(49 days)
No
The description focuses on traditional signal processing and analysis techniques (ECG waveform analysis, ST analysis, Heart Rate Variability) and does not mention AI or ML terms or concepts. The performance evaluation is based on standard Holter metrics and comparison to predicate devices, not AI/ML specific metrics or training/test data descriptions.
No
The device is used for assessment and diagnosis of cardiac conditions, not for treating them. It analyzes recorded ECG data and generates reports, which are then used by medical personnel for diagnostic purposes.
Yes
This device, the 2010 Plus Holter for Windows, is explicitly described as analyzing recorded cardiac ECG to create reports and provide cardiac data that is "used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns." Its intended uses, such as "Assessment of symptoms that may be related to rhythm disturbances of the heart" and "Assessment of risk in Patients With or Without Symptoms of Arrhythmia," also clearly indicate its purpose in diagnosing conditions.
No
The device description explicitly states that the system has options available for "12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer," indicating it includes hardware components for data acquisition and output, not just software analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The device described, the 2010 Plus Holter for Windows, analyzes pre-recorded cardiac ECG data. This data is obtained from a Holter monitor, which is a non-invasive device that records the electrical activity of the heart over a period of time. The analysis is performed on the recorded electrical signals, not on a biological sample taken from the patient.
- Intended Use: The intended uses listed are all related to the assessment of cardiac rhythm disturbances, risk assessment based on arrhythmia, evaluation of therapy efficacy, and assessment of pacemaker function. These are all based on the analysis of the heart's electrical activity, not on the analysis of a biological sample.
While the device provides data used by trained medical personnel for diagnosis, the diagnostic process is based on the interpretation of the electrical signals of the heart, not on the results of a test performed on a biological specimen.
N/A
Intended Use / Indications for Use
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.
Product codes
MLO
Device Description
The 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the 2010 Plus Holter for Windows. The 2010 Plus Holter for Windows software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns.
The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool.
The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
pediatric to adult age
Intended User / Care Setting
trained medical personnel
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)
Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) Overall Holter performance was mesal Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each Schartives (DD), positive production Couplets, Short runs and Long runs. Separate database and measured for Ques, Veneroitive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis. High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm, and performance in the presence of noise whill 1000mmended gaudent to the old system when looking at baseline, electrode or muscle as the cause of noise.
In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivities (SE), positive predictivity (+P), and false positive rate (FPR), Veneoitive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOO3940
FEB = 8 2001
Zymed Inc.
1201-B N. Rice Ave. Oxnard, California 93030 800.235.5941 - 805.604.0457 Fax 805.604.0493
510(k) Summary
Submitter:
| Gretel Lumley, Quality Assurance Engineer | |
|---|---|
| Zymed Medical Instrumentation | |
| 1201 B North Rice Avenue | |
| Fax: | 805-604-0493 |
| Phone: | 800-235-5941 (7417) |
| Date of Summary: | 12-20-00 |
| Contact: | G. Lumley - see above |
Trade Name: Common Name: Classification Name: 2010 Plus Holter for Windows Holter Analyzer Electrocardiograph, ambulatory, with analysis algorithm (per 21 CFR 870.2800)
Legally marketed device to which S.E. is claimed.
Zymed Holter Scanner Model Holter 2000 -- 510(k) K990170 Zymed Holter Scanner Model 1610 - 510(k) K895208 Biosensor's Holter Monitor System - 510(k) K974192
Description: The 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the 2010 Plus Holter for Windows. The 2010 Plus Holter for Windows software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by 2010 Plus Holter for Windows is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns.
The Zymed system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool.
The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Choice of Cassette Tape or Digital Input Laser Printer
1
Indications for Use:
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g.: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.
Review of Technology characteristics compared to the predicate device:
| Specification/Feature | Current Holter
Holter Scanner Holter 2000 | Modified Holter
2010 Plus Holter for
Windows |
|--------------------------------------|---------------------------------------------------------|----------------------------------------------------|
| Platform: | | |
| Type | IBM PC AT Compatible | Same |
| CPU | Pentium II 400 MHz
Or greater | Same |
| RAM | 128 Mbytes or greater | Same |
| Hard Disk | 6 Gbytes or greater | Same |
| Floppy Disk | 1.44 Mbytes | Same |
| Display | Direct Draw Capable,
1024 x 768 pixels, 16 bit Color | Same |
| Mouse | Yes | Same |
| USB | USB 1.2 or greater | Same |
| Software: | | |
| Operating System | Windows 98, Windows NT | Same |
| Hardware and Software
Diagnostics | Included | Same |
| Data Acquisition: | | |
| Number of Channels | 2 or 3 | Same |
| Resolution | 8 bit | Same |
2
Sampling Frequency Playback Speed Digital Input
192 samples per second 240 times real time Yes
Same Same Same
The only difference between the two Zymed systems is the addition of Frequency Domain Heart Rate Variability to the 2010 Plus for Windows System.
Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) Overall Holter performance was mesal Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each Schartives (DD), positive production Couplets, Short runs and Long runs. Separate database and measured for Ques, Veneroitive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis. High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm, and performance in the presence of noise whill 1000mmended gaudent to the old system when looking at baseline, electrode or muscle as the cause of noise.
In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 8 2001
Ms. Gretel Lumley Quality Assurance Engineer Zymed Inc. 1201-B North Rice Avenue Oxnard, CA 93030
Re: K003940
Trade Name: 2010 Plus Holter for Windows Regulatory Class: II (two) Product Code: MLO Dated: January 26, 2001 Received: January 29, 2001
Dear Ms. Lumley:
We have reviewed your Section 510(k) notification of intent to market the device referenced
for the indically of the last to the last the last interestively for the indicati We have reviewed your Section 910(x) notificantially equivalent (for the indications for use above and we nave delemined the devices marketed in interstate comments, or to devices th stated in the enclosure) to legally marked preaced is al Device Amendments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Drug, and prior to May 26, 1970, the chaomicn auto of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Cosmetic Act (Act). Tourmay, merciolo, manuel as act include requirements for annual provisions of the Act. "The general control provisions of the receing, and prohibitions against
registration, listing of devices, good manufacturing practice, labeling, and p misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classifica (see abovo) into such additional controls. Existing major regulations (Premarket Apploval), it may be subject to saal and in the Code of Federal Regulations, Title Courset Good allecting your device can be round in also somes compliance with the Current Good 893. A substantially Cqurvaicht decommination the Quality System Regulation (OS) for Manufacturing I Tactice requirements, as certe Part 820) and that, through periodic QSS
Medical Devices: General regulation (21 CFR Part 820) and that, through personalisms, Medical Devices. General regulation (FDA) will verify such assumptions. Failure to mspections, the Food and Drag i may result in regulatory action. In addition, comply with the Unit Tegulation may result in regared in the Federal Register. Please FDA may publish luruler announcements contoning Jour affect any obligation you
4
Page 2 - Ms. Lumley
might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Stypt Rhodes
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
510(k) Number:
Device Name: 2010 Plus Holter for Windows
Indications for Use:
- Assessment of symptoms that may be related to rhythm disturbances of the heart in patients . from pediatric to adult age. Patients with palpitations.
- Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with . symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g .: ventricular ectopy, as method of risk assessment.
- Assessment of efficacy of Antiarrhythmia Therapy. Patients with baseline high frequency, . reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
- Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, . detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
- Detection of Myocardial Ischemia. Patients with chest pain suggestive of Prinzmetal's . angina.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atut Rhodes
Division of Cardiovascular & Respiratory Devices
510(k) Number K003940
Prescription Use (CFR21 CFR 801.109)
or
Over-The-Counter Use