(43 days)
The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Mix2vial Transfer Device". This document does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria in the computational or AI sense.
The letter explicitly states: "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..."
This means the FDA granted clearance based on the device being substantially equivalent to a predicate device, rather than requiring performance data from a specific study against predefined acceptance criteria for the new device. The FDA process for 510(k) clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot extract the requested information (acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) from the provided text, as it pertains to a different type of regulatory review that doesn't involve these elements in the context of AI/computational device performance validation.
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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.
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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
§ 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.