IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

K050415 · Impedimed Pty , Ltd. · OBH · Mar 30, 2007 · Cardiovascular

Device Facts

• Record ID: K050415
• Device Name: IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS
• Applicant: Impedimed Pty , Ltd.
• Product Code: OBH · Cardiovascular
• Decision Date: Mar 30, 2007
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The Imp XCA: 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 lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity. Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

Device Story

Imp XCA is a battery-powered, handheld, single-frequency bioelectrical impedance analyzer; operates in tetra-polar mode. Device passes 200uA constant current at 10kHz through arms; measures voltage drop to calculate impedance, resistance, and reactance. Optional PC software receives data via infrared transfer for storage, processing, and analysis. Used by clinicians to assess unilateral arm lymphoedema; provides extracellular fluid (ECF) volume difference estimates. Serves as alternative to circumferential measurements or water immersion; assists in tracking trends and assessing lymphoedema development. Does not diagnose or predict condition.

Clinical Evidence

No clinical data provided. Device relies on established bioelectrical impedance analysis principles and peer-reviewed literature to convert impedance measurements to extracellular fluid volume estimates. Bench testing only.

Technological Characteristics

Battery-powered, handheld, single-frequency (10 kHz) bioelectrical impedance analyzer. Tetra-polar electrode configuration. Measures current, voltage, phase angle; calculates impedance, resistance, reactance. Infrared data transfer to PC. Calibration circuit accessory provided for quality assurance.

Indications for Use

Indicated for clinical assessment of unilateral lymphoedema of the arm by measuring extracellular fluid volume differences between arms. Not for diagnosis or prediction of lymphoedema.

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

• Xitron Technologies, Inc Bio-Impedance Analyzer (K904109)
• Bodystat Ltd Bodystat Quad Scan 4000 (K002835)

Submission Summary (Full Text)

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## lmpediMed Ltd

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

Telephone: [phone]

ABN 65 089 705 144

Email: [e-mail]

Facsimile: [phone]

## 510 (k) Summary ImpediMed Imp XCA ExtraCellular Fluid Analysis

#### APPLICANT INFORMATION

Company Name and address:

Contact Name and numbers:

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

Mr Roger Render VP Quality & Requlatory Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date of summary prepared:

March 27 2007

#### DEVICE IDENTIFICATION

Trade/Proprietary name:

Classification name:

Regulation number/CFR section:

Product code:

, Classification panel:

Device class:

Imp XCA ExtraCellular Fluid Analysis

Impedance Plethysmograph

21 CFR 870.2770

DSB

Cardiovascular

Class II

510(k) 6.0 Letterhead SUmmary

page 1 of 5

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Telephone: [phone] Facsimile: [phone]

### Email: [e-mail]

| 1. | |
|-----------------------|--------------------------|
| Company: | Xitron Technologies, Inc |
| Device name: | Bio-Impedance Analyzer |
| 510 (K) number: | K 904109 |
| Product code: | DSB |
| Classification panel: | Cardiovascular |
| Device class: | Class II |

## 2.

lmpediMed Ltd

Garden City Office Park

Eight Mile Plains QLD 4113

Building 4B

Australia

PO Box 4612

| Company | Bodystat Ltd |
|-----------------------|-------------------------|
| Device name: | Bodystat Quad Scan 4000 |
| 510 (K) number: | K 002835 |
| Product code: | MNW |
| Classification panel: | Cardiovascular |
| Device class: | Class II |

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# ImpediMed Ltd

Telephone: [phone] Facsimile: [phone]

Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia INTENDED USE / INDICATIONS FOR USE

Email: [e-mail]

The Imp XCA: 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 lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.

Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

### DEVICE DESCRIPTION

The Imp XCA 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 extracellular fluid (ECF) allowing for the clinical assessment of unilateral Lymphedema of the arm.

### TECHNOLOGICAL CHARECTERISTICS

The ImpediMed Imp XCA ExtraCellular Fluid 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 fluid volume. The tissue and organs of the body are composed of cells surrounded by a cell membrane. This membrane separates fluid inside

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ImpediMed Ltd

Telephone: [phone] Facsimile: [phone]

Email: [e-mail]

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

cells called intracellular fluid (ICF) from that surrounding the cells termed as extracellular 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.

Therefore, an alternating electric current has two possible pathways through a biological tissue; at low frequencies it will pass only through the extracellular fluid since the capacitance of the cell membrane acts as a barrier to penetration by the current, while at high frequencies the current will cross the cell membrane and take a path through both the ICF and ECF, i.e. the total fluid volume.

The ImpediMed Imp XCA is specifically designed for segmental bioelectrical impedance analysis to measure the ECF of the arms in which a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed low frequency of 10 kHz is passed between two current electrodes spanning the body. The voltage drop measured between a second pair of voltagesensing 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.

Bioelectrical impedance basics, simple mathematics, bioelectrical and anthropometric parameters from peer reviewed published journal articles are used to convert measured impedance to a corresponding estimate of extracellular fluid ratio (extracellular fluid index or lymphoedema index), and extracellular fluid volume difference between the arms. These

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## ImpediMed Ltd

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

Telephone: [phone] Facsimile: [phone]

Email: [e-mail]

estimates can be used as alternatives to the current circumferential measurements and water immersion methods, to indicate trends and to assist in the assessment of the development of Lymphedema.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2007

Mr. Roger Render VP Quality Regulatory ImpediMed Limited 4B / 2404 Logan Road Brisbane Queensland 4113 AUSTRALIA

Re: K050415

Trade/Device Name: Imp XCA with Lymphoedema Analysis PC Software Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: Undated Received: March 29, 2007

Dear Mr. Render:

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 (for the indications for use stated in the enclosure) 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. Roger Render

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 (21 CFR Part 807); 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/industry/support/index.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

Enclosure

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# Indications for Use Statement

Device Name: Imp XCA with Lymphoedema Analysis PC Software

(1) Imp XCA – 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 lymphoedema of the arm. This device is not intended to diagnose or predict lymphoedema of an extremity.

(2) Lymphoedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed Imp XCA analyzer/monitor for uploading the data on to the PC from the Imp XCA via an infrared transfer for storing, processing and analyzing of bioimpedance measurements.

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)

Page 1 of 1

Nancy C Brogdon

Division of Reproductive, Abdominal, a Radiological Device 510(k) Number