SYNEFLASH & SYNEVIEW

K990727 · Ela Medical, Inc. · DQK · Nov 26, 1999 · Cardiovascular

Device Facts

• Record ID: K990727
• Device Name: SYNEFLASH & SYNEVIEW
• Applicant: Ela Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period. High-resolution recording of surface ECG data. Analysis of recorded Holter ECG data.

Device Story

Syneflash™ is a digital ambulatory Holter ECG recorder; Syneview™ is a Windows-based analysis software. Recorder captures 2- or 3-channel surface ECG signals via patient cable; stores data on removable flash-memory cards (10-40 MB). Features include graphic LCD, patient event marker, and pacemaker detection. Syneview™ software runs on IBM-compatible PCs; reads flash cards via reader. Clinicians use software to perform arrhythmia detection, ST-segment analysis, template screening, and report generation. System facilitates diagnostic evaluation of ambulatory ECG data to assist physicians in cardiac rhythm assessment. Used in clinical settings; operated by healthcare professionals.

Clinical Evidence

Bench testing only. System validated using standardized databases: AHA, MIT, ST, and NST per ANSI/AAMI EC38-1994. Safety and environmental testing performed per EN 60601-1, EN 60601-1-2, and ANSI/AAMI EC38-1994. Software verification and unit functional testing completed.

Technological Characteristics

Digital Holter system. Recorder: Polycarbonate/ABS case, flash-memory storage, 200Hz/1000Hz sampling, 2-3 channels. Connectivity: PCMCIA flash card interface. Power: 2x AA batteries. Software: Windows 95/98-based. Standards: EN 60601-1, EN 60601-1-2, ANSI/AAMI EC38-1994.

Indications for Use

Indicated for ambulatory patients requiring 24-hour 2- or 3-channel surface ECG recording, high-resolution ECG recording, and subsequent analysis of recorded data.

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

• BURDICK ALTAIR Disc recorder (K942565)
• BRAEMAR DL700 (K945130)
• OXFORD MEDILOG FD4 (K970902)
• ELA Medical ELATEC (K895806)
• BURDICK ALTAIR 8200 (K945985)
• REYNOLDS Pathfinder 700 (K951902)

Submission Summary (Full Text)

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# 2. Summary & Certification

#### 2.1 Summary of safety and effectiveness information

#### 2.1.1 General Information

Device Generic Name: Holter ECG system (recorder and analysis software)

Device Trade Name: Syneflash™ (recorder) and Syneview™ (analysis software)

Applicant's Name and Address: ELA Medical, Inc., 2950 Xenium Lane North, Plymouth, MN 55441, Tel. [phone]

Date of Summary Preparation: February 26, 1999

Contact Person: Cathy G. Goble

510(k) Number: K990727

Date of Judgment of Substantial Equivalence Sent to Applicant:

Predicate Devices:

For SyneflashI™: BURDICK ALTAIR Disc recorder (510(k) K942565, Burdick Inc.), BRAEMAR DL700 (510(k) K945130, Braemar Inc.) and OXFORD MEDILOG FD4 (510(k) K970902, Oxford Instruments).

For Syneview™: ELA Medical ELATEC (510(k) K895806, ELA Medical Inc.), BURDICK ALTAIR 8200 (510(k) K945985, Burdick Inc.) and REYNOLDS Pathfinder 700 (510(k) K951902, Reynolds Medical Ltd.).

### 2.1.2 Description of Conditions for Which the Devices are Indicated

Generally accepted indications for Holter ECG systems include:

- · Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period.
- · High-resolution recording of surface ECG data.
- · Analysis of recorded Holter ECG data.

### 2.1.3 Device Description

Syneflash™ is a light-weight digital ambulatory electrocardiogram (ECG) recorder (Holter monitor) equipped with a graphic LCD screen, and using a flash-memory card

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for data storage. It allows 24-hour ambulatory ECG recording and high-resolution recording, using 2 or 3 channels.

Syneflash™ is supplied in a case containing a 10-, 20- or 40-MB flash-memory card, two 1.5-V AA batteries, a carrying case, a strap, a five-lead (or seven-lead) patient cable and a user's manual.

Syneview™ is a Holter ECG analysis software application that allows evaluation of Holter recordings obtained with Syneflash™. Syneview™ is a Microsoft Windows95/98-based application run on an IBM-compatible personal computer equipped with a flash-card reader.

