(53 days)
The intended use of SE-1201 12-channel electrocardiograph 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-1201 is 12-channel electrocardiograph, it's configured with a 7inch Multi-color screen with 800*480 dots resolution. SE-1201 is mainly composed of the ECG board, the power supply board, the Key board and the main board. SE-1201 can acquire 12 channel waveforms simultaneously, which can also print out 12 channel electrocardiograph wave simultaneously by a 216mm wide thermal printer, and the waveforms also can be displayed in LCD and stored in flash memory or send to PC by Ethernet. SE-1201 has the features as follows: Supporting barcode scanner Supporting multi-language ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously Full alphanumeric keyboard (touch screen is optional) Real-time uploading to PC ECG Multiple file formats: DAT, PDF, SCP, FDA-XML High resolution thermal recorder, recording frequency response ≤150Hz Flexible printing formats The auto, manual, rhythm, R-R analysis and off modes can be chosen freely Automatic baseline adjustment for optimal printing Convenient operation of system setup and file management Measurement function and interpretation function Hint information of lead off, lack of paper, low battery capacity etc. Built-in rechargeable lithium battery with large capacity ECG data can be transmitted to the PC software through the net cable, or wireless AP (optional).
Here's an analysis of the provided text regarding the acceptance criteria and study for the SE-1201 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly define acceptance criteria as quantitative metrics for specific performance parameters of an interpretive ECG algorithm (e.g., sensitivity, specificity for certain heart conditions). Instead, the "Test Summary" and "Conclusion" indicate a broader approach to demonstrating substantial equivalence for the entire device, which includes software functionality like "measurement function and interpretation function."
The acceptance criteria implied are that the device's overall performance and safety are comparable to the predicate device (MAC 5000 ECG Analysis System K014108). The study merely states that "Verification and validation testing was done on SE-1201" and concludes "This pre-market notification submission demonstrates that SE-1201 is substantially equivalent to the predicate device."
Therefore, a table of specific quantitative acceptance criteria and reported performance cannot be generated from the given text. The relevant parts are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Overall safety and effectiveness comparable to predicate device. | Substantially equivalent to the predicate device (MAC 5000 ECG Analysis System K014108). |
| Meets the requirements of applicable quality assurance measures. | Software testing, risk analysis, safety testing, and environment testing were applied. |
| Functionality (including measurement and interpretation function) as described. | Device has "Measurement function and interpretation function." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set, nor the data provenance (e.g., country of origin, retrospective/prospective nature). The "Test Summary" broadly states "Verification and validation testing was done," but no specifics about the dataset used for this testing are included.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for any testing, particularly for the "interpretation function." Given that this is a 510(k) summary for an electrocardiograph, and not a detailed clinical study report for an AI diagnostic algorithm, such granular information is typically not included. The interpretation function is offered "on an advisory basis only," suggesting that human experts are ultimately responsible for diagnosis.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for a test set. This level of detail is absent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, nor any effect size. This device is an electrocardiograph that includes an interpretation function, not explicitly an AI-assisted diagnostic platform in the contemporary sense that would warrant an MRMC study from this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not explicitly state that a standalone performance study was done for its interpretation algorithm. The "interpretation function" is listed as a feature, but its standalone diagnostic accuracy metrics are not presented. The overall "substantial equivalence" is for the entire device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for evaluating the "interpretation function" (e.g., expert consensus, pathology, outcomes data). For an ECG interpretation algorithm of this era, ground truth would most commonly involve expert cardiologist interpretation or potentially correlation with patient outcomes or other diagnostic tests, but this information is not provided.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. The process described is for a predicate device comparison for an electrocardiograph, not an AI model requiring a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (see point 8), there is no information provided on how ground truth for a training set was established.
Summary of Missing Information:
This 510(k) summary is for a more traditional medical device (electrocardiograph) that includes an "interpretation function." It is not structured like a submission for a modern AI/ML diagnostic software, which would typically contain detailed performance metrics, ground truth establishment, sample sizes, and study designs for the algorithm itself. The focus of this document is on establishing substantial equivalence of the entire device, including its electrical, mechanical, and basic software functions, to a predicate device. Therefore, much of the specific information requested in the prompt regarding AI model evaluation is not present in this 2011 document.
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510(K)Summary of Safety and Effectiveness MAR 1 6 2012
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter: | Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: +86 755 26882220Fax:+86 755 26882223 |
|---|---|
| Contact person: | Yue QiuhongEdan Instruments, Inc. |
| Date: | 2011-12-01 |
| Proprietary Name: | SE-1201 |
| Classification Name: | 21 CFR 870.2340 ElectrocardiographClass II |
| Product code: | DPS |
| Predicate Devices: | MAC 5000 ECG Analysis System K014108Manufacturer: GE medical systems information technologies |
| Device Description: | SE-1201 is 12-channel electrocardiograph, it's configuredwith a 7inch Multi-color screen with 800*480 dots resolution.SE-1201 is mainly composed of the ECG board, the powersupply board, the Key board and the main board.SE-1201 can acquire 12 channel waveforms simultaneously,which can also print out 12 channel electrocardiograph wavesimultaneously by a 216mm wide thermal printer, and thewaveforms also can be displayed in LCD and stored in flashmemory or send to PC by Ethernet.SE-1201 has the features as follows:Supporting barcode scannerSupporting multi-language |
| 25 | |
| ECG signals of 12 leads are gathered and amplified | |
| simultaneously, 12-channel waves are displayed and | |
| recorded simultaneously | |
| Full alphanumeric keyboard (touch screen is optional) | |
| Real-time uploading to PC ECG | |
| Multiple file formats: DAT, PDF, SCP, FDA-XML | |
| High resolution thermal recorder, recording frequency | |
| response ≤150Hz | |
| Flexible printing formats | |
| The auto, manual, rhythm, R-R analysis and off modes can | |
| be chosen freely | |
| Automatic baseline adjustment for optimal printing | |
| Convenient operation of system setup and file management | |
| Measurement function and interpretation function | |
| Hint information of lead off, lack of paper, low battery | |
| capacity etc. | |
| Built-in rechargeable lithium battery with large capacity | |
| ECG data can be transmitted to the PC software through the | |
| net cable, or wireless AP (optional). | |
| Intended Use: | The intended use of SE-1201 12-channel electrocardiograph |
| 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: | The following quality assurance measures were applied to |
| the development of the SE-1201. | |
| ● Software testing | |
| ● Risk analysis | |
| ● Safety testing | |
| ● Environment testing |
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Verification and validation testing was done on SE-1201. Conclusion: This pre-market notification submission demonstrates that SE-1201 is substantially equivalent to the predicate device.
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 6 2012
Edan Instruments c/o Ms. Tracy Yue Certification Engineer 3/F - B Nanshan Medical Equipments Park, Nanhai Rd 1019# Shenzhen Guangdong 518067 CHINA
Re: K120188
Trade/Device Name: SE-1201 Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: February 17, 2012 Received: February 21, 2012
Dear Ms. Yue:
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
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Page 2 - Ms. Tracy Yue
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 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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Indication for Use
510(k) Number (if known):
SE-1201 Device Name:
The intended use of SE-1201 12-channel electrocardiograph is to acquire ECG signals from The micilaed are of of 92 02 02 through body surface ECG electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare mofessionals. The cardiogram recorded by the electrocardiograph can help users to analyze and prorose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
Over the Counter Use Or Prescription Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K120188
§ 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).