VITALMIX PLUS EMPTY I.V. CONTAINER by PACIFIC DEVICE, INC.

The provided text is a 510(k) clearance letter from the FDA for a device called "Vitalmix Plus I.V. Containers and Transfer Set Components." This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

Confirming that the device is substantially equivalent to a legally marketed predicate device.
Stating that the manufacturer can market the device subject to general controls and existing regulations.
Providing contact information for regulatory inquiries.
Listing the intended use of the device: "The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, standalone performance, or training set details) from this document. This typically requires reviewing a more detailed submission or study report, which is not part of this FDA clearance letter.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald R. Young ·Director of Quality Assurance Pacific Device, Incorporated 8572 Spectrum Lane Sandiego, California 92121

NOV - 5 1997

Re : K972464 Vitalmix Plus I.V. Containers and Transfer Trade Name: Set Components Requlatory Class: II Product Code: KPE August 13, 1997 Dated: August 21, 1997 Received:

Dear Mr. Young:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general 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. ਉ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 - Mr. Young

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,

Clus-L/fr
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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510(k) Number (if known): K972464

Device Name: VITALMIX PLUS EMPTY I.V. CONTAINER

Indications For Use:

The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

talucia Crucenti
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K972464

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 880.5025 I.V. container.

(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).