SPIDERVIEW

K032466 · Ela Medical, Inc. · MWJ · Aug 22, 2003 · Cardiovascular

Device Facts

• Record ID: K032466
• Device Name: SPIDERVIEW
• Applicant: Ela Medical, Inc.
• Product Code: MWJ · Cardiovascular
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2
• Attributes: Pediatric

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-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.

Device Story

SpiderView Holter recorder acquires/stores 2-9 channels of surface ECG data for up to 96 hours; stores data on removable flash memory card (MMC/SD). Device performs no on-board analysis; data transferred to external Holter scanner software (Synescope, Synetec, or Syneview) for interpretation. Used in hospital/clinic settings by trained practitioners. Input: surface ECG signals (200-1000 samples/sec). Output: digital ECG file. Benefits: enables long-term ambulatory monitoring for cardiac symptom evaluation, ischemia detection, and device function assessment.

Clinical Evidence

Bench testing only. Testing included environmental and safety assessments per IEC 60601-2-47, IEC 60601-1-2, and ANSI/AAMI EC38-1998. Software validation and verification testing performed for recorder software applications.

Technological Characteristics

Digital ambulatory ECG recorder; 2-9 channels; 200-1000 sps sampling; 15-bit dynamic range (+/- 16mV). Removable flash memory (MMC/SD). Powered by 1.5V AA battery. Graphic LCD display with keyboard. Includes impedance measurement and pacemaker detection. Dimensions: 97x54x23mm; Weight: 110g. Standards: IEC 60601-2-47, IEC 60601-1-2, ANSI/AAMI EC38-1998.

Indications for Use

Indicated for ambulatory multi-channel ECG recording in pediatric and adult patients for up to 96 hours. Used for evaluation of symptoms (syncope, dizziness, palpitations), ischemia, and pacemaker/defibrillator function. Requires supervision by licensed practitioners in hospital or clinic settings.

Regulatory Classification

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.

Predicate Devices

• Cardio ID+ (RZ153+) (K022540)
• Digitrak Plus (K993617)
• SyneFlash (K990727)
• SyneFlash MMC (K990727)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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 RECORDER<br>MODEL | SpiderView™ | SYNEFLASH<br>SYNEFLASH MMC | CARDIO ID+(RZ153+) | DIGITRAKPLUS |
|----------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------|
| COMPANY | ELA MEDICAL | ELA MEDICAL | ROZINN | BRAEMAR<br>(sold by PHILIPS) |
| 510(k) Number | Present application | K990727 | K022540 | K993617 |
| Type | Digital | Digital | Digital | Digital |
| Analysis | Retrospective<br>(on the analyzer) | Real Time and<br>Retrospective<br>(on the analyzer) | Retrospective<br>(on the analyzer) | Retrospective<br>(on the analyzer) |
| Record duration | 24H to 96H | 24H | Up to 120H | Up to 48H |
| Recording medium | MMC or SD Flash card<br>(16,32 64 MB) | PCMCIA FLASH CARD<br>(10, 20, 40, 64MB)<br>MMC or SD<br>(16,32 64, 128MB) | CompactFlash Memory<br>Card Type I or II | Internal Flash memory<br>(non-removable) |
| Data transfer method | Via Removable memory<br>card | Via Removable memory<br>card | Via Removable memory<br>card | Via USB port |
| Signal compression | Yes (delta + variable<br>length bit coding = no<br>notable loss) | Yes (delta + variable<br>length bit coding = no<br>notable loss) | No | No |
| CHANNELS | 2, 3, 5, or 9 (the 5<br>channel recording<br>authorizes true 9-lead<br>ECG by calculation) | 2 or 3 | Multiple (2, 3, + true 12-<br>Lead recording in option) | 3 (+ EASI 12-Lead derived<br>ECG) |
| Sampling rate | 200sps | 200sps | 1024sps | 175sps |
| Frequency Response | 0.05Hz to 25Hz in<br>standard mode<br>0.05Hz to 100Hz in no<br>compression mode | 0.05Hz to 25Hz in<br>standard mode<br>0.05Hz to 80Hz in no<br>compression mode | 0.05Hz to 75Hz<br>(0.05Hz to 150Hz in 12-<br>Lead) | 0.05Hz to 60Hz |
| Dynamic Range | +/-16 mV<br>15 bit | +/-10 mV<br>12 bit | +/-6mV<br>12 bit | +/-6mV<br>10 bit |
| Amplitude Resolution | 10μV<br>(2.5μV in High<br>Resolution mode) | 10μV<br>(2.5μV in High Resolution<br>mode) | 1.465μV | |
| High Resolution mode | Yes | Yes | No | No |
| High Resolution<br>Sampling rate | 1000sps | 1000sps | NA | NA |
| High Resolution Transfer | Software utility to create<br>a file in ISHNE format | Software utility to create<br>a 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<br>+ keyboard | With the graphic display<br>+ keyboard | With the graphic display +<br>keyboard | With the graphic display +<br>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 battery<br>or 1 AA 1.2V NiMH<br>rechargeable battery | 2 AA 1.5V batteries<br>or 2 AA 1.2V NiMH<br>rechargeable batteries | 1 or 2 AA 1.5V batteries<br>Accept rechargeable<br>batteries | 1 AA 1.5V battery |
| Pacemaker Detection | Yes | Yes | Yes | Yes |
| DISPLAY | GRAPHIC LCD | GRAPHIC LCD | GRAPHIC LCD | LCD |
| Time Displayed | Yes<br>(only during hookup) | Yes<br>(only during hookup) | Yes | Yes |
| Carrying case | Belt + pouch | Belt + pouch | Belt + pouch | Belt + pouch |
| Keyboard | Yes | Yes | Yes | Yes |
| Sound | Yes<br>(Buzzer) | Yes<br>(Buzzer) | No | No |
| Patient event marker | Yes | Yes | Yes | Yes |
| On-board ECG analysis | No | Yes / Yes | No | No |
| Replay and Analysis<br>system | SYNETEC, SYNEVIEW<br>SYNESCOPE for multi-<br>lead and multi-day<br>recordings | SYNETEC, SYNEVIEW | Holter for Windows® | Philips Holter analyzer |
| Weight | 110g with batteries and<br>flash card | 290g with batteries and<br>flash 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<br>(Electromagnetic Compatibility) tests, according to<br>the IEC 60601-2-47, IEC 60601-1-2 and<br>ANSI/AAMI EC38-1998 standards. |
| SpiderView™ software validation<br>and verification testing | Module and functional testing for SpiderView™<br>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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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 [phone]. 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 [phone] or [phone] 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)