BODYSTAT

K971554 · Bodystat , Ltd. · MNW · Nov 26, 1997 · Cardiovascular

Device Facts

• Record ID: K971554
• Device Name: BODYSTAT
• Applicant: Bodystat , Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND

Device Story

BodyStat MultiScan 5000 is a bioelectrical impedance device used to estimate body water compartments. It measures electrical impedance of the body; uses these measurements to calculate extra-cellular, intra-cellular, and total body water. Operated by healthcare professionals in clinical settings. Output provides quantitative estimates of fluid compartments to assist in clinical assessment of hydration status and body composition.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

Bioelectrical impedance analyzer; measures electrical impedance to estimate body water compartments. Class II device (21 CFR 870.2770).

Indications for Use

Indicated for the measurement of estimated extra-cellular water, estimated intra-cellular water, and estimated total body water in patients.

Regulatory Classification

Identification

An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

Mr. I. J. Meeuwsen Managing Director BodyStat Limited P.O. Box 50 Douglas Isle of Man IM99 IDQ British Isles

Re:

K971554 BodyStat® MultiScan 5000 Dated: September 22, 1997 Received: September 26, 1997 Regulatory Class: II 21 CFR §870.2770/Product Code: 74 MNW

Dear Mr.Meeuwsen:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 question 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 vours.

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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210(k) Number (if known):
K971554
Device Name: BODYSTATⓇ MULTI SCAN 5000
Indications For Use:
MEASUREMENT
OF
ESTIMATED EXTRA-CELLULAR WATER;
ESTIMATED INTRA-CELLULAR WATER.
ESTIMATED TOTAL BODY WATER; AND

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

UE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ryber R. Sather/
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971134

iption Use
Per 21 CFR 801.109)

OR

Over-The-Counter Use L