(308 days)
No
The description mentions using an "algorithm" for measurements and interpretation, which is standard for ECG devices and does not specifically indicate AI/ML. There are no mentions of AI, DNN, or ML, nor descriptions of training or test sets typically associated with AI/ML development.
No
The description states its purpose is to "acquire ECG signals" and "help users to analyze and diagnose heart disease," which are diagnostic functions, not therapeutic.
No
The device acquires ECG signals and provides interpretive statements for advisory purposes, but the "Intended Use" states that the cardiogram "can help users to analyze and diagnose heart disease" while the interpretive statements are "offered to clinicians on an advisory basis only." This indicates the device assists in diagnosis rather than performing it definitively. Additionally, the device's primary function is signal acquisition and presentation.
No
The device description explicitly mentions hardware components such as an LCD touch screen, operation panel, and the ability to operate on battery or AC power, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The SE-1200 Pro & SE-1201 Pro electrocardiographs acquire ECG signals directly from the patient's body surface using electrodes. This is a non-invasive procedure performed on the body (in vivo).
- Intended Use: The intended use is to acquire ECG signals and help analyze and diagnose heart disease based on these signals. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, because the device works by acquiring signals directly from the patient's body rather than analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DPS
Device Description
SE-1201 Pro&SE-1200 Pro (2 models: SE-1201 Pro and SE-1200 Pro) features a LCD touch screen, an operation panel, user-programmable reports, and the ability to operate on either battery or AC power. It is capable of simultaneous acquisition, display, and print of 12-lead ECG. It uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The record can be saved in flash memory or send to PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
doctors and trained healthcare professionals in hospitals or healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan
District, Shenzhen, 518122 P.R.China.
Tel: +86(0755) 84513592
Fax: +86(0755) 26882223 | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Liu Yongying | |
| Contact person:
Preparing date: | September 19, 2022 | |
| | Trade Name: Electrocardiograph, model: SE-1200 Pro, SE-1201 Pro | |
| 2. Device name and
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
(Primary)
2) Edan Instruments, SE-1202 Electrocardiograph, cleared under K210140
(Reference) | |
| 4. Device Description: | SE-1201 Pro&SE-1200 Pro (2 models: SE-1201 Pro and SE-1200 Pro) features
a LCD touch screen, an operation panel, user-programmable reports, and the
ability to operate on either battery or AC power. It is capable of simultaneous
acquisition, display, and print of 12-lead ECG. It uses algorithm to generate
measurements, data presentations, graphical presentations and interpretative
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
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 | |
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
(iSE-1210) | Proposed device
(SE-1201 Pro&SE-1200 Pro) | Comparison Result |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| K# | K212278 | K222902 | — |
| Intended Use | The iSE Series 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 electrocardiograph
is capable of network communications and
supports the informatized management of
workflows in hospital and healthcare
facilities. | 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. | Different |
| Algorithm | SEMIP | SEMIP or Glasgow | Different |
| Number of electrodes | 10 | 10 | Same |
| Safety Specifications | | | |
| Safety Standards | IEC 60601-1:2005/A1:2012
IEC 60601-1-2:2014
IEC 60601-2-25:2011 | IEC 60601-1:2005/A1:2012
IEC 60601-1-2:2014
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
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
Pack | When the battery is fully charged, iSE can
work (without printing) continuously at
least 8 hours.
100% recharge time: ≤ 5 hours
90% recharge time: