(198 days)
No
The summary describes a device for recording heart rate signals for sleep quality analysis, but it does not mention any AI or ML components for the analysis itself. The analysis is performed on a computer after data transmission.
No
The device is a sleep quality recorder used for analysis and is not intended for treatment or monitoring. Its purpose is to record data, not to provide therapy.
No
The device description explicitly states, "This device is not intended to substitute for a hospital device for diagnosis of sleep disorders." While it records data for "sleep quality analysis," it clarifies it's not for diagnosis.
No
The device description explicitly states it is a "small battery powered device" with "integrated microcontroller and LED displays and all necessary interface electronics," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the EZsleep Sleep Quality Recorder 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.
- EZsleep function: The EZsleep Sleep Quality Recorder is a device that is placed on the patient's chest to record heart rate signals from the body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for recording heart rate signals for sleep quality analysis, not for analyzing biological samples.
Therefore, the EZsleep Sleep Quality Recorder falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis. The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.
Product codes
MWI, MWJ
Device Description
The EZsleep Sleep Quality Recorder is a small battery powered device designed to be simple and easy to use by a patient who suffers from sleep disorder. It is self-contained, with integrated microcontroller and LED displays and all necessary interface electronics for performing recording functions. The device has a storage function in which the recorded signals can be transmitted through a USB port to a computer for data analysis. The proposed device is intended for adults who suffer from sleep disorders such as abnormal pauses in breathing (apnea), or instances of abnormally low breathing during sleep (hypopnea). This device is not intended to substitute for a hospital device for diagnosis of sleep disorders. This device is also not intended for recording and transmission of user's heart rate signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
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)
Various bench tests were performed to ensure that the EZsleep Sleep Quality Recorder meets all functional and performance for its intended use. The electrical safety and EMC requirements were tested by independent labs in accordance with the requirements specified in IEC 60601-1 and IEC 60601-1-2. Biocompatibility of the recorder outer casing material was tested according to ISO 10993 guidelines for "short-term exposure, skin contact devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
も服分有
MAR 2 2 2012
Pre-market Notification for EZsleep Sleep Quality Recorder
510(k) Summary of Safety and Effectiveness
1. Submitter
The Platinum Team Co., Ltd. 396 Daye Road Beitou District Taipei City, 11268 TAIWAN
Applicant Correspondent: James Ho Product Director Phone: (011) 886 2 2896 8019 Email: jamesho@platinum-team.net
2. Name and Classification of Device
EZsleep Sleep Quality Recorder Trade Name: Heart rate recorder Common/Usual Name: Classification Name: Electrocardiograph, Ambulatory, Without Analysis 21CFR 870.2800 Classification Number: Product Code: MWI
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| Braemar DigiTrak Plus Holter Recorder | K993617 | 11/24/1999 |
| Del Mar Lifecard CF Compact Holter Recorder | K001025 | 04/19/2000 |
4. Device Description
The EZsleep Sleep Quality Recorder is a small battery powered device designed to be simple and easy to use by a patient who suffers from sleep disorder. It is self-contained, with integrated microcontroller and LED displays and all necessary interface electronics for performing recording functions. The device has a storage function in which the recorded signals can be transmitted through a USB port to a computer for data analysis.
The proposed device is intended for adults who suffer from sleep disorders such as abnormal pauses in breathing (apnea), or instances of abnormally low breathing during sleep (hypopnea). This device is not intended to substitute for a hospital device for diagnosis of sleep disorders. This device is also not intended for recording and transmission of user's heart rate signal simultaneously. Users with implanted pacemaker are not recommended to use this device.
1
Platinum Team
鉑眾科技股份有限公司
5. Indications for Use
The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis using the software, Sleep Quality Apnea Examination System, which was already cleared by US FDA, as K070855.
The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.
6. Technological Characteristics
The technological characteristics of the EZsleep Sleep Quality Recorder are as follows:
- Powered by a lithium battery: -
- Operating voltage and current: 3.8 4.2 v. 1.7 2.4 mA; -
- -The battery can be recharged in less than 4 hours;
- The device does not allow recording while recharging is in progress; -
- Simple and easy to use -
- Self-contained, with integrated microcontroller and LED displays and all necessary interface electronics for performing recording functions.
- Has a storage function for up to four 8-hour recording; -
- -Recorded signals can be transmitted through a USB port to a computer for data analysis.
7. Performance Summary
Various bench tests were performed to ensure that the EZsleep Sleep Quality Recorder meets all functional and performance for its intended use. The electrical safety and EMC requirements were tested by independent labs in accordance with the requirements specified in IEC 60601-1 and IEC 60601-1-2. Biocompatibility of the recorder outer casing material was tested according to ISO 10993 guidelines for "short-term exposure, skin contact devices".
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAR 2 2 2012
The Platinum Team Co., Ltd. c/o Mr. James Ho Product Director 396 Daye Road Beitou District Taipei City, 11268 TAIWAN
Re: K112573
Trade/Device Name: EZsleep Sleep Quality Recorder Regulatory Number: 21 CFR 870.2800 Regulation Name: Ambulatory Electrocardiograph Regulatory Class: II (two) Product Code: MWJ Dated: March 1, 2012 Received: March 2, 2012
Dear Mr. Ho:
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. Iisting 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
3
Page 2 – Mr. James Ho
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name: EZsleep Sleep Quality Recorder
Indications For Use:
The EZsleep Sleep Quality Recorder is to be placed on patient's chest for recording of heart rate signals while patient is asleep. The recorded data is for sleep quality analysis.
The EZsleep Sleep Quality Recorder is not intended for monitoring purpose.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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 | R112573 |
| Page 1 of __ |