IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7

K052319 · Impedimed Pty , Ltd. · MNW · Apr 4, 2006 · Cardiovascular

Device Facts

• Record ID: K052319
• Device Name: IMPEDIMED - BODY COMPOSITION ANALYZER, MODEL IMP SFB7
• Applicant: Impedimed Pty , Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Apr 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Indications for Use

Imp SFB7 – A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, age and sex. Biolmp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fatfree Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above. These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.

Device Story

Imp SFB7 is a portable, battery-powered, multiple-frequency bioelectrical impedance analyzer (MFBIA). It uses tetra-polar (4-lead) electrodes to pass a constant 200 uA RMS current through the body across 256 frequencies (4 kHz to 1000 kHz). The device measures voltage, current, and phase angle to calculate impedance, resistance, and reactance. Data is processed using Cole-Cole plots and Hanai modeling to estimate total body water (TBW), extracellular fluid (ECF), intracellular fluid (ICF), fat-free mass (FFM), and fat mass (FM). Used in home or clinical environments by patients or practitioners. Data can be stored on-device or transferred via Ethernet to a PC running BioImp software for analysis, reporting, and visualization of body composition parameters. Provides objective body composition metrics to assist in health monitoring.

Clinical Evidence

No clinical data provided; bench testing only. Device performance validated through technical measurements of impedance, resistance, and reactance using a test cell and mathematical modeling (Cole-Cole/Hanai) to derive body composition parameters.

Technological Characteristics

Rechargeable battery-powered, portable, tetra-polar (4-lead) bioelectrical impedance analyzer. Frequency range: 4 kHz to 1000 kHz. Constant current source: 200 uA RMS. Connectivity: Ethernet for PC data transfer. Calibration via external test cell. Software utilizes Cole-Cole plots and Hanai modeling for fluid estimation.

Indications for Use

Indicated for healthy patients desiring body composition estimation in home or clinical settings.

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

• Bio-Impedance Analyzer (K904109)

Submission Summary (Full Text)

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4 2006 APR

# 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 SFB7 Body Composition Analyzer

#### APPLICANT INFORMATION

ImpediMed Limited Company Name and address: 4B/2404, Logan Road Eight Mile Plains Brisbane, QLD - 4113 Mr Neville Bertwistle Contact Name and numbers: VP Operations Phone: [phone] Fax: [phone] E-mail: [e-mail] Date of summary prepared: January 27, 2006 DEVICE IDENTIFICATION Trade/Proprietary name: Imp SFB7 Body Composition Analyzer Classification name: Impedance Plethysmograph Regulation number/CFR section: 21 CFR 870.2770 DSB Product code:

Classification panel: Cardiovascular Device class: Class II

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# lmpediMed Limited

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

Telephone: [phone] Facsimile: [phone]

BN 65 089 705 144

#### Email: [e-mail]

#### PREDICATED DEVICE

| Company: | Xitron Technologies, Inc |
|-----------------------|--------------------------|
| Device name: | Bio-Impedance Analyzer |
| 510 (K) number: | K 904109 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |
| Device class: | Class II |

#### INDICATIONS FOR USE

The indications for use of this device are healthy patients, who wish to have their body composition estimated, in the home and clinical environment.

#### DEVICE DESCRIPTION

The Imp SFB7 is a multiple frequency bioelectrical impedance analyzer. 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 (TBW), intracellular fluid (ICF), and extracellular fluid (ECF).

The device has 2 modes of operation

- 1. MFBIA Mode This is a Multiple Frequency Bioelectrical Impedance mode. Impedance readings are taken by applying all 256 frequencies sequentially in a very short time in the range of 4 kHz to 1000 kHz.

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# ImpediMed Limited

ABN 65 089 705 144

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

Telephone: [phone] Facsimile: [phone]€

- Email: [e-mail] 2. Selected Frequencies Mode - Any three user selected frequencies between 4 kHz to 1000 kHz and five pre set (5, 10, 50, 100, 500 kHz) frequencies are used to measure impedance of a subject.
In MFBIA and Selected Frequencies mode, selection of single, continuous measurements or measurements at a selected interval of time is available. Over 1000 records can be stored and analyzed on Imp SFB7 or can be downloaded to a PC or laptop loaded with an optional Biolmp Body Composition Analysis software via an Ethernet connection.

