IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS

K130338 · ImpediMed Limited · OBH · May 31, 2013 · Cardiovascular

Device Facts

• Record ID: K130338
• Device Name: IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
• Applicant: ImpediMed Limited
• Product Code: OBH · Cardiovascular
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The L-Dex® U400 is a bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men. The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated. Lymphedema Analysis PC Software - an optional PC software package that is intended to be used only with the ImpediMed L-Dex U400 device 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 battery-powered bioimpedance spectroscopy device. It measures current, voltage, and phase angle via tetra-polar leads and self-adhesive skin electrodes. It operates across a frequency range of 4–1000 kHz (256 data points). The device calculates impedance (Z), resistance (R), and reactance (Xc) to estimate extracellular fluid ratios and generate an L-Dex ratio. Used in clinical settings by healthcare providers to assess unilateral lymphedema. Output is displayed on-screen as a resistance vs. reactance complex impedance plot and an L-Dex value. Data can be transferred to Impsoft PC software for history tracking and report generation. The device aids clinicians in monitoring fluid volume differences, potentially facilitating earlier lymphedema detection and management.

Clinical Evidence

No clinical data provided; reliance on literature reports describing device use for the indicated purpose.

Technological Characteristics

Battery-powered bioimpedance spectroscopy device; tetra-polar mode; 4–1000 kHz frequency range; 256 data points; dimensions 190mm x 130mm x 110mm; weight 1 kg; connectivity via data transfer to Impsoft database software.

Indications for Use

Indicated for adult patients who have had or will have lymph nodes in the axillary or pelvic regions removed, damaged, or irradiated, to aid in the clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

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

• L-Dex® U400 BIS Extra Cellular Fluid Analysis (K100811)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) SUMMARY

#### lmpediMed Limited's L-Dex® U400

## MAY 3 1 2013

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Company Name and Address: | ImpediMed Limited<br>Unit 1<br>50 Parker Court<br>Pinkenba, QLD - 4008<br>Australia |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Catherine Kingsford<br>Vice President of Clinical and Regulatory Affairs and<br>Intellectual Property<br>Phone: [phone] Ext 1225<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date of summary prepared: | February 8, 2013 |

#### Proprietary Device Name / Common Name / Classification

| Trade/Proprietary name: | L-Dex® U400 BIS Extra Cellular Fluid Analysis |
|--------------------------------|-----------------------------------------------|
| Classification name: | Impedance Plethysmograph |
| Regulation number/CFR section: | 21 C.F.R. § 870.2770 |
| Product code: | OBH |
| Regulation Medical Specialty: | Cardiovascular |
| Review Panel: | Gastroenterology/Urology |
| Device class: | Class II |

#### Predicate Devices

ImpediMed Limited, L-Dex® U400 BIS Extra Cellular Fluid Analysis (K100811)

.

#### Intended Use / Indications for Use

The L-Dex® U400 is a bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

{1}------------------------------------------------

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.

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

#### Technological Characteristics / Principles of Operation

The ImpediMed L-Dex U400 Extra Cellular Fluid Analysis device is a battery powered bioimpedance spectroscopy device operating in tetra-polar mode via a set of leads that are attached to self-adhesive skin electrodes by means of alligator clips. The subject device accurately measures current, voltage and phase angle, and cakulates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc). These measurements and calculations are used to estimate extracellular fluid ratios, and calculate the Lymphedema Index or L-Dex

The L-Dex U400 measures bioimpedance parameters over a frequency range of 4 - 1000 kHz with 256 data points. An on-screen graph displays the raw measured data in the form of a resistance vs. reactance complex impedance plot. These bioelectrical parameters are then used in algorithms to give an L-Dex value for the affected compared to the unaffected limb.

Measured impedance ratios (L-Dex values) and normal ranges are shown on the device immediately after measurement and stored for later reference. Measured data may be transferred to the ImpediMed Impsoft database software. The Impsoft software adds extra functionality and ease of data management, including viewing patient histories and printing reports.

#### Performance Data

The company has provided an overview of reports in the literature that describes the use of the device for its indications for use.

#### Substantial Equivalence

The L-Dex U400 is as safe and effective as the company's cleared device of the same name (K100811). The L-Dex U400 has the same intended use, technological characteristics, and principles of operation and similar indications as its predicate device. The minor change in indications for use between the subject and cleared device does not impact the diagnostic effect of the L-Dex U400. Performance data demonstrate that the subject device is as safe and effective as the company's predicate device for the proposed indications for use. Thus, the L-Dex U400 is substantially equivalent.

