(109 days)
No
The description focuses on bioimpedance measurements, calculations using algorithms, and data display/management. There is no mention of AI, ML, or related concepts like training/test sets for model development.
No
The device is described as an "aid to their clinical assessment" of lymphedema and does not directly provide therapy or treatment.
Yes
The device aids in the clinical assessment and supports the measurement of extracellular fluid volume differences, providing an L-Dex ratio that helps identify unilateral lymphedema. This process involves collecting data (impedance ratios) from a patient and presenting it to a clinician to assist in the diagnosis of a medical condition.
No
The device description clearly states it 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." This indicates the presence of physical hardware components beyond just software. While there is optional PC software, the core medical device is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states the device is used on adult human patients, utilizing electrodes attached to the skin to measure bioimpedance directly. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device measures physical parameters directly from the patient. Bioimpedance spectroscopy measures the electrical properties of the body's tissues. This is a direct measurement on the living subject, not an analysis of a sample removed from the body.
The device is a medical device used for diagnostic purposes (aiding in the clinical assessment of lymphedema), but it falls under the category of devices that interact directly with the patient's body, not IVDs.
N/A
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.
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.
Product codes
OBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm and leg
Indicated Patient Age Range
adult human patients
Intended User / Care Setting
clinician
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)
The company has provided an overview of reports in the literature that describes the use of the device for its indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ImpediMed Limited, L-Dex® U400 BIS Extra Cellular Fluid Analysis (K100811), K080825
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
Unit 1
50 Parker Court
Pinkenba, QLD - 4008
Australia |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Catherine Kingsford
Vice President of Clinical and Regulatory Affairs and
Intellectual Property
Phone: (+61) 7 3860 3700 Ext 1225
Fax: (+61) 7 3260 1225
E-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.
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 | ||
| 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. | A bioelectrical impedance | ||
| analyzer/monitor 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. | A bioelectrical impedance | ||
| analyzer/monitor utilizing impedance | |||
| ratios that supports the measurement of | |||
| extracellular fluid volume differences | |||
| between the arms to aid in the clinical | |||
| assessment of unilateral lymphedema of | |||
| the arm women. This device is not | |||
| intended to diagnose or predict | |||
| lymphedema of and extremity. | |||
| 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. | 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. | |||
| 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. | This device is not intended to diagnose or | ||
| predict lymphedema of and extremity. | |||
| 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. |
33
:
035
3
| | 2
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 | ||
| kHz to 1000 kHz (256 frequencies). | Bioelectrical impedance in the range of 4 | ||
| kHz to 1000 kHz (256 frequencies) | Bioelectrical impedance in the range of 4 | ||
| 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
.
- September 19.
and the comments of the comments of the comments of the comments of
- 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 (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
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