ECG-6 SERIES ELECTROCARDIOGRAPH

K112135 · Advanced Instrumentations, Inc. · DPS · Aug 5, 2011 · Cardiovascular

Device Facts

• Record ID: K112135
• Device Name: ECG-6 SERIES ELECTROCARDIOGRAPH
• Applicant: Advanced Instrumentations, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

ECG-6 Series (Pro, Plus, ECG-6) is a portable, lightweight electrocardiograph for hospital/clinical use by trained professionals. Device acquires ECG signals via body surface electrodes; processes signals using SEMIP software for automatic analysis/diagnosis and HRV analysis. Output includes visual display of ECG waveforms, internal thermal printouts, or external printing; data can be archived via USB/card reader or transmitted to PC via Ethernet/serial port. Clinicians use interpreted ECG measurements and statements as advisory tools to assist in heart disease diagnosis. Device operates on AC/DC power with built-in rechargeable battery.

Clinical Evidence

No clinical data. Bench testing only, including software testing, risk analysis, and performance testing.

Technological Characteristics

Portable electrocardiograph; alphanumeric keyboard; internal thermal printer; AC/DC power with rechargeable battery. Connectivity: Ethernet, serial port, USB, card reader. Software: SEMIP automatic analysis and diagnostic software for adults. Class II device (21 CFR 870.2340).

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition. Interpretive statements and measurements are indicated for adult patients only. Intended for use by doctors and trained healthcare professionals in hospitals or healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• SE-601 Series Electrocardiograph (K090367)

Submission Summary (Full Text)

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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: [phone] Fax:

Registration # 1066270

## Official correspondent :

Jorge Millan, PhD Email: [e-mail] 601 West 20 St Hialeah, FL 33010 Phone : [phone]

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:

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.

#### 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 [phone] or [phone] 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:

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.

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)

J

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

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