IMPEDIMED - BODY COMPOSITION ANALYSIS

K050395 · Impedimed Pty , Ltd. · MNW · Jul 13, 2005 · Cardiovascular

Device Facts

• Record ID: K050395
• Device Name: IMPEDIMED - BODY COMPOSITION ANALYSIS
• Applicant: Impedimed Pty , Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water (TBW), intracellular water (ICW), and extracellular water (ECW).

Device Story

Imp DF50 is a single-frequency bioelectrical impedance analyzer (BIA). Device passes small constant current (200 uA peak-to-peak at 50 kHz) through body via tetra-polar electrode configuration. Measures current, voltage, and phase angle to calculate impedance, resistance, and reactance. Software uses peer-reviewed prediction equations to correlate impedance with total body water (TBW); derives lean body mass from TBW; calculates fat mass by subtracting lean mass from total body weight. Used in home or clinical settings by patients or practitioners. Output includes body composition parameters (FFM, FM, TBW, ICW, ECW, BMI, BMR), user demographics, and measurement metadata. Provides quantitative body composition data to assist in health assessment.

Clinical Evidence

No clinical data provided. Device relies on established prediction equations from peer-reviewed literature to convert impedance measurements into body composition estimates.

Technological Characteristics

Battery-powered, handheld, single-frequency (50 kHz) bioelectrical impedance analyzer. Operates in tetra-polar mode. Measures current, voltage, and phase angle. Includes calibration circuit accessory for quality assurance. Software performs mathematical conversions using established prediction equations.

Indications for Use

Indicated for body composition assessment in healthy children (9-16 years) and general/obese adult subjects. Used in home or clinical environments to estimate and display FFM, FM, TBW, ICW, ECW, BMI, and BMR.

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.

Predicate Devices

• RJL Systems, Inc BIOELECTRICAL IMPEDANCE ANALYZER #101 (K830292)
• BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT (K994242)

Submission Summary (Full Text)

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K050395
PAGE 1 OF 4

ImpediMed

JUL 1 3 2005

# ImpediMed Limited

Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia

ABN 65 089 705 144

Telephone: [phone] Facsimile: [phone]

Email: [e-mail]

# 510 (k) Summary ImpediMed Imp DF50 Body Composition Analysis

#### APPLICANT INFORMATION

Company Name and address:

Contact Name and numbers:

ImpediMed Limited 4B/2404, Logan Road Eight Mile Plains Brisbane, QLD - 4113_

> Mr Neville Bertwistle General Manager Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date of summary prepared:

Dec 24, 2004

#### DEVICE IDENTIFICATION

Trade/Proprietary name:

Classification name:

Regulation number/CFR section:

Product code:

Classification panel:

Device class:

Imp DF50 Body Composition Analysis

Impedance Plethysmograph

21 CFR 870.2770

DSB MN W

Cardiovascular

Class II

Letterhead Summary.doc

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# ImpediMed Limited

Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia

ABN 65 089 705 144

Telephone: [phone] Facsimile: [phone]

Email: [e-mail]

1.

| Company: | RJL Systems, Inc |
|--------------|------------------------------------------|
| Device name: | BIOELECTRICAL IMPEDANCE ANALYZER<br>#101 |

510 (K) number:

Product code:

K 830292

DSB

- 2
.

| Company | BODYSTAT LTD |
|-----------------|------------------------------------------------------|
| Device name: | BODYSTAT 1500MDD BODY COMPOSITION<br>MONITORING UNIT |
| 510 (K) number: | K 994242 |
| Product code: | MNW |

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ABN 65 089 705 144

ImpediMed Limited

Garden City Office Park

Eight Mile Plains QLD 4113

Building 4B

PO Box 4612

Telephone: [phone] Facsimile: [phone]

Email: [e-mail]

# Australia

## INTENDED USE / INDICATIONS FOR USE

IN ENDED USE / INDIOATIONS / Office / Sturements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water (TBW), intracellular water (ICW), and extracellular water (ECW).

