(268 days)
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.
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.
The provided document is a 510(k) premarket notification for an ECG device. It outlines the device's technical characteristics and compares them to a predicate device to demonstrate substantial equivalence. However, it explicitly states in Section 8: "There was no clinical testing performed."
Therefore, I cannot provide the information requested in points 1 through 7, or 9, as no clinical study or performance testing against acceptance criteria was conducted for this specific submission to establish clinical accuracy or improvement with AI assistance. The document focuses on non-clinical tests (safety, EMC, software verification) to demonstrate substantial equivalence to a predicate device.
The requested information regarding acceptance criteria and study data would typically be found in a clinical study report or a different section of a more extensive submission for a device that relies on clinical performance data for clearance.
Here's what I can extract and explain based on the provided document:
8. The sample size for the training set:
Not applicable. The document states, "There was no clinical testing performed." This implies no training set was used for performance validation in a clinical context for this submission. The device, an "Electrocardiograph," as described, does not appear to incorporate AI or machine learning that would typically require a training set for its core functionality of acquiring ECG signals. It explicitly states, "ECG301 does not include any automated measurement or analysis of the ECG signal, and does not produce interpretative statements."
9. How the ground truth for the training set was established:
Not applicable, as no training set (for clinical performance evaluation) was used or mentioned.
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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.
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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).
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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
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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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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, ShiYanSub-District, Baoan District, ShenZhen, China. |
| Contact Person of applicant: | |
| Name: | wuyaxiong |
| Address: | 5F, Block A, XinYongFeng Industrial Park,No.2,Tianbao Road, YinRenShi Community, ShiYanSub-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.18Shenzhou Road, Huangpu, Guangzhou, Guangdong510663 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 |
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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
| SEComparisons | Subject device(Electrocardiograph,model: ECG301) | Predicate device(Electrocardiographs, Model: SE-301, SE-300A, SE-300B, SE-3) | Discussion ofdifference | |
|---|---|---|---|---|
| 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 toacquire ECG signals from adult andpediatric patients(above 3 yearsold) through body surface ECGelectrodes. The electrocardiographis intended to be used only inhospitals or healthcare facilities bydoctors and trained healthcareprofessionals. The cardiogramrecorded by ECG301 can helpusers to diagnose heart disease. | The intended use of the 3-ChannelElectrocardiograph is to acquire ECGsignals from adult and pediatricpatients (beginning at birth through 21years of age) through body surfaceECG electrodes. Theelectrocardiograph is intended to beused only in hospitals or healthcarefacilities by doctors and trainedhealthcare professionals. Thecardiogram recorded by the 3-Channel | Similar, the subjectdevice has sameindication aboutECG signals with12-leadsynchronousacquisition andrecord throughbody surface ECGelectrodes withpredicate device | |
| ECG301 does not include anyautomated measurement oranalysis of the ECG signal, anddoes not produce interpretativestatements. The ECG recorded isnot intended to be used formeasurement or analysis of theECG signal, or for the automatedgeneration of interpretativestatements. | Electrocardiograph can help users toanalyze and diagnose heart disease.However, the ECG with measurementsand interpretive statements is offeredto clinicians on an advisory basis only. | not have ECG withmeasurements andinterpretivestatements.Therefore,indication for use ofsubjectdevice(ECG301) iscovered bypredicate device,the difference doesnot raise newquestions of safetyand effectiveness. | ||
| Safety Standards | ANSI AAMI ES 60601-1,IEC 60601-1-2,IEC 60601-2-25 | IEC 60601-1IEC 60601-1-2IEC/EN60601-2-25 | Same | |
| Anti-electric-shocktype | Class I with external power supplyand internal power supply | Class I with internal power supply | Different(Discussion isindicated in D1) | |
| Anti-electric-shockdegree | Type CF | Type CF | Same | |
| Degree ofprotection againstharmful ingress ofwater | Ordinary equipment (Sealedequipment without liquid proof) | Ordinary equipment (Sealedequipment without liquid proof) | Same | |
| Degree of safety ofapplication in thepresence offlammable gas | Equipment not suitable for use inthe presence of flammable gas | Equipment not suitable for use in thepresence 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 ~40°C | Same | |
| 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% RHNon-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~/220V-240 V~ | Different | |
| Operating frequency = 50 Hz / 60Hz | Operating frequency = 50 Hz / 60 Hz | (Discussion isindicated in D2) | ||
| input power = 90 VA | input power = 35 VA | |||
| Built-in LithiumBattery Pack: | Rated voltage = 7.4 V | Rated voltage = 14.4 V | ||
| Rated capacity =4400 mAhWhen the battery is fully charged,ECG301 can work normally 2hours. | Rated capacity =1600 mAhWhen the battery is fully charged, SE-3can work normally 6 hours. | Different(Discussion isindicated 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 thermalpaper | Same | |
| Effective Width: | 80mm | 72 mm | Different(Discussion isindicated in D4) | |
| Paper Speed: | 12.5 mm/s, 25 mm/s, 50mm/s(±3% ) | 5 mm/s, 6.25 mm/s, 10 mm/s, 12.5mm/s, 25 mm/s, 50 mm/s(±3%) | Covered inpredicate 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 | |
| FrequencyResponse: | 0.05 ~ 150Hz(-3db) | 0.05 Hz ~ 150 Hz (-3 dB) | Same | |
| Input Impedance: | ≥50MΩ ( 10Hz ) | ≥50 MΩ (10 Hz) | Same | |
| Input CircuitCurrent: | ≤0.05 µA | ≤0.05 µA | Same | |
| Input VoltageRange | ≤±10 mVpp | ≤±5 mVpp | Different(Discussion isindicated in D5) | |
| Calibration Voltage: | 1mV±2% | 1 mV±3% | Different(Discussion isindicated in D6) | |
| DC Offset Voltage: | ±500 mV | ±500 mV | Same | |
| Noise: | < 15μVp-p | ≤12.5µVp-p | Different(Discussion isindicated in D7) | |
| Multi-channelCrosstalk | ≤0.5 mm | ≤0.5 mm | Same | |
| Filter | AC Filter: Off /50Hz/60Hz | AC Filter: On / Off | Different | |
| DFT Filter: Off/0.05Hz / 0.5Hz | DFT Filter: 0.05Hz / 0.15Hz /0.25Hz /0.32Hz / 0.5Hz /0.67Hz | (Discussion isindicated in D8) | ||
| EMG Filter: 25Hz / 35Hz/45Hz/75Hz/100Hz/150Hz/ | EMG Filter: 25 Hz/35 Hz/45Hz/OFF | |||
| LOWPASS Filter: 300 Hz/270 Hz/150Hz/100 Hz/75 Hz | ||||
| CMRR | ≥100dB | ≥110 dB | Different(Discussion isindicated in D9) | |
| SamplingFrequency | 1000 Hz | 1000 Hz | Same | |
| External Input/ Output | ||||
| Input | > 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)
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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 RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2:2014+A1 :2020 | Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particularrequirements for the basic safety and essential performance ofelectrocardiographs |
| 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.
§ 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).