(65 days)
No
The device is a mechanical reconstitution device and the 510(k) is for a labeling update. There is no mention of AI or ML in the description or performance studies.
No.
The device is described as a reconstitution device for preparing drugs for administration, not for directly treating a condition or disease.
No
The device is described as a reconstitution device used to connect a drug vial to an IV solution container for mixing, not for diagnosis.
No
The device description and performance studies clearly indicate a physical device used for reconstituting and transferring drugs, involving components like a cannula, septum, and vial gripper. The submission is for a labeling modification, not a software change.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a drug vial to an IV solution container for reconstitution and administration to a patient. This is a process related to drug delivery and preparation, not diagnostic testing performed in vitro (outside the body).
- Device Description: The description focuses on the physical connection and transfer of substances between a drug vial and an IV container. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (markers, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
The device is clearly intended for the preparation and administration of medication, which falls under the category of medical devices used in patient care, but not specifically for in vitro diagnosis.
N/A
Intended Use / Indications for Use
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the patient.
Product codes
LHI
Device Description
The VIAL-MATE Reconstitution Device is intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. The VIAL MATE Reconstitution Device provides a means of connecting a standard 20 mm single dose powdered drug vial to an I.V. solution container without mixing the vial contents with the diluents until immediately before reconstitution and administration of the drug to the patient. This device has been previously cleared under 510(k) premarket notification K973654 (cleared on October 24, 1997).
The basis for this premarket notification is a modification to the labeling of the product. This modification will update the label to clarify the description of the product and user instructions. Additionally, Baxter will update the product labeling to comply with Baxter's labeling standards and add the indications for use statement that was previously cleared for this device under 510(k) premarket notification K973654. The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pharmacist or health practitioner
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
The following bench tests were conducted to evaluate the functional performance of the VIAL-MATE Reconstitution Device:
- Seal flange to bag port adapter integrity
- Cannula to medication port integrity
- Septum to cannula hub integrity ●
- Septum to drug vial stopper integrity
- Port adapter removal force from the VIAFLEX container medication port
- Tamper evident seal integrity
- Vial gripper removal force from drug vial
- Flow through device to and from drug vial and VIAFLEX container
- Residual volume: Device vial and VIAFLEX container
All tests met the acceptance criteria.
Biocompatibility assessment of the VIAL-MATE Reconstitution Device has been conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path, and Blue Book Memorandum G95-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as recommended in the IV administration sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19,2014
Baxter Healthcare Corporation Mr. Gary Chumbimune Manager 32650 N. Wilson Road Round Lake, IL 60073
Re: K142600
Trade/Device Name: VIAL-MATE Reconstitution Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 22, 2014 Received: October 23, 2014
Dear Mr. Chumbimune:
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.
1
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K142600
Device Name VIAL-MATE Reconstitution Device
Indications for Use (Describe)
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the patient.
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)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 5 – 510(k) Summary
September 12, 2014
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Gary Chumbimune Manager, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270-3312 Fax: (224) 270-4119
DEVICE NAME:
Trade Name: VIAL-MATE Reconstitution Device
Table 1. VIAL-MATE Reconstitution Product Code
| Code Number | Name |
|---|---|
| 2B8071 | VIAL-MATE Adaptor |
Common name:
VIAL-MATE Reconstitution Device
Classification name:
Intravascular administration set (21 CFR 880.5440, Product Code LHI)
5
PREDICATE DEVICE:
Table 2. Predicate 510(k)s
| Device | Company | Predicate 510(k) | Clearance date |
|---|---|---|---|
| VIAL-MATE Reconstitution Device | Baxter Healthcare | K973654 | October 24, 1997 |
DEVICE DESCRIPTION:
The VIAL-MATE Reconstitution Device is intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. The VIAL MATE Reconstitution Device provides a means of connecting a standard 20 mm single dose powdered drug vial to an I.V. solution container without mixing the vial contents with the diluents until immediately before reconstitution and administration of the drug to the patient. This device has been previously cleared under 510(k) premarket notification K973654 (cleared on October 24, 1997).
The basis for this premarket notification is a modification to the labeling of the product. This modification will update the label to clarify the description of the product and user instructions. Additionally, Baxter will update the product labeling to comply with Baxter's labeling standards and add the indications for use statement that was previously cleared for this device under 510(k) premarket notification K973654. The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update.
STATEMENT OF INTENDED USE:
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the reconstituted drug to the patient.
6
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed VIAL-MATE Reconstitution Device is equivalent to Baxter's currently legally marketed VIAL-MATE Reconstitution Device cleared on October 24, 1997 (K973654). The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update. The intended use, the basic design, function and the materials for the proposed device are equivalent to the predicate device.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria, and support that the VIAL-MATE Reconstitution Device is appropriately designed for its intended use.
Performance Data:
The following bench tests were conducted to evaluate the functional performance of the VIAL-MATE Reconstitution Device:
- Seal flange to bag port adapter integrity
- Cannula to medication port integrity
- Septum to cannula hub integrity ●
- Septum to drug vial stopper integrity
- . Port adapter removal force from the VIAFLEX container medication port
- Tamper evident seal integrity
- . Vial gripper removal force from drug vial
- Flow through device to and from drug vial and VIAFLEX container
- . Residual volume: Device vial and VIAFLEX container
All tests met the acceptance criteria.
7
Biocompatibility:
No new materials of construction are being introduced into this device as part of this Special 510(k) premarket submission. Biocompatibility assessment of the VIAL-MATE Reconstitution Device has been conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path, and Blue Book Memorandum G95-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", as recommended in the IV administration sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]".
CONCLUSION:
The data from the non-clinical tests demonstrate that the proposed device is as safe and effective, and perform as well as the predicate device.