#### 2.1.4 Comparison to predicate devices

Comparison table between ELA MEDICAL SYNEFLASH and predicate recorders:

| HOLTER RECORDER<br>MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC<br>RECORDER | DL 700 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------|
| COMPANY | ELA MEDICAL | OXFORD<br>INSTRUMENTS<br>MEDICAL SYSTEMS | BURDICK | BRAEMAR |
| 510(k) Number | | K970902 | K942565 | K945130 |
| CE mark (93/42 MDD) | Yes | No | | |
| Type | Digital | Digital | Digital | Digital |
| Analysis | Real Time | Retrospective<br>(on the analyzer) | Retrospective<br>(on the analyzer) | Retrospective<br>(on the analyzer) |
| Record duration | 24H | 24H | 24H | 24H |
| Recording medium | PCMCIA FLASH CARD<br>(10, 20 40 MB) | PCMCIA FLASH CARD<br>(ATA) | Hard disk (170MB) | PCMCIA ATA FLASH<br>CARD (10, 20 40 MB) |
| Signal compression | Yes (delta + variable<br>length bit coding = no<br>notable loss) | Yes | No | Yes |
| CHANNELS | 2 or 3 | 2 or 3 | 2 or 3 | 2 or 3 |
| Sampling Frequency | 200Hz | 512Hz | 200Hz | 128Hz |
| Frequency Response | 0.05Hz to 50Hz in<br>standard mode<br>(extension to 500Hz<br>possible in High<br>Resolution mode) | | 0.05Hz to 100Hz in<br>standard mode<br>(extension to 300Hz<br>possible in High<br>Resolution mode) | |
| Overall<br>Recorder/Analyzer<br>Frequency Response | 0.05Hz to 50Hz in<br>standard mode | 0,05Hz to 40Hz | | |
| Dynamic Range | 10µV to 10 mV | 10µV to 10 mV | 5mV in standard mode<br>(10 mV in High Resolution<br>mode) | |
| Amplitude Resolution | 10µV<br>(2.5µV in High Resolution<br>mode) | | | |
| HOLTER RECORDER<br>MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC<br>RECORDER | DL 700 |
| High Resolution mode | Yes<br>(Hi Res or Hi Res +<br>Holter) | No | Yes<br>(Hi Res or Hi Res +<br>Holter) | No |
| High Resolution<br>Sampling Frequency | 1000Hz | | 1000Hz | |
| High Resolution<br>Transfer | By a transferring utility<br>Between Flash Card and<br>PC | | By connection to the PC<br>with an interface. | |
| Setup | With the graphic display +<br>keyboard | By connection to the PC<br>with fiber optical cable | | |
| Verification of the ECG | With the graphic display | By connection to the PC<br>with fiber optical cable | | |
| Test Cable /<br>Impedance check | Yes / Yes | | | |
| CABLE | 5 or 7 wires | 3, 5 or 7 wires | | |
| POWER | 2AA 1.5V Alkaline<br>Batteries<br>(for 2x24H records)<br>or 1x24H record with<br>1.2V NiMh rechargeable<br>batteries (1200mA/H) | 2AA 1.5V Alkaline<br>Batteries or 1.2V NiMh<br>rechargeable batteries | 2 x 9V batteries | 9V batteries |
| Pacemaker Detection | Yes | Yes | Yes | Yes |
| DISPLAY | GRAPHIC LCD | 4 digits (7 segments) LCD<br>display | LCD | LCD |
| Time Displayed | Yes<br>(only during hookup) | Yes | Yes | Yes |
| Carrying case | Strap + pouch | Strap + pouch | | |
| Keyboard | Yes | Yes | Yes | No |
| ON/OFF Button | Yes | Yes | | No |
| Sound | Yes<br>(Buzzer) | Yes | | |
| Patient event marker | Yes<br>(resolution at sampling<br>frequency) | Yes<br>(resolution at sampling<br>frequency) | | Yes |
| Case | Polycarbonate / ABS | Polycarbonate / ABS | | |
| Replay and Analysis<br>system | SYNEVIEW | OXFORD OPTIMA &<br>EXCEL | BURDICK ALTAIR 8200 | REYNOLDS<br>PATHFINDER 700 and<br>others. |
| Weight | 290g with batteries and<br>flash card | 310g with batteries and<br>flash card | 425g | |
| Dimensions | 130x90x25mm | 120x90x40mm | 129x91x32mm | |
| HOLTER RECORDER<br>MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC<br>RECORDER | DL 700 |
| Operating temperature | 0°C to 50°C | 0°C to 45°C | | |
| Storage temperature | -15°C to 60°C | | | |
| Humidity | 85% (at 20°C) | 10-95% non condensing | | |
| Firmware Upgrade | Yes | Yes | | |

