(268 days)
Not Found
No
The document explicitly states that the device "does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements." This indicates a lack of AI/ML functionality for signal processing or interpretation.
No
The "Intended Use" states that the device helps users diagnose heart disease by acquiring ECG signals, but it does not treat or directly alleviate any medical condition; its purpose is diagnostic, not therapeutic.
Yes
The text states, "The cardiogram recorded by ECG301 can help users to diagnose heart disease," indicating its role in diagnosis.
No
The device description explicitly mentions hardware components such as an LCD display with touchscreen, functional buttons, AC power cord, embedded rechargeable battery, and a built-in thermal dot-matrix recorder.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ECG301 Function: The ECG301 acquires electrical signals directly from the patient's body surface through electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it acquires ECG signals "through body surface ECG electrodes" and helps users "diagnose heart disease" based on these signals. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, based on the provided information, the ECG301 is a medical device, but it falls under the category of a physiological signal acquisition device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
Product codes
DPS
Device Description
Electrocardiograph, models: ECG301, is to acquire multi-channel ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The device can gather and record ECG signals of 12 leads simultaneously. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
Electrocardiograph, models: ECG301, has LCD display with touchscreen and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal dot-matrix recorder for ECG report printing. The Electrocardiograph includes main unit and an AC power cord.
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(above 3 years old)
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)
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1 for safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-2-25:2011 for performance and IEC 62304 for software verification are complied.
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Content of Premarket Submissions for Device Software Functions - Guidance for Industry and FDA Staff, May 2023.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
June 7, 2024
Shenzhen Le Medical Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China
Re: K232816
Trade/Device Name: Electrocardiograph, model: ECG301 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 6, 2024 Received: May 6, 2024
Dear You Yijie:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Kimberly Crowley
For: Jennifer Shih Kozen Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232816
Device Name Electrocardiograph, model: ECG301
The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
Section 5: 510(k) Summary
1. Submitters Information
Establishment Registration Information
| Name: | Shenzhen Le medical Technology Co., Ltd. |
|---|---|
| Address: | 5F, Block A, XinYongFeng Industrial Park, |
| No.2,Tianbao Road, YinRenShi Community, ShiYan | |
| Sub-District, Baoan District, ShenZhen, China. | |
| Contact Person of applicant: | |
| Name: | wuyaxiong |
| Address: | 5F, Block A, XinYongFeng Industrial Park, |
| No.2,Tianbao Road, YinRenShi Community, ShiYan | |
| Sub-District, Baoan District, ShenZhen, China. | |
| TEL: | +86 13316869982 |
| Email: | Wuyaxiongda@163.com |
| Contact Person of the Submission: | |
| Name: | You Yijie |
| Address: | RM.406, Building C, Run Science Park, No.18 |
| Shenzhou Road, Huangpu, Guangzhou, Guangdong | |
| 510663 P.R.China | |
| TEL: | (+86)020-82245821 |
| FAX: | (+86)020-82245821 |
| Email: | jet.you@gimmiq-med.com |
Date prepared: Sep. 12, 2023
2. Device Information
| Trade Name: | Electrocardiograph |
|---|---|
| Model: | ECG301 |
| Classification name: | Electrocardiograph |
| Common or Usual Name: | Cardiovascular Devices |
| Review panel: | Cardiovascular |
| Product code: | DPS |
| Regulation Class: | II |
| Regulation Number: | 870.2340 |
3. Predicate Device Information
| 510(k)
| submitter/holder: | Edan Instruments, Inc. |
|---|---|
| 510(K) Number: | K171943 |
| Trade Name: | Electrocardiographs |
| Model: | SE-301, SE-300A, SE-300B, SE-300G |
5
Classification name: Electrocardiograph Review panel: Cardiovascular Product code: DPS Regulation Class: Regulation Number: 870.2340
4. Device description
Electrocardiograph, models: ECG301, is to acquire multi-channel ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The device can gather and record ECG signals of 12 leads simultaneously. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
Electrocardiograph, models: ECG301, has LCD display with touchscreen and functional buttons. The device can be powered from AC power or through an embedded re-chargeable battery. The device contains built-in thermal dot-matrix recorder for ECG report printing. The Electrocardiograph includes main unit and an AC power cord.
