ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)

K113264 · Ld Technology, LLC · DXN · Mar 2, 2012 · Cardiovascular

Device Facts

• Record ID: K113264
• Device Name: ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
• Applicant: Ld Technology, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management. The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.

Device Story

ES Complex Software is a PC-based software accessory for data management. It interfaces with four specific medical devices: Contec 08A (blood pressure), ESO (oximeter), EIS-GS (galvanic skin response), and ES-BC (body composition analyzer). The software uploads patient data from these devices—or from local backup files—and displays it on a workstation for clinical review. It provides historical tracking and tabular presentation of physiological parameters, including SpO2, heart rate, HRV metrics, skin conductance, body composition (fat, water, BMI), and blood pressure. Used in clinical settings by healthcare professionals, the software facilitates the review and evaluation of historical test results to support clinical decision-making. It does not perform automated data analysis; it serves as a centralized repository and display tool for data generated by the connected hardware.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of software verification and validation (D-11SRS/SDS/D-12 STD/STR D-33 and 34) and risk management documentation (D-28) to ensure the software correctly uploads and displays data from the connected medical devices.

Technological Characteristics

PC-based software running on Windows 7; Intel architecture. Developed in C++ using Microsoft Visual C++ compiler. Requires 2GB free space and 27MB program size. Integrates with off-the-shelf software (MedCalc, MS Office Word 2007/2010). Connectivity via data upload from device memory or local PC backup files. Complies with ISO 14971 (risk management) and ISO 62304 (software life cycle).

Indications for Use

Indicated for use in clinical settings by healthcare professionals to review, analyze, and evaluate historical test results from connected blood pressure, oximetry, galvanic skin response, and body composition devices.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• Health care system software (K110948)

Reference Devices

• Contec 08A (K110774)
• Electro Sensor Oxi (ESO) (K102442)
• EIS-GS Software (K102166)
• ES-BC Software (K103026)

Submission Summary (Full Text)

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K113264 pg lof5

MAR - 2 2012

#### L.D Technology LLC.

510(k) Premarket Notification Number: K113264 Preparation date: September, 21 2011

#### 510(k) Summary Electro Sensors Complex Software (ES Complex Software)

Name of the device: Electro Sensors Complex Software Common name: ES Complex Software

#### This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 8807.92

#### 1. Submitter's Identification:

Manufacturer: L.D TECHNOLOGY Quality Control and designer: MAAREK Albert Address: L.D Technology 100 N.Biscayne Blvd, Suite 500 Miami, FL, 33132, USA Tel: [phone] E mail: [e-mail]

#### 2. Device Name / Classification

Electro Sensors Complex Software (ES Complex Software) Class II System components: Regulation number: 21CFR 8701130: Non Invasive Blood pressure measurement system, Class II 21 CFR 870 2700: Oximeter, Class II 21 CFR 882 1540: Galvanic Skin responses device Class II 21 CFR 870 2770: Analyzer Body Composition Class II 21 CFR 862 2100: Calculator/data processing module for clinical use, Class I Product Code: NXD, DQA, GZO, MNW Classification: Class II Classification Panel: Cardiology/Neurology

#### 3. Predicate legally marketed devices

- Health care system software K110948. Applicant: TaiDoc Technology . Corporation. Product codes NBW, DXN, FLL

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#### 4. Device Description

ES Complex Software is an optional software accessory for use with the following models with management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition

When use combination Contec 08A and ESO, and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the 4 devices and displays the data into a computer for enhanced data management.

#### Description of the features

- Upload data:
- V ESO data: Patient stats, calculation and Historical Tracking of: SpO2 %, Wave value, Signal Strength, b/a, c/a, d/a, e/a, oximeter wave form in coding digits. Heart Rate (HR), Mean values of RR intervals, Maximum values (Mx), Minimum values (Mn), MxDMn HIB, SDNN, RMSSD, NN50 count, pNN50 %, VLF, LF ,HF and LF/HF ratio.
- > EIS-GS data: Patient stats, measurement and Historical Tracking of :the conductance values of 22 skin pathways
- V ES-BC data: Patient stats, calculation and Historical Tracking of: Actual Impedance, Actual Phase Angle (PA), Estimated Body Fat (FAT), 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) and actual Body Mass Index (BMI)
- > Contec 08A data: Patient stats, measurement and Historical Tracking of: Systolic and diastolic pressure
- Data management .

#### 5. Intended use and indications for use

ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management. The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.

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#### 6. Specifications and performances

#### Software specifications

- Hardware platform : Laptop or PC based workstation (Intel architecture) .
- Operating system : Windows 7 .
- Use of Off-the-Shelf software : Windows 7, MedCalc and Microsoft office Word (v, 2007 . or 2010)
- Language : C++ .
- . Microsoft Visual C++ compiler requirements: 2 Gb free space
- program size requirements 27Mb .

