(11 days)
- Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period.
- High-resolution recording of surface ECG data.
- Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.
The SpiderView ™ Holter recorder is designed to acquire and store, in a digital format, multiple channels of surface ECG data (from 2 to 9 Leads) for a period up to 96 hours. The device stores the acquired ECG data on a removable flash memory card. ECG signals are converted at a rate of 200 to 1000 samples per second, which allows accurate reproduction of the ECG signal to perform signal averaging ECG analysis. The Holter scanner software (sold separately) reads these data and prints them out in tabular or graphical form. This recorder does not perform any analysis on the ECG data. SpiderView™ is supplied in a case containing a 16, 32, or 64 MB flash-memory card, one 1.5 V AA battery, a carrying case, a strap, five patient cables, a set of ECG electrodes, and a user's manual.
The manufacturer, ELA Medical, Inc., submitted a 510(k) premarket notification for the SpiderView Holter ECG recorder. This device is intended to acquire and store multi-channel surface ECG data for up to 96 hours. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence by comparing the SpiderView Holter ECG recorder's technological characteristics to those of predicate devices. Formal acceptance criteria with specific performance thresholds (e.g., accuracy percentages) are not explicitly stated in the provided text. Instead, the "performance" is implicitly demonstrated through the functional capabilities and specifications that are comparable to or exceed those of the predicate devices.
| Feature | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported SpiderView Performance |
|---|---|---|
| Device Type | Digital Holter recorder | Digital |
| Analysis | Retrospective (on the analyzer) | Retrospective (on the analyzer) - Note: Device does not perform analysis itself. |
| Record Duration | At least 24 hours (predicates range from 24H to 120H) | 24H to 96H |
| Recording Medium | Removable memory card (e.g., PCMCIA, CompactFlash, MMC, SD) | MMC or SD Flash card (16, 32, 64 MB) |
| Data Transfer | Via Removable memory card or USB port | Via Removable memory card |
| Signal Compression | Acceptable if no notable loss OR no compression (predicates vary) | Yes (delta + variable length bit coding = no notable loss) |
| Channels | 2 or 3 channels (predicates offer 2, 3, 5, 7, 9, 12) | 2, 3, 5, or 9 (5-channel recording authorizes true 9-lead ECG by calculation) |
| Sampling Rate | Comparable to predicate devices (e.g., 175sps to 1024sps) | 200sps (standard) / 1000sps (High Resolution mode) |
| Frequency Response | Comparable to predicate devices (e.g., 0.05Hz to 25Hz, up to 150Hz) | 0.05Hz to 25Hz (standard) / 0.05Hz to 100Hz (no compression mode) |
| Dynamic Range | Comparable to predicate devices (e.g., +/-6mV to +/-10mV, 10-12 bit) | +/-16 mV (15 bit) |
| Amplitude Resolution | Comparable to predicate devices (e.g., 1.465μV to 10μV) | 10μV (standard) / 2.5μV (High Resolution mode) |
| High Resolution Mode | Available on some predicates | Yes (with 1000sps sampling rate and software utility for ISHNE format transfer) |
| Setup | Graphic display + keyboard | With the graphic display + keyboard |
| ECG Channel Preview | Yes | Yes |
| CABLE | 3, 5, 7, or 10 wires (predicates vary) | 3, 5 or 7 wires |
| Test Cable | Yes on some predicates | Yes |
| Impedance measurement | Yes | Yes |
| Power | AA 1.5V batteries (rechargeable options acceptable) | 1 AA 1.5V battery or 1 AA 1.2V NiMH rechargeable battery |
| Pacemaker Detection | Yes | Yes |
| Display | Graphic LCD or LCD | GRAPHIC LCD |
| Time Displayed | Yes (at least during hookup) | Yes (only during hookup) |
| Patient event marker | Yes | Yes |
| On-board ECG analysis | No (for most predicates for comparable function) | No |
| Safety Testing | Compliance with standards IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998 | Environmental and safety tests, including EMC tests, according to the specified standards. |
| Software Validation | Module and functional testing for software applications | Module and functional testing for SpiderView™ software applications |
2. Sample Size and Data Provenance for Test Set
The provided summary does not detail a "test set" in the context of clinical performance data. The studies mentioned are:
- In-vitro functional testing: This refers to the testing performed in a controlled laboratory environment, not on human subjects.
- Safety testing: This includes environmental, safety, and EMC tests according to specified standards.
- Software validation and verification testing: Module and functional testing for software applications.
Therefore, there is no sample size or data provenance for a clinical test set involving patient data mentioned for the SpiderView Holter ECG recorder. The device is a data acquisition device, and its safety and performance are primarily assessed through engineering and functional testing against standards, and comparison of its technical specifications to those of legally marketed predicate devices.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As there is no clinical "test set" or human-in-the-loop performance evaluation described, there are no experts mentioned as establishing ground truth for such a set. The "ground truth" for the functional and safety testing would be adherence to engineering specifications and regulatory standards.
