(186 days)
No
The description mentions an "algorithm" (WPI algorithm) for analysis, but there is no mention of AI, ML, deep learning, or any related concepts. The analysis features described (arrhythmia analysis, ST deviation analysis, pacemaker beat detection, beat type determination) are typical of traditional Holter analysis software and do not inherently require AI/ML. The lack of information on training or test sets further supports this conclusion.
No.
The device is a Holter scanner system intended for the replay and analysis of pre-recorded ECG data for diagnostic purposes, not for direct therapeutic intervention.
Yes
The device's intended use explicitly includes "Cardiac evaluation of heart rate and rhythm" and "ST segment analysis," which are diagnostic activities. It analyzes pre-recorded ECG data to identify medical conditions related to cardiac function and assess risk.
No
The device description explicitly states it is a "Holter ECG analysis software application" but also mentions it allows evaluation of recordings obtained using "solid-state digital Holter recorders or standard cassette tape Holter recorders." This implies the system includes or interacts with hardware components (the recorders) for data acquisition, even if the analysis itself is software-based. The predicate device also appears to be a hardware/software system.
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.
- Device function: The Century Series Holter Scanner System analyzes ECG data, which is electrical activity recorded from the surface of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the analysis of heart rate and rhythm, assessment of risk, evaluation of drug response, and ST segment analysis, all based on the interpretation of ECG signals.
Therefore, this device falls under the category of a medical device used for the analysis of physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MLO
Device Description
The Century Series Holter Scanner System, Model C3000/C2000/C1000 is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained using solid-state digital Holter recorders or standard cassette tape Holter recorders. It is the successor to the Century Color Trace Holter Analyzer, 510(k) # K884152. The analysis is based on the WPI algorithm, as was the Century Color Trace. The unit features arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and determination of beat types, in both an automatic and interactive mode.
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
human beings without restrictions of age, sex, or race requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.
Intended User / Care Setting
Physician office, clinic, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUN 3 0 2003 |(024323
510(k) Summary of Safety and Effectiveness
| Submitter | Biomedical Systems Corporation
2464 West Port Plaza Drive
St. Louis, MO 63146 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 314-576-6800
FAX: 877-286-8141 |
| Contact person | K. Michael Kroehnke
Director, Quality Assurance/Regulatory Affairs |
| Date of preparation | December 20, 2002 |
| Device trade name | Century Series TM Holter Scanner System
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
Systems) |
| Device Description | The Century Series Holter Scanner System, Model
C3000/C2000/C1000 is a Holter ECG analysis
software application that allows evaluation of
Holter recordings obtained using solid-state digital
Holter recorders or standard cassette tape Holter
recorders. It is the successor to the Century Color
Trace Holter Analyzer, 510(k) # K884152. The
analysis is based on the WPI algorithm, as was the
Century Color Trace. The unit features arrhythmia
analysis, ST deviation analysis, pacemaker beat
detection, and determination of beat types, in both
an automatic and interactive mode. |
| 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 |
1
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
Color Trace | Century
Series C3000 | Century
Series C2000 | Century
Series C1000 |
|------------------|------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|
| Recording medium | Reel-to-Reel
tape or tape
cassette | Digital
recorder or
tape cassette | Digital
recorder or
tape cassette | Digital
recorder or
tape cassette |
| Channels | 2 | 3 | 3 | 3 |
2
| System Requirements | ||||
|---|---|---|---|---|
| CPU | 80386 20 | |||
| MHz | ||||
| 4 MB RAM | ||||
| 80 MB hard | ||||
| drive | Pentium 300 | |||
| MHZ | ||||
| 128 MB | ||||
| RAM | ||||
| 4 GB hard | ||||
| drive | Pentium 300 | |||
| MHZ | ||||
| 128 MB | ||||
| RAM | ||||
| 4 GB hard | ||||
| drive | Pentium 300 | |||
| MHZ | ||||
| 128 MB | ||||
| RAM | ||||
| 4 GB hard | ||||
| drive | ||||
| Operating System | MS-DOS 3.3 | MS Windows | ||
| 98, 2000, XP | MS Windows | |||
| 98, 2000, XP | MS Windows | |||
| 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 | ||||
| w/ Editing | Yes | Yes | N/a | n/a |
| Full Disclosure | Yes | Yes | Yes | Yes |
| Customized Report | Yes | Yes | Yes | Yes |
| Remote Transmission | ||||
| Capability | Yes | Yes | Yes | Yes |
| ST segment analysis | Yes | Yes | Yes | Yes |
| QRS detection/arrhythmia | ||||
| analysis | Yes | Yes | Yes | Yes |
| HRV-time domain analysis | No | Yes | Yes | Yes |
| QT analysis | No | Yes | Yes | Yes |
| Pacemaker evaluation | ||||
| 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 | ||||
| summary | Yes | Yes | Yes | Yes |
| Ventricular tachycardia | ||||
| summary | Yes | Yes | Yes | Yes |
| VE pair summary | Yes | Yes | Yes | Yes |
| Bigeminy summary | Yes | Yes | Yes | Yes |
| Target Population | Humans | |||
| without | ||||
| restrictions of | ||||
| age, sex, or | ||||
| race requiring | ||||
| ambulatory | ||||
| ECG as | ||||
| determined | ||||
| by a medical | ||||
| practitioner | Same | Same | Same | |
| Where Used | Physician | |||
| office, clinic, | ||||
| hospital | Same | Same | Same |
3
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.
4
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
5
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
6
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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