(9 days)
No
The description focuses on standard ECG analysis techniques and data processing, with no mention of AI or ML.
No.
The device is an analysis system for ECG data, displaying and organizing information for a physician's review rather than directly treating a condition or performing therapy on a patient.
No
The device explicitly states, "The Holter Plus TM does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form." It is intended for review and analysis by a clinician, who then makes the diagnosis.
No
The device description explicitly states that the system is comprised of a standard computer display, a standard PC-based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder). This indicates the device includes hardware components beyond just software.
Based on the provided text, the Holter Plus™ Ambulatory ECG Analysis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Holter Plus™ Function: The Holter Plus™ system analyzes electrical signals from the heart (ECG data) recorded externally on a patient's body. It does not process or analyze biological specimens taken from the body.
- Intended Use: The intended use clearly states it's for assessing a patient's ambulatory ECG data, reviewing and analyzing it, and producing reports. This is a physiological measurement and analysis, not an in vitro test.
Therefore, the Holter Plus™ Ambulatory ECG Analysis System falls under the category of a physiological monitoring and analysis device, not an IVD.
N/A
Intended Use / Indications for Use
The Holter Plus ™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Product codes
DQK
Device Description
The Holter Plus™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder - 510(k) K993618). The Holter Plus™ Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar RZ153+ recorder.
The Holter Plus™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Holter Plus TM does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form. The physician will be able to review, edit, and print the data collected. The Holter Plus™ will provide information such as when patient-activated events occurred.
The Holter Plus™ Ambulatory ECG Analysis System provides storage of patient data for archiving and printing various reports. This includes waveform and patient parameter data for the ambulatory ECG data and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.
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
General hospital or clinical use by medical professionals. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
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)
Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices.
Conformance to the product development procedures and plans have been assured by the application of the system tests, design reviews, and product verification testing performed prior to product release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K930564, K012686, K881905, K002544, K8841524
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
SEP 2 2 2004
510(k) Summary of Safety and Effectiveness
Submitter Information:
Rozinn Electronics Inc. 71-22 Myrtle Ave. Glenside. NY 11385-7254 Phone: 718-386-5526 Contact: Mark Rosoff, President
Product Name:
Holter Plus™ Ambulatory ECG Analysis System Proprietary: Common: Programmable Diagnostic Computer and Software. Classification: Class II (see 21 CFR - 870.1425)
Predicate Devices:
The predicate device(s) are the following:
-
- Northeast Monitoring Inc. Holter for Windows System (510(k) K930564).
-
- Caird Technology Holter 2000 System. (510(k) K012686).
- Advanced BioSensor ABS Holter (formerly Micro SI Ambulatory ECG Monitor) 3. System (510(k) K881905).
-
- Oxford Scientific Medilog Excel 2 System. (510(k) K002544).
-
- Biomed Systems Inc. WinPV Holter System. (510(k) K8841524).
These predicate devices have the same performance specifications as the Holter Plus™ Ambulatory ECG Analysis System
Device Description:
The Holter Plus™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder - 510(k) K993618). The Holter Plus™ Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar RZ153+ recorder.
The Holter Plus™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Holter Plus TM does not perform any diagnosis of data, but only displays the
1
ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form. The physician will be able to review, edit, and print the data collected. The Holter Plus™ will provide information such as when patient-activated events occurred.
The Holter Plus™ Ambulatory ECG Analysis System provides storage of patient data for archiving and printing various reports. This includes waveform and patient parameter data for the ambulatory ECG data and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.
Intended Uses:
The Holter Plus™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and enidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities(e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Technological Comparison to Predicate Device(s):
The Holter Plus™ Ambulatory ECG Analysis System uses the same type of technology (i.e. personal computers and Microsoft Windows-based data analysis software) that is found in the predicate devices listed above.
Summary of Performance Testing:
Tests demonstrating ambulatory ECG testing equivalence with the predicate devices listed above has been performed, and these results show similar performance with these devices.
Conformance to the product development procedures and plans have been assured by the application of the system tests, design reviews, and product verification testing performed prior to product release.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
SEP 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rozinn Electronics, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K042463 K042405
Trade Name: Holter Plus™ Ambulatory ECG Analysis System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 10, 2004 Received: September 13, 2004
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togals actment date of the Medical Device Amendments, or to Conninered processified in accordance with the provisions of the Federal Food, Drug, devices that have been recuire in asse equire approval of a premarket approval application (PMA). allu Cosmette Act (71ct) market the device, subject to the general controls provisions of the Act. The r ou may, dicierore, market the Act include requirements for annual registration, listing of general voltable provider ing 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to basil adalarians, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Robert Mosenkis
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B.Zimmerman for
B. Z. Zimmerman, M.D.
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K042463
Ind, fort
Indications for Use
510(k) Number (if known):
Device Name: Holter Plus
Indications for Use:
The Holter Plus ™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Prescription Use (Per 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)
Blummenstiel
510(k) Number
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