Electrocardiograph: SE-1200 Pro and SE-1201 Pro

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. July 28, 2023 Edan Instruments, Inc. Milin Wu Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122, China Re: K222902 Trade/Device Name: Electrocardiograph, model: SE-1200 Pro and SE-1201 Pro Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 28, 2023 Received: July 5, 2023 Dear Milin Wu: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shruti N. Mistry -S for Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222902 Device Name Electrocardiograph(SE-1200 Pro. SE-1201 Pro) #### Indications for Use (Describe) The SE-1200 Pro&SE-1201 Pro 12-lead electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrocardiographs are only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recordiograph 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. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary # Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92 | 1. Submitter: | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan<br>District, Shenzhen, 518122 P.R.China.<br>Tel: +86(0755) 84513592<br>Fax: +86(0755) 26882223 | | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | | Liu Yongying | | | Contact person:<br>Preparing date: | September 19, 2022 | | | | Trade Name: Electrocardiograph, model: SE-1200 Pro, SE-1201 Pro | | | 2. Device name and<br>classification: | Common/Usual Name: Electrocardiograph | | | | Classification Name | Product code | | | 21 CFR 870.2340 Electrocardiograph | DPS | | | Regulatory Class: Class II | | | 3. Predicate Device(s): | 1) Edan Instruments, iSE-1210 Electrocardiograph, cleared under K212278<br>(Primary)<br>2) Edan Instruments, SE-1202 Electrocardiograph, cleared under K210140<br>(Reference) | | | 4. Device Description: | SE-1201 Pro&SE-1200 Pro (2 models: SE-1201 Pro and SE-1200 Pro) features<br>a LCD touch screen, an operation panel, user-programmable reports, and the<br>ability to operate on either battery or AC power. It is capable of simultaneous<br>acquisition, display, and print of 12-lead ECG. It uses algorithm to generate<br>measurements, data presentations, graphical presentations and interpretative<br>statements. The record can be saved in flash memory or send to PC. | | | 5. Indication for Use | The SE-1200 Pro&SE-1201 Pro 12-lead electrocardiographs are intended to<br>acquire ECG signals from adult and pediatric patients through body surface<br>ECG electrodes. The electrocardiographs are only intended to be used in<br>hospitals or healthcare facilities by doctors and trained healthcare professionals.<br>The cardiogram recorded by the electrocardiograph can help users to analyze<br>and diagnose heart disease. However, the interpreted ECG with measurements | | {4}------------------------------------------------ # 6. Predicate Device Comparison Comparison to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following tables: | Item | Primary predicate device<br>(iSE-1210) | Proposed device<br>(SE-1201 Pro&SE-1200 Pro) | Comparison Result | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | K# | K212278 | K222902 | — | | Intended Use | The iSE Series electrocardiograph is<br>intended to acquire ECG signals from adult<br>and pediatric patients through body surface<br>ECG electrodes. The electrocardiograph is<br>only intended to be used in hospitals or<br>healthcare facilities by doctors and trained<br>healthcare professionals. The cardiogram<br>recorded by the electrocardiograph can<br>help users to analyze and diagnose heart<br>disease. However, the interpreted ECG<br>with measurements and interpretive<br>statements is offered to clinicians on an<br>advisory basis only. The electrocardiograph<br>is capable of network communications and<br>supports the informatized management of<br>workflows in hospital and healthcare<br>facilities. | The SE-1200 Pro&SE-1201 Pro 12-lead<br>electrocardiographs are intended to acquire<br>ECG signals from adult and pediatric<br>patients through body surface ECG<br>electrodes. The electrocardiographs are only<br>intended to be used in hospitals or<br>healthcare facilities by doctors and trained<br>healthcare professionals. The cardiogram<br>recorded by the electrocardiograph can help<br>users to analyze and diagnose heart disease.