ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH

K032200 · Remco Italia S.P.A. · DPS · Oct 3, 2003 · Cardiovascular

Device Facts

• Record ID: K032200
• Device Name: ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
• Applicant: Remco Italia S.P.A.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 3, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

Device Story

ELAN® is a digital 12-channel electrocardiograph for clinical use; acquires and digitizes 12-lead ECG waveforms; features built-in LCD monitor for real-time visualization of 1-6 leads; includes alphanumeric keyboard and thermal printer. Device stores up to 100 ECG tests in internal memory; supports data transmission to PC via serial cable, LAN, or modem. Physician operates device to obtain automatic waveform measurements and preliminary diagnostic interpretations; output provided on advisory basis; physician must review, validate, or modify interpretations. Benefits include standardized ECG data acquisition, automated preliminary analysis, and efficient storage/transmission of diagnostic tests.

Clinical Evidence

Bench testing only. Data includes electrical safety, EMC, and user testing to demonstrate performance equivalence to predicate devices.

Technological Characteristics

Tabletop 12-channel ECG; digital thermal array printer (210 mm paper); LCD preview screen; input impedance 160 Mohms at 10 Hz; CMRR > 100 dB; frequency range 0.05-150 Hz. Connectivity via serial, LAN, or modem. Power: 115-230 VAC or rechargeable NiMH battery. Software performs automatic ECG measurements and preliminary interpretation.

Indications for Use

Indicated for patients requiring diagnostic 12-lead ECG acquisition, digitization, and analysis. Used by clinicians for automatic waveform measurement and preliminary interpretation to assist in clinical decision-making. Physician review and validation of all automated interpretations is required.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• M1770A Pagewriter 200i (K954980)
• Brentwood Telemed 12 Lead Resting ECG Analysis Library (K010505)
• Telemed Omnigraph 6000 (K880357)

Submission Summary (Full Text)

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## EXHIBIT 2

# 510(k) Summary REMCO ITALIA S.p.A. 53, STRADA RIVOLTANA NUOVA SOUTH PEDRINO DI VIGNATE, MI., ITALY 20060 PHONE [phone] Fax [phone] Contact: Carlo Depero, Director Date: July 1, 2003

OCT 03 2003

- 1 . Identification of the Device: Proprietary-Trade Name: ELAN® Digital 12 Channel Electrocardiograph. Classification Name: 74 DPS and LOS Common/Usual Name: Electrocardiograph, ECG Analysis
- 2. Equivalent legally marketed devices The legally marketed device to which equivalence is being claimed is the M1770A Pagewriter 200i manufactured by Hewlett-Packard, K954980, Brentwood "Telemed 12 Lead Resting ECG Analysis Library," K010505 and Telemed Omnigraph 6000, K880357
- 3. Indications for Use (intended use) ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor. ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem. ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.
- 4. Description of the Device: ELAN® is a digital 12 channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads, featuring 6-lead LCD screen, alphanumeric keyboard and high resolution thermal printer on 210 mm paper. ELAN ® can record and store in its internal memory up to 100 ECG tests. Each ECG test can include patient data, ECG measurements, automatic interpretation, physician report. Stored ECG tests can be reviewed, printed on the internal thermal printer and/or sent to a local or remote PC via serial cable, LAN network or external standard modem.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.

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| Substantial Equivalence Chart<br>6. | | |
|--------------------------------------|----------------------------------|------------------------------------|
| SPECIFICATION | PAGEWRITER 200i, K954980 | ELAN |
| CONFIGURATION | Tabletop / cart mount (optional) | Tabletop |
| LEADS | | |
| Lead switching | Automatic / manual | Automatic / manual |
| Sensitivity, mm/mV | 5, 10, 20 | 5, 10, 20 |
| Calibration signal | Manual | Manual |
| Frequency range, Hz Diagnostic | 0.05 - 150 | 0.05 - 150 |
| Filtered | Notch, EMG, baseline wander | Notch, EMG, baseline wander |
| Input impedance, Mohms | 100 | 160 Mohms at 10 Hz |
| CMRR @ 60 Hz, dB | 110 | > 100 |
| Leads-off indicator | Yes | Yes |
| RECORDER | | |
| Recording method | Digital thermal array | Digital thermal array |
| Paper size | A4 | 210 mm z-fold |
| Lead marker | Automatic | Automatic |
| Timing marker | No | No |
| Event marker | No | No |
| Chart speed, mm/sec | 5, 10, 25, 50 | 6.25, 12.5, 25, 50 |
| Channels acquired<br>simultaneously | 12 | 12 |
| Channels printed simultaneously | 3,6,12 | 3, 6, 12 |
| PREVIEW SCREEN | LCD | LCD |
| NO. WAVEFORMS STORED | Optional 30, flash | Flash 25, optional 100 |
| ECG TRANSMISSION | Optional | Yes |
| Type | Fax, Programmable modem, RS232 | Programmable modem, RS232, LAN |
| INTERPRETATION | Yes | Yes |
| ECG MEASUREMENTS | Yes | Yes |
| DEFIBRILLATOR OVERLOAD<br>PROTECTION | Yes | Yes |
| POWER REQUIREMENTS | 110-220 VAC | 115-230 VAC |
| DIMENSION, mm | 102x432x381 | 340 x 400 x 110 |
| WEIGHT, Kg | 8.5 | 5.8 |
| BATTERY OPERATION | Yes | Yes |
| Battery type | Lead acid | Built-in rechargeable NiMH |
| No. / Voltage | 1/6 | 20 / 1.2 V |
| Operating time, hours | 40 min | 5 patient monitoring<br>2 printing |
| ENVIRONMENTAL | | |
| Operating temperature | +10 to +40 °C | +10 to +40 °C |
| Operating humidity | | |
| (non condensing) | 25% to 75% | 25% to 75% |
| Operating altitude | 700-1060 mbar | 700-1060 mbar |
| PLANNING & PURCHASE | | |
| Warranty | 3 years in USA | 2 years in USA |

### Conclusion 7.

After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of Remco Italia S.p.A. that the ELAN® Digital 12 Channel Electrocardiograph is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2003

REMCO ITALIA S.p.A. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K032200

Trade Name: ELAN® Digital 12 Channel Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph, ECG Analysis Regulatory Class: Class II (two) Product Code: DPS Dated: September 15, 2003 Received: September 16, 2003

Dear Mr. Kamm:

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.

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Page 2 - Mr. Daniel Kamm, P.E.

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 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 (OS) 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 vours.

K. Oa. Ce. TM

Bram D. uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# i) Indications for Use

510(k) Number Ko322000

Device Name: ELAN® Digital 12 Channel Electrocardiograph.

# Indications for Use:

ELAN® is a digital 12 channel electrocardiograph designed for acquisition and digitization of conventional diagnostic 12-lead simultaneous ECG waveforms and ECG data and real-time visualization of 1 to 6 leads on its built-in LCD monitor.

ELAN® can also record and store in its internal memory up to 100 ECG tests. Each ECG test can be analyzed, printed on the internal thermal printer and/or sent to a PC via serial cable, LAN or modem.

ELAN® can perform automatic measurements of ECG waveform and preliminary interpretation of ECG test; measurements and diagnostic statements are offered to the physician on an advisory basis only; the physician is asked to review and validate or change the ECG interpretation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K032200

Prescription Use *X* OR Over the Counter Use **__**

(Per 21 CFR 801.109)