(252 days)
Not Found
No
The description focuses on data acquisition, storage, and transfer to a third-party analysis software. There is no mention of AI/ML being used within the device itself or the described workflow.
No
The device is a Holter recorder, which is used for monitoring and diagnosis of cardiac conditions, not for providing therapy or treatment.
Yes
The device is intended for the "Evaluation of symptoms suggesting arrhythmia or myocardial ischemia," which are diagnostic purposes. It records ECG data for analysis by a third-party software, aiding in the diagnosis of cardiac conditions.
No
The device description explicitly states it is comprised of three main components: a patient-worn Sensor (hardware), a Lead wire (hardware), and a host application (software). The Sensor is described as a USB dongle that acquires and stores data, clearly indicating a hardware component.
Based on the provided information, the CK100 CardioKey Holter Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the living body.
- CK100 Function: The CK100 CardioKey Holter Recorder is an ambulatory ECG recorder. It acquires electrical signals directly from the patient's body via electrodes attached to the skin. This is a form of in vivo (within the living body) measurement, not in vitro (outside the living body).
- Intended Use: The intended uses listed all relate to monitoring and evaluating the electrical activity of the heart within the patient, not analyzing bodily fluids or tissues.
Therefore, the CK100 CardioKey Holter Recorder falls under the category of a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The CardioKey Holter Recorder is intended for patients requiring ambulatory (Holter) monitoring. Such monitoring is most frequently used for the indications below:
-
- 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
Product codes (comma separated list FDA assigned to the subject device)
MWJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
1
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:
-
- 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
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
2
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.
3
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
4
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:
-
- 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.
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'