SMART SET

K972663 · Top Spins, Inc. · FPA · Sep 2, 1997 · General Hospital

Device Facts

• Record ID: K972663
• Device Name: SMART SET
• Applicant: Top Spins, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.

Device Story

Smart Set is a fluid administration system designed for use during MRI or MRA examinations. It facilitates the delivery of fluids into a patient's vascular system within the MRI environment. The device is intended for prescription use by healthcare professionals. By enabling fluid administration during imaging, it supports clinical procedures requiring contrast or other fluid delivery while the patient is undergoing magnetic resonance scanning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid administration system designed for compatibility with MRI/MRA environments. Specific materials, dimensions, and energy sources are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring fluid administration into the vascular system during MRI or MRA examinations.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 1997

Dr. Martin R. Prince Chairman Topspins, Incorporated . 1642 Gloucester ----Plymouth, Michigan 48170

Re : K972663 Trade Name: Smart Set Regulatory Class: II Product Code: FPA Dated: July 2, 1997 Received: July 8, 1997

Dear Dr. Prince:

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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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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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 ation 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 obeation from the number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Kist Walbert

Directbr 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): | K972663 |
|---------------------------|----------|
| Device Name: | SMARTSET |
| Indications For Use: | |

This product is intended to be used to assist in : the administration of fluids into a patient's vascular system during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) examination.

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Prescription Use
(Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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Division of Dental, Infection of Devision Division
and General Hospital D 510(k) Number