(592 days)
Not Found
No
The summary describes a bioelectrical impedance analyzer that calculates impedance ratios and displays them on a scale. It mentions processing and analyzing bioimpedance measurements but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe any learning or adaptive capabilities. The analysis is based on established bioelectrical impedance principles.
No.
The device is described as an "analyzer/monitor" used to measure fluid volume differences and aid clinical assessment, but it is explicitly stated that it is "not intended to diagnose or predict lymphedema of the extremity" and does not provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device provides an "L-Dex ratio that supports the measurement of extra cellular 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". While it explicitly states it is not intended to "diagnose or predict lymphedema," providing information that aids in clinical assessment of a medical condition falls under the broad definition of a diagnostic device.
No
The device description clearly states it is a "multi-frequency bioelectrical impedance analyzer" and a "non-invasive, battery powered extracellular fluid status analyzer," indicating it is a hardware device that measures electrical properties. While there is optional PC software, the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a "bioelectrical impedance analyzer/monitor" that utilizes "impedance ratios" and measures "current, voltage and phase angle" on the adult human patient. This is a non-invasive measurement taken directly from the body, not from a sample taken from the body.
- Intended Use: The intended use describes the device as supporting the measurement of extracellular fluid volume differences between limbs as an aid to clinical assessment. This is a measurement of a physiological parameter within the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples (blood, urine, tissue, etc.).
Therefore, the device operates by taking measurements directly from the patient's body, which is characteristic of a non-IVD medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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 extra cellular 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. The device is not intended to diagnose or predict lymphedema of the 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
This premarket submission is to expand the previously cleared Indications for Use/Intended Use in the predicate device to include legs in women and men in addition to the predicate device clearance for arms in women, and clarify that it is for use on adult human patients.
The L-Dex® U400 ExtraCellular Fluid Analyzer like its predicate is a multi-frequency bioelectrical impedance analyzer. It is a non-invasive, battery powered extracellular fluid status analyzer.
The L-Dex® U400 accurately measures current, voltage and phase angle, calculates impedance, resistance and reactance as with its predicate. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for aiding in the assessment of the development of unilateral Lymphedema of the limbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs, arm, leg (specifically axillary and pelvic regions for lymph nodes)
Indicated Patient Age Range
adult human patients
Intended User / Care Setting
physician or licensed healthcare professional
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)
Clinical Performance data in support of the expanded indications for use is included within this submission.
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.
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K100811
PAGE 1 OF 3
NOV - 4 2011
L-Dex® U400 ExtraCellular Fluid Analyzer
510(k) Traditional Premarket Notification Summary
| Device Trade or Proprietary Name: | L-Dex® U400 ExtraCellular Fluid Analyzer |
|---|---|
| Common / Classification Name: | Impedance Plethysmograph |
| Class: | II |
| Regulation Number: | 870.2770 |
| Panel: | Cardiovascular |
| Product Code: | DSB |
Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.
Predicate Device for Substantial Equivalence Comparison:
The L-Dex® U400 ExtraCellular Fluid Analyzer, also referred to as the L-Dex U400 in the rest of this document, is claimed to be substantially equivalent to the following currently marketed Predicate Device and currently being marketed by ImpediMed Limited:
| Manufacturer | Device Name | 510-K
Number | Decision Date |
|----------------------|---------------------------------------------|-----------------|---------------|
| ImpediMed
Limited | L-Dex® U400 ExtraCellular Fluid
Analyzer | K080825 | Oct. 03, 2008 |
Device Description:
This premarket submission is to expand the previously cleared Indications for Use/Intended Use in the predicate device to include legs in women and men in addition to the predicate device clearance for arms in women, and clarify that it is for use on adult human patients.
The L-Dex® U400 ExtraCellular Fluid Analyzer like its predicate is a multi-frequency bioelectrical impedance analyzer. It is a non-invasive, battery powered extracellular fluid status analyzer.
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The L-Dex® U400 accurately measures current, voltage and phase angle, calculates impedance, resistance and reactance as with its predicate. These measurements and calculations are used to estimate extracellular fluid (ECF) allowing for aiding in the assessment of the development of unilateral Lymphedema of the limbs.
Indications for Use/Intended Use:
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 extra cellular 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. The device is not intended to diagnose or predict lymphedema of the 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.
Contraindications for Use:
Patients with active implanted medical devices, pregnant patients (unless under the guidance of a medical specialist), and patients undergoing external defibrillation.
Patients with allergies to electrode hydrogel, skin sensitivities to electrode hydrogel and skin breakdown in areas where the L-Dex electrode placement is required.
This device is contraindicated for use on compromised skin surfaces primarily due to the adherence of the EKG type electrodes used.
Clinical Performance Data:
Clinical Performance data in support of the expanded indications for use is included within this submission.
Rationale for Substantial Equivalence:
-
- The L-Dex® U400 employs the same patient interface design as the predicate device.
-
- The hardware and software of the L-Dex® U400 is identical in design, construction and manufacturer as the predicate device.
-
- The operational features of the L-Dex® U400 are the same as those of the predicate device.
-
- The safety features of the L-Dex® U400 are the same as those of the predicate device.
Therefore, in summary, the L-Dex® U400 ExtraCellular Fluid Status Analyzer is substantially equivalent to the predicate device.
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Safety and Effectiveness
The L-Dex® U400 ExtraCellular Fluid Analyzer complies with the electrical standards for Safety and Electro Magnetic Compatibility / Immunity (EMC / EMI) in accordance with the International Standards IEC 60101-1 and IEC 60601-1-2. This testing to the low voltage directive and to emissions / immunity requirements for EMC/EMI requirements reasonably assures the device is safe when used as directed for its prescribed intended use.
The L-Dex® U400 ExtraCellular Fluid Status Analyzer does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device.
Conclusions:
The data submitted in this 510(k) Premarket Notification, for the L-Dex® U400
ExtraCellular Fluid Status Analyzer demonstrates that this product is substantially
equivalent with respect to the indications for use, operating principles, operational features
and safety features to the legally marketed predicate device. With the information
provided, the safety and effectiveness of the product can be reasonably assured, and we
believe that this device clearly meets the requirements for a "Substantial Equivalence"
decision in accordance with the 510(k) guidelines.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV - 4 2011
ImpediMed Limited % Mr. Alden Kav Vice President Quality & Regulatory ImpediMed Limited 5959 Cornerstone Court West, Suite 100 SAN DIEGO CA 92121 ·
Re: K100811
Trade/Device Name: L-Dex® U400 ExtraCellular Fluid Analyzer Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: May 16, 2011 Received: May 18, 2011
Dear Mr. Kay:
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) 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. 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 of medical device-related
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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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K100811 510(k) Number: L-Dex® U400 ExtraCellular Fluid Analyzer Device Name:
Indications for Use/Intended Use:
A bioclectrical 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 extra cellular 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.
The device is not intended to diagnose or predict lymphedema of the 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.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____ (Per 21 CFR 801.109)
Hulut
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
K100811
510(k) Number