(14 days)
No
The summary describes a standard ambulatory ECG analysis system that performs high-speed analysis, classification of morphologies, and data display/reporting. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: The device is an ECG analysis system used for assessing and reviewing ambulatory ECG data, but it does not perform any diagnosis or offer therapeutic interventions. Its primary function is to display and analyze data for review by a clinician.
Yes
The device is intended to assist trained physicians or healthcare professionals in evaluating arrhythmias and ischemic attacks, among other conditions, by analyzing ambulatory ECG data. This analytical function is a key aspect of diagnosis.
No
The device description explicitly states that the system is 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 DXP1000 data recorder). This indicates it is a system that includes hardware components, not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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.
- Device Function: The QRS-Card Cardiology Suite 4.0™ analyzes ambulatory ECG data, which is electrical activity recorded directly from the patient's body via electrodes. This is an in-vivo measurement, not an in-vitro test on a sample.
- Intended Use: The intended use clearly states the system is for assessing a patient's ambulatory ECG data to evaluate arrhythmias, ischemic attacks, etc. This is based on physiological signals, not laboratory analysis of biological samples.
Therefore, the device falls under the category of a medical device that performs physiological monitoring and analysis, not an IVD.
N/A
Intended Use / Indications for Use
The Cardiology Suite 4.0™ 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 patient’s response after resuming clinic / occupational / and / 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 associations and medical professional, and not intended for any home use applications.
Product codes
DQK
Device Description
The Cardiology Suite 4.0™ 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 DXP1000 data recorder - 510(k) K993618). The Cardiology Suite 4.0TM 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 XP 1000 recorder.
The Cardiology Suite 4.0™ 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 Cardiology Suite 4.0™ does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated from the data, such as heart rate trends and RR variability in graphical form. A PC will provide a means of review, such as when patient-activated events occurred.
The Cardiology Suite 4.0™ Ambulatory ECG Analysis System provides storage of waveform and patient data for archiving and printing various reports. This includes waveform and patient data for archiving and printing various reports. Also, the waveform and parameter data can be retrieved for patient 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
medical professionals, trained physician or health care professional / general hospital or clinical use, Cardiology areas of the hospital
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
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 and validation testing performed prior to product release.
Key Metrics
Not Found
Predicate Device(s)
K930564, K012686, K881905, K002544, K8841524
Reference Device(s)
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
OCT 2 2 2004
K042799
page 1 of 2
510(k) Summary of Safety and Effectiveness
Submitter Information:
Pulse Biomedical Inc. 935 South Trooper Rd. Norristown, PA 19403 Phone: 610-666-5510 Contact: Saleem Hasan, President FAX: 610 666-5630 Product Name:
Cardiology Suite 4.0™ Ambulatory ECG Analysis System Proprietary: Programmable Diagnostic Computer and Software. Common: 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) 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 Cardiology Suite 4.0TM Ambulatory ECG Analysis System
Device Description:
The Cardiology Suite 4.0™ 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 DXP1000 data recorder - 510(k) K993618). The Cardiology Suite 4.0TM 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 XP 1000 recorder.
The Cardiology Suite 4.0™ 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 Cardiology Suite 4.0™ does not perform any diagnosis of data,
1
but only displays the ECG morphologies, and associated curves calculated form the data but only displays the LCG morphologics, and graphical form. The physician will be able
such as heart rate trends and RR variability in graphical form. A PM will provide such as nearl Tate trends and ICC variability in grapped on will provide io roviow, och, as when patient-activated events occurred.
The Cardiology Suite 4.0™ Ambulatory ECG Analysis System provides storage of The Cardionogy Sunte 4.0 - Finouiing various reports. This includes waveform and patient data for atchiving and priming furtous i dpata 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 Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for general The Cardionoly Barto 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) professional, and maring personory 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 of armythmias; foonemas, evaluation of a patients response after resuming chicemore/four 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 The need to recorntered 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 associations and medical professional, and not intended for any home use applications.
Technological Comparison to Predicate Device(s):
The Cardiology Suite 4.0™ 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 I vote 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 and validation testing performed prior to product release.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a seal or logo. It features a circular design with text around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Pulse Biomedical, Inc. c/o Mr Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
Re: K042799
Trade Name: QRS-Card Cardiology Suite 4.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II (two) Product Code: DQK Dated: October 06, 2004 Received: October 08, 2004
Dear Mr. Mosenkis:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and nave decembers and and and and and one incessare of interstate for use stated in the encrosule) to regally manacted proad to fice Americal Device American For to American Drug commerce prior to May 28, 1970, the enastment assist of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the reliesting (RMA) devices that have been recatismed in accee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen the general controls provisions of the Act. The You may, merciole, market the devices, courses, courtements for annual registration, listing of general controls provisions of the Act mortals comments.
devices, good manufacturing 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 II your device is classified (500 above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller in the 21, Parts 800 to 898. In addition, FDA may be found in the Ouc of I cases oncerning 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 Please be advised that FDA's issuance of a substanter equires with other requirements of the Act
that FDA has made a determination that your device and other requirements that FDA has made a determination that your ac-res by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listing or any Federal statutes and regulations and limited to: registration and listing (2)
comply with all the Act's requirements, including, but not limited to: registerents as se comply with all the Act s requirements, including, barufacturing pracice requirements as set
CFR Part 807); labeling (21 CFR Part 81) ; good manufacturing practice the electr CFR Part 807); labeling (21 CFR Patl 601); good manatanaga; and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 1 CFF) 1000-1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation confor provisions (Sections 95 12 42 420))
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin harketing your article equivalence of your device to a legally premarket notification. The PDA Inding of substantial equivalians 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
rs the latest of the may on to tall (16 (11 (11 (11 ) and see mate the regu If you desire specific advice for your de need on one note the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note the regulation contact the Orice of Compliance at (2017) of CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Parts the obtained from the " Misbranding by release to premarket housiness ander the Act may be obtained from the Other general information on your responsional 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.Brimsmotor for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(042799
Indication for Use
510(k) Number (if known):_
Device: Name: QRS-Card Cardiology Suite 4.0
Indication for Use:
The QRS-Card Cardiology Suite 4.0™ Ambulatory ECG Analysis System is intended for essess The QRS-Card Cardiology Sulte 4.6 - 1 milionfessionals whenever it is required to assess
general hospital or clinical use by medical professionals whence whencision or health a patient's ambulatory ECG data. This product allows a trained physician or health care
a patient's ambulatory ECG data. This product allows alostracerdiograph (FGCG) a patient's amounatory LCC data. This product as continuous electrocardiograph (ECG) protessional, alter having periormed a long term to download and analyze the data recording on a digital frash memory fronter reports. This will enable the evaluation
from the recorder, review it and produce printed reports. This will end If in the recorder, fevior it and proporting of PQRST intervals, clinical and of arthyllinias, ischentle anables, reportable of a patients response affer epidemological research staties, ties (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 I he need to record, review, can and also areas of the hospital during cardiac patient commonly encountered in the Cardiotogy areast of a physician or other assessment. This device is a wallable for sale sincended for any home use applications.
Prescription Use: (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 A IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Anima
in Sian-O on of Cardlov 510(k) Number
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