(261 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using an "algorithm" for interpretation, which is a general term and doesn't specifically indicate AI/ML.
No
The device is an electrocardiograph used for acquiring ECG signals to help diagnose heart disease, not to treat it.
Yes
The device is an electrocardiograph that acquires ECG signals and uses an algorithm to generate measurements, data presentations, graphical presentations, and interpretative statements to help users analyze and diagnose heart disease. The interpreted ECG information is provided on an advisory basis to clinicians.
No
The device description explicitly refers to an "Electrocardiograph" which is a hardware device that acquires ECG signals through body surface electrodes. The summary also mentions electrical safety and EMC testing, which are relevant to hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device acquires ECG signals directly from the patient's body surface using electrodes. It is measuring electrical activity of the heart, not analyzing a biological sample.
The description clearly states its purpose is to acquire ECG signals from the body surface and help users analyze and diagnose heart disease based on those signals. This falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes
DPS
Device Description
iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling of maximum 12 leads and maximum 18 leads separately. iSE series electrocardiograph uses algorithm to generate measurements, data presentations, graphical presentations and interpretative statements. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.
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
hospitals or healthcare facilities by doctors and trained healthcare professionals.
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) assessed for conformity with ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 and IEC 60601-1-2:2014 (Fourth Edition).
- Performance testing-Bench: Functional and system level testing conducted. Results show the subject device meets its accuracy specification and relevant consensus standards (IEC 60601-2-25 Edition 2.0 2011-10).
- Human Factors Engineering Testing: Usability testing conducted. Results show the device is safe and effective for intended users, uses, and use environments, meeting FDA's Guidance "Applying Human Factors and Usability Engineering to Medical Devices" (February 3, 2016) and IEC 62366-1:2020.
- Software Verification and Validation Testing: Conducted and documented as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Summary: The non-clinical performance testing showed that the subject devices are as safe and as effective as predicate devices.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 7, 2022
Edan Instruments, Inc. Ying Dai Regulatory Engineer #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China
Re: K212278
Trade/Device Name: Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 28, 2022 Received: March 7, 2022
Dear Ying Dai:
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.
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-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.
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Electrocardiograph
Indications for Use (Describe)
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.
| 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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510(k) Summary
Prepared in accordance with the 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 |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:
Preparing date: | Joan. Wei
June 25th, 2021 |
| 2. Device name and
classification: | Electrocardiograph
Classification Name/ Product code: |
| | 21 CFR 870.2340 Electrocardiograph, DPS
Regulatory Class: Class II |
| 3.Premarket Notification
Class III Certification
and Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, SE-18 Electrocardiograph, cleared under K170995
(Primary)
2) Edan Instruments, SE-12, SE-12 Express, SE-1200, and SE-1200 Express
Electrocardiograph, cleared under K171942(Reference) |
| 5. Reason for
Submission | By submission of the Traditional 510(k), Edan Instruments is requesting
clearance for new devices iSE-1210 and iSE-1810 Electrocardiograph. |
| 6.Pre-Submission,
IDE | Not applicable, there is no pre-submission. |
| 7. Device Description: | iSE-1210 and iSE-1810 Electrocardiograph can support ECG Data Sampling of
maximum 12 leads and maximum 18 leads separately. iSE series
electrocardiograph uses algorithm to generate measurements, data presentations,
graphical presentations and interpretative statements. The electrocardiograph is
only intended to be used in hospitals or healthcare facilities by doctors and
trained healthcare professionals. |
4
-
- Indication for 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.
9. Predicate Device Comparison
Comparison to the predicate and reference 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 | Predicate device
(SE-18) | Proposed device
(iSE Series) | Comparison
Result | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------|
| K# | K170995 | K212278 | — | |
| Indications for Use/
Intended Use | The SE-18 18-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 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 | Different | |
| | | workflows in hospital and healthcare
facilities. | | |
| Algorithm | SEMIP V1.8 | SEMIP V1.92 | Different | |
| The number of
electrodes | 16 | iSE-1810: 16
iSE-1210: 10 | Different | |
| Power Supply Specifications | | | | |
| Mains Supply: | Operating Voltage = 100V-240V~
Operating Frequency = 50Hz/60Hz
Input Current = 0.9A ~ 0.4A | Operating Voltage = 100V-240V~
Operating frequency=50Hz/60Hz
Input current=1.1 A | Same
Same
Different | |
| Lithium Battery Pack: | Rated voltage = 14.8 V
Rated capacity = 5000mAh
-- | Rated voltage = 15.2 V
Rated capacity = 3550mAh
When the battery is fully charged, iSE can work (without printing) continuously at least 8 hours.
100% recharge time: ≤ 5 hours
90% recharge time: