(138 days)
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No
The document describes a sophisticated arrhythmia analysis program and various programmable software features, but it does not mention or imply the use of AI or ML technologies. The language used is consistent with traditional signal processing and rule-based algorithms common in medical devices of that era.
No
The device is described as a "Holter scanner system" designed for analyzing Holter recordings to detect cardiac abnormalities and produce reports for clinicians. It is an analytical tool, not a device that directly treats a condition.
Yes
Explanation: The device analyzes patient ECG to detect abnormalities and provides clinical tools to review cardiac performance, which are functions of a diagnostic device.
No
The device description explicitly lists numerous hardware components including a computer unit, monitor, hard drive, CPU, RAM, tape drive, mouse, keyboard, floppy drive, and printer. While it includes analysis software, it is clearly a system that integrates both hardware and software.
Based on the provided text, 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 description clearly states that the Model 2010 Plus analyzes recorded patient ECG. ECG (electrocardiogram) is a measurement of electrical activity of the heart, which is obtained non-invasively from the body surface. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for analyzing Holter recordings to detect cardiac abnormalities and review a patient's cardiac performance. This is a diagnostic process, but it's based on physiological signals, not in vitro testing of biological samples.
Therefore, the Model 2010 Plus is a diagnostic device, but it falls under the category of in vivo diagnostics (diagnostics performed on a living organism) rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the "muscle" to analyze even the most difficult recordings quickly and accurately.
Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts. trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance.
The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or, the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.
Product codes
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Device Description
A Zymed Holter Scanner system consists of a series of interface devices to include a central monitoring computerized unit, a high Resolution Super VGA raster graphics display monitor, a minimum 500 megabites hard disk drive for two 36-hour digital tape readings, Intel Pentium System Board CPU, 8 megabites of RAM, built in math co-processor, cassette tape drive, mouse and keyboard , 3.5 " floppy disk drive, and a laser printer.
Over 1000 final reports can be stored on line, the operating system is DOS compatible, and Holter reports can be transmitted via facsimile systems.
The analysis software package includes standard, pediatric, and AFib to name a few, and the user can program individual custom styles. Other programmable software features include ECG display; scanning speed up to 240 X real time; scanning styles to include retrospective, prospective, superimposition, and paging; auto stops; highlighting; noise algorithm; color schemes, and report formats. The system 3-channel QRS detection/arrhythmia analysis, 3-channel ST segment analysis, full provides disclosure, automatic 2 of 3 channel morphology analysis, customized report software, HRV-Time Domain, and Pacemaker evaluation display.
The system dimensions include:
Tower: Width: 9.5" (24CM): Height: 25.5" (64.7CM) Depth: 19" (48.2CM): Weight 36lbs (16.35KG) Printer: Width: 16.4" (41.6CM); Height: 11.7" (29.7CM) Depth: 15.9" (40.3CM): Weight; 37lbs (16.8KG) Graphics Display: Width: 14.3" (36.3CM); Height: 14.5" (36.8CM) Depth: 14.9" (37.8CM); Weight; 26.2lbs (11.9KG)
The System meets UL544 and CSA601 compliance and is ETL Listed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K95015
510(K) SUMMARY
Submitter:
| Dudley Harris, Director of Regulatory Affairs/QA | ||
|---|---|---|
| Zymed Medical Instrumentation | ||
| 20 North Aviador Street | MAR 18 1998 | |
| Camarillo, CA 93010-8301 | ||
| Fax: | 805/987-9532 | |
| Phone: | 800/235-5941 | |
| Date of Summary: | 2/15/96 | |
| Contact: | D. Harris - see above | |
| Trade Name: | Zymed Holter Scanner; Model 2010 Plus | |
| Common Name: | Holter Analyzer | |
| Classification Name: | Arrhythmia Detector/Medical Cathode-Ray Tube Display |
Legally marketed device to which S.E. is claimed:
Zymed Holter Scanner Model 2010; 510(k) #K930806 .
A Zymed Holter Scanner system consists of a series of interface devices to include a Description: central monitoring computerized unit, a high Resolution Super VGA raster graphics display monitor, a minimum 500 megabites hard disk drive for two 36-hour digital tape readings, Intel Pentium System Board CPU, 8 megabites of RAM, built in math co-processor, cassette tape drive, mouse and keyboard , 3.5 " floppy disk drive, and a laser printer.
Over 1000 final reports can be stored on line, the operating system is DOS compatible, and Holter reports can be transmitted via facsimile systems.
The analysis software package includes standard, pediatric, and AFib to name a few, and the user can program individual custom styles. Other programmable software features include ECG display; scanning speed up to 240 X real time; scanning styles to include retrospective, prospective, superimposition, and paging; auto stops; highlighting; noise algorithm; color schemes, and report formats. The system 3-channel QRS detection/arrhythmia analysis, 3-channel ST segment analysis, full provides disclosure, automatic 2 of 3 channel morphology analysis, customized report software, HRV-Time Domain, and Pacemaker evaluation display.
The system dimensions include:
Tower: Width: 9.5" (24CM): Height: 25.5" (64.7CM) Depth: 19" (48.2CM): Weight 36lbs (16.35KG) Printer: Width: 16.4" (41.6CM); Height: 11.7" (29.7CM) Depth: 15.9" (40.3CM): Weight; 37lbs (16.8KG) Graphics Display: Width: 14.3" (36.3CM); Height: 14.5" (36.8CM) Depth: 14.9" (37.8CM); Weight; 26.2lbs (11.9KG)
The System meets UL544 and CSA601 compliance and is ETL Listed.
1
Intended Use: The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the "muscle" to analyze even the most difficult recordings quickly and accurately.
Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts. trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance.
The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or, the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.
A review of the technological characteristics compared to the predicate device are:
| Platform: | 2010 Plus (new) | 2010 (old |
|---|---|---|
| Type | IBM PC Compatible | Same |
| CPU | Intel Pentium | 486 |
| RAM | 8 Megs | Same |
| Hard Disk | Min 500 Megs | Same |
| Display | Super VGA | Same |
| Data Acquisition: | ||
| Channels | 2 or 3 | Same |
| Resolution | 8 bits | Same |
| Playback Speed | 240X real time | Same |
| Software: | ||
| Operating System | DOS | Same |
| Final Reports stored on-line | Over 1000 | Same |
| FAX Ready | Yes | Same |
| Full Disclosure | Yes | Same |
| Customized report SW | Yes | Same |
| 3-Channel ST Segment Analysis | Yes | Same |
| 3-Channel QRS Detection/Arrhythmia Analysis | Yes | Same |
| HRV-Time Domain | Yes | No |
| Pacemaker Evaluation Display | Yes | Same |
The primary difference between the two Zyned Systems is the microprocessor speed - 486 VS Pentium, and the addition of an HRV-Time Domain SW module. Performance between the two systems is almost identical and clearly supports a claim of substantial equivalence.