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# Comparison table between ELA MEDICAL SYNEVIEW and predicate analyzers:

| HOLTER ANALYZER<br>MODEL | SYNEVIEW | ELATEC | ALTAIR 8200 | PATHFINDER 700 |
|---------------------------------|----------------------------------------------|------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|
| COMPANY | ELA MEDICAL | ELA MEDICAL | BURDICK | REYNOLDS<br>MEDICAL |
| 510(k) Number | | K895806 | K945985 | K951902 |
| CE / MDD certification | Yes | No | | |
| Type | Holter Analyzer (Software) | Holter Analyzer | Holter Analyzer | Holter Analyzer |
| Read digital / tape | Digital (dedicated to<br>SyneFlash recorder) | Standard 1mm/s tape<br>(and 1,5mm/s, 2mm/tape) | Digital (Burdick Disc<br>recorder only) and<br>Standard Tape | Digital (Braemar DL700<br>REYNOLDS eRAM)<br>and Standard Tape |
| PC based | Yes | Yes | Yes | Yes (+transputer) |
| PCMCIA interface<br>compatible | Yes | No | No | Yes |
| Operating System | Microsoft Windows 95 or 98 | Microsoft DOS | Microsoft DOS | Microsoft DOS |
| Graphic User Interface<br>(GUI) | Yes | Yes | Yes | Yes |
| Network | Yes | No | | |
| Re-analysis | No | Yes | Yes | Yes |
| Events list edition | Yes | No | No | No |
| Arrhythmia detection | Yes | Yes | Yes | Yes |
| ST | Yes | Yes | Yes | Yes |
| Templates screen | Yes | Yes | Yes | Yes |
| Superimposition | Yes | Yes | Yes | Yes |
| Pacemaker detection | Yes | Yes | Yes | Yes |
| Editing report | Yes | Yes | Yes | Yes |
| Customized report | Yes | Yes | Yes | Yes |
| Archiving | Yes | Yes | Yes | Yes |
| Printing ECG strip | Yes | Yes | Yes | Yes |
| Printing Full Disclosure | Yes | Yes | Yes | Yes |

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#### 2.1.5 Alternatives

The alternatives for Syneflash™ and Syneview™ are other commercially available Holter ECG systems.

#### 2.1.6 Marketing History

Syneflash™ and Syneview™ are not in commercial distribution in the U.S. They were recently introduced into commercial distribution outside the U.S (April 1997 for Syneview™, March 1998 for Syneflash™). No unanticipated adverse device effects have been reported for this Holter ECG system.

#### 2.1.7 Potential Adverse Effects

As Holter ECG systems are diagnostic devices, there are no potential adverse effects or complications related to this type of device.

#### 2.1.8 Summary of Studies

The following in-vitro functional testing was performed on the Syneflash™ / Syneview™ Holter ECG system:

| Test group | Tests |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syneflash™ safety testing | Environmental and safety tests, including EMC<br>(Electromagnetic Compatibility) tests, according to<br>the EN 60601-1, EN 60601-1-2 and ANSI/AAMI<br>EC38-1994 standards |
| Syneview™ database<br>testing | Database testing according to the ANSI/AAMI<br>EC38-1994 standard using the following databases:<br>• AHA (American Heart Association),<br>• MIT (Massachusetts Institute of Technology),<br>• ST (European database on ST segment)<br>• NST (Noise Stress Test) |
| Syneflash™ / Syneview™<br>software validation and<br>verification testing | Unit and functional testing for both Syneflash™<br>and Syneview™ software applications |

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#### 2.1.9 Conclusion

The information presented in this submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner.

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Image /page/6/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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1999

Ms. Catherine G. Goble ELA Medical, Inc. 2950 Xenium Lane North Plymouth, MN 55441

Re: K990727 Syneflash™ and Syneview™ Holter ECG System Regulatory Class: II (two) Product Code: 74 DQK October 25, 1999 Dated: Received: October 26, 1999

Dear Ms. Goble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Ms. Catherine G. Goble

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Carole C. Carey

Celia M. Witten, Ph.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K990727

#### 1.10 Indications for Use Statement

#### 510 (k) Number:

Device Name: Syneflash™ / Syneview™ Holter ECG system.

Indications for Use:

- · Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period.
- · High-resolution recording of surface ECG data.
- · Analysis of recorded Holter ECG data.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use **__**
(Per 21 CFR 801.109)

":

#### ELA Medical Incorporated

#### Confidential and Proprietary

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