CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
Device Facts
| Record ID | K024323 |
|---|---|
| Device Name | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 |
| Applicant | Biomedical Systems Corp. |
| Product Code | MLO · Cardiovascular |
| Decision Date | Jun 30, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
Indications for Use
The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
Device Story
Century Series Holter Scanner System (Models C3000/C2000/C1000) processes pre-recorded ECG data from digital or cassette tape Holter recorders. System performs automated and interactive arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and beat type determination. Additional modules include HRV-time domain and QT analysis. Used in physician offices, clinics, and hospitals by clinicians to review ambulatory ECG recordings. Output includes full disclosure, customized reports, and summaries of ventricular/supraventricular ectopy, bradycardia, and ST trends. Assists clinicians in diagnosing cardiac rhythm disorders, assessing drug efficacy, and evaluating cardiac event risk. Enables remote transmission of analysis results.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and performance of the WPI algorithm consistent with the predicate device.
Technological Characteristics
Holter ECG analysis software running on PC hardware (Pentium 300 MHz, 128 MB RAM). Supports 3-channel input from digital or cassette tape recorders. Features include WPI-based arrhythmia analysis, ST segment analysis, pacemaker detection, HRV-time domain, and QT analysis. Connectivity via remote transmission capability. Operates on MS Windows 98/2000/XP.
Indications for Use
Indicated for cardiac evaluation of heart rate/rhythm in patients with syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain, or transient arrhythmias; risk assessment for future cardiac events in asymptomatic patients with congestive heart failure, idiopathic hypertrophic cardiomyopathy, or post-MI with left ventricular dysfunction; assessment of antiarrhythmic drug response; and ST segment analysis in patients with known coronary heart disease, chest pain, or suspected variant angina. Applicable to all ages, genders, and races requiring 24-hour ambulatory ECG analysis as determined by a practitioner.
Regulatory Classification
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.
Predicate Devices
- Century Color Trace (K884152)
Submission Summary (Full Text)
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## JUN 3 0 2003 |(024323
## 510(k) Summary of Safety and Effectiveness
| Submitter | Biomedical Systems Corporation<br>2464 West Port Plaza Drive<br>St. Louis, MO 63146 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 314-576-6800<br>FAX: 877-286-8141 |
| Contact person | K. Michael Kroehnke<br>Director, Quality Assurance/Regulatory Affairs |
| Date of preparation | December 20, 2002 |
| Device trade name | Century Series TM Holter Scanner System<br>Model C3000/C2000/C1000 |
| Common or usual name | Holter ECG analysis software |
| Classification name | Medical Magnetic Tape Recorder |
| Product classification | 74 MLO, 21 CFR 870.2800, Class II |
| Predicate Device | Century Color Trace (K884152, Biomedical<br>Systems) |
| Device Description | The Century Series Holter Scanner System, Model<br>C3000/C2000/C1000 is a Holter ECG analysis<br>software application that allows evaluation of<br>Holter recordings obtained using solid-state digital<br>Holter recorders or standard cassette tape Holter<br>recorders. It is the successor to the Century Color<br>Trace Holter Analyzer, 510(k) # K884152. The<br>analysis is based on the WPI algorithm, as was the<br>Century Color Trace. The unit features arrhythmia<br>analysis, ST deviation analysis, pacemaker beat<br>detection, and determination of beat types, in both<br>an automatic and interactive mode. |
| Intended use | The Century Series Holter Scanner System, Model<br>C3000/C2000/C1000 is intended for the replay and<br>analysis of ECG data pre-recorded on compatible<br>cassette tape or digital Holter recorders and is |
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indicated for:
- Cardiac evaluation of heart rate and rhythm ● in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
- To assess risk for future cardiac events in ● patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
- Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
- ST segment analysis in patients with known . coronary heart disease, chest pain, and suspected variant angina.
| human beings without |
|-------------------------------|
| restrictions of age, sex, or |
| race requiring analysis of 24 |
| hour ambulatory ECG |
| recordings as determined by a |
| medical practitioner. |
| |
Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.
