BIOMEDICAL HORIZONS INC. COMPRESSION PUMP, MODEL 651 by BIOMEDICAL HORIZONS, INC.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a compression pump and does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device's performance. It primarily focuses on the substantial equivalence determination for marketing the device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.

5 1998 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William J. Donahue President Biomedical Horizons, Inc. P.O. Box 889 1331 Horton Road Jackson, MI 49204

Re : K971892 Biomedical Horizons Compression Pump, Model 651 Regulatory Class: II Product Code: JOW Dated: May 19, 1998 Received: May 20, 1998

Dear Mr. Donahue:

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 leqally 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). You may, therefore, market the device, subject to the qeneral 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 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 might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

Page 2 - Mr. William J. Donahue

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 (301) 594-4648. 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" (21CFR 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/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

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

Enclosure

{2}------------------------------------------------

Page 1 of 1

K971892 510(k) Number (il known):

Compression Pump, Model 651 Device Name: Biomedical Horizons, Inc.

Indications For Use:

Common Indications

Peripheral edema Lymphedema (Postmastectomy, congenital) Venous Stasis Ulcers Stump reduction Hand edema

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bese E. Kemper Q

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

Kazi892 510(k) Number_

Prescription Use_سي_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).