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 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.

AI/ML Overview

This submission K113264 is for the Electro Sensors Complex Software (ES Complex Software). The documentation indicates that performance was evaluated through Software Verification & Validation and Risk Management, rather than a clinical study comparing device performance against specific acceptance criteria. This means the typical metrics for diagnostic accuracy (sensitivity, specificity, etc.) and associated study design elements (sample size, expert ground truth, etc.) are not applicable here.

The device's performance is described in terms of its functionality and its ability to manage data from connected medical devices. The "Table of comparison" highlights its equivalence to the predicate device in terms of data management, historical test results, operating system, and results screen.

Here's a breakdown of the requested information based on the provided text, with clarifications where direct answers are not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criterion (Implied by Predicate Equivalence)	Reported Device Performance (ES Complex Software)
Intended Use	Provide an optional software accessory for data management from specific medical devices, facilitating review, analysis, and evaluation of historical test results for healthcare professionals in clinical settings.	ES Complex Software is an optional software accessory for use with Contec 08A (blood pressure), ESO (oximeter), EIS-GS (galvanic skin response), and ES-BC (body composition) to upload and display data for enhanced data management. Intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate historical test results. (Equivalent to predicate's intent for data management from various devices in clinical settings).
Data Management	YES (Ability to transfer and manage data from connected devices into a computer)	YES (Uploads data from Contec 08A, ESO, EIS-GS, ES-BC, displays data in a computer for enhanced data management, includes historical tracking).
Historical Test Results	YES (Capability to track and display historical test results)	YES (Provides historical tracking for SpO2%, HRV data analysis, photoelectrical Plethysmography analysis and waveform, conductance values, body composition, and Blood pressure data).
Operating System	Windows	Windows (Specifically Windows 7 is mentioned in specifications).
Results Screen	PC	PC
Displayed Data	Display of relevant physiological measurements from connected devices (e.g., Blood glucose, Blood pressure, body temperature for predicate)	Displays SpO2%, HRV data analysis, photoelectrical Plethysmography analysis and waveform, conductance values, body composition, and Blood pressure (Systolic and diastolic pressure) from the connected devices: Contec 08A, ESO, EIS-GS, ES-BC.
Data Acquisition	Upload from the device memory	Upload from backup folder located in the C/Drive of the PC or upload from the device memory.
Data Analysis	NO (Predicate did not perform data analysis)	NO (ES Complex Software also does not perform data analysis; it provides data management for review and evaluation by healthcare professionals).
Indication for Use	At home and clinical settings (for predicate)	Clinical settings. (Note: Predicate included home settings, this device specifies clinical settings, which is a narrower and thus inherently equivalent or safer scope for use by healthcare professionals for direct patient care/review).
Safety and Effectiveness	Not raise new questions of safety and effectiveness compared to predicate; demonstrates the device is at least as safe and effective as the legally marketed predicate device.	Demonstrated through substantial equivalence comparison (Section 7 & 8) and adherence to standards (Section 11) including ISO 14971 (Risk Management) and ISO 62304 (Software life cycle processes), and completion of software verification & validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34) and risk management (D-28). The data comes from 510k cleared medical devices.

2. Sample size used for the test set and the data provenance:

The submission does not mention a traditional "test set" or sample size in the context of diagnostic performance evaluation with patient data.
The performance evaluation focused on Software Verification & Validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34) and Risk Management (D-28). These types of tests typically involve controlled functional testing, integration testing, and simulated scenarios rather than a dataset of patient cases.
Data Provenance: Not applicable as there wasn't a test set of patient data from a specific country or collected retrospectively/prospectively for diagnostic performance. The input data for the software is stated to come from other 510(k) cleared medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no "test set" of patient cases requiring expert interpretation to establish ground truth. Software verification and validation utilize established software engineering practices and possibly simulated data or test cases based on expected device outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no test set of patient cases requiring adjudication of ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This type of MRMC study was not performed or referenced. The device is a data management software, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or complex data with and without AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The "standalone" performance, in this context, refers to the software's ability to fulfill its stated functions independently. The submission indicates that Software Verification & Validation was performed. This would confirm the algorithm's functional correctness in uploading, displaying, and managing data as intended, without human intervention in the data processing itself, but human professionals are the intended users for reviewing the managed data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable as there was no diagnostic "test set" requiring ground truth for clinical accuracy. For software verification, the "ground truth" would be the expected functional behavior and output of the software according to its design specifications (e.g., data is uploaded correctly, displayed accurately, historical tracking functions as intended).

8. The sample size for the training set:

Not applicable. The Electro Sensors Complex Software is a data management software, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. Its functionality is based on programmed logic and integration with other medical devices.

9. How the ground truth for the training set was established:

Not applicable, as no training set was used for this software.

Summary of Device Performance Evaluation:

The K113264 submission demonstrates substantial equivalence for the Electro Sensors Complex Software primarily through comparison to a predicate device (Health care system software K110948) and by declaring adherence to an established software development lifecycle (Software Verification & Validation) and risk management processes. The focus is on the software's functional performance in data management from connected medical devices, rather than a diagnostic accuracy claim that would necessitate patient-level performance studies. The key performance evaluations cited are:

Software Verification & Validation (D-11SRS/SDS/ D-12 STD/ STR D-33 and 34): This confirms that the software's components and system meet specified requirements and perform their intended functions correctly.
Risk Management (D-28) according to ISO 14971: This ensures that potential risks associated with the software have been identified, evaluated, and mitigated.
Adherence to ISO 62304: This standard governs medical device software life cycle processes, ensuring a structured approach to software development, maintenance, and risk management.

The comparison table highlights that the ES Complex Software shares the same core functions (data management, historical data tracking, operating system, PC display) as the predicate device, although it handles different types of physiological data and is indicated for clinical settings only (whereas the predicate included home use). The conclusion is that the device is "equivalent in performances, technology, safety and efficacy to the legally marketed predicate devices."

Summary

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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: 305-379-9900 E mail: albert.ldteck@gmail.com

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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K113264 pg. 2 of 5

4. Device Description

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

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K 113264 pg 3 of 5

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 (510knumber)	Health care system software K110948	ES Complex Software : uploaded data
Intended use	Health care system software is an optionalsoftware accessory for use with the followingmodels with data management capabilities: a)Clever Check blood glucose meter b) CleverCheck blood glucose and blood pressuremonitors and c) Clever blood pressuremonitors. When use with one of these device,Health care system software transfers datafrom the device's memory into a computer forenhanced data management. The Health CareSystem Software is intended for use in homeand clinical settings as an aid for users andtheir health care professionals to review,analyze and evaluate the historical test resultsto support health management effectively	ES Complex Software is an optional softwareaccessory for use with the following models withdata 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-GSand/or ES-BC, ES Complex software uploads thedata of the devices and displays the data into acomputer for enhanced data management.The ES Complex software is intended for use inclinical settings as an aid for health careprofessionals to review, analyze and evaluate thehistorical 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 bodytemperature	SpO2%, HRV data analysis, photoelectricalPlethysmography analysis and waveform,conductance values, body composition and Bloodpressure.
Displayed data
Data acquisition	Upload from the device memory	upload from backup folder located in the C/Driveof 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)
1. 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 (800) 638-2041 or (301) 796-7100 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:

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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).