4. Adjudication method for the Test Set
Given the nature of the studies described (in-vitro functional, safety, and software validation), an adjudication method (like 2+1, 3+1) is not applicable or mentioned. Adjudication typically applies to evaluating interpretations of clinical data by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This type of study would typically assess how human readers perform with and without an AI-assisted device in interpreting clinical cases. Since the SpiderView device is solely a data recorder and does not perform any analysis or interpretation, an MRMC study is not relevant or described in the submission.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No standalone performance study is explicitly described as the device itself does not contain an "algorithm" for analysis or interpretation of ECG data. Its function is to record high-fidelity ECG signals. The statement "This recorder does not perform any analysis on the ECG data" directly indicates that it is not an AI-enabled interpretative device. The software validation mentioned is for the device's operational software, not an analytical algorithm.
7. Type of Ground Truth Used
For the in-vitro functional, safety, and software validation testing, the ground truth would be based on:
- Engineering specifications: The device is expected to perform according to its design specifications.
- Regulatory standards: The safety and EMC testing confirms compliance with harmonized standards (IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998).
- Predicate device characteristics: Substantial equivalence is argued based on the SpiderView's technical characteristics being comparable to, or improved upon, the predicate devices.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's premarket notification.
8. Sample Size for the Training Set
Since the SpiderView is a data recording device and not an analytical or AI-driven system that would require a "training set" for an algorithm, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an analytical algorithm, the concept of establishing ground truth for a training set is not applicable to this submission.
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5 510 (k) summary of Safety and Effectiveness
Date: August 7, 2003
Submitter:
ELA Medical, Inc. 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441 Phone: (763) 519-9400 Fax: (763) 519-9440
Contact Person:
Susan Olive, Regulatory Affairs Manager
Device trade name:
SpiderView Holter ECG recorder
Common/usual name:
Ambulatory Holter Recorder
Classification name:
Electrocardiograph, Ambulatory (without analysis) MWJ (21 CFR 870.2800)
Predicate devices:
-
Cardio ID+ (RZ153+) (K022540, ROZINN ELECTRONICS, INC.),
-
Digitrak Plus (Philips) (K993617, Braemar Corp.),
-
SyneFlash (K990727, ELA MEDICAL, INC) and SyneFlash MMC
Device description:
The SpiderView ™ Holter recorder is designed to acquire and store, in a digital format, multiple channels of surface ECG data (from 2 to 9 Leads) for a period up to 96 hours. The device stores the acquired ECG data on a removable flash memory card. ECG signals are converted at a rate of 200 to 1000 samples per second, which allows accurate reproduction of the ECG signal to perform signal averaging ECG analysis.
The Holter scanner software (sold separately) reads these data and prints them out in tabular or graphical form.
This recorder does not perform any analysis on the ECG data.
SpiderView™ is supplied in a case containing a 16, 32, or 64 MB flash-memory card, one 1.5 V AA battery, a carrying case, a strap, five patient cables, a set of ECG electrodes, and a user's manual.
Intended use:
The Spiderview Holter recorder is intended to perform ambulatory multi-channel ECG recording on pediatric or adult patients for periods up to 96 hours, and to perform high-
Proprietary and confidential
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resolution recording of surface ECG data. It does not perform any analysis on the ECG data.
The SpiderView Holter recorder is intended to be used under the supervision of licensed and trained practitioners, in a hospital or clinic setting. Applications for Holter monitoring include, but are not limited to, evaluation of the following:
- Patient symptoms such as syncope, dizziness or palpitations ●
- Ischemia, especially in patients who cannot exercise or in patients with variant angina ●
- Function of an implanted pacemaker or defibrillator ●
Multi-day, multi-channel Spiderview recordings can be read and interpreted using Synescope Holter analysis software. Data collected on SpiderView using 2 to 3 channels and up to 24 hours can be read and interpreted using Synescope, Synetec or Syneview Holter analysis software.