#### DEVICE DESCRIPTION

DEVICE DESCRIP HON
The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water.

## TECHNOLOGICAL CHARECTERISTICS

The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage

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Image /page/3/Picture/0 description: The image shows the logo for ImpediMed. The logo is in black and white and features the company name in a stylized font. Above the logo, there is some handwritten text that reads '2050395' and 'AGE 4 OF 4'. The logo is surrounded by a series of curved lines that resemble sound waves.

ABN 65 089 705 144

# ImpediMed Limited

Telephone: [phone] Facsimile: [phone]

Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia

Email: [e-mail]

drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes.

Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three wavy lines representing the staff and a simplified head at the top.

JUL 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neville Bertwistle VP Operations ImpediMed Limited Building 4B, Garden City Office Park P.O. Box 4612 Eight Mile Plains QLD 4113 AUSTRALIA

Re: K050395

K030575
Trade/Device Name: Imp DF50 and Body Composition Analysis software Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: June 24, 2005 Received: June 24, 2005

Dear Mr. Bertwistle:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained institution workstad in interests a referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regary manated provice Amendments or to commerce prior to May 28, 1970, the chacultions of the Federal Food. Drug, 1994, Drug, devices that have been reclassified in accessed to the device, subject to the general controls and Cosment Act (Act). Tou may, metere, maille to determine that the medical devices you
provisions of the Act. However, you are responsible to determine that the a provisions of the Act. Trowever, you are respensioner with equivalent under the results reast use as components in the Kir have enner beth active act), or were legally on the market prior to
r were notification process (Section 510(k) of the act), or were legally of t premarket fromicallon process (Section 3 ro(s) of the Medical Device Amendments. Please not: If your May 28, 1970, the enacinent une of the Medical Britished) and further process (e.g., sterilize)
purchase your device components in bulk (i.e., unfinished) and further The spe purchase your device components in ounk (f.o., annualing these components in your like in a f days of you must submit a new 516(x) before mouthing ans for annual registration, listing of devices, controls provisions of the Fet meridate rigated ing and prohibitions against misbranding and : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classificu (\$cc above) into entine regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affective if may be subject to additional controls. Extroing might on 898. In addition, FDA may found in the Code of Peacharting your device in the Federal Register.

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Page 2 -- Mr. Neville Bertwistle

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ Issualice of a substance orgains with other requirements of the Act
that FDA has made a determination that your devices with of earning - You mus that FDA has made a delerimiation that your acceded by other federal agencies. "You must or any Federal statutes and regulations and including, but not limited to: registration (21 CFR Part
comply with all the Act's requirements, including, and manufacturing pra comply with all the Act s requirements, mending (21 CFR Part 801); good manufacturing practice
807); listing (21 CFR Part 807), labeling (21 CFR Part 801); and if 807); listing (21 CFR Fall 807); laboling (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set lorth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)
1978 (the subserver and allers of a line of a legsinglemes of your device to a This letter will allow you to begin matical equivalence of your device of your device to a legally
premarket notification. The FDA finding of substance and this permits vour premarket notification. The PDA Indusg of Jacks, for your device and thus, permits your device on the Jabeli marketed proceed to the market. If you desire specific advice for your device on the labeling
device to proceed to the market. If you desire specific advice for your device n device to proceed to the market. Tryou desire speces as (240) 276-011 15. Also, please note the regulation, please contact the Office of Complaner as (are in 10 CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notifical under the Ast from th regulation entitled, "Misolanding of responsibilities under the Act from the Act from the You may obtain other general information on your respearer Assistance at its toll free number Division of Smanr [phone], or at its Internet address (000) 050 = 6da.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Swogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

# 510(k) Number (if known): K050395

Device Name: Imp DF50 and Body Composition Analysis software

#### Indications For Use:

A body composition analyzer and a software package that will estimate display and store the following body composition parameters:

Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number.

This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _YES_ (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off |
|-------------------|
|-------------------|

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K050395 |
|---------------|---------|
|---------------|---------|

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