Who is the manufacturer of Electrocardiograph, model: ECG301?

Shenzhen LE Medical Technology Co., Ltd. filed the 510(k) submission for Electrocardiograph, model: ECG301 (K232816).

What is the FDA product code for Electrocardiograph, model: ECG301?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Electrocardiograph, model: ECG301?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Electrocardiograph, model: ECG301?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Electrocardiograph, model: ECG301

K232816 · Shenzhen LE Medical Technology Co., Ltd. · DPS · Jun 7, 2024 · Cardiovascular

Device Facts

Record ID	K232816
Device Name	Electrocardiograph, model: ECG301
Applicant	Shenzhen LE Medical Technology Co., Ltd.
Product Code	DPS · Cardiovascular
Decision Date	Jun 7, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Electrocardiograph (ECG301) acquires 12-lead ECG signals simultaneously via body surface electrodes; device features LCD touchscreen, functional buttons, and built-in thermal dot-matrix recorder for report printing; powered by AC or internal rechargeable battery; used in hospitals/healthcare facilities by physicians and trained professionals; device provides raw ECG signal recordings to assist clinicians in heart disease diagnosis; device explicitly excludes automated measurement, analysis, or interpretative statements; clinical benefit derived from providing high-quality ECG data for professional interpretation.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, and IEC 60601-2-25 confirmed safety and performance specifications.

Technological Characteristics

12-lead ECG; thermal dot-matrix recorder (80mm width); 1000 Hz sampling frequency; 12-bit A/D resolution; input impedance ≥50MΩ; CMRR ≥100dB; AC/battery power; touchscreen interface; software compliant with IEC 62304.

Indications for Use

Indicated for acquisition of ECG signals from adult and pediatric patients (above 3 years old) via body surface electrodes in hospitals or healthcare facilities by trained professionals to assist in heart disease diagnosis.

Regulatory Classification

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.

Predicate Devices

Electrocardiographs (K171943)

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K971440 — FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH · Fukuda Denshi USA, Inc. · Dec 2, 1997
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Submission Summary (Full Text)

{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) | 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." {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 ~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% 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~/220 V-240 V~ | Different | | | | 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: | < 15μVp-p | ≤12.5µVp-p | Different (Discussion is indicated in D7) | | | Multi-channel Crosstalk | ≤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…