(29 days)
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.
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.
This document describes a 510(k) Premarket Notification for the Vial-Mate Reconstitution Device. As such, it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a complex algorithm or AI system.
Here's an analysis based on the provided text, addressing your points where applicable, and noting where the information is not provided because it pertains to a different type of device or regulatory submission:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a quantitative acceptance criteria table with reported device performance in the manner you'd expect for an AI/algorithm-based device. Instead, it refers to overall functional requirements and regulatory standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | The new elastomeric material (solution contact) was assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. Found to be "acceptable for its intended use." |
| Functional Performance | Data indicate that the proposed reconstitution device "meets or exceeds all functional requirements." (Specific metrics are not detailed in this summary). |
| Substantial Equivalence | Device found substantially equivalent to the predicate device (ReConPlus™ Reconstitution Device) in intended use and overall safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the 510(k) summary. For a medical device like a reconstitution device, testing typically involves bench testing, sterility testing, and biocompatibility assessments, rather than clinical studies with "test sets" in the AI sense. The number of samples for these tests would be determined by relevant standards and protocols, but are not disclosed here. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This concept of "ground truth" established by experts for a test set is not applicable to a physical medical device like a reconstitution device. Ground truth, in the context of AI/ML, refers to a label or diagnosis that an algorithm attempts to predict, which would then be compared to expert consensus or pathology. The evaluation of this device is based on its physical properties, material safety, and functional operation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device and regulatory submission. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., medical images) to resolve discrepancies among multiple expert opinions, which isn't relevant here.
5. 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. MRMC studies are designed to compare the diagnostic accuracy of human readers with and without AI assistance, which is irrelevant for a passive mechanical device like the Vial-Mate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Vial-Mate is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for a mechanical device relates to its adherence to engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional performance requirements (e.g., leak-proof, proper drug transfer).
8. The sample size for the training set
Not applicable. The concept of a "training set" applies to machine learning algorithms, not to the development and testing of a physical medical device like the Vial-Mate.
9. How the ground truth for the training set was established
Not applicable for the same reasons as points 7 and 8.
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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.
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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.
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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
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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
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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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§ 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.