The intended use of 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

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. 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

The provided text does not contain detailed information about specific acceptance criteria for the SE-601 Series Electrocardiograph, nor does it describe a detailed study proving the device meets particular performance metrics. The summary focuses on regulatory compliance, outlining the device description, intended use, and substantial equivalence to a predicate device.

However, based on the limited information available and making some inferences about standard regulatory practices for ECG devices, I can construct a response. Please note that many fields will be marked as "Not provided" because the document does not offer that level of detail.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Inferred)	Acceptance Threshold (Inferred/Not Provided)	Reported Device Performance (From Summary)
Safety	Electrical Safety	Compliant with relevant standards (e.g., IEC 60601)	"Safety testing" performed
Performance	ECG Signal Acquisition Accuracy	Substantially equivalent to predicate device	"Performance test" performed
	Analysis & Diagnostic Software (SEMIP) Accuracy	Substantially equivalent to predicate device for advisory use	"Automatic analysis and diagnostic software (SEMIP) for adults"
Software Functionality	Software Verification & Validation	Compliant with software development standards	"Software testing" performed
Risk Management	Risk Mitigation Effectiveness	Acceptable risk level	"Risk analysis" performed
Intended Use	Ability to acquire ECG signals from adults and pediatric patients	Meets intended use description	"Acquire ECG signals from adult and pediatric patients"
	Diagnostic statements for adults (advisory only)	Meets intended use description	"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."

Note: The "Acceptance Threshold" and specific "Specific Metric" are largely inferred based on typical regulatory requirements for ECG devices seeking 510(k) clearance, as the document only generally states that "Verification and validation testing was done" and that the device is "substantially equivalent."

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

Sample Size for Test Set: Not provided. The document mentions "Verification and validation testing" but does not specify the number of patients or ECGs used in any performance evaluation.
Data Provenance (e.g., country of origin, retrospective/prospective): Not provided.

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

Number of Experts: Not provided.
Qualifications of Experts: Not provided.
- Inference: For ECG interpretation software, ground truth is typically established by board-certified cardiologists or physicians experienced in ECG reading.

4. Adjudication Method for the Test Set

Adjudication Method: Not provided.
- Inference: If multiple experts were used, common methods include 2-out-of-3 consensus, 3-out-of-5 consensus, or a lead expert adjudicating disagreements.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The submission focuses on substantial equivalence, implying a comparison to a predicate device rather than an evaluation of human reader improvement with AI assistance.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was described.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Study: Yes, an implicit standalone performance evaluation of the "Automatic analysis and diagnostic software (SEMIP)" was likely performed as part of the "Verification and validation testing" and "Performance test." The document states this software provides "analysis and diagnostic software (SEMIP) for adults" 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." This suggests the algorithm's output was evaluated, even if the specific metrics are not detailed.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated.
- Inference: For ECG interpretation software, ground truth is typically established by:
  - Expert Consensus: Independent review by a panel of cardiologists.
  - Clinical Outcomes/Follow-up: Though less common for individual ECG features, clinical correlation might be used for certain diagnoses.
  - Pathology: Not directly applicable to ECG interpretation.
  - Given the "advisory basis only" statement, it's highly probable that expert consensus was the primary method for establishing ground truth for the interpretive statements.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not provided. The document does not describe the development or training of the SEMIP algorithm, only its existence and intended use.

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

Ground Truth Establishment for Training Set: Not provided.
- Inference: Similar to the test set, ground truth for training data would typically be established by expert cardiologists reviewing ECG waveforms and clinical data.

Summary

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510 (K) Summary of Safety and Effectiveness

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

Submitter:

JUN - 3 2009

Edan Instruments, Inc 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#,3x shekou, Nanshan Shenzhen, 518067 P.R. China Tel: +86755 26882220 Fax:+86 755 26882223

Contact person:

Jiang yucai Edan Instruments, Inc.

Proprietary Name:

Classification information: 21 CFR 870.2340, Electrocardiograph Class II

SE-601 Series Electrocardiograph

Product code:

Review Panel:

Cardiovascular

DPS

Predicate Devices:

Device Description:

ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES K072217 CARDIOFAX M Manufacturer: NIHON KOHDEN AMERICA, INC

SE-601 series Smart ECG includes three models SE-601A, SE-601B and SE-601C. 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 4-1

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K090367 pg 2082

RE K090367 Se-601 series 510(k) SUBMISSION

ATTACHMENT 4

Support external archiving: USB flash disk, card reader .
Data transmission to PC via Ethernet or serial port .

The intended use of electrocardiograph is to acquire ECG Intended Use: 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.

Test Summary:

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

Software testing
Risk analysis .
Safety testing .
Performance test

Conclusion:

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edan Instruments, Inc. c/o Mr. William Stern 1 Odell Plaza Yonkers, NY 10701

IIIN - 3 2009

Re: K090367

SE-601 Series Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Codes: DPS Dated: April 9, 2009 Received: April 29, 2009

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 such 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. William Stern

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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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Indication for Use

510(k) Number: K090367

Device Name: SE-601 Series Electrocardiograph

Prescription Use (21 CFR Part 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

At. R. Ste. fo B Zuckerman

(Division Sign-Off) 6/2/09
Division of Cardiovascular Devices

510(k) Number K090367

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).