(168 days)
Not Found
No
The device description explicitly states that it uses "accepted peer reviewed published algorithms" to compute body composition values, not AI or ML.
No
Explanation: The device is described as an electrical bioimpedance analyzer that calculates body composition metrics (e.g., fat mass, total body water). The "Intended Use" section explicitly states, "The device is not intended for use for diagnosis." This indicates it is not for therapeutic purposes.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended for use for diagnosis."
No
The device description explicitly states it is a "single frequency electrical bioimpedance analyzer" and "It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes." This indicates the device includes hardware components for measuring electrical bioimpedance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The device is not intended for use for diagnosis." This is a key characteristic that differentiates it from an IVD.
- Focus on Body Composition Estimation: The primary function of the device is to estimate body composition parameters (fat mass, fat-free mass, total body water, etc.) using electrical bioimpedance. While these parameters can be relevant to health, the device is not presented as a tool for diagnosing a disease or condition.
- Over-the-Counter Use: The intended user is the general public for over-the-counter use, which is not typical for devices intended for clinical diagnosis.
- Lack of Diagnostic Claims: The intended use and device description focus on measurement and estimation, not on identifying or characterizing a disease or condition.
IVDs are typically used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform such examinations.
N/A
Intended Use / Indications for Use
Calculation and Historical Tracking of:
- . Actual Resistance
- Actual Reactance .
- Actual Impedance
- Actual Phase Angle (PA) .
- Estimated Body Fat Mass (FM) ●
- Estimated Fat Free Mass (FFM)
- Estimated Total Body Water (TBW) .
- Estimated Intra-Cellular Water (ICW) ●
- Estimated Extra-Cellular Water (ECW) ●
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- Actual Body Mass Index (BMI) .
The device is not intended for use for diagnosis.
The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only.
The data are stored in PC in the Backup system of the E.S-BC software.
As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population .
As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
The E.S- BC is a single frequency electrical bioimpedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), total body water (TWB) and fluid distribution: intracellular water, and extracellular water.
It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes. The E.S- BC has two operating modes: Direct and Algorithm.
Direct Mode measures and displays values for impedance (Z), phase (Ph), resistance (R) and reactance (Xc).
Algorithm Mode displays estimates of fat-free mass (FFM) ,fat mass (FM), total body Water (TBW), intracellular water (ICW), and extracellular water (ECW), plus their percentages. The device computes these values using accepted peer reviewed published algorithms tailored to the patient type: general population, obese patients, or children.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For estimated TWB, ICW, and ECW: over 12 years old and under 80 years old.
For estimated FM and FFM: over 19 years old and under 63 years old.
Intended User / Care Setting
over-the-counter use
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)
Performance testing:
-
- Testing and Calibration
-
- Software verification (SRS/STD/STR)
-
- Clinical investigation (Miami University)
The facts that:
- The device is USB interface powered
- The hardware data's are directly transmitted to the software via the USB port of the laptop.
- Some peer reviews 'algorithms chosen are different
Do not affect the performances and the effectiveness of the E.S/BC system as shown by the testing and calibration and the clinical investigation conclusion.
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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L.D Technology LLC.
MAR 2 9 2011
510(k) Premarket Notification Number: K103026
Preparation date: September, 15 2010
510(k) Summary E.S-BC Electro Sensor / Body Composition
Name of the device: Electro Sensor- Body Composition Common name: E.S-BC Impedance Plethysmograph Regulation number: 21 CFR 870.2770 Product Code: MNW Classification: Class II Classification Advisory: Cardiovascular
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
- Submitter's Identification: Manufacturer: L.D TECHNOLOGY LLC Owner of LD Technology: MAAREK Albert Address: L.D Technology 100 N.Biscavne Blvd. Suite 500 Miami, FL, 33132, USA Tel: 305-379-9900 Fax: 305-468-3956 E mail: albert.ldteck@gmail.com
Contact Information: Consultant and reviewer Richard Clement MD 11459 NW 34 Street Miami FL 33178 Tel: 305-594-2145 Fax: 305-594 2174 Email: richardclementmd@yahoo.com Date of Preparation: September, 15, 2010
1
- Device Name / Classification E.S-BC Electro Sensor-Body Composition System components: 21 CFR 870.2770 Product Code: MNW Classification: Class II Classification Advisory: Cardiovascular
3. Predicate legally marketed devices
BC body composition software, K070999 Applicant: RJL systems. Inc Product code MNW DF50 Body Composition Analysis K052395 Applicant: ImpediMed Limited. Product code: MNW
4. Device Description
Description of the features
The E.S- BC is a single frequency electrical bioimpedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), total body water (TWB) and fluid distribution: intracellular water, and extracellular water.
