MANIFOLD

K972654 · Medical Specialties Intl., Inc. · DTL · Oct 8, 1997 · Cardiovascular

Device Facts

• Record ID: K972654
• Device Name: MANIFOLD
• Applicant: Medical Specialties Intl., Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The intended use is to direct the flow of fluids, via the stopcock arrangement, into tubing, catheters and collection systems during a heart catheterization procedure.

Device Story

Manifold device used during heart catheterization procedures; functions as fluid flow control system. Device utilizes stopcock arrangement to direct fluids into tubing, catheters, and collection systems. Operated by clinicians in clinical settings. Facilitates fluid management during cardiac interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manifold assembly with stopcock arrangement for fluid flow control. Mechanical device; no electronic or software components.

Indications for Use

Indicated for use during heart catheterization procedures to direct fluid flow into tubing, catheters, and collection systems. Prescription use only.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle's head.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Larry G. Junker Vice President, General Manager Medical Specialties International, Inc. 615 Jasmine Avenue, North Tarpon Springs, Florida 34689

OCT - 8 1997

Re : K972654 Manifold Regulatory Class: II (Two) Product Code: DTL Dated: July 11, 1997 Received: July 15, 1997

Dear Mr. Larry G. Junker:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Larry G. Junker

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 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 at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Callahan, Ph.D. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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MON 15:30 FAX [phone]/©6/97-

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K972654 510(k) Number (if known):

Manifold Device Name:

Indications For Use:

The intended use is to direct the flow of fluids, via the stopcock arrangement, into tubing, catheters and collection systems during a heart catheterization procedure.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Glena Schucke)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109) QR

Over-The-Counter Use___

(Optional Format 1-2-96)