ZYMED HOLTER SCANNER MODEL 2010

K955015 · Zymed Medical Instrumentation · DQK · Mar 18, 1996 · Cardiovascular

Device Facts

• Record ID: K955015
• Device Name: ZYMED HOLTER SCANNER MODEL 2010
• Applicant: Zymed Medical Instrumentation
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

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 patient’s 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.

Device Story

Zymed Holter Scanner Model 2010 Plus is a computerized Holter analyzer for clinical environments. It processes 2 or 3-channel digital Holter tape recordings. System utilizes Intel Pentium CPU to perform arrhythmia analysis, ST segment analysis, and HRV-Time Domain analysis. Operation modes include prospective (technician-supervised, real-time tuning) or retrospective (automated analysis in ~12 minutes). Output includes ECG printouts, trend data, full disclosure reports, and pacemaker evaluation displays. Clinicians use these outputs to review cardiac performance and make diagnostic decisions. System supports high-speed scanning (up to 240x real-time) and report transmission via fax.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and performance similarity to the predicate device.

Technological Characteristics

IBM PC-compatible architecture; Intel Pentium CPU; 8MB RAM; min 500MB hard disk; Super VGA display. Data acquisition: 2 or 3-channel, 8-bit resolution, 240x playback speed. Software: DOS-based, includes arrhythmia, ST segment, and HRV-Time Domain analysis. Compliance: UL544, CSA601, ETL Listed.

Indications for Use

Indicated for analysis of Holter ECG recordings to detect cardiac abnormalities, including arrhythmia and ST segment changes, and for pacemaker evaluation in patients requiring cardiac monitoring.

Regulatory Classification

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.

Predicate Devices

• Zymed Holter Scanner Model 2010 (K930806)

Submission Summary (Full Text)

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K93015

510(K) SUMMARY

**Submitter:**

Dudley Harris, Director of Regulatory Affairs/QA
Zymed Medical Instrumentation
20 North Aviador Street
Camarillo, CA 93010-8301

Fax: [phone]
Phone: [phone]
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

**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 provides 3-channel QRS detection/arrhythmia analysis, 3-channel ST segment analysis, full 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.

MAR 18 1996

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**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 patient’s 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: | 2010 Plus (new) | 2010 (old) |
| --- | --- | --- |
| Channels | 2 or 3 | Same |
| Resolution | 8 bits | Same |
| Playback Speed | 240X real time | Same |
| Software: | 2010 Plus (new) | 2010 (old) |
| --- | --- | --- |
| 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 Zymed 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.