(29 days)
No
The device description and intended use clearly describe a mechanical device for reconstituting drugs, with no mention of software, data processing, or AI/ML terms.
No
The device is described as an accessory for reconstituting and transferring drugs, not for therapeutic use on a patient.
No
The device is described as a "reconstitution device" intended for mixing drug vials with IV solution containers, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical device used for connecting drug vials to IV solution containers, mentioning materials and functional performance testing.
Based on the provided text, the 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 the purpose of reconstituting and administering a drug to a patient. This is a process related to drug preparation and administration, not diagnostic testing.
- Device Description: The device is described as an accessory for reconstituting and transferring drugs into solution containers. This aligns with drug delivery and preparation, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. The Vial-Mate Reconstitution Device does not fit this description.
N/A
Intended Use / Indications for Use
The Vial-Mate Reconstitution Device is intended 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.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Vial-Mate Reconstitution Device is an accessory intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. This product is similar to the currently marketed Baxter ReConPlus™ Reconstitution Device, cleared under K910793 on March 21, 1991. Like the ReConPlus™ Reconstitution Device, it provides a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without reconstituting and mixing the vial contents with the diluent until immediately before administration of the drug to the patient.
There is one solution contact material in the proposed Vial-Mate Reconstitution Device which is new to Baxter. It is an elastomeric material which is used in the septum of the device. The other solution materials used in the proposed device were previously tested and used in other Baxter devices for similar IV solution administration applications.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The biological and chemical reactivity of the new solution contact material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed Vial-Mate have been generated and submitted. The data indicate that the proposed reconstitution device meets or exceeds all functional requirements.
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.
ReconPlus™ Reconstitution Device
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
510(k) Premarket Notification Vial-Mate Reconstitution Device
510(k) SUMMARY
Vial-Mate Reconstitution Device
Submitted by:
OCT 2 4 1997
Tamima Itani, Ph.D. Associate Director. Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
September 24, 1997
Proposed Device:
Vial-Mate Reconstitution Device
Predicate Devices: ReconPlus™ Reconstitution Device
Proposed Device Description:
The Vial-Mate Reconstitution Device is an accessory intended for use by the pharmacist or health practitioner in the reconstitution and transfer of drugs into Baxter solution containers. This product is similar to the currently marketed Baxter ReConPlus™ Reconstitution Device, cleared under K910793 on March 21, 1991. Like the ReConPlus™ Reconstitution Device, it provides a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without reconstituting and mixing the vial contents with the diluent until immediately before administration of the drug to the patient.
There is one solution contact material in the proposed Vial-Mate Reconstitution Device which is new to Baxter. It is an elastomeric material which is used in the septum of the device. The other solution materials used in the proposed device were previously tested and used in other Baxter devices for similar IV solution administration applications.
Statement of Intended Use:
The proposed Vial-Mate Reconstitution Device has the same intended use as previously cleared devices of its type. The Vial-Mate Reconstitution Device is intended 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 reconstituting and mixing the vial contents with the diluent until immediately before administration of the drug to the patient.
s:\510k\vialmate\vialmate
1
Summary of Technological Characteristics of New Device to Predicate Devices
The existing ReConPlus™ Reconstitution Device uses a one step motion for reconstitution where a frangible plastic cannula (breakaway seal) is broken. The proposed Vial-Mate Reconstitution Device uses a two-step rotating action for drug reconstitution. In addition, while the ReConPlus™ device penetrates the drug vial stopper when attached, the Vial-Mate device can be pre-attached without penetration into the stopper until ready for activation and use through the two-step rotating action.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
The biological and chemical reactivity of the new solution contact material have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed Vial-Mate have been generated and submitted. The data indicate that the proposed reconstitution device meets or exceeds all functional requirements.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Tamima Itani, Ph.D. Associate Director, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073
OCT 2 4 1997
Re: K973654 Vial-Mate Reconstitution Device (2B8071) Trade Name: Requlatory Class: II Product Code: LHI September 24, 1997 Dated: Received: September 25, 1997
Dear Dr. Itani:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Dr. Itani
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
.Enclosure
4
Indication for Use
510(k) Number: Not Available
Vial-Mate Reconstitution Device Device Name:
Indication for Use:
The proposed Vial-Mate Reconstitution Device has the same intended use as previously cleared devices of its type. The Vial-Mate Reconstitution Device is intended 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.
Patrica Crescenti
(Division Sign-On
"sion of Dental, In Pheral Hospita ilia Number
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
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