(135 days)
Not Found
No
The summary describes a standard administration set for fluid delivery and mentions only manufacturing and sterilization changes, with no indication of AI/ML technology.
No.
The device administers fluids but does not directly treat a disease or condition; it is a delivery mechanism.
No
Explanation: The device is described as an "Administration Set" used to administer fluids, not to diagnose a condition. The key function is fluid delivery, not information gathering for diagnosis.
No
The device description and performance studies clearly indicate this is a physical medical device (administration set) with hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids to a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description reinforces the administration of fluids into the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
Therefore, the Zyno Medical Administration Set is a medical device used for fluid delivery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
The intended use of the modified device is the same as the predicate device.
Zyno Medical Administration Set is a device used to administer to a patient's vascular system through a neede or a catheter inserted into a vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
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.
Zyno Medical LLC is submitting this Special 510(k): Zyno Medical Administration Sets to request a modification to our currently marketed administration sets. The major modifications are: 1) extended selection of interchangeable components manufactured by additional suppliers; 2) additional contract manufacturer for the device: 3) Gamma Irradiation as additional sterilization method. Verification and validation results support that the device is as safe and effective as the predicate device. We believe this application is eligible for the Special 510 (k) process since the same fundamental scientific technology and intended use as the predicate device. The principles of operation, intended use and the applications remain the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical Testing:
Zyno Medical performed extensive verification and validation testing with the Zyno Medical Administration Set with modifications listed in above section II. Testing was completed in accordance with Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] issued on July 11, 2008. In planning for bench testing to ensure proper functions and safety when used with the intended infusion pumps. Guidance for Industry and FDA Staff - Total Product Life Cycle: Jnfusion Pump - Premarket Notification [510(k)] Submissions, issued on April 23, 20 10 was used as a reference.
Summary of the nonclinical testing and evaluation performed. All results successfully met acceptance criteria:
- A. Biocompatibility testing
- B. Pyrogenicity testing
- C. Chemical testing
- Microbial ingress evaluation D.
- E. DEHP testing
- F. Sterilization testing
- G. Bench testing, including integration testing with Z-800 series infusion pumps, physical and mechanical testing
- H. Aging testing
Conclusion of Nonclinical Testing:
All nonclinical testing results successfully demonstrated that the Zyno Medical Administration Sets performed as intended. Conclusions drawn from the nonclinical testing is that the testing data demonstrated that the device is as safe, as effective, and performs as well as the legally marketed device cleared in K120685.
Clinical Study:
Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Zyno Medical Administration Sets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KI32841
JAN 2 3 2014
SPECIAL 510(K) SUMMARY
Submitted By:
Chaoyoung Lee, PhD President / CEO Zyno Medical. LLC 177 Pine Street Natick, MA 01760, USA Fax: 508-650-2006 Phone: 508-650-2008 x 103 Email: cylee@zynomed.com
Company Contact:
Mei Zhang, PhD Director of Engineering Zyno Medical. LLC 177 Pine Street Natick, MA 01760, USA Fax: 508-650-2006 Phone: 508-650-2008 x 205 Email: mei.zhang@zynomed.com
Date Originated: September 6, 2013 Establishment Registration No: 3006575795 Device Proprietary Name: Zyno Medical Administration Sets Device Common, Usual or Classification Name: Intravascular Administration Set Device Class: Class II Panel: 80 General Hospital Procodes: FPA 880.5440
Predicate Device
Zyno Medical Administration Sets (K120685, September 2012)
I. INTENDED USE
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.
The intended use of the modified device is the same as the predicate device.
Page 1 of 3
1
II. DEVICE DESCRIPTION AND COMPARISON
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.
Zyno Medical LLC is submitting this Special 510(k): Zyno Medical Administration Sets to request a modification to our currently marketed administration sets. The major modifications are: 1) extended selection of interchangeable components manufactured by additional suppliers; 2) additional contract manufacturer for the device: 3) Gamma Irradiation as additional sterilization method. Verification and validation results support that the device is as safe and effective as the predicate device. We believe this application is eligible for the Special 510 (k) process since the same fundamental scientific technology and intended use as the predicate device. The principles of operation, intended use and the applications remain the same.
III.SUMMARY OF NONCLINICAL TESTING
Zyno Medical performed extensive verification and validation testing with the Zyno Medical Administration Set with modifications listed in above section II. Testing was completed in accordance with Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)] issued on July 11, 2008. In planning for bench testing to ensure proper functions and safety when used with the intended infusion pumps. Guidance for Industry and FDA Staff - Total Product Life Cycle: Jnfusion Pump - Premarket Notification [510(k)] Submissions, issued on April 23, 20 10 was used as a reference.
Below is a summary of the nonclinical testing and evaluation performed. All results successfully met acceptance criteria:
- A. Biocompatibility testing
- B. Pyrogenicity testing
- C. Chemical testing
- Microbial ingress evaluation D.
- E. DEHP testing
- F. Sterilization testing
- G. Bench testing, including integration testing with Z-800 series infusion pumps, physical and mechanical testing
- H. Aging testing
Conclusion of Nonclinical Testing
All nonclinical testing results successfully demonstrated that the Zyno Medical Administration Sets performed as intended. Conclusions drawn from the nonclinical
2
testing is that the testing data demonstrated that the device is as safe, as effective, and performs as well as the legally marketed device cleared in K120685.
IV. CLINICAL STUDY
Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Zyno Medical Administration Sets.
V. STATEMENT OF EQUIVALENCE
The Zyno Medical Administration Sets are substantially equivalent to the predicate devices, based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the devices for their intended uses. The test results did not raise any safety or performance questions. and confirmed that the Zyno Medical Administration Sets are substantially equivalent to the predicate device.
The equivalency matrix (Table 1) compares the modified device with the predicate device (K120685).
Table 1: Equivalency Matrix
| Parameter | Zyno Administration Set
(Submitted in this package) | Zyno Administration Set
(K120685) |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device Type | Administration Set | Administration Set |
| Intended use | To administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. | To administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. |
| Tubing material | Approved Standard PVC | Approved Standard PVC |
| Single use? | Yes | Yes |
| Sterile | Yes | Yes |
| ISO 8536-
4:2010
compliant? | Yes | Yes |
| ISO 10993
compliant? | Yes | Yes |
| Operation mode | For use with Z-800 series of infusion pumps or gravity feed | For use with Z-800 series of infusion pump or gravity feed |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2014
Zyno Medical LLC C/O Mei Zhang Director of Engineering 177 Pine Street Natick, MA 01760
Re: K132841
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: December 20, 2013 Received: December 24, 2013
Dear Ms. Zhang:
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,
4
Page 2 - Ms. Zhang
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 you 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.
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for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132841
Device Name
Zyno Medical Administration Sets
Indications for Use (Describe)
Zyno Medical Administration Set is a device used to administer to a patient's vascular system through a neede or a catheter inserted into a vein.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2014.01.22 14:07:30 -05'00' Page 1 of 2 PSC Publishing Scriptions (301) 443-6740 EF FORM FDA 3881 (1/14)
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