IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400

K080825 · Impedimed Pty , Ltd. · OBH · Oct 3, 2008 · Cardiovascular

Device Facts

• Record ID: K080825
• Device Name: IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
• Applicant: Impedimed Pty , Ltd.
• Product Code: OBH · Cardiovascular
• Decision Date: Oct 3, 2008
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Indications for Use

The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity. Lymphedema Analysis PC Software – an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400. processing and analyzing of bioimpedance measurements.

Device Story

L-Dex U400 is a multi-frequency bioelectrical impedance analyzer. It inputs current, voltage, and phase angle measurements via tetra-polar electrodes spanning the arms. A 200uA RMS constant current (4kHz to 1000kHz) is applied; voltage drop is measured to calculate impedance, resistance, and reactance. These values are processed using bioelectrical impedance basics and anthropometric parameters to estimate extra cellular fluid (ECF) ratios (L-Dex index). The device is used in clinical settings to assess unilateral lymphedema trends in women. Output is provided via an optional PC software package for data upload and analysis. Clinicians use these estimates as an alternative to circumferential measurements or water immersion methods to monitor fluid volume differences between arms, aiding in clinical assessment.

Clinical Evidence

No clinical data provided. The device relies on bioelectrical impedance basics, mathematical models, and anthropometric parameters derived from peer-reviewed published journal articles to convert measured impedance to ECF estimates.

Technological Characteristics

Battery-powered, multi-frequency bioelectrical impedance analyzer. Operates in tetra-polar mode. Frequency range: 4kHz to 1000kHz. Current: 200uA RMS. Measures current, voltage, phase angle; calculates impedance, resistance, and reactance. Includes optional PC software for data processing. Calibration circuit accessory provided for quality assurance.

Indications for Use

Indicated for women to aid in the clinical assessment of unilateral lymphedema of the arm by measuring extra cellular fluid volume differences between arms. Not intended to diagnose or predict lymphedema.

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

• Imp XCA Extra Cellular Fluid Analysis (K050415)
• Imp SFB7 Body Composition Analyzer (K052319)

Submission Summary (Full Text)

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KC80825
PAGE 1 OF 4
ImpediMed

# OCT - 3 2008

### ImpediMed Limited

ABN 65 089 705 144

Unit l 50 Parker Court Pinkenba Qld 4008

[phone] Tel: Freecall: | 800 638 477 Fax: [phone]

Email: [e-mail] www.impedimed.com

# 510 (k) Summary ImpediMed L-Dex U400 BIS Extra Cellular Fluid Analysis

## APPLICANT INFORMATION

| Company Name and address: | ImpediMed Limited<br>Unit1<br>50 Parker Court<br>Pinkenba, QLD - 4008 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and numbers: | Mr Phillip Auckland<br>Chief Operations Officer<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date of summary prepared: | August 26, 2008 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary name: | L-Dex U400 BIS Extra Cellular Fluid Analysis |
| Classification name: | Impedance Plethysmograph |
| Regulation number/CFR section: | 21 CFR 870.2770 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |
| Device class: | Class II 000013R |

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# ImpediMed Limited

ABN 65 089 705 144

Unit l 50 Parker Court Pinkenba Qld 4008

[phone] Tel: Freecall: | 800 638 477 Fax: [phone]

Email: [e-mail] www.impedimed.com

## PREDICATED DEVICE

| Company: | ImpediMed Limited |
|-----------------------|---------------------------------------|
| Device name: | Imp XCA Extra Cellular Fluid Analysis |
| 510 (K) number: | K050415 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |
| Device class: | Class II |
| PREDICATED DEVICE | |
| Company: | ImpediMed Limited |
| Device name: | Imp SFB7 Body Composition Analyzer |
| 510 (K) number: | K052319 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |

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#### ImpediMed Limited

ABN 65 089 705 144

Unit I 50 Parker Court Pinkenba Qld 4008

Tel: Freecall: 1 800 638 477 [phone] Fax:

Email: [e-mail] www.impedimed.com

#### INTENDED USE / INDICATIONS FOR USE

The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity.

Lymphedema Analysis PC Software – an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400. processing and analyzing of bioimpedance measurements.

#### DEVICE DESCRIPTION

The L-Dex U400 is a multi frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance as with the XCA. These measurements and calculations are used to estimate extra cellular fluid (ECF) allowing for the assessment of the development of unilateral Lymphedema of the arms.

#### TECHNOLOGICAL CHARECTERISTICS

The ImpediMed L-Dex U400 Extra Cellular Fluid Analyzer, like the SFB7, is a battery powered, accurate, multi 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 fluid volume. The tissue and organs of the body are composed of cells surrounded by a cell membrane separates fluid inside cells called intracellular

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#### ImpediMed Limited

ABN 65 089 705 144

Unit l 50 Parker Court Pinkenba Qld 4008

[phone] Tel: Freecall: 1 800 638 477 [phone] Fax:

Email: [e-mail] www.impedimed.com

fluid (ICF) from that surrounding the cells termed as extra cellular fluid (ECF) that act as conductors to the flow of current through the body.

However, the cell membrane and tissue interfaces because they are 'imperfect capacitors' act as a barrier to penetration of current at low frequencies. Thus the total impedance and phase angle of alternating current flow will be frequency dependent.

The ImpediMed L-Dex U400 is specifically designed for segmental bioelectrical impedance analysis to measure the ECF of the arms in which a small alternating constant current of 200uA RMS at a frequency of 4kHz+ 100Hz to 1000 kHz+ is passed between two current electrodes spanning the body. The voltace drop measured between a second pair of voltage-sensing electrodes is used to calculate the impedance value. The performance of the device may be checked with the aid of a calibration circuit (supplies as an accessory) for quality assurance or servicing purposes.

Bioelectrical impedance basics, simple mathematics, bioelectrical and anthropometric parameters from peer reviewed published iournal articles are used to convert measured impedance to a corresponding estimate of extra cellular fluid ratio (extra cellular fluid index or lymphedema index referred to as L-Dex), and differences between the arms. These estimates can be used as alternatives to the current circumferential measurements and water immersion methods, to indicate trends toward the potential development of Lymphedema.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Phillip Auckland Chief Operations Officer ImpediMed Limited Unit 1, 50 Parker Court Pinkenba Queensland 4008 AUSTRALIA

OCT - 3 2008

Re: K080825

Trade/Device Name: ImpediMed L-Dex U400 and optional Lymphedema Analysis PC Software Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: August 26, 2008 Received: August 29, 2008

Dear Mr. Auckland:

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., unfinished) 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. Phillip Auckland

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.dsmamain.html.

Sincerely yours,

Hubert Leiner

Joyce M. Whang, Ph.D. Acting 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): K080825

#### Device Name: ImpediMed L-Dex U400

Indications for Use:

The L-Dex U400: A bioelectrical impedance analyzer/monitor utilizing impedance ratios that supports the measurement of extra cellular fluid volume differences between the arms to aid in the clinical assessment of unilateral lymphedema of the arm in women. This device is not intended to diagnose or predict lymphedema of an extremity.

Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 analyzer/monitor for uploading data on to the PC from the L-Dex U400, processing and analyzing of bioimpedance measurements.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Huld Leuer

(Division Sign-Off)

Divisi: : )f Reproductive, Abdomin and Rachological Devices 510(k) Number

K806625

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