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.

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.

AI/ML Overview

This 510(k) premarket notification for the EZsleep Sleep Quality Recorder does not contain the detailed information typically found in a study report that directly establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards.

Here's an analysis based on the provided document, addressing your specific points where information is available or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a performance table in the format usually associated with clinical or analytical validation studies. Instead, it relies on general performance claims and adherence to standards.

Acceptance Criterion (Inferred)	Reported Device Performance
Electrical Safety	Meets IEC 60601-1 requirements.
EMC Requirements	Meets IEC 60601-1-2 requirements.
Biocompatibility	Outer casing material tested according to ISO 10993 guidelines for "short-term exposure, skin contact devices."
Functional Performance	"Various bench tests were performed to ensure that the EZsleep Sleep Quality Recorder meets all functional and performance for its intended use." (No specific metrics provided).
Data Storage Capacity	Stores up to four 8-hour recordings.
Battery Life/Charging	Battery can be recharged in less than 4 hours.
User-Friendliness	"Simple and easy to use."
Data Transfer	Recorded signals can be transmitted via USB to a computer for analysis.

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

The document does not specify a sample size for a test set in the context of a clinical performance study. The "Performance Summary" primarily refers to bench tests for electrical safety, EMC, and biocompatibility. These types of tests typically involve a limited number of device units or specific materials rather than patient data.

Data Provenance: Not applicable based on the type of tests described.

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

This information is not provided in the document. The filing describes safety and engineering tests, not a clinical study involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As explained above, the document details engineering and safety tests, not clinical evaluations that typically employ adjudication methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) submission. The device is a "Sleep Quality Recorder" which records heart rate signals. The recorded data is intended for "sleep quality analysis using the software, Sleep Quality Apnea Examination System, which was already cleared by US FDA, as K070855." This implies the EZsleep device is a data acquisition tool, and its primary function being evaluated here is accurate signal recording and safe operation, not diagnostic efficacy compared to human readers.

6. Standalone Performance Study

A standalone performance study, in the sense of an algorithm-only diagnostic performance without human-in-the-loop, is not described for the EZsleep device itself. The EZsleep is a recorder. Its "performance" in this context is about accurately recording signals and meeting safety/EMC standards, not about making diagnostic interpretations. The document explicitly states the recorded data is for analysis by another cleared software (K070855), implying that diagnostic interpretation is handled by that separate system, not the EZsleep recorder in standalone mode.

7. Type of Ground Truth Used

For the bench tests mentioned:

Electrical Safety & EMC: Ground truth would be defined by the specifications in IEC 60601-1 and IEC 60601-1-2. The "truth" is whether the device's electrical characteristics and electromagnetic compatibility fall within the limits set by these standards. This is generally determined by calibrated test equipment.
Biocompatibility: Ground truth is established by ISO 10993 guidelines, which define acceptable levels of biological response to materials. Testing would involve observing biological reactions (e.g., irritation) to the device's materials.

No human expert consensus, pathology, or outcomes data is referenced for establishing ground truth for the EZsleep recorder's performance in this document.

8. Sample Size for the Training Set

The document does not mention a training set as this filing describes a hardware device (recorder) and its associated bench tests, not an AI/ML algorithm that would typically require a training set.

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

Since no training set for an AI/ML algorithm is mentioned, this point is not applicable.

Summary

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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 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.

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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".

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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

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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

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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
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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).