(105 days)
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.
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 and pediatrics Two-step exercise test with periodic recording. 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
Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments SE-601 Series Electrocardiograph:
Based on the provided text, the device is an Electrocardiograph (ECG) and the submission is for modifying its indication for use to include the pediatric population. The information does not describe performance characteristics or a specific study proving the device meets particular acceptance criteria, in the way one might expect for an AI-powered diagnostic device. Instead, it focuses on regulatory clearance for an existing ECG device to expand its intended use.
Therefore, many of the requested categories for a study proving device performance are not explicitly present in the provided 510(k) summary. I will extract what is available and note where specific information is missing based on the context of an AI/algorithm-focused study.
Acceptance Criteria and Device Performance Study Analysis:
The provided document is a 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph, primarily focused on modifying its indication for use to include pediatric patients. It describes the regulatory clearance process rather than a detailed performance study with explicit acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) of an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria related to diagnostic performance or explicit reported performance metrics like sensitivity, specificity, or F1-score. The "Test Summary" section lists general quality assurance measures applied to the development of the device, rather than specific performance outcomes against predefined acceptance criteria for diagnostic output.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated for diagnostic performance) | Reported Device Performance (Not explicitly stated for diagnostic performance) |
|---|---|---|
| Software Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Risk Analysis | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Safety Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Performance Testing | (General, not specific performance metrics; likely refers to electrical, signal integrity, and functionality) | "[Performed]" (Implied by submission) |
| Environmental Testing | (General, not specific performance metrics) | "[Performed]" (Implied by submission) |
| Substantial Equivalence | Device is "substantially equivalent" to predicate devices. | Verified through "Verification and validation testing." |
| Pediatric Use | (Not explicitly stated, but implied by the submission requesting this expanded indication) | Device is suitable for pediatric patients. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "Verification and validation testing was done on SE-601 This premarket Series Electrocardiograph" but does not detail the sample size or data provenance for any specific performance study related to its diagnostic capabilities, especially regarding the advisory diagnostic software (SEMIP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes an ECG device with "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics," but it does not detail any expert review process for establishing ground truth if such software's performance was evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no indication that an MRMC comparative effectiveness study was performed or any reporting of an effect size for human reader improvement with AI assistance. The diagnostic software is described as "advisory basis only," suggesting it's an interpretive aid rather than a primary diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "Automatic analysis and diagnostic software (SEMIP) for adults and pediatrics" which implies a standalone algorithmic function. However, no specific standalone performance metrics (e.g., sensitivity, specificity of SEMIP) are reported in this 510(k) summary. The statement that "interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only" reinforces that the algorithm's output is not intended as a definitive diagnosis without human review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of Findings:
The provided 510(k) summary for the Edan Instruments SE-601 Series Electrocardiograph is a regulatory document focused on obtaining clearance for an expanded indication for use (pediatric patients) for an existing ECG device. It emphasizes the device's substantial equivalence to predicate devices and general quality assurance measures applied during development.
It does not contain the detailed information typically expected for a study evaluating the performance of an AI or algorithmic diagnostic component, such as specific acceptance criteria for diagnostic accuracy, test set sample sizes, data provenance, expert ground truth establishment, or comparative effectiveness studies. The interpretive software (SEMIP) is acknowledged, but its specific performance metrics are not detailed, and its role is explicitly stated as "advisory only."
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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, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86755 26882220Fax:+86 755 26882223 |
|---|---|
| Contact person: | Jiang yucaiEdan Instruments, Inc. |
| Proprietary Name: | SE-601 Series Electrocardiograph |
| Classificationinformation: | 21 CFR 870.2340, ElectrocardiographClass II |
| Product code: | DPS |
| Review Panel: | Cardiovascular |
| Predicate Devices: | PC ECG cleared under K092010Manufacturer: Edan Instruments, Inc.SE-601 series Electrocardiograph cleared under K090367Manufacturer: Edan Instruments, Inc. |
| 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 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 (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: 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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§ 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).