{2}------------------------------------------------

| | Subject Device | Predicate Devices | |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | L-Dex® U400 | K080825 | |
| Class | Class II | Class II | |
| Regulation | 870.2770 | 870.2770 | |
| Common Name | L-Dex | L-Dex | |
| Intended Use | A bioimpedance spectroscopy device for<br>use on adult human patients, utilizing<br>impedance ratios that are displayed as<br>an L-Dex ratio that supports the<br>measurement of extracellular fluid<br>volume differences between the limbs<br>and is presented to the clinician on an L-<br>Dex scale as an aid to their clinical<br>assessment of unilateral lymphedema of<br>the arm and leg in women and the leg in<br>men. | A bioelectrical impedance<br>analyzer/monitor for use on adult human<br>patients, utilizing impedance ratios that<br>are displayed as an L-Dex ratio that<br>supports the measurement of<br>extracellular fluid volume differences<br>between the limbs and is presented to<br>the clinician on an L-Dex scale as an aid<br>to their clinical assessment of unilateral<br>lymphedema of the arm and leg in<br>women and the leg in men. | A bioelectrical impedance<br>analyzer/monitor utilizing impedance<br>ratios that supports the measurement of<br>extracellular fluid volume differences<br>between the arms to aid in the clinical<br>assessment of unilateral lymphedema of<br>the arm women. This device is not<br>intended to diagnose or predict<br>lymphedema of and extremity. |
| | The device is only indicated for patients<br>who will have or who have had lymph<br>nodes, from the axillary and pelvic<br>regions, either removed, damaged or<br>irradiated. | The device is only indicated for patients<br>who will have or who have had lymph<br>nodes, from the axillary and pelvic<br>regions, either removed, damaged or<br>irradiated. | Lymphedema Analysis PC Software - an<br>optional PC software package that is<br>intended to be used only with the<br>ImpediMed L-Dex U400 device for<br>uploading data on to the PC from the L-<br>Dex U400, processing and analyzing of<br>bioimpedance measurements. |
| | Lymphedema Analysis PC Software - an<br>optional PC software package that is<br>intended to be used only with the<br>ImpediMed L-Dex U400 device for<br>uploading data on to the PC from the L-<br>Dex U400, processing and analyzing of<br>bioimpedance measurements. | This device is not intended to diagnose or<br>predict lymphedema of and extremity. | |
| | | Lymphedema Analysis PC Software - an<br>optional PC software package that is<br>intended to be used only with the<br>ImpediMed L-Dex U400 device for<br>uploading data on to the PC from the L-<br>Dex U400, processing and analyzing of<br>bioimpedance measurements. | |

33

:

035

{3}------------------------------------------------

| | 2<br>processil |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Aland Book Children Aller | |
| | |
| 111 1 70 7 7 0 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 7 | |

| | | Dex U400, processing and analyzing of bioimpedance measurements. | |
|------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Principle | Bioelectrical impedance in the range of 4<br>kHz to 1000 kHz (256 frequencies). | Bioelectrical impedance in the range of 4<br>kHz to 1000 kHz (256 frequencies) | Bioelectrical impedance in the range of 4<br>kHz to 1000 kHz (256 frequencies) |
| Dimensions | L=190mm, W=130mm, D=110mm | L=190mm, W=130mm, D=110mm | L=190mm, W=130mm, D=110mm |
| Weight | 1 kg / 2.2 lbs (including battery) | 1 kg / 2.2 lbs (including battery) | 1 kg / 2.2 lbs (including battery) |

036

.

1. September 19.

and the comments of the comments of the comments of the comments of

1. The state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### May 31, 2013

ImpediMed Limited % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004

Re: K130338

Trade/Device Name: L-Dex® U400 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: May 7, 2013 Received: May 7, 2013

Dear Dr. Smith:

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-todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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.

{5}------------------------------------------------

Page 2 - John J. Smith, M.D., J.D.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for_

Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The letters "P" and "L" are stylized with a decorative pattern.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

#### Indications for Use Statement

K130338 510(k) Number (if known):

Device Name: L-Dex® U400

Indications for Use:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of unilateral lymphedema of the arm and leg in women and the leg in men.

The device is only indicated for patients who will have or who have had lymph nodes, from the axillary and pelvic regions, either removed, damaged or irradiated.

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

| Prescription Use | X |
|-----------------------------|---|
| (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Herbert | Polygrner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130338 510(k) Number

Page 1 of 1