(266 days)
- 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.
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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Group | Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|---|
| Syneflash™ Safety Testing | 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. | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies compliance with these standards.) |
| Syneview™ Database Testing | 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). | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies satisfactory performance against these databases.) |
| Syneflash™ / Syneview™ Software Validation and Verification Testing | Unit and functional testing for both Syneflash™ and Syneview™ software applications. | The submission provides reasonable assurance that the Syneflash™ / Syneview™ Holter ECG system will perform in a safe and effective manner. (Implies successful completion of these tests.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions validation against the AHA (American Heart Association), MIT (Massachusetts Institute of Technology), ST (European database on ST segment), and NST (Noise Stress Test) databases. However, it does not specify the sample size (number of cases/recordings) used from each of these databases for the test set.
The provenance of these databases is given by their names:
- AHA (American Heart Association): Implies data from the United States.
- MIT (Massachusetts Institute of Technology): Implies data from the United States.
- ST (European database on ST segment): Implies data from Europe.
- NST (Noise Stress Test): This likely refers to a synthetic or specifically prepared dataset designed to test noise robustness, rather than a collection of clinical patient data.
The document does not explicitly state whether the data from these databases was retrospective or prospective, but publicly available, established databases like AHA and MIT are typically retrospective collections of previously recorded data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used or their qualifications for establishing the ground truth of the databases used (AHA, MIT, ST, NST). For established public databases, the ground truth is typically pre-annotated by experts or derived from established clinical criteria.
4. Adjudication Method for the Test Set:
The document does not specify the adjudication method used for establishing the ground truth in the test sets. For public databases, the annotations are usually a result of a consensus process among previous experts or follow specific guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in this submission. The testing described focuses on the standalone performance of the device against established databases, not on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was done. The "Syneview™ database testing" directly assessed the performance of the Syneview™ analysis software (the algorithm) against the AHA, MIT, ST, and NST databases. This is a measure of the algorithm's performance without a human in the loop during the analysis phase.
7. The Type of Ground Truth Used:
The ground truth used was based on expert consensus/established annotations from the reference databases:
- AHA (American Heart Association) database: Contains expert-annotated ECG recordings, often used for arrhythmia detection algorithm validation.
- MIT (Massachusetts Institute of Technology) database: Specifically, the MIT-BIH Arrhythmia Database, which is widely used and contains expert-verified annotations for various cardiac arrhythmias.
- ST (European database on ST segment): Likely contains expert-verified annotations related to ST-segment changes relevant to ischemic events.
- NST (Noise Stress Test): This database would have a predefined "ground truth" concerning the presence and characteristics of noise, against which the system's robustness is evaluated.
8. The Sample Size for the Training Set:
The document does not specify the sample size used for the training set. It only describes the testing performed on the device.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. The focus of this submission is on the validation and verification of the device, not the details of its development or training data.
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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. (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
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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 RECORDERMODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISCRECORDER | DL 700 |
|---|---|---|---|---|
| COMPANY | ELA MEDICAL | OXFORDINSTRUMENTSMEDICAL 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 FLASHCARD (10, 20 40 MB) |
| Signal compression | Yes (delta + variablelength bit coding = nonotable 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 instandard mode(extension to 500Hzpossible in HighResolution mode) | 0.05Hz to 100Hz instandard mode(extension to 300Hzpossible in HighResolution mode) | ||
| OverallRecorder/AnalyzerFrequency Response | 0.05Hz to 50Hz instandard mode | 0,05Hz to 40Hz | ||
| Dynamic Range | 10µV to 10 mV | 10µV to 10 mV | 5mV in standard mode(10 mV in High Resolutionmode) | |
| Amplitude Resolution | 10µV(2.5µV in High Resolutionmode) | |||
| HOLTER RECORDERMODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISCRECORDER | DL 700 |
| High Resolution mode | Yes(Hi Res or Hi Res +Holter) | No | Yes(Hi Res or Hi Res +Holter) | No |
| High ResolutionSampling Frequency | 1000Hz | 1000Hz | ||
| High ResolutionTransfer | By a transferring utilityBetween Flash Card andPC | By connection to the PCwith an interface. | ||
| Setup | With the graphic display +keyboard | By connection to the PCwith fiber optical cable | ||
| Verification of the ECG | With the graphic display | By connection to the PCwith fiber optical cable | ||
| Test Cable /Impedance check | Yes / Yes | |||
| CABLE | 5 or 7 wires | 3, 5 or 7 wires | ||
| POWER | 2AA 1.5V AlkalineBatteries(for 2x24H records)or 1x24H record with1.2V NiMh rechargeablebatteries (1200mA/H) | 2AA 1.5V AlkalineBatteries or 1.2V NiMhrechargeable batteries | 2 x 9V batteries | 9V batteries |
| Pacemaker Detection | Yes | Yes | Yes | Yes |
| DISPLAY | GRAPHIC LCD | 4 digits (7 segments) LCDdisplay | 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 samplingfrequency) | Yes(resolution at samplingfrequency) | Yes | |
| Case | Polycarbonate / ABS | Polycarbonate / ABS | ||
| Replay and Analysissystem | SYNEVIEW | OXFORD OPTIMA &EXCEL | BURDICK ALTAIR 8200 | REYNOLDSPATHFINDER 700 andothers. |
| Weight | 290g with batteries andflash card | 310g with batteries andflash card | 425g | |
| Dimensions | 130x90x25mm | 120x90x40mm | 129x91x32mm | |
| HOLTER RECORDERMODEL | SYNEFLASH | MEDILOG FD4 | ALTAIR-DISCRECORDER | 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 ANALYZERMODEL | SYNEVIEW | ELATEC | ALTAIR 8200 | PATHFINDER 700 |
|---|---|---|---|---|
| COMPANY | ELA MEDICAL | ELA MEDICAL | BURDICK | REYNOLDSMEDICAL |
| 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 toSyneFlash recorder) | Standard 1mm/s tape(and 1,5mm/s, 2mm/tape) | Digital (Burdick Discrecorder only) andStandard Tape | Digital (Braemar DL700REYNOLDS eRAM)and Standard Tape |
| PC based | Yes | Yes | Yes | Yes (+transputer) |
| PCMCIA interfacecompatible | Yes | No | No | Yes |
| Operating System | Microsoft Windows 95 or 98 | Microsoft DOS | Microsoft DOS | Microsoft DOS |
| Graphic User Interface(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(Electromagnetic Compatibility) tests, according tothe EN 60601-1, EN 60601-1-2 and ANSI/AAMIEC38-1994 standards |
| Syneview™ databasetesting | Database testing according to the ANSI/AAMIEC38-1994 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 andverification testing | Unit 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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§ 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).