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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the ImpediMed L-Dex U400 and its performance claim, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission is a 510(k) for substantial equivalence to a predicate device (K100811), not a de novo clearance with defined performance acceptance criteria. The "Performance Data" section explicitly states: "The company has provided an overview of reports in the literature that describes the use of the device for its indications for use." This indicates that the submission relies on existing literature and comparison to its own previously cleared device, rather than new, primary performance studies with explicit acceptance criteria for the current submission.

Therefore, since no specific acceptance criteria for this 510(k) submission are mentioned, and the performance data refers to an "overview of reports in the literature," a table of acceptance criteria and reported performance cannot be generated from the given text. The FDA's substantial equivalence decision is based on the new device being "as safe and effective" as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail any specific de novo test set for this 510(k) submission. It states: "Performance data demonstrate that the subject device is as safe and effective as the company's predicate device for the proposed indications for use." This implies reliance on data from the predicate device's clearance (K100811) or general literature, but no sample size or data provenance (country, retrospective/prospective) for a new test set is provided in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no de novo test set or specific performance study is detailed for this 510(k) in the provided text, there is no information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As no de novo test set or specific performance study is detailed, no adjudication method is mentioned in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention any MRMC comparative effectiveness study being performed for this 510(k) submission, nor does it discuss the effect size of human readers with or without AI assistance. The device is a bioimpedance spectroscopy device, not an image-reading AI.

6. Standalone (Algorithm Only) Performance Study

The information provided suggests that the device's function is to measure bioelectrical parameters and calculate an L-Dex value, which is then "presented to the clinician on an L-Dex scale as an aid to their clinical assessment." This implies human-in-the-loop use. However, the document does not detail a standalone performance study in the context of this 510(k) submission. The performance claim is for substantial equivalence to its predicate.

7. Type of Ground Truth Used

The document focuses on substantial equivalence based on technological characteristics and intended use. It does not describe the type of ground truth (e.g., pathology, outcomes data, expert consensus) used for any specific performance study related to this 510(k) submission. Any "ground truth" would likely refer to the data used in the "reports in the literature" that describe the use of the device.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a device, not a new AI algorithm development requiring a distinct training phase to develop the L-Dex algorithm itself. The algorithms are already established in the predicate device.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned in the context of this 510(k) submission, there is no information on how its ground truth was established. The L-Dex algorithm itself would have been developed and validated previously, and those details are not part of this specific 510(k) summary.

Summary

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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 LimitedUnit 150 Parker CourtPinkenba, QLD - 4008Australia
Contact Person:	Catherine KingsfordVice President of Clinical and Regulatory Affairs andIntellectual PropertyPhone: (+61) 7 3860 3700 Ext 1225Fax: (+61) 7 3260 1225E-mail: ckingsford@impedimed.com
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.

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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.

Technological Characteristics / Principles of Operation

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.

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	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 foruse on adult human patients, utilizingimpedance ratios that are displayed asan L-Dex ratio that supports themeasurement of extracellular fluidvolume differences between the limbsand is presented to the clinician on an L-Dex scale as an aid to their clinicalassessment of unilateral lymphedema ofthe arm and leg in women and the leg inmen.	A bioelectrical impedanceanalyzer/monitor for use on adult humanpatients, utilizing impedance ratios thatare displayed as an L-Dex ratio thatsupports the measurement ofextracellular fluid volume differencesbetween the limbs and is presented tothe clinician on an L-Dex scale as an aidto their clinical assessment of unilaterallymphedema of the arm and leg inwomen and the leg in men.	A bioelectrical impedanceanalyzer/monitor utilizing impedanceratios that supports the measurement ofextracellular fluid volume differencesbetween the arms to aid in the clinicalassessment of unilateral lymphedema ofthe arm women. This device is notintended to diagnose or predictlymphedema of and extremity.
	The device is only indicated for patientswho will have or who have had lymphnodes, from the axillary and pelvicregions, either removed, damaged orirradiated.	The device is only indicated for patientswho will have or who have had lymphnodes, from the axillary and pelvicregions, either removed, damaged orirradiated.	Lymphedema Analysis PC Software - anoptional PC software package that isintended to be used only with theImpediMed L-Dex U400 device foruploading data on to the PC from the L-Dex U400, processing and analyzing ofbioimpedance measurements.
	Lymphedema Analysis PC Software - anoptional PC software package that isintended to be used only with theImpediMed L-Dex U400 device foruploading data on to the PC from the L-Dex U400, processing and analyzing ofbioimpedance measurements.	This device is not intended to diagnose orpredict lymphedema of and extremity.
		Lymphedema Analysis PC Software - anoptional PC software package that isintended to be used only with theImpediMed L-Dex U400 device foruploading data on to the PC from the L-Dex U400, processing and analyzing ofbioimpedance measurements.

035

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		Dex U400, processing and analyzing of bioimpedance measurements.
Principle	Bioelectrical impedance in the range of 4kHz to 1000 kHz (256 frequencies).	Bioelectrical impedance in the range of 4kHz to 1000 kHz (256 frequencies)	Bioelectrical impedance in the range of 4kHz 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

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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 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.

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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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use Statement

K130338 510(k) Number (if known):

Device Name: L-Dex® U400

Indications for Use:

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.

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

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
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.(b)
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.