The intended use of the ECG-6 Series Electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface with ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only.

Device Description

ECG-6 series Smart ECG includes three models ECG-6 Pro, ECG-6 Plus and ECG-6. Device features include as follows: Portable, lightweight design. Easy data input and operation. Alphanumeric keyboard and one-touch operation. Built-in rechargeable battery, AC/DC power supply. Automatic analysis and diagnostic software (SEMIP) for adults. Heart rate variability (HRV) analysis. Internal thermal printer and external printer. Support external archiving: USB flash disk, card reader. Data transmission to PC via Ethernet or serial port.

AI/ML Overview

This submission describes the ECG-6 Series Electrocardiograph, which includes models ECG-6 Pro, ECG-6 Plus, and ECG-6. The device is intended to acquire ECG signals from adult and pediatric patients and provides automatic analysis and diagnostic software (SEMIP) for adults.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) for the diagnostic software. Instead, it states that "Software testing," "Risk analysis," "Safety testing," and "Performance test" were conducted.

The "Predicate Device" section indicates comparisons were made to the SE-601 Series Electrocardiograph (K090367) by EDAN Instruments, implying that the new device aims for similar performance. However, no specific performance values are reported for either the predicate or the new device in terms of diagnostic accuracy.

Table: Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Software testing completed	Conducted
Risk analysis completed	Conducted
Safety testing completed	Conducted
Performance test completed	Conducted
Substantial equivalence to predicate device (SE-601 Series Electrocardiograph K090367) based on similar technology and intended use	Claimed and granted (K112135)
Compliance with general controls and relevant regulations (e.g., GMP, labeling)	Implied by 510(k) clearance

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide information on the sample size used for any test set related to the automatic analysis and diagnostic software. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data) for any testing that might have been performed to validate the diagnostic software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts or how ground truth was established for any test set related to the diagnostic software.

4. Adjudication Method for the Test Set:

No information is provided regarding any adjudication method for a test set, as details about a test set and ground truth establishment are absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The document does not describe an MRMC comparative effectiveness study. There is no mention of human readers improving with or without AI assistance, nor any effect size. The interpreted ECG is offered to clinicians "on an advisory basis only," suggesting it's an aid, but no formal study comparing human performance with and without this aid is described.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document states that the device includes "Automatic analysis and diagnostic software (SEMIP) for adults." This implies a standalone algorithm for interpretation. However, no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for disease detection) are reported for this algorithm. The statement "Clinical testing is not required" further indicates that rigorous clinical validation of the diagnostic performance was not part of this 510(k) submission. The FDA letter confirms the 510(k) was based on substantial equivalence, not necessarily extensive clinical performance testing.

7. The Type of Ground Truth Used:

Since no performance metrics are reported for the diagnostic software, and no specific test set is described, the type of ground truth used is not specified and appears not to have been a requirement for this specific 510(k) clearance. The clearance is based on substantial equivalence to a predicate device, implying that the predicate's established performance (which is also not detailed here) was sufficient.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size of the training set for the SEMIP diagnostic software.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide any information regarding how the ground truth for the training set was established for the SEMIP diagnostic software.

Summary of Device Performance Study:

Based on the provided text, the 510(k) submission for the ECG-6 Series Electrocardiograph primarily relies on a demonstration of substantial equivalence to a predicate device (SE-601 Series Electrocardiograph K090367 by EDAN Instruments).

No specific clinical study demonstrating the performance of the diagnostic software (SEMIP) in terms of accuracy, sensitivity, or specificity is presented. The document explicitly states "Clinical testing is not required."
The "effectiveness" of the device, particularly the diagnostic software, is implicitly assumed through its similarity to the predicate device and the conduct of non-clinical tests (software, risk, safety, and performance).
The 510(k) focuses on the device's ability to "acquire ECG signals" and that the "interpreted ECG with measurements and interpretive statements is only intended to be used on adult patients and is offered to clinicians on an advisory basis only," rather than proving definitive diagnostic performance of the automated interpretation.

Summary

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510(k) Summary of Safety and Effectiveness -

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

Submitter

AUG - 5 2011

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 305-477-6331 Telephone: 305-477-5351 Fax:

Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: imillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

August 1, 2011

Device name and classification:

ECG-6 Series Electrocardiograph Device Name: .
Classification Name: 870.2340 Electrocardiograph ● Product code: DPS
Regulatory Class: Class II

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K112135 p.2/3

ECG-6 Series Electrocardiograph

Predicate Device:

SE-601 Series Electrocardiograph K090367 Manufacturer: EDAN Instruments

Device Description:

ECG-6 series Smart ECG includes three models ECG-6 Pro, ECG-6 Plus and ECG-6.

Device features include as follows:

Portable, lightweight design .
Easy data input and operation .
. Alphanumeric keyboard and one-touch operation
Built-in rechargeable battery, AC/DC power supply .
Automatic analysis and diagnostic software (SEMIP) for adults ●
Heart rate variability (HRV) analysis .
Internal thermal printer and external printer ●
Support external archiving: USB flash disk, card reader .
Data transmission to PC via Ethernet or serial port ●

Image /page/1/Picture/16 description: The image shows a solid black circle. The circle is slightly irregular in shape, with a few minor imperfections along its perimeter. The background is white, providing a stark contrast to the black circle.

Intended Use:

Effectiveness and Safety Contraindications:

Clinical Test

Clinical testing is not required

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Non-clinical test:

The following safety standards are conducted on the subject device:

Software testing .
Risk analysis .
Safety testing .
Performance test .

Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use as the predicate device.

Substantially Equivalent Determination:

Verification and, validation testing was done on the ECG-6 Series Electrocardiograph. This premarket notification submission demonstrates that ECG-6 Series Electrocardiograph is substantially equivalent to the predicate device.

Image /page/2/Picture/11 description: The image shows the text 'ADVANCED INSTRUMENTATIONS, INC.' in a bold, sans-serif font. The text is black and appears to be a company name or title. The letters are evenly spaced and the overall impression is clean and professional.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above a series of wavy lines, possibly symbolizing water or movement. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement.

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

AUG - 5 2011

Advanced Instrumentations, Inc. c/o Dr. Jorge Millan Official Correspondent for Advanced Instrumentations Hialeah Technology Center 601 West 20 St Hialeah, FL 33010

Re: K112135

Trade/Device Name: ECG-6 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: July 19, 2011 Received: July 26, 2011

Dear Dr. Millan:

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 - Dr. Jorge Millan

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 yours,

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 (if known):

Device Name:

ECG-6 Series Electrocardiograph

Indications for Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ਿੱ- ਅੰਮ (Division St Cardiovas Division of 510/k) Númber

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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).