<br>However, the interpreted ECG with<br>measurements and interpretive statements is<br>offered to clinicians on an advisory basis<br>only. | Different | | Algorithm | SEMIP | SEMIP or Glasgow | Different | | Number of electrodes | 10 | 10 | Same | | Safety Specifications | | | | | Safety Standards | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-25:2011 | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-2-25:2011 | Same | | Anti-electric-shock type | Class I with internal power supply | Class I with internal power supply | Same | | Anti-electric-shock<br>degree | Type CF | Type CF | Same | | Power Supply Specifications | | | | | Mains Supply | Operating Voltage = 100V-240V~ | Operating Voltage = 100V-240V~ | Same | | | Operating frequency = 50 Hz / 60 Hz | Operating frequency = 50 Hz / 60 Hz | | | | Output Power: 19V, 2.53A | Output Power: 19V, 2.53A | | | | Rated voltage = 15.2V | Rated voltage = 14.8 V | Different | | | Rated capacity = 3550mAh | Rated capacity = 2500mAh | | | Built-in Lithium Battery<br>Pack | When the battery is fully charged, iSE can<br>work (without printing) continuously at<br>least 8 hours.<br>100% recharge time: ≤ 5 hours<br>90% recharge time: < 4 hours | When the battery is fully charged, the<br>SE-1200 Pro&SE-1201 Pro<br>electrocardiograph can work for ≥4 H in<br>auto mode (printing a report once every 2<br>minutes), the SE-1200 Pro&SE-1201 Pro<br>electrocardiograph can work for≥2 H in<br>manual mode, and print 3*4+1R copies of<br>reports automatically ≥ 250 copies.<br>The battery takes just under 2 hours to<br>charge from empty to 90%. | | | Recording | | | | | Recorder | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | | Effective Width | 210mm | 210mm | Same | | ECG Unit | | | | | HR Range | 30 BPM ~ 300 BPM<br>±1 BPM | 30 BPM ~ 300 BPM<br>±1 BPM | Same | | A/D | 24 bits | 24 bits | Same | | Sampling Frequency | 64,000 Hz | 64,000 Hz | Same | | Frequency<br>Response | 0.01 Hz ~ 350 Hz (-3 dB) | 0.01 Hz ~ 350 Hz (-3 dB) | Same | | Input Impedance | ≥100 MΩ(10 Hz) | ≥100 MΩ(10 Hz) | Same | | DC Offset Voltage | ±900 mV | ±960mV, ±5% | Different | | Noise | ≤12.5 μVp-p | ≤12.5 μVp-p | Same | | Filter | AC Filter:<br>50 Hz / 60 Hz / Off<br>DFT Filter:<br>0.01 Hz / 0.05 Hz / 0.32 Hz / 0.67 Hz<br>EMG Filter: | AC Filter:<br>50 Hz / 60 Hz / Off<br>DFT Filter:<br>0.01 Hz / 0.05 Hz / 0.32 Hz / 0.67 Hz<br>EMG Filter: | Same | | | LOWPASS Filter:<br>350 Hz / 300 Hz / 270 Hz / 150 Hz / 100 Hz / 75 Hz | LOWPASS Filter:<br>350 Hz / 300 Hz / 270 Hz / 150 Hz / 100 Hz / 75 Hz | | | CMRR | ≥140 dB (AC filter on)<br>≥123 dB (AC filter off) | ≥140 dB (AC filter on)<br>≥123 dB (AC filter off) | Same | | Pacemaker Detection | | | | | Amplitude | ±500μV to ±700mV | ±500μV to ±700mV | | | Width | 30μs to 2.0ms | 30μs to 2.0ms | Same | | Sampling Frequency | 80,000 /sec/channel, Rhythm Lead | 80,000 /sec/channel, Rhythm Lead | | | Connection | | | | | Wireless connection | WIFI, 4G, Bluetooth, NFC | WIFI, 4G, Bluetooth, | Different | Table 2-1: Comparison between SE-1201 Pro&SE-1200 Pro and iSE-1210 (primary predicate device) {5}------------------------------------------------ {6}------------------------------------------------ #### Table 2-2: Comparison between SE-1201 Pro&SE-1200 Pro and SE-1202 (reference predicate device) | Item | Reference predicate device<br>(SE-1202) | Proposed device<br>(SE-1201 Pro&SE-1200 Pro) | Comparison Result | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | K# | K210140 | Current Submission | — | | Intended Use | The SE-1202 12-lead electrocardiograph is intended 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. | The SE-1200 Pro&SE-1201 Pro 12-lead electrocardiographs are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiographs are 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. | Same | | Algorithm | SEMIP or Glasgow | SEMIP or Glasgow | Same | As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness. # 7. Performance Data: {7}------------------------------------------------ # Non-clinical data: # Electrical safety and electromagnetic compatibility (EMC) The SE-1201 Pro&SE-1200 Pro electrocardiograph were assessed for conformity with the relevant requirements of the following standards and found to comply: - ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010(R) 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. - IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests. ## Performance testing-Bench Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards. - IEC 60601-2-25 Edition 2.0 2011-10 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs ## Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". ## Clinical data: Not applicable. ## Summary The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device. ## 8. Conclusion The bench testing data and software verification and validation demonstrate that Electrocardiograph SE-1201 Pro&SE-1200 Pro is substantially equivalent to the predicate devices.