SE-601 SERIES ELECTROCARDIOGRAPH

K093869 · Edan Instruments, Inc. · DPS · Apr 1, 2010 · Cardiovascular

Device Facts

• Record ID: K093869
• Device Name: SE-601 SERIES ELECTROCARDIOGRAPH
• Applicant: Edan Instruments, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Apr 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface 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 offered to clinicians on an advisory basis only.

Device Story

SE-601 series (models A, B, C) is a portable, lightweight electrocardiograph; acquires ECG signals via body surface electrodes. Features include alphanumeric keyboard, one-touch operation, built-in rechargeable battery, AC/DC power, and internal/external printing. Device performs automatic analysis and diagnostic software (SEMIP) for adults and pediatrics; supports two-step exercise testing with periodic recording and heart rate variability (HRV) analysis. Data output via USB flash disk, card reader, Ethernet, or serial port to PC. Used in hospitals/healthcare facilities by physicians and trained professionals. Interpreted ECG measurements and statements provided on advisory basis to assist clinical diagnosis of heart disease.

Clinical Evidence

No clinical data provided. Verification and validation were based on bench testing, including software testing, risk analysis, safety testing, performance testing, and environmental testing.

Technological Characteristics

Portable electrocardiograph; includes alphanumeric keyboard, internal thermal printer, and rechargeable battery. Connectivity via USB, Ethernet, and serial port. Software includes SEMIP automatic analysis and diagnostic software for adult and pediatric ECG interpretation. Operates on AC/DC power.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes. Intended for use in hospitals or healthcare facilities by doctors and trained healthcare professionals to assist in the analysis and diagnosis of heart disease.

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

• PC ECG (K092010)
• SE-601 series Electrocardiograph (K090367)

Submission Summary (Full Text)

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## 510(K)Summary of Safety and Effectiveness APR - 1 2010

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

The 510(k) number is (if known)_ KO93869

| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax:[phone] |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Jiang yucai<br>Edan Instruments, Inc. |
| Proprietary Name: | SE-601 Series Electrocardiograph |
| Classification<br>information: | 21 CFR 870.2340, Electrocardiograph<br>Class II |
| Product code: | DPS |
| Review Panel: | Cardiovascular |
| Predicate Devices: | PC ECG cleared under K092010<br>Manufacturer: Edan Instruments, Inc.<br>SE-601 series Electrocardiograph cleared under K090367<br>Manufacturer: Edan Instruments, Inc. |
| Device Description: | SE-601 series Smart ECG includes three models SE-601A,<br>SE-601B and SE-601C.<br>Device features include as follows:<br>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 and pediatrics Two-step exercise test with periodic recording |

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- . 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

This submission is to modify the indication for use (intended us) by adding the applicable pediatric population. The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface 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 offered to clinicians on an advisory basis only.

## Test Summary:

Intended Use:

The following quality assurance measures were applied to the development of the SE-601 Series Electrocardiograph:

- Software testing
- . Risk analysis
- Safety testing
- . Performance testing
- . Environmental testing

## Conclusion:

Verification and validation testing was done on SE-601 This premarket Series Electrocardiograph. notification submission demonstrates that the subject device SE-601 Series Electrocardiograph is substantially equivalent to the predicate device above mentioned

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

APR - 1 2010

Edan Instruments, Inc. c/o William Stern, Official Correspondent l Odell Plaza Yonkers, NY 10701

Re: K093869

Trade/Device Name: SE-601 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: March 9, 2010 Received: March 10, 2010

Dear Mr. Stern:

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.

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 (reporting of medical

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Page 2 - Mr. William Stern

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: K093869

Device Name: SE-601 Series Electrocardiograph

Indications For Use:

The intended use of SE-601 is to acquire ECG signals from adult and pediatric patients through body surface 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 offered to clinicians on an advisory basis only.

× Prescription Use _

AND/OR

(21 CFR Part 801 Subpart D)

Over the Counter Use __ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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