| HOLTER RECORDERMODEL | SpiderView™ | SYNEFLASHSYNEFLASH MMC | CARDIO ID+(RZ153+) | DIGITRAKPLUS |
|---|---|---|---|---|
| COMPANY | ELA MEDICAL | ELA MEDICAL | ROZINN | BRAEMAR(sold by PHILIPS) |
| 510(k) Number | Present application | K990727 | K022540 | K993617 |
| Type | Digital | Digital | Digital | Digital |
| Analysis | Retrospective(on the analyzer) | Real Time andRetrospective(on the analyzer) | Retrospective(on the analyzer) | Retrospective(on the analyzer) |
| Record duration | 24H to 96H | 24H | Up to 120H | Up to 48H |
| Recording medium | MMC or SD Flash card(16,32 64 MB) | PCMCIA FLASH CARD(10, 20, 40, 64MB)MMC or SD(16,32 64, 128MB) | CompactFlash MemoryCard Type I or II | Internal Flash memory(non-removable) |
| Data transfer method | Via Removable memorycard | Via Removable memorycard | Via Removable memorycard | Via USB port |
| Signal compression | Yes (delta + variablelength bit coding = nonotable loss) | Yes (delta + variablelength bit coding = nonotable loss) | No | No |
| CHANNELS | 2, 3, 5, or 9 (the 5channel recordingauthorizes true 9-leadECG by calculation) | 2 or 3 | Multiple (2, 3, + true 12-Lead recording in option) | 3 (+ EASI 12-Lead derivedECG) |
| Sampling rate | 200sps | 200sps | 1024sps | 175sps |
| Frequency Response | 0.05Hz to 25Hz instandard mode0.05Hz to 100Hz in nocompression mode | 0.05Hz to 25Hz instandard mode0.05Hz to 80Hz in nocompression mode | 0.05Hz to 75Hz(0.05Hz to 150Hz in 12-Lead) | 0.05Hz to 60Hz |
| Dynamic Range | +/-16 mV15 bit | +/-10 mV12 bit | +/-6mV12 bit | +/-6mV10 bit |
| Amplitude Resolution | 10μV(2.5μV in HighResolution mode) | 10μV(2.5μV in High Resolutionmode) | 1.465μV | |
| High Resolution mode | Yes | Yes | No | No |
| High ResolutionSampling rate | 1000sps | 1000sps | NA | NA |
| High Resolution Transfer | Software utility to createa file in ISHNE format | Software utility to createa file in ISHNE format | NA | NA |
Comparison of technology characteristics to predicate devices:
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| HOLTER RECORDER | SpiderView™ | SYNEFLASH | CARDIO ID+(RZ153+) | DIGITRAKPLUS |
|---|---|---|---|---|
| MODEL | SYNEFLASH MMC | |||
| Setup | With the graphic display+ keyboard | With the graphic display+ keyboard | With the graphic display +keyboard | With the graphic display +keyboard |
| ECG channel preview | Yes | Yes | Yes | Yes |
| CABLE | 3, 5 or 7 wires | 5 or 7 wires | 7 or 10 wires | 5 wires |
| Test Cable | Yes | Yes | Yes | No |
| Impedance measurement | Yes | Yes | Yes | Yes |
| POWER | 1 AA 1.5V batteryor 1 AA 1.2V NiMHrechargeable battery | 2 AA 1.5V batteriesor 2 AA 1.2V NiMHrechargeable batteries | 1 or 2 AA 1.5V batteriesAccept rechargeablebatteries | 1 AA 1.5V battery |
| Pacemaker Detection | Yes | Yes | Yes | Yes |
| DISPLAY | GRAPHIC LCD | GRAPHIC LCD | GRAPHIC LCD | LCD |
| Time Displayed | Yes(only during hookup) | Yes(only during hookup) | Yes | Yes |
| Carrying case | Belt + pouch | Belt + pouch | Belt + pouch | Belt + pouch |
| Keyboard | Yes | Yes | Yes | Yes |
| Sound | Yes(Buzzer) | Yes(Buzzer) | No | No |
| Patient event marker | Yes | Yes | Yes | Yes |
| On-board ECG analysis | No | Yes / Yes | No | No |
| Replay and Analysissystem | SYNETEC, SYNEVIEWSYNESCOPE for multi-lead and multi-dayrecordings | SYNETEC, SYNEVIEW | Holter for Windows® | Philips Holter analyzer |
| Weight | 110g with batteries andflash card | 290g with batteries andflash card | 145g | 100g |
| Dimensions | 97x54x23mm | 130x90x25mm | 108x79x22mm | 85x65x20mm |
Summary of Studies
The following in-vitro functional testing was performed on the SpiderView™ Holter ECG recorder:
| Test group | Tests |
|---|---|
| SpiderView™ safety testing | Environmental and safety tests, including EMC(Electromagnetic Compatibility) tests, according tothe IEC 60601-2-47, IEC 60601-1-2 andANSI/AAMI EC38-1998 standards. |
| SpiderView™ software validationand verification testing | Module and functional testing for SpiderView™software applications |
Conclusion
The information presented in this submission provides reasonable assurance that the SpiderView™ Holter ECG recorder will perform in a safe and effective manner.
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three horizontal lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
AUG 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ELA Medical, Inc. c/o Ms. Susan J. Olive Regulatory Affairs Manager 2950 Xenium Lane North, Suite 120 Plymouth, MN 55441
Re: K032466
Trade Name: Spiderview Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: August 8, 2003 Received: August 11, 2003
Dear Ms. Olive:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Ms. Susan J. Olive
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Vollan
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known):
Device Name: ELA Medical Spiderview Holter ECG Recorder
Indications For Use:
- Recording of up to nine-channel surface ECG (Electrocardiogram) data from . ambulatory patients during a 96-hour maximum period.
- High-resolution recording of surface ECG data. .
- Note: Analysis of recorded Holter ECG data requires separately-supplied ELA . Synetec, Syneview, or Synescope Holter analysis software.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V. Celentano
(Division Sign-Off)
Division of Cardiovascular Devices
510/
Prescription Use Only
(Optional Format 3-10-98)
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).