The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG measuring device for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.

It is suitable for the adult users (age 18 or older), who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references. This Device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended to use with implanted pacemaker.

Device Description

PC-80 / Prince 180 Easy ECG Monitor is a handheld electrocardiograph unit which can measure, display, and store ECG data by the user. The device can calculate the average heart rate and display the heart rhythm after analysis. Furthermore, it's small, light, and easy to use. A 30-second ECG record is measured and stored in this device. The waveform data and heart rate value can be displayed on LCD screen, and those ECG data records can be reviewed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PC-80 /Prince 180 Easy ECG Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its performance in detecting or interpreting ECG signals. Instead, the performance testing focuses on compliance with established medical device standards.

Acceptance Criteria (Not explicitly stated as performance targets, but implied by compliance)	Reported Device Performance (Summary of compliance)
Safety based on IEC 60601-1	Device has undergone and validated against IEC 60601-1.
Electromagnetic Compatibility (EMC) based on IEC 60601-1-2	Device has undergone and validated against IEC 60601-1-2.
Performance of Ambulatory Electrocardiographs based on AAMI EC 38	Device has undergone and validated against AAMI EC 38.
Risk management and mitigation compliance	Risk analysis identifying potential hazards and documenting mitigation has been developed and applied.
Quality system compliance (21CFR820, ISO 13485)	Quality system conforms to 21CFR820, MDCAS ISO 13485 certified by ORKI.
Heart Rate Monitoring Range	Monitors from 30-240 bpm (Predicate: 2-200 bpm).
ECG measurement capabilities	Measures, displays, and stores ECG data by user. Calculates average heart rate and displays heart rhythm after analysis.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on the sample size used for any clinical test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described is primarily focused on engineering and quality system compliance rather than a clinical performance study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention any clinical test set involving expert review to establish ground truth for ECG interpretation. The device's intended use is for home health care and as a reference tool for doctors, not as a diagnostic tool itself.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with human review requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical standards and device features, not on improved human reader performance with AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

The testing described is focused on the device as a whole, including its ability to measure, display, and store ECG data, and to provide average heart rate and rhythm information. There's no specific mention of a standalone algorithm performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for automatically detecting specific cardiac events. The performance validation is against engineering and safety standards (IEC, AAMI).

7. The Type of Ground Truth Used

For the engineering and safety standards (IEC 60601-1, IEC 60601-1-2, AAMI EC 38) to which the device was validated, the "ground truth" would be the specifications and requirements outlined in those standards. This would involve calibrated test equipment and established protocols to verify electrical safety, EMC, and the accuracy of ECG signal acquisition and basic heart rate calculation as per the AAMI standard. There is no mention of clinical ground truth (e.g., expert consensus, pathology, or outcomes data) in the context of diagnostic accuracy.

8. The Sample Size for the Training Set

The document does not mention a training set, which would typically be associated with AI/ML algorithm development. The device's description suggests a direct measurement and display function, with basic analysis for heart rate and rhythm, rather than a sophisticated AI-driven interpretive algorithm that would require a large training dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned.

Summary

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510(k) Summary of Safety and Effectiveness

Submitter

Shenzhen Creative Industry Co., Ltd. 2/F, Block 3, Nanyou Tian'an Industry Town, Shenzhen, GD, 518054 P. R. China 518054 Fax: +86 755 2643 2832 Tel .: +86 755 2643 3514 E-mail: market@creative-sz.com

JAN 10 2008

Device Name

Trade Name: PC-80 /Prince 180 Easy ECG Monitor Common Name: ECG Monitor Classification Name: Electrocardiograph (21CFR870.2340) Classification: Class II

Predicate Devices (Legally Marketed Devices)

The predicate device for ECG Monitor, Model PC-80 /Prince 180 Easy ECG Monitor series is:

Omron Healthcare, Inc.

Omron Portable ECG Monitor Model: HCG-801 510(K) number: K060766

Device Description

Intended Use

The device is a handheld, personal electrocardiograph (ECG) unit, which can measure electrical activities of the heart easily and conveniently. It's a single LEAD ECG monitor for home health care use. The users can use it themselves to check their heart condition. The device can detect average Heart Rate, display ECG waveform, and give some information about heart rhythm.

It is suitable for the adult user who suffers from cardio-vascular disease, or adults who care about their heart functions during their daily life.

This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide a doctor recorded data as a reference. This device is also not intended for recording and transmission of user's ECG signal simultaneously, and it's not recommended for use with an implanted pacemaker.

The unit is suitable for personal use at home, not suitable for long term monitoring, but spot-checking or clinical patrol at a medical institution or hospital.

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Summary of Technical Characteristics of the Device Compared to the Predicate Devices (Legally Marketed Devices)

The Shenzhen Creative Industry PC-80/Prince 180 Easy ECG Monitor and the Omron ECG Model HCG-801 are used to monitor heart rates via three electrodes. The Omron monitors from 2-200 bpm and the Shenzhen device monitors from 30-240 bpm. Both devices use two AAA batteries and are software driven. Both devices are for use on adults and are for prescriptive use. The Shenzhen device's electrodes can be placed on the chest. leg, and palm; however, the Omron device is to be used on the Chest only. They are similar in weight and operating environments.

Summary of Performance Testing

The Shenzhen Creative Industry Co. LTD PC-80/Prince 180 ECG Easy Monitor has undergone IEC 60601-1, IEC 60601-1-2 and AAMI EC 38 testing validation. PC-80/ Prince 180 ECG Easy Monitor substantially have been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market.

A risk analysis identifying potential hazards and documenting mitigation of the hazards have been developed and applied as part of Shenzhen Creative Industry Co., LTD design control procedure. Shenzhen Creative Industry Co., LTD quality system confirms to 21CFR820, MDCAS ISO 13485 certified by ORKI.

Conclusions

As stated above, the Shenzhen Creative Industry Co. LTD PC-80/Prince 180 ECG Easy Monitor is safe and effective, complies with the appropriate medical device standards, and is substantially equivalent to the earlier identified predicate device.

End of Section -

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized eagle or bird in flight.

JAN 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shenzhen Creative Industry Co., Ltd. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313

Re: K073152

Trade/Device Name: Easy ECG Monitor Models PC-80 and Prince 180 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: DSH Dated: December 18, 2007 Received: December 19, 2007

Dear Mr. Job:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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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Page 2 -Mr. Mark Job

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Bzimmernan for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if know): Device Name: Easy ECG Monitor Model Name 1: PC-80 Model Name 2: Prince 180 Shenzhen Creative Industry Co., Ltd.

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K073152

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).