Table of Comparison:
| | Century<br>Color Trace | Century<br>Series C3000 | Century<br>Series C2000 | Century<br>Series C1000 |
|------------------|------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|
| Recording medium | Reel-to-Reel<br>tape or tape<br>cassette | Digital<br>recorder or<br>tape cassette | Digital<br>recorder or<br>tape cassette | Digital<br>recorder or<br>tape cassette |
| Channels | 2 | 3 | 3 | 3 |
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| System Requirements | | | | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| CPU | 80386 20<br>MHz<br>4 MB RAM<br>80 MB hard<br>drive | Pentium 300<br>MHZ<br>128 MB<br>RAM<br>4 GB hard<br>drive | Pentium 300<br>MHZ<br>128 MB<br>RAM<br>4 GB hard<br>drive | Pentium 300<br>MHZ<br>128 MB<br>RAM<br>4 GB hard<br>drive |
| Operating System | MS-DOS 3.3 | MS Windows<br>98, 2000, XP | MS Windows<br>98, 2000, XP | MS Windows<br>98, 2000, XP |
| Monitor | 13" color | 15" SVGA | 15" SVGA | 15" SVGA |
| Printer | Laser | Same | Same | Same |
| Software | | | | |
| Analysis algorithm | WPI | Same | Same | Same |
| Analysis Modes | | | | |
| Automated Analysis | Yes | Yes | Yes | Yes |
| Retrospective | Yes | Yes | Yes | Yes |
| Superimposition | | | | |
| Prospective Superimposition | Yes | Yes | Yes | n/a |
| Prospective Superimposition<br>w/ Editing | Yes | Yes | N/a | n/a |
| Full Disclosure | Yes | Yes | Yes | Yes |
| Customized Report | Yes | Yes | Yes | Yes |
| Remote Transmission<br>Capability | Yes | Yes | Yes | Yes |
| ST segment analysis | Yes | Yes | Yes | Yes |
| QRS detection/arrhythmia<br>analysis | Yes | Yes | Yes | Yes |
| HRV-time domain analysis | No | Yes | Yes | Yes |
| QT analysis | No | Yes | Yes | Yes |
| Pacemaker evaluation<br>display | Yes | Yes | Yes | Yes |
| Ventricular ectopy summary | Yes | Yes | Yes | Yes |
| Bradycardia table | Yes | Yes | Yes | Yes |
| ST Trend | Yes | Yes | Yes | Yes |
| Strip List | Yes | Yes | Yes | Yes |
| Supraventricular ectopy<br>summary | Yes | Yes | Yes | Yes |
| Ventricular tachycardia<br>summary | Yes | Yes | Yes | Yes |
| VE pair summary | Yes | Yes | Yes | Yes |
| Bigeminy summary | Yes | Yes | Yes | Yes |
| Target Population | Humans<br>without<br>restrictions of<br>age, sex, or<br>race requiring<br>ambulatory<br>ECG as<br>determined<br>by a medical<br>practitioner | Same | Same | Same |
| Where Used | Physician<br>office, clinic,<br>hospital | Same | Same | Same |
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The primary differences between the Century Color Trace and the Century Series Holter Scanner System, Model C3000/C2000/C1000 are the microprocessor speed - 386 vs. Pentium, the addition of the HRV-Time Domain and QT analysis modules and the migration from the MS-DOS operating system to the MS Windows™ operating system.
These differences do not, however, represent a change of the intended use(s) and indications of the Century Series Holter Scanner System, Model C3000/C2000/C1000 from those described for the Century Color Trace, or alter the fundamental technology of the Holter analysis as described for the Century Color Trace.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2003
Biomedical Systems Corporation c/o Mr. K. Michael Kroehnke Director. Quality Assurance/Regulatory Affairs 2464 West Port Plaza Dr. St. Louis, Missouri 63146
Re: K024323
> Trade Name: Century Series™ Holter Scanner System, Model C3000/C2000/C1000 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: April 1, 2003 Received: April 2, 2003
Dear Mr. Kroehnke:
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. Iisting of 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 may be subject to such 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.
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
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Page 2 - Mr. K. Michael Kroehnke
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.
Elsa D'Olay for
Bram D. Zuckerman, Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## 024323 Intended Use
The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for:
- Cardiac evaluation of heart rate and rhythm in patients ● experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
- To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
- Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
- ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
Patient population: human beings without restrictions of age, sex, or race requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.
Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed practitioner.
**Prescription Use Only**
Prescription Use ✓
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