FORMULA FOR ARCHIMED

K974079 · Biosound Esaote, Inc. · DPS · Jan 22, 1998 · Cardiovascular

Device Facts

• Record ID: K974079
• Device Name: FORMULA FOR ARCHIMED
• Applicant: Biosound Esaote, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Indications for Use

The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance.

Device Story

Formula for ArchiMed (model 4230) is a multi-channel electrocardiograph; inputs 12-lead ECG signals; features SVGA monitor, PC keyboard, trackball. Device performs acquisition, digitization, display, and recording of ECG waveforms; includes resting interpretation program for adults and exercise stress testing software. Operates via physician; provides advisory interpretation requiring physician overread/validation. Incorporates hard disk, 4 serial ports for networking, laser printer support. Benefits include automated cardiac performance analysis to assist clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and algorithmic similarity to the predicate device.

Technological Characteristics

Multi-channel electrocardiograph; SVGA display; PC keyboard/trackball interface. Power: 100-115/200-230V, 50-60Hz. Connectivity: RS232, Network, Floppy/HardDisk storage. Features: 500 Hz digital storage resolution, linear interpolation baseline filter, 12-lead time alignment, fiducial point identification, ST level/slope measurement, aberrant beat detection. Software: Resting interpretation program (adults), exercise stress testing module.

Indications for Use

Indicated for use by physicians to analyze cardiac performance in adult populations via acquisition, digitization, display, and recording of 12-lead ECG waveforms and exercise stress testing.

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

• Esaote Formula (K922703)

Reference Devices

• Schiller Cardiovit CS-200
• SunTech Medical Instruments Tango pressurometer

Submission Summary (Full Text)

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K974079

Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

# Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 807.92(a).

807.92(a)(1)

## Submitter Information

| Colleen Hittle, Official Correspondent<br>8000 Castleway Drive<br>Indianapolis, IN 46250<br>Phone: [phone]<br>Facsimile: [phone] | | | | JAN 22 1998 | | FDA/CDRH/ODE/DMC | | OCT 29<br>11 14 AM 97 |
|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|---------|-------------|--|------------------|--|-----------------------|
| Contact Person: | Colleen Hittle | | | | | | | |
| Date: | October 13, 1997 | | | | | | | |
| 807.92(a)(2) | | | | | | | | |
| Trade Name: | Formula for ArchiMed | | | | | | | |
| Common Name: | Electrocardiograph data analysis firmware | | | | | | | |
| Classification Name(s): | Electrocardiograph 870.2340 | | | | | | | |
| Classification Number: | 74DPS | | | | | | | |
| 807.92(a)(3) | Predicate Device(s) | | | | | | | |
| Esaote | Formula | | K922703 | | | | | |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

W
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#### Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

### Comparison Chart for Substantial Equivalence

| General Characteristics | ESAOTE 4230<br>Formula for ArchiMed | ESAOTE ACTA<br>Formula (K#922703) |
|---------------------------------------------------|-------------------------------------|-----------------------------------|
| Dimensions (l,w,h) in mm | 78 x 66 x 144 | 75 x 68 x 145 |
| Weight | 80 kg | 100 kg |
| Power Supply | 100 - 115 / 200 - 230 V, 50 - 60 Hz | 115 / 230 V, 50 - 60 Hz |
| Display | SVGA | SAME |
| ECG storage | | |
| • Digital device | Floppy, HardDisk | SAME |
| • Remote data storage | RS232, Network | No |
| • Digital storage resolution | 500 Hz | 250 Hz |
| Environmental Conditions | | |
| • Operating temperature | +10 / + 40°C | SAME |
| • Relative humidity | 25 to 95% RH | SAME |
| Stress Testing Capabilities | | |
| Baseline Filter | Linear Interpolation, programmable | SAME |
| 12 Leads Time Alignment (Medians) | Yes | SAME |
| Fiducial Points Identification | Yes | SAME |
| ST Measurements | ST level and ST slope | SAME |
| Aberrant Beats Detection | Yes | SAME |
| Arrhythmias classification | No | No |
| 12 Leads Continuous Digital Recording and Storage | Yes (standard) | Yes (optional) |
| Stress Peripherals | | |
| • Treadmill | Trackmaster | SAME |
| • Bicycle | SECA | SAME |
| Other peripherals | Pressurometer | Pressurometer |

The recommended pressurometer for Model 4230 is the Tango unit from SunTech Medical Instruments (USA).

Note: The new systems incorporate the same algorhythms for baseline stabilization, template and medians update, fiducial points (and ST measurements) and aberrant beat detection than the predicate device. A description of these algorhythms can be found in the User Manual.

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Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote

807.92(a)(4)

#### Device Description

Formula for ArchiMed (model 4230) represents a multi-channel electrocardiograph machine equipped with an SVGA monitor, a PC keyboard and a trackball. It is intended to be used for acquisition, digitization, display and recording of conventional diagnostic twelve (12) simultaneous lead ECG waveforms. The 4230 is equipped with a resting interpretation program covering adult populations. This analysis program is offered to the physician on an advisory basis only and the physician is asked to overread and validate (or change) the ECG interpretation.

Formula for ArchiMed is also equipped with software that can be used for exercise stress testing. It incorporates a hard disk with 4 serial ports to add networking capabilities and to accommodate printing to a laser printer. Such laser recording abilities have been recently adopted by Schiller (Cardiovit CS-200), whose product literature is attached in Appendix E.

807.92(a)(5)

#### Intended Use(s)

The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Ms. Colleen Hittle Biosound Esaote, Inc. 8000 Castleway Drive 46250 Indianapolis, IN

Re : K974079 Formula for ArchiMed (Model 4230) Regulatory Class: II (two) Product Code: 74 DPS Dated: January 9, 1998 Received: January 12, 1998

Dear Ms. Hittle:

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 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, qood 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 Requlations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) .. inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. 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. Colleen Hittle

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 dev`ice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications For Use

510(k) Number (if known):

K974079

Device Name:

Formula for ArchiMed

Indications for Use:

The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use **__**

(Division Sign-Off)
Division of Cardiovascular, Respiratory.
and Neurological Devices
510(k) Number. K974079