SPIDERVIEW

• K Number: K032466
• Device Name: SPIDERVIEW
• Manufacturer: ELA MEDICAL, INC.
• Date Cleared: 2003-08-22 ( 11 days)
• Product Code: MWJ
• Regulation Number: 870.2800

Intended 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.

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.

Predicate Devices

K022540, K993617, K990727

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that the recorder does not perform any analysis on the ECG data, and analysis requires separate software. There is no mention of AI or ML in the description or performance studies.

Therapeutic

No

Explanation: The device is designed to acquire and store ECG data for diagnostic purposes, not to provide therapy or treatment.

Diagnostic

Yes

The device is designed to acquire and store ECG data for analysis, which is a key function of diagnostic devices. Although it does not perform the analysis itself, it provides the necessary data for a diagnosis to be made using separate software.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the SpiderView™ Holter recorder is a hardware device designed to acquire and store ECG data. It is supplied with physical components like a flash memory card, battery, cables, and electrodes. While it interacts with separate software for analysis, the core device itself is hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the SpiderView™ Holter recorder is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• SpiderView™ Function: The SpiderView™ Holter recorder is designed to record electrical signals from the surface of the patient's body (ECG data). It does not analyze or test biological specimens.
• Intended Use: The intended use clearly states "Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients". This is a physiological measurement, not an in vitro test.
• Device Description: The description focuses on acquiring and storing ECG data, not on analyzing biological samples.
• Performance Studies: The performance studies mentioned are functional and safety tests related to the device's operation and compliance with standards for medical electrical equipment, not studies on the accuracy of analyzing biological specimens.

Therefore, the SpiderView™ Holter recorder falls under the category of a medical device that performs physiological monitoring, but it is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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.

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

MWJ

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.

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

pediatric or adult patients

Intended User / Care Setting

licensed and trained practitioners, in a hospital or clinic setting.

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 SpiderView Holter ECG recorder:

Test group: SpiderView safety testing
Tests: Environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the IEC 60601-2-47, IEC 60601-1-2 and ANSI/AAMI EC38-1998 standards.

Test group: SpiderView software validation and verification testing
Tests: Module and functional testing for SpiderView 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.

K022540, K993617, K990727

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

Regulation Number and Section

§ 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).

Summary

0

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

1

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
MODEL | SpiderView™ | SYNEFLASH
SYNEFLASH 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 and
Retrospective
(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 Memory
Card Type I or II | Internal Flash memory
(non-removable) |
| Data transfer method | Via Removable memory
card | Via Removable memory
card | Via Removable memory
card | Via USB port |
| Signal compression | Yes (delta + variable
length bit coding = no
notable loss) | Yes (delta + variable
length bit coding = no
notable loss) | No | No |
| CHANNELS | 2, 3, 5, or 9 (the 5
channel recording
authorizes true 9-lead
ECG by calculation) | 2 or 3 | Multiple (2, 3, + true 12-
Lead recording in option) | 3 (+ EASI 12-Lead derived
ECG) |
| Sampling rate | 200sps | 200sps | 1024sps | 175sps |
| Frequency Response | 0.05Hz to 25Hz in
standard mode
0.05Hz to 100Hz in no
compression mode | 0.05Hz to 25Hz in
standard mode
0.05Hz to 80Hz in no
compression mode | 0.05Hz to 75Hz
(0.05Hz to 150Hz in 12-
Lead) | 0.05Hz to 60Hz |
| Dynamic Range | +/-16 mV
15 bit | +/-10 mV
12 bit | +/-6mV
12 bit | +/-6mV
10 bit |
| Amplitude Resolution | 10μV
(2.5μV in High
Resolution mode) | 10μV
(2.5μV in High Resolution
mode) | 1.465μV | |
| High Resolution mode | Yes | Yes | No | No |
| High Resolution
Sampling rate | 1000sps | 1000sps | NA | NA |
| High Resolution Transfer | Software utility to create
a file in ISHNE format | Software utility to create
a file in ISHNE format | NA | NA |

Comparison of technology characteristics to predicate devices:

2

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 battery
  or 1 AA 1.2V NiMH
  rechargeable battery | 2 AA 1.5V batteries
  or 2 AA 1.2V NiMH
  rechargeable batteries | 1 or 2 AA 1.5V batteries
  Accept rechargeable
  batteries | 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 Analysis
  system | SYNETEC, SYNEVIEW
  SYNESCOPE for multi-
  lead and multi-day
  recordings | SYNETEC, SYNEVIEW | Holter for Windows® | Philips Holter analyzer |
  | Weight | 110g with batteries and
  flash card | 290g with batteries and
  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
(Electromagnetic Compatibility) tests, according to
the IEC 60601-2-47, IEC 60601-1-2 and
ANSI/AAMI EC38-1998 standards.
SpiderView™ software validation
and 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.

3

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

4

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

5

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)