#### Software performances

Image /page/2/Figure/10 description: The image shows a flowchart of the ES Complex software. The flowchart starts with Contec 08A, ESO, EIS-GS, and ES-BC, which all feed into "Back up in DAT.files". The next step is "ES Complex software", which feeds into "Data Management: To Display results in table and historical tracking", and the final step is "Back up ES Complex Software".

#### 7. Substantial equivalence

#### Predicate legally marketed devices

- Health care system software K110948. Applicant: TaiDoc Technology . Corporation. Product codes NBW, DXN, FLL
The substantial equivalence with the Heath care system software K110948 is based upon: The same intended use and

Different uploaded data, and the information submitted;

- a. Does not raise new questions of safety and effectiveness; and
- b. Demonstrates that the device is at least as safe and effective as the legally marketed device.

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# KII3264

#### 8. Table of comparison

#### Table of comparison Health care system software K110948 / ES Complex Software

| Name device (510k<br>number) | Health care system software K110948 | ES Complex Software : uploaded data |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Health care system software is an optional<br>software accessory for use with the following<br>models with data management capabilities: a)<br>Clever Check blood glucose meter b) Clever<br>Check blood glucose and blood pressure<br>monitors and c) Clever blood pressure<br>monitors. When use with one of these device,<br>Health care system software transfers data<br>from the device's memory into a computer for<br>enhanced data management. The Health Care<br>System Software is intended for use in home<br>and clinical settings as an aid for users and<br>their health care professionals to review,<br>analyze and evaluate the historical test results<br>to support health management effectively | ES Complex Software is an optional software<br>accessory for use with the following models with<br>data management capabilities: a) Contec 08A,<br>blood pressure device b) ESO, oximeter c) EIS-GS,<br>galvanic skin response device and d) ES-BC.<br>Analyzer body composition.<br>When use Contec 08A and ESO and/or EIS-GS<br>and/or ES-BC, ES Complex software uploads the<br>data of the devices and displays the data into a<br>computer for enhanced data management.<br>The ES Complex software is intended for use in<br>clinical settings as an aid for health care<br>professionals to review, analyze and evaluate the<br>historical tests results. |
| Results/Performances | | |
| Data management | YES | YES |
| Historical test results | YES | YES |
| Operating system | Windows | Windows |
| Results screen | PC | PC |
| | Blood glucose ,Blood pressure and body<br>temperature | SpO2%, HRV data analysis, photoelectrical<br>Plethysmography analysis and waveform,<br>conductance values, body composition and Blood<br>pressure. |
| Displayed data | | |
| Data acquisition | Upload from the device memory | upload from backup folder located in the C/Drive<br>of the PC or upload from the device memory |
| Data analysis | NO | NO |
| Indication for use | At home and clinical settings | Clinical settings |

### 9. Performances and Effectiveness

- 1. Software verification & validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34)
- 2. Risk management (D-28)

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K113264 pg 5 of 5

#### 10. General Safety Concerns

The data come from medical devices with 510k clearance:

- Contec 08A software K110774.Applicant : Contec Medical Systems CO.LDT Product code: . DXN
- Electro Sensor Oxi (ESO) software K102442.Applicant: LD Technology LLC Product Code . DOA
- . EIS-GS Software K102166. Applicant: LD Technology LLC Product Code GZO
- ES-BC Software K103026. Applicant: LD Technology LLC Product Code MNW .

#### 11. Standards

- Guidance for: Industry; FDA staff; and Content of Premarket Submissions for Software . Contained in Medical Devices May 11, 2005
- ISO 14971: Medical devices Application of risk management to medical devices. March . 01 2007
- . ISO 62304: Medical device software -- Software life cycle processes. May 1 2006

#### 12. Conclusions

Electro Sensors Complex Software (ES Complex Software) is equivalent in performances, technology, safety and efficacy to the legally marketed predicate devices.

#### Signature:

**Albert MAAREK**

Premarket notification |510K| Number: K113264

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 2 2012

LD Technology, LLC c/o Mr. Albert Maarek 100 N. Biscayne Blvd. Suite 500 Miami, FL 33132

Re: K113264 Trade/Device Name: Electro Sensor Complex Software Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DQA, GZO Dated: February 29, 2012 Received: March 1, 2012

Dear Mr. Maarek:

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.

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Page 2 - Mr. Albert Maarek

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 (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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M. A. Willemsen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: k113264

Device Name: Electro Sensors Complex Software (ES Complex Software) Indications for Use:

ES Complex Software is an optional software accessory for use with the following models with data management capabilities: a) Contec 08A, blood pressure device b) ESO, oximeter c) EIS-GS, galvanic skin response device and d) ES-BC. Analyzer body composition

When use Contec 08A and ESO and/or EIS-GS and/or ES-BC, the ES Complex software uploads the data of the devices and displays the data into a computer for enhanced data management.

The ES Complex software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results.

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)

M.A. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K-113264