(186 days)
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.
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.
The provided 510(k) summary (K024323) for the Century Series™ Holter Scanner System (Models C3000/C2000/C1000) does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Century Color Trace, K884152). This means the submission argues that the new device performs similarly to a previously cleared device, rather than providing a detailed study against specific performance metrics for the new device.
Here's an breakdown of why the requested information cannot be fully provided from the given text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. The submission relies on the predicate device's performance as the benchmark for substantial equivalence.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are reported for the new device in the provided text. The "Table of Comparison" primarily lists features and technical specifications, not performance outcomes.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No test set is mentioned, nor are details about data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- No test set is mentioned, therefore no information on experts for ground truth is provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No test set is mentioned, therefore no adjudication method is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study is mentioned. This device is an "ECG analysis software" and the submission focuses on automated analysis and interaction with the software, not human-in-the-loop performance improvement with AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device is an "ECG analysis software application" that performs "arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and determination of beat types, in both an automatic and interactive mode," the document does not describe a standalone performance study with specific metrics for the algorithm's performance without human interaction. It implies an automated analysis capability ("Automated Analysis: Yes"), but doesn't quantify its standalone accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not mentioned, as no specific performance study is detailed.
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The sample size for the training set:
- Not mentioned, as no AI/machine learning training details are provided. It states the analysis is "based on the WPI algorithm," which implies an existing established algorithm rather than a newly trained one for this submission.
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How the ground truth for the training set was established:
- Not mentioned.
Summary of what is present:
- Device Description: The Century Series Holter Scanner System is an ECG analysis software application for evaluating Holter recordings. It features arrhythmia analysis, ST deviation analysis, pacemaker beat detection, and beat type determination. It is based on the WPI algorithm, similar to its predicate device.
- Intended Use: For replay and analysis of ECG data from Holter recorders for cardiac evaluation of heart rate/rhythm, assessing risk for future cardiac events, assessing drug response, and ST segment analysis in specific patient populations.
- Predicate Device: Century Color Trace (K884152).
- Key Argument for Substantial Equivalence: The primary differences (microprocessor speed, OS, addition of HRV-Time Domain and QT analysis) "do not, however, represent a change of the intended use(s) and indications... or alter the fundamental technology of the Holter analysis." This statement is the core of their "proof" for equivalence, rather than a detailed performance study against acceptance criteria.
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JUN 3 0 2003 |(024323
510(k) Summary of Safety and Effectiveness
| Submitter | Biomedical Systems Corporation2464 West Port Plaza DriveSt. Louis, MO 63146 |
|---|---|
| Phone: 314-576-6800FAX: 877-286-8141 | |
| Contact person | K. Michael KroehnkeDirector, Quality Assurance/Regulatory Affairs |
| Date of preparation | December 20, 2002 |
| Device trade name | Century Series TM Holter Scanner SystemModel 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, BiomedicalSystems) |
| Device Description | The Century Series Holter Scanner System, ModelC3000/C2000/C1000 is a Holter ECG analysissoftware application that allows evaluation ofHolter recordings obtained using solid-state digitalHolter recorders or standard cassette tape Holterrecorders. It is the successor to the Century ColorTrace Holter Analyzer, 510(k) # K884152. Theanalysis is based on the WPI algorithm, as was theCentury Color Trace. The unit features arrhythmiaanalysis, ST deviation analysis, pacemaker beatdetection, and determination of beat types, in bothan automatic and interactive mode. |
| Intended use | The Century Series Holter Scanner System, ModelC3000/C2000/C1000 is intended for the replay andanalysis of ECG data pre-recorded on compatiblecassette 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:
| CenturyColor Trace | CenturySeries C3000 | CenturySeries C2000 | CenturySeries C1000 | |
|---|---|---|---|---|
| Recording medium | Reel-to-Reeltape or tapecassette | Digitalrecorder ortape cassette | Digitalrecorder ortape cassette | Digitalrecorder ortape cassette |
| Channels | 2 | 3 | 3 | 3 |
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| System Requirements | ||||
|---|---|---|---|---|
| CPU | 80386 20MHz4 MB RAM80 MB harddrive | Pentium 300MHZ128 MBRAM4 GB harddrive | Pentium 300MHZ128 MBRAM4 GB harddrive | Pentium 300MHZ128 MBRAM4 GB harddrive |
| Operating System | MS-DOS 3.3 | MS Windows98, 2000, XP | MS Windows98, 2000, XP | MS Windows98, 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 Superimpositionw/ Editing | Yes | Yes | N/a | n/a |
| Full Disclosure | Yes | Yes | Yes | Yes |
| Customized Report | Yes | Yes | Yes | Yes |
| Remote TransmissionCapability | Yes | Yes | Yes | Yes |
| ST segment analysis | Yes | Yes | Yes | Yes |
| QRS detection/arrhythmiaanalysis | Yes | Yes | Yes | Yes |
| HRV-time domain analysis | No | Yes | Yes | Yes |
| QT analysis | No | Yes | Yes | Yes |
| Pacemaker evaluationdisplay | 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 ectopysummary | Yes | Yes | Yes | Yes |
| Ventricular tachycardiasummary | Yes | Yes | Yes | Yes |
| VE pair summary | Yes | Yes | Yes | Yes |
| Bigeminy summary | Yes | Yes | Yes | Yes |
| Target Population | Humanswithoutrestrictions ofage, sex, orrace requiringambulatoryECG asdeterminedby a medicalpractitioner | Same | Same | Same |
| Where Used | Physicianoffice, clinic,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 ✓
Jose GA for
§ 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).