(63 days)
Not Found
No
The summary describes basic signal processing for heart rate calculation and rhythm analysis, but there is no mention of AI, ML, or related concepts.
No.
The device is described as a healthcare tool that provides recorded data as reference and is not intended for use as a conventional diagnostic tool.
No
The device's "Intended Use / Indications for Use" explicitly states: "This device is not intended for use as a conventional diagnostic tool".
No
The device description explicitly states it is a "handheld electrocardiograph unit" and mentions a "LCD screen" for displaying data, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: This device measures electrical activity of the heart directly from the body surface (chest, leg, palm). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a handheld electrocardiograph unit for measuring electrical activities of the heart. It's for home health care use and provides ECG signals and heart rate information.
- Lack of mention of samples: There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of a medical device that interacts directly with the body, rather than an in vitro diagnostic device that analyzes samples taken from the body.
N/A
Intended Use / Indications for 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.
Product codes
DSH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest, leg, and palm
Indicated Patient Age Range
adult users (age 18 or older)
Intended User / Care Setting
personal use at home, or clinical patrol at a medical institution or hospital.
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 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.
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
§ 870.2800 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).
0
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
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.
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.
1
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 -
2
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.
3
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
4
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:
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.
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