(193 days)
Not Found
No
The summary describes a bioelectrical impedance analyzer that measures and calculates standard electrical properties to estimate fluid volume. There is no mention of AI, ML, or any learning-based algorithms. The analysis is based on direct measurements and calculations, not pattern recognition or predictive modeling typically associated with AI/ML in medical devices.
No
The device aids in the clinical assessment of unilateral lymphedema, but it is explicitly stated that "This device is not intended to diagnose or predict lymphedema of an extremity." Therefore, it is not a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "This device is not intended to diagnose or predict lymphedema of an extremity." While it aids in clinical assessment, it disclaims diagnostic intent.
No
The device description clearly states the L-Dex U400 is a "multi frequency bioelectrical impedance analyser" and an "instrument operating in tetra-polar mode," indicating it is a hardware device that performs measurements. While there is optional PC software, the core device is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The L-Dex U400 is a bioelectrical impedance analyzer that measures electrical properties of the body (specifically, the arms) to estimate fluid volume. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "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 is a direct measurement on the body, not an analysis of a sample.
Therefore, the L-Dex U400 falls under the category of a medical device that performs measurements directly on the patient, rather than an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DSB, OBH
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KC80825
PAGE 1 OF 4
ImpediMed
OCT - 3 2008
ImpediMed Limited
ABN 65 089 705 144
Unit l 50 Parker Court Pinkenba Qld 4008
+61 (0)7 3860 3700 Tel: Freecall: | 800 638 477 Fax: +61 (0)7 3260 1225
Email: enquiries@impedimed.com www.impedimed.com
510 (k) Summary ImpediMed L-Dex U400 BIS Extra Cellular Fluid Analysis
APPLICANT INFORMATION
| Company Name and address: | ImpediMed Limited
Unit1
50 Parker Court
Pinkenba, QLD - 4008 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and numbers: | Mr Phillip Auckland
Chief Operations Officer
Phone: (+61) 7 3860 3700
Fax: (+61) 7 3260 1225
E-mail: pauckland@impedimed.com |
| 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 |
1
Image /page/1/Picture/0 description: The image shows the logo for ImpediMed, a medical technology company. The logo features the company name in a stylized font, with curved lines above and below the name. At the top of the image, handwritten text reads "K080825 PAGE 2 OF 4".
ImpediMed Limited
ABN 65 089 705 144
Unit l 50 Parker Court Pinkenba Qld 4008
+61 (0)7 3860 3700 Tel: Freecall: | 800 638 477 Fax: +61 (0)7 3260 1225
Email: enquiries@impedimed.com 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 |
Image /page/1/Picture/8 description: The image shows a series of numbers and a letter. The numbers appear to be "00014" followed by the letter "R". The text is in black and the background is white. The text is slightly blurred.
:
Surviving cancer without compromising lifestyle
.
2
Image /page/2/Picture/0 description: The image shows the logo for ImpediMed. The logo is black and white and features the company name in a stylized font. Above the logo, the text "K080825 PAGE 3 OF 4" is visible. The logo is surrounded by curved lines, giving it a dynamic appearance.
ImpediMed Limited
ABN 65 089 705 144
Unit I 50 Parker Court Pinkenba Qld 4008
Tel: Freecall: 1 800 638 477 +61 (0)7 3260 1225 Fax:
Email: enquiries@impedimed.com 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
000015R
3
Image /page/3/Picture/0 description: The image shows the logo for ImpediMed, a medical technology company. Above the logo is the text "K089825 PAGE 4 OF 4". The ImpediMed logo is a stylized design with curved lines and bold text.
ImpediMed Limited
ABN 65 089 705 144
Unit l 50 Parker Court Pinkenba Qld 4008
+61 (0)7 3860 3700 Tel: Freecall: 1 800 638 477 +61 (0)7 3260 1225 Fax:
Email: enquiries@impedimed.com 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.
annois R
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
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.
5
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150, 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
6
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Huld Leuer
(Division Sign-Off)
Divisi: : )f Reproductive, Abdomin and Rachological Devices 510(k) Number
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