K Number
K990727
Device Name
SYNEFLASH & SYNEVIEW
Manufacturer
Date Cleared
1999-11-26

(266 days)

Product Code
Regulation Number
870.1425
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 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.
More Information

Not Found

No
The summary describes a standard digital Holter monitor and analysis software. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The analysis software appears to use standard algorithms for ECG analysis, validated against established databases.

No
This device is a diagnostic tool (Holter monitor) used for recording and analyzing ECG data, which aids in diagnosing heart conditions, but it does not directly treat or alleviate symptoms.

Yes

The device records and analyzes Holter ECG data, which is used for the diagnosis of heart conditions.

No

The device description clearly states that Syneflash™ is a "light-weight digital ambulatory electrocardiogram (ECG) recorder (Holter monitor)" and lists hardware components such as a graphic LCD screen, flash-memory card, batteries, patient cable, and carrying case. While Syneview™ is a software application, the overall system includes significant hardware.

Based on the provided information, the Syneflash™ / Syneview™ system is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Syneflash™ / Syneview™ Function: This system records and analyzes surface ECG data directly from the patient's body. It is a physiological monitoring device, not a device that analyzes samples taken from the body.

The intended use, device description, and performance studies all point to the system being a Holter monitor for recording and analyzing electrical activity of the heart from the body surface. This falls under the category of medical devices, but specifically in vivo diagnostic devices (used within the living body) or physiological monitoring devices, not IVDs.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

74 DQK

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 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.

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

Not Found

Intended User / Care Setting

Not Found

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)

The following in-vitro functional testing was performed on the Syneflash™ / Syneview™ Holter ECG system:
Test group: Syneflash™ safety testing
Tests: Environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the EN 60601-1, EN 60601-1-2 and ANSI/AAMI EC38-1994 standards

Test group: Syneview™ database testing
Tests: Database testing according to the ANSI/AAMI EC38-1994 standard using the following databases:
• AHA (American Heart Association),
• MIT (Massachusetts Institute of Technology),
• ST (European database on ST segment)
• NST (Noise Stress Test)

Test group: Syneflash™ / Syneview™ software validation and verification testing
Tests: Unit and functional testing for both Syneflash™ and Syneview™ software applications

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K942565, K945130, K970902, K895806, K945985, K951902

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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

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. (612) 519-9400

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

1

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
MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC
RECORDER | DL 700 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------|
| COMPANY | ELA MEDICAL | OXFORD
INSTRUMENTS
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
(on the analyzer) | Retrospective
(on the analyzer) | Retrospective
(on the analyzer) |
| Record duration | 24H | 24H | 24H | 24H |
| Recording medium | PCMCIA FLASH CARD
(10, 20 40 MB) | PCMCIA FLASH CARD
(ATA) | Hard disk (170MB) | PCMCIA ATA FLASH
CARD (10, 20 40 MB) |
| Signal compression | Yes (delta + variable
length bit coding = no
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
standard mode
(extension to 500Hz
possible in High
Resolution mode) | | 0.05Hz to 100Hz in
standard mode
(extension to 300Hz
possible in High
Resolution mode) | |
| Overall
Recorder/Analyzer
Frequency Response | 0.05Hz to 50Hz in
standard mode | 0,05Hz to 40Hz | | |
| Dynamic Range | 10µV to 10 mV | 10µV to 10 mV | 5mV in standard mode
(10 mV in High Resolution
mode) | |
| Amplitude Resolution | 10µV
(2.5µV in High Resolution
mode) | | | |
| HOLTER RECORDER
MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC
RECORDER | DL 700 |
| High Resolution mode | Yes
(Hi Res or Hi Res +
Holter) | No | Yes
(Hi Res or Hi Res +
Holter) | No |
| High Resolution
Sampling Frequency | 1000Hz | | 1000Hz | |
| High Resolution
Transfer | By a transferring utility
Between Flash Card and
PC | | By connection to the PC
with an interface. | |
| Setup | With the graphic display +
keyboard | By connection to the PC
with fiber optical cable | | |
| Verification of the ECG | With the graphic display | By connection to the PC
with fiber optical cable | | |
| Test Cable /
Impedance check | Yes / Yes | | | |
| CABLE | 5 or 7 wires | 3, 5 or 7 wires | | |
| POWER | 2AA 1.5V Alkaline
Batteries
(for 2x24H records)
or 1x24H record with
1.2V NiMh rechargeable
batteries (1200mA/H) | 2AA 1.5V Alkaline
Batteries or 1.2V NiMh
rechargeable batteries | 2 x 9V batteries | 9V batteries |
| Pacemaker Detection | Yes | Yes | Yes | Yes |
| DISPLAY | GRAPHIC LCD | 4 digits (7 segments) LCD
display | LCD | LCD |
| Time Displayed | Yes
(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
(Buzzer) | Yes | | |
| Patient event marker | Yes
(resolution at sampling
frequency) | Yes
(resolution at sampling
frequency) | | Yes |
| Case | Polycarbonate / ABS | Polycarbonate / ABS | | |
| Replay and Analysis
system | SYNEVIEW | OXFORD OPTIMA &
EXCEL | BURDICK ALTAIR 8200 | REYNOLDS
PATHFINDER 700 and
others. |
| Weight | 290g with batteries and
flash card | 310g with batteries and
flash card | 425g | |
| Dimensions | 130x90x25mm | 120x90x40mm | 129x91x32mm | |
| HOLTER RECORDER
MODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISC
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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3

Comparison table between ELA MEDICAL SYNEVIEW and predicate analyzers:

| HOLTER ANALYZER

MODELSYNEVIEWELATECALTAIR 8200PATHFINDER 700
COMPANYELA MEDICALELA MEDICALBURDICKREYNOLDS
MEDICAL
510(k) NumberK895806K945985K951902
CE / MDD certificationYesNo
TypeHolter Analyzer (Software)Holter AnalyzerHolter AnalyzerHolter Analyzer
Read digital / tapeDigital (dedicated to
SyneFlash recorder)Standard 1mm/s tape
(and 1,5mm/s, 2mm/tape)Digital (Burdick Disc
recorder only) and
Standard TapeDigital (Braemar DL700
REYNOLDS eRAM)
and Standard Tape
PC basedYesYesYesYes (+transputer)
PCMCIA interface
compatibleYesNoNoYes
Operating SystemMicrosoft Windows 95 or 98Microsoft DOSMicrosoft DOSMicrosoft DOS
Graphic User Interface
(GUI)YesYesYesYes
NetworkYesNo
Re-analysisNoYesYesYes
Events list editionYesNoNoNo
Arrhythmia detectionYesYesYesYes
STYesYesYesYes
Templates screenYesYesYesYes
SuperimpositionYesYesYesYes
Pacemaker detectionYesYesYesYes
Editing reportYesYesYesYes
Customized reportYesYesYesYes
ArchivingYesYesYesYes
Printing ECG stripYesYesYesYes
Printing Full DisclosureYesYesYesYes

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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 groupTests
Syneflash™ safety testingEnvironmental and safety tests, including EMC
(Electromagnetic Compatibility) tests, according to
the EN 60601-1, EN 60601-1-2 and ANSI/AAMI
EC38-1994 standards
Syneview™ database
testingDatabase testing according to the ANSI/AAMI
EC38-1994 standard using the following databases:
• AHA (American Heart Association),
• MIT (Massachusetts Institute of Technology),
• ST (European database on ST segment)
• NST (Noise Stress Test)
Syneflash™ / Syneview™
software validation and
verification testingUnit and functional testing for both Syneflash™
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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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