The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use:

Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
Evaluation of patients for ST segment changes.
Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
Clinical and epidemiological research studies.
Reporting of time and frequency domain heart rate variability.
Reporting of QT Interval.

Device Description

The CardioKey Hotter Recorder, Model CK100, is an ambulatory ECG recorder which is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Lead wire and 3) a host application.
The Sensor is a USB dongle that acquires ECG data and stores the data in nonvolatile memory. The Sensor is worn for up to 14 days and operates on one coin cell battery for the duration of the recording period. This Sensor can plug directly into a host computer's USB port for data transfer.
The female end of the lead wire cable assembly plugs onto the Sensor. The lead wire cabling on the other end of the assembly is connected to the User via two electrodes
The host application extracts user data from the Sensor and translates it to processing by a 510(k) cleared third party analysis software.

AI/ML Overview

The provided text describes the CardioKey Holter Recorder, Model CK100, a medical device for ambulatory ECG monitoring. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported performance metrics, ground truth establishment, or sample sizes for test and training sets.

The document states that the device "meets the requirements of following performance standards" and lists:

ANSI/AAMI EC 38:2007 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
IEC60601-1:1988+A1:1991+A2:1995 - Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

These are general safety and performance standards for medical electrical equipment, not specific, quantitative acceptance criteria with corresponding device performance metrics. The document does not provide any specific "reported device performance" against quantitative acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text.

Based on the provided information, I can answer some of the other requested points:

1. A table of acceptance criteria and the reported device performance

Not provided in the text. The document states compliance with general medical device standards (ANSI/AAMI EC 38:2007, IEC60601-1:1988, IEC60601-1-2:2007) but does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy for a particular arrhythmia detection) or corresponding reported device performance for these criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the text. No information on a specific test set, its size, or data provenance is mentioned. The "Summary of Performance Testing" refers to compliance with safety and performance standards generally, not a specific clinical or performance evaluation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Since no specific test set and ground truth establishment are detailed, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No adjudication method is mentioned as there's no detailed test set described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a Holter recorder, a data acquisition device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not provided/Not fully applicable. The device records ECG data and stores it for processing by a "510(k) cleared third party analysis software." The document does not describe the performance of this third-party analysis software or any standalone algorithm performance testing of the recorder itself beyond its ability to record and store data according to general standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. No specific ground truth type is mentioned as there is no detailed performance study described.

8. The sample size for the training set

Not applicable/Not provided. This device is a hardware recorder, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8).

Summary

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510(k) Summary

Date: 02/04/2013

Submitter Name and Address Braemar Manufacturing LLC 750 B St. Suite 1400 San Diego, CA 92101

Contact Person Kent Savler Tel # 619-243-7560

OCT 1 6 2013

Name of Device

Model CK100 - CardioKey Holter Recorder

Common/Usual Name:

Trade/Proprietary Name:

Medical Magnetic Tape Recorder

Classification Name:

CFR 8870.2800 Product Code: MWJ Medical Magnetic Tape Recorder

Class:

Class II

Predicate Device The predicate device is as follows:

Braemar Model DL900 Series Holter Recorder manufactured by Braemar, Inc. cleared by FDA under 510(k) number K071733; 870.2800 Product code MWJ 'Medical Magnetic Tape Recorder' on July 24, 2007

Device Description

The CardioKey Hotter Recorder, Model CK100, is an ambulatory ECG recorder which is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Lead wire and 3) a host application.

The Sensor is a USB dongle that acquires ECG data and stores the data in nonvolatile memory. The Sensor is worn for up to 14 days and operates on one coin cell battery for the duration of the recording period. This Sensor can plug directly into a host computer's USB port for data transfer.

The female end of the lead wire cable assembly plugs onto the Sensor. The lead wire cabling on the other end of the assembly is connected to the User via two electrodes

The host application extracts user data from the Sensor and translates it to processing by a 510(k) cleared third party analysis software.

Indications for Use

The indications for use for the subject device are as follows:

Braemar Manufacturing LLC 750 B Street, Suite 1400 San Diego, CA 92101 (619) 243-7500

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CardioKey Holter Recorder

The CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia
1. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
1. Evaluation of patients for ST segment changes
1. Evaluation of a patient's response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery)
1. Clinical and epidemiological research studies
1. Reporting of time and frequency domain heart rate variability
1. Reporting of QT interval

Technological comparison to predicate device

The primary technological differences between the subject device and the predicate device (K071733) are that the subject device uses a common coin cell battery while predicate device uses a AAA alkaline battery and the recording time is minimum 14 days for the subject device while predicate device records up to 7 days only. The subject device also has higher memory capacity. The subject device records only one channel of data while predicate device can record 2 or 3 channels.

Summary of Performance Testing

The CardioKey Holter Recorder Model CK100 meets the requirements of following performance standards,

. ANSI/AAMI EC 38:2007 - Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
. IEC60601-1:1988+A1:1991+A2:1995 - Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

Substantial Equivalence Conclusion

CardioKey Holter Recorder, Model CK100 is safe, effective, and substantially equivalent to the predicate device as supported by the descriptive information and the performance testing.

Braemar Manufacturing LLC 750 B Street, Suite 1400 San Diego, CA 92101 (619) 243-7500

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2013

Braemar Manufacturing, LLC c/o Mr. Kent Sayler VP of Regulatory Affairs and Quality Assurance 750 B Street, Suite 1400 San Diego, CA 92101

Re: K130294

Trade/Device Name: Model CK100 - Braemar CardioKey Holter Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: September 13, 2013 Received: September 16, 2013

Dear Mr. Sayler:

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. 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.

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Page 2 - Mr. Kent Savler

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Safetv/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.

Sincercly vours,

Owen-P.Faris -S

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 known): K130294

Device Name: __ Model CK100 - BraemarCardioKeyHolterRecorder

Indications for Use:

The CK100 CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) Monitoring. The following is a listing of the most frequent indications for use:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
1. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
1. Evaluation of patients for ST segment changes.
1. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
1. Clinical and epidemiological research studies.
1. Reporting of time and frequency domain heart rate variability.
1. Reporting of QT Interval.

Prescription Use X (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)

Clove
H
Digitally signed by
Owen P. Faris -S
Date: 2013.10.16
09:4521-04'00'

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).