It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes. The E.S- BC has two operating modes: Direct and Algorithm.
Direct Mode measures and displays values for impedance (Z), phase (Ph), resistance (R) and reactance (Xc).
Algorithm Mode displays estimates of fat-free mass (FFM) ,fat mass (FM), total body Water (TBW), intracellular water (ICW), and extracellular water (ECW), plus their percentages. The device computes these values using accepted peer reviewed published algorithms tailored to the patient type: general population, obese patients, or children.
5. Indications or Intended use
Calculation and Historical Tracking of:
- . Actual Resistance
- Actual Reactance .
- Actual Impedance �
- Actual Phase Angle (PA) .
- Estimated Body Fat Mass (FM) ●
- Estimated Fat Free Mass (FFM) �
- Estimated Total Body Water (TBW) .
- Estimated Intra-Cellular Water (ICW) ●
- Estimated Extra-Cellular Water (ECW) ●
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- Actual Body Mass Index (BMI) .
The device is not intended for use for diagnosis.
The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only.
The data are stored in PC in the Backup system of the E.S-BC software.
2
As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population .
As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use
6. Performances, specifications and materials Technical specifications Box technical specifications
| Power supply | 5V (power supply by USB port) |
|---|---|
| Electrical Classification | Class II |
| Degree of protection against electric shocks | BF |
| Operating mode | Continuous use |
| Current in operating mode | $200\mu A \pm 10 \mu A$ |
| Range Frequency in operating mode | $50 KHz \pm 100 Hz$ |
| Resistance range | 0 to 1000 ohms |
| Impedance resolution | 0.1 ohms |
| Phase resolution | 0.1 degree |
| Galvanic decoupling of the analogical part, | 3 KV |
| Box Dimensions in mm | 128 X 143 X 33 |
| Box Weight kg | 1,2 |
Accessories
| Component | Technical specifications |
|---|---|
| 4 disposable electrodes | Ref 3M |
| Connection | Redel 3P |
| Calibration box | Ref. CPA 5509 |
| Reusable Cable | Ref. OEM459-C |
| USB cable | Ref: USB 2.0 |
3
Features' chart flow
Image /page/3/Figure/2 description: The image shows a diagram of a system with different components and their connections. The components include "HARDWARE", "SOFTWARE", "Algorithms' Mode", "Direct Mode", "BACKUP", "OTS", "Table", "Report", "Follow up graph", and "Status report". The diagram also includes arrows with numbers indicating the flow of information or processes between the components.
Comments of the chart flow
-
- Protocol communication1: The hardware is USB port of the laptop powered and the hardware functions are controlled by the software :
- . Start /pause
- . Time of measurement
- Testing and calibration .
-
- Protocol communication 2: Hardware data transmission to the software
-
- Hardware measurement (direct mode)
-
- Software analysis : algorithms application to the hardware measurement (algorithms 'mode)
-
- Results in table, report, follow up graphs and status report.
-
- Backup of the direct mode and algorithms 'mode results
-
- Off-the-Shelf software interface to edit and print the status report (Microsoft Office Word).
Other specifications
- Programming language: C++ .
- Hardware platform : PC based workstation (Intel architecture) .
