(43 days)
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No
The provided text describes a simple drug transfer device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device description states its purpose is for transferring and mixing drugs between vials, which is a drug preparation function, not a direct therapeutic application to a patient.
No
This device is described as a "transfer device" for mixing drugs in two vials, which is a functional role for drug preparation, not for diagnosing medical conditions.
No
The intended use describes a "Transfer Device" for transferring and mixing drugs between two vials, which strongly suggests a physical hardware component is involved. There is no mention of software as the primary or sole component.
Based on the provided information, the Mix2vial Transfer Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "transferring and mixing drugs contained in two vials." This describes a process involving the preparation and administration of medications, which is a therapeutic or procedural function, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
- No Mention of IVD-Related Components: The description doesn't mention any components typically associated with IVDs, such as reagents, assays, or analytical capabilities.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Mix2vial Transfer Device's function falls outside of this definition.
N/A
Intended Use / Indications for Use
The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.
Product codes
LHI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird in flight or a stylized human profile.
Public Health Service
JUL 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDIOP MEDICAL PROJECT LIMITED C/O Mr. Benny Arazy Mintzpe Aviv, Industrial Park 13 M.P Misgav 20187 ISRAEL
Re: K031861
Trade/Device Name: Mix2vial Transfer Device Regulation Number: 880. 5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 12, 2003 Received: June 16, 2003
Dear Mr. Arazy
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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
Page 2 - Mr. Arazy
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Patricio Caceres ffa
Susan Runner, DDS, MA Interim 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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IX. C: INDICATION FOR USE STATEMENT
The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.
Freddy Zinger f.z
General Manager (Name & Signature)
13|6|2003
Date
(Premarket Notification [510(k)] Number)
Paloria Crescenti
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental D
510(k) Number: K031861