade extruded DEHP-free Polyvinyl Chloride (PVC).	Verified through material specifications. Substantially equivalent or identical to predicate devices.
Sterilization	Sterilized with Ethylene Oxide gas.	Verified through sterilization testing, ensuring sterility for patient safety.
Components	May include: 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).	Device configurations are described and are identical/similar to predicate devices. Bench testing confirms components function as expected.
Safety and Effectiveness	Complies with safety and effectiveness criteria.	Demonstrated through bench testing, sterilization testing, and biocompatibility testing, showing substantial equivalence to predicate devices.
Performance Standards	"met its intended use requirements" and "complies with the safety and effectiveness criteria."	Non-clinical testing included evaluation studies and testing to relevant safety standards. Predicate devices were also tested for direct comparison where appropriate.
Substantial Equivalence	Demonstrated substantial equivalence to predicate devices: Baxter Healthcare Corporation (K981792), Amsino International, Inc (K973107), Health Line International Corporation (K060352).	This is the overarching "acceptance criterion" for a 510(k) submission like this. The device was found to be substantially equivalent based on intended use, basic design, function, materials, and non-clinical test results.

Study Details (Applicable to this type of device/submission)

This 510(k) is for a basic medical device (intravascular administration set), not an AI/software device. Therefore, the study conducted is primarily non-clinical bench testing for substantial equivalence. Clinical studies in the AI/software sense were not necessary or performed.

Sample size used for the test set and the data provenance:
- Sample Size: The document states, "When appropriate, predicate devices were tested using the exact same method and sample size, for direct comparison of results." However, the specific number of units tested for the Zyno Medical Administration Set itself is not explicitly stated in the provided summary. This information would typically be found in the full 510(k) submission, not the summary.
- Data Provenance: This refers to bench testing. The testing was conducted by or on behalf of Zyno Medical, LLC in Natick, MA, USA. It is prospective bench testing based on design specifications to confirm performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like an I.V. administration set, "ground truth" isn't established by human experts in the same way it would be for an AI diagnostic. Ground truth is derived from engineering specifications, industry standards, and measurable physical properties (e.g., flow rates, leak integrity, material strength).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As there are no human interpretive "readings" involved, there's no adjudication method in play for the test set. Performance is objectively measured against specifications.
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 physical medical device, not an AI or software-assisted diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its physical properties and function are tested independently of a human "loop" for its intended use (fluid administration).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's testing is based on engineering specifications, recognized industry standards, and performance characteristics of legally marketed predicate devices. For example, ground truth for sterility is a sterile state, ground truth for material properties is adherence to chemical/physical specifications, and ground truth for functional performance (e.g., integrity, flow) is meeting pre-defined acceptable ranges.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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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: (508) 650-2008 Ext.205 Fax: (508) 650-2006 Email: mei.zhang@zynomed.com

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.

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

510(k) Number: K120685

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.