- Operating system : Windows .
- Use of Off-the-Shelf software : Microsoft office Word 2003 or 2007 .
4
7. Contra-indications
- . Patients undergoing external defibrillation Risk: The injected voltage and current could provoke injury to the patient.
- This device should not be used in association with or presence of defibrillators, cardiac . pacemakers, patients connected to electronic life support devices, or any implanted electronic device.
Risk: The injected voltage and current could provoke injury to the patient.
Image /page/4/Picture/5 description: The image shows a black warning sign. The sign is a triangle with a black border. Inside the triangle is a black exclamation point.
8. Undesirable side effects:
Side effects or adverse reactions are none known to date.
Image /page/4/Picture/8 description: The image shows the text "9. Substantial equivalence". The number 9 is followed by a period. The text is in a bold, sans-serif font. The text is left-aligned.
Predicate legally marketed devices
BC body composition software, K070999 Applicant: RJL systems. Inc Product code MNW DF50 Body Composition Analysis K052395 Applicant: ImpediMed Limited. Product code: MNW
Similarities:
Substantial equivalence
- Same intended use
Differences:
- The device is USB interface powered
- The hardware data's are directly transmitted to the software via the USB port of the laptop.
- Some peer reviews 'algorithms chosen are different
- I.e. Tables of comparison of the E.S-BC modules and SE discussion: i.e. Executive summary
11. Performances and Effectiveness
Performance testing:
-
- Testing and Calibration
-
- Software verification (SRS/STD/STR)
-
- Clinical investigation (Miami University)
The facts that:
-
The device is USB interface powered
- The hardware data's are directly transmitted to the software via the USB port of the laptop.
- Some peer reviews 'algorithms chosen are different
Do not affect the performances and the effectiveness of the E.S/BC system as shown by the testing and calibration and the clinical investigation conclusion.
12. General Safety Concerns
The facts that:
- √ The device is USB powered
- The hardware data's are directly transmitted to the software via the USB port of the PC.
5
of 6
Do not change the general safety to the legally marketed predicate devices as shown by the laboratory tests reports (IEC 60601-1-2 and IEC 60601-1-1), the risk management and the testing procedure.
13. Standards
IEC60601-1-1 Issued: 2000/12/14 Ed:2 Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2 Issued: 2001/09/30 Ed: 2 Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility - Req. and Tests - Including Section 6 manual review
Conclusions
E.S-BC is equivalent in performances, technology, safety and efficacy to the legally marketed predicate devices
Signature:
Albert MAAREK
Premarket notification |510K] Number: K103026
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned above a wavy line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
L.D. Technology, LLC c/o Richard Clement, M.D. 11459 NW 34 Street MIAMI FL 33178
MAR 2 9 2011
Re: K103026
Trade/Device Name: E.S-BC (Electro Sensor-Body Composition) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II Product Code: MNW Dated: March 22, 2011 Received: March 25, 2011
Dear Dr. Clement:
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
7
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 H. Humphrey
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
8
Indications for Use
510(k) Number (if known): K103026
Device Name: E.S-BC (Electro Sensor-Body Composition)
Indications for Use:
Calculation and Historical Tracking of:
- . Actual Resistance
- Actual Reactance .
- Actual Impedance .
- Actual Phase Angle (PA) .
- Estimated Body Fat Mass (FM) .
- Estimated Fat Free Mass (FFM) .
- . Estimated Total Body Water (TBW)
- Estimated Intra-Cellular Water (ICW) �
- Estimated Extra-Cellular Water (ECW) .
- Estimated Basal Metabolic Rate (BMR) .
- . Estimated Daily Energy Expenditure (DEE)
- Actual Body Mass Index (BMI) .
The device is not intended for use for diagnosis.
The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only.
The data are stored in PC in the Backup system of the E.S-BC software.
As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population .
As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
(Division Sign-Off)
Division of Reproductive. Gastro-Renal, and
Page
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K1030216