5. Indications for Use
The intended use of ECG301 is to acquire ECG signals from adult and pediatric patients(above 3 years old) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by ECG301 can help users to diagnose heart disease. ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements. The ECG recorded is not intended to be used for measurement or analysis of the ECG signal, or for the automated generation of interpretative statements.
6. Summary of technological characteristics of device compared to the
| SE
Comparisons | Subject device
(Electrocardiograph,
model: ECG301) | Predicate device
(Electrocardiographs, Model: SE-
301, SE-300A, SE-300B, SE-3) | Discussion of
difference | |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510K Number | K232816 | K171943 | / | |
| Classification | 21CFR 870.2340 | 21CFR 870.2340 | Same | |
| Product Code | DPS | DPS | Same | |
| Model | ECG301 | SE-301, SE-300A, SE-300B, SE-3 | / | |
| Indication for use | The intended use of ECG301 is to
acquire ECG signals from adult and
pediatric patients(above 3 years
old) through body surface ECG
electrodes. The electrocardiograph
is intended to be used only in
hospitals or healthcare facilities by
doctors and trained healthcare
professionals. The cardiogram
recorded by ECG301 can help
users to diagnose heart disease. | The intended use of the 3-Channel
Electrocardiograph is to acquire ECG
signals from adult and pediatric
patients (beginning at birth through 21
years of age) through body surface
ECG electrodes. The
electrocardiograph is intended to be
used only in hospitals or healthcare
facilities by doctors and trained
healthcare professionals. The
cardiogram recorded by the 3-Channel | Similar, the subject
device has same
indication about
ECG signals with
12-lead
synchronous
acquisition and
record through
body surface ECG
electrodes with
predicate device | |
| | ECG301 does not include any
automated measurement or
analysis of the ECG signal, and
does not produce interpretative
statements. The ECG recorded is
not intended to be used for
measurement or analysis of the
ECG signal, or for the automated
generation of interpretative
statements. | Electrocardiograph can help users to
analyze and diagnose heart disease.
However, the ECG with measurements
and interpretive statements is offered
to clinicians on an advisory basis only. | not have ECG with
measurements and
interpretive
statements.
Therefore,
indication for use of
subject
device(ECG301) is
covered by
predicate device,
the difference does
not raise new
questions of safety
and effectiveness. | |
| Safety Standards | ANSI AAMI ES 60601-1,
IEC 60601-1-2,
IEC 60601-2-25 | IEC 60601-1
IEC 60601-1-2
IEC/EN60601-2-25 | Same | |
| Anti-electric-shock
type | Class I with external power supply
and internal power supply | Class I with internal power supply | Different
(Discussion is
indicated in D1) | |
| Anti-electric-shock
degree | Type CF | Type CF | Same | |
| Degree of
protection against
harmful ingress of
water | Ordinary equipment (Sealed
equipment without liquid proof) | Ordinary equipment (Sealed
equipment without liquid proof) | Same | |
| Degree of safety of
application in the
presence of
flammable gas | Equipment not suitable for use in
the presence of flammable gas | Equipment not suitable for use in the
presence of flammable gas | Same | |
| Working mode: | Continuous operation | Continuous operation | Same | |
| EMC: | CISPR 11 Group 1, Class A | CISPR 11 Group 1, Class A | Same | |
| Environment Specifications | | | | |
| Temperature | | | | |
| Transport | -20℃~55℃ | -20℃~55℃ | Same | |
| Storage | -20℃~55℃ | -20°C ~ +55°C | Same | |
| Working | 5°C 40°C | 5°C | Different | |40°C | Same | |/220
| Relative Humidity: | | | | |
| Transport &
Storage | 25% RH ~ 93% RH Non-