## TECHNOLOGICAL CHARECTERISTICS

The ImpediMed Imp SFB7 Body Composition Analyzer is a rechargeable battery powered, accurate, portable, multiple frequency bioelectrical impedance analysis instrument operating in tetra-polar (4 leads - 2 current source and 2 voltage sensing) mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance.

Bioimpedance analyzers calculate complex impedance or opposition to the flow of an electric current by the body. The applied electrical current travels through the extra cellular fluid of the body and through the lean muscle-organs via the intracellular fluid. Impedance is low in lean tissue, extra cellular fluid and intracellular fluid, where electrolytes are primarily contained, but high in fat tissue because fat is primarily an insulator containing very few conducting elements. Therefore impedance can be related to the total water volume of the body because the impedance is a direct measure of both intracellular and extra cellular fluid. In the Imp SFB7 a small constant current, typically 200 uA RMS, with in the frequency range of 4 kHz to 1000 kHz sequentially, is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltage-sensing electrodes is used to calculate the

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# ImpediMed Limited

ABN 65 089 705 144

Telephone: [phone] Building 4B Facsimile: [phone] Garden City Office Park PQ Box 4612 Eight Mile Plains QLD 4113 Email: [e-mail] Australia complex impedance value. The calibration of the device may be checked with the aid of the supplied test cell.

### MFBIA Mode:

Imp SFB7 in MFBIA mode works by calculating the complex impedance, applying all 256 frequencies (4 kHz to 1000 kHz) sequentially in a very short time to reduce the time to complete the test and the inconvenience to the subject.

Impedance calculations made over a range of frequencies (4 kHz-1000 kHz) are used to create a Cole-Cole plot. Hanai modeling, which treats body as a concentrated suspension of cells in a conductive medium is used to estimate extracellular fluid (ECF) at low frequency and total body water (TBW) at high frequency. Intra cellular fluid (ICF) is then estimated by the difference between TBW and ECF. Fat free mass (FFM) is estimated from measured TBW assuming the hydration constant of a person as 73.2%. Fat mass (FM) is estimated from the difference between body mass and fat free mass.

## Selected Frequencies Mode:

Imp SFB7 in Selected Frequencies mode has 5 pre set frequencies (5, 10, 50, 100, 500 kHz) and allows user to enter 3 frequencies of their choice in the range of 4 kHz to 1000 kHz to measure impedance of a subject. It measures, displays, and stores the impedance readings for these selected frequencies.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2006 APR

Mr. Neville Bertwistle VP Operations ImpediMed Pty Limited Building 4B/2404 Logan Road, Eight Mile Plains Brisbane, Queensland AUSTRALIA 4113

Re: K052319

Trade/Device Name: ImpediMed Imp SFB7 Body Composition Analyzer & BioImp Body Composition Analyzer PC Software Regulation Number: 21 CFR 8870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: undated Received: March 13, 2006

Dear Mr. Bertwistle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally 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 general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unlinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification'(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh.dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

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

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# Indications for Use

## 510(k) Number (if known): K052319

Device Name(s): Imp SFB7 Biolmp Body Composition Analyzer PC Software

## Indications for Use:

(1) Imp SFB7 – A bioelectrical impedance analyzer/monitor that is intended to estimate the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), and Body Mass Index (BMI). The device measures current, voltage and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device/software will also display the Cole-Cole plot, resistance vs. frequency plot, reactance vs. frequency plot, subject height, age and sex.

(2) Biolmp Body Composition Analyzer PC Software: A PC software package that is intended to be used only with the ImpediMed Imp SFB7 Analyzer for uploading the MFBIA mode data on to the PC from Imp SFB7 via an Ethernet port for storing, processing and analysing of MFBIA bioimpedance measurements. This displays Cole-Cole plot, body composition parameters: Fatfree Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Fluid (ICF), Extra cellular Fluid (ECF), Body Mass Index (BMI), and subject height, weight, age, sex, time, and date of measurement, Practitioner's name and Device serial number, and bioelectrical parameters resistance (R), reactance (Xc), and impedance (Z) and phase angle (Phi) at different frequencies (Between 4 kHz to 1000 kHz). The software can be used to generate patient body composition report displaying all the parameters stated above.

These devices are intended to be used only on healthy patients, who wish to have their body composition estimated in the home or clinical environment.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(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)

Nancy C brogdon

vision of Reproductive. Abdomin adiological Devices 0(k) Number

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