Condensing | 25% RH ~ 95% RH Non-Condensing | Similar | |
| Working | 25% RH ~ 85% RH Non-
Condensing | 25% RH ~ 80% RH
Non-Condensing | Similar | |
| Atmospheric Pressure: | | | | |
| Transport &
Storage | 700 hPa ~ 1060 hPa | 700 hPa ~ 1060 hPa | Same | |
| Working | 800 hPa ~ 1060 hPa | 800 hPa ~ 1060 hPa | Same | |
| Power Supply Specifications | | | | |
| Mains Supply: | Operating voltage =100 V - 240 V | Operating voltage =100 V-115 V
V-240 V
| | Operating frequency = 50 Hz / 60
Hz | Operating frequency = 50 Hz / 60 Hz | (Discussion is
indicated in D2) | |
| | input power = 90 VA | input power = 35 VA | | |
| Built-in Lithium
Battery Pack: | Rated voltage = 7.4 V | Rated voltage = 14.4 V | | |
| | Rated capacity =4400 mAh
When the battery is fully charged,
ECG301 can work normally 2
hours. | Rated capacity =1600 mAh
When the battery is fully charged, SE-3
can work normally 6 hours. | Different
(Discussion is
indicated in D3) | |
| | Cycle life ≥ 300 times | Cycle life ≥ 300 times | | |
| Performance Specifications | | | | |
| Recording | | | | |
| Recorder: | Thermal dot-matrix recorder | Thermal dot-matrix recorder | Same | |
| Recorder Paper: | Rolled thermal paper | Folded thermal paper Rolled thermal
paper | Same | |
| Effective Width: | 80mm | 72 mm | Different
(Discussion is
indicated in D4) | |
| Paper Speed: | 12.5 mm/s, 25 mm/s, 50mm/s
(±3% ) | 5 mm/s, 6.25 mm/s, 10 mm/s, 12.5
mm/s, 25 mm/s, 50 mm/s(±3%) | Covered in
predicate device | |
| Accuracy of data: | ±5% (x-axis), ±5% (y-axis) | ±5% (x-axis), ±5% (y-axis) | Same | |
| HR Recognition | | | | |
| Technique: | Peak-Peak Detection | Peak-Peak Detection | Same | |
| HR Range: | 30 BPM ~ 300 BPM | 30 BPM ~ 300 BPM | Same | |
| Accuracy: | ±1 BPM | ±1 BPM | Same | |
| ECG Unit | | | | |
| Leads: | Standard 12 leads | Standard 12 leads | Same | |
| Acquisition Mode: | Simultaneously 12 leads | Simultaneously 12 leads | Same | |
| A/D Resolution: | 12 bits | 12 bits | Same | |
| Time Constant: | ≥ 3.2 s | ≥ 3.2 s | Same | |
| Frequency
Response: | 0.05 ~ 150Hz(-3db) | 0.05 Hz ~ 150 Hz (-3 dB) | Same | |
| Input Impedance: | ≥50MΩ ( 10Hz ) | ≥50 MΩ (10 Hz) | Same | |
| Input Circuit
Current: | ≤0.05 µA | ≤0.05 µA | Same | |
| Input Voltage
Range | ≤±10 mVpp | ≤±5 mVpp | Different
(Discussion is
indicated in D5) | |
| Calibration Voltage: | 1mV±2% | 1 mV±3% | Different
(Discussion is
indicated in D6) | |
| DC Offset Voltage: | ±500 mV | ±500 mV | Same | |
| Noise: | 100 kΩ; Sensitivity 10 mm/V±5%;
Single ended | ≥100 kΩ; Sensitivity 10 mm/V±5%;
Single ended | Same | |
| Output | ≤1000; Sensitivity 1 V/mV ±5%;
Single ended | ≤1000; Sensitivity 1 V/mV ±5%;
Single ended | Same | |
predicate devices (K171943)
6
7
8
7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1 for safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-2-25:2011 for performance and IEC 62304 for software verification are complied. See below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601- | |
| 1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General Requirements |
| For Basic Safety And Essential Performance | |
| IEC 60601-1-2:2014+A | |
| 1 :2020 | Medical Electrical Equipment -- Part 1-2: General Requirements |
| For Basic Safety And Essential Performance -- Collateral | |
| Standard: Electromagnetic Disturbances -- Requirements And | |
| Tests | |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular |
| requirements for the basic safety and essential performance of | |
| electrocardiographs | |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Content of Premarket Submissions for Device Software Functions - Guidance for Industry and FDA Staff, May 2023.
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Electrocardiograph, model ECG301 is substantially equivalent to the predicate devices.