ARCHIMED 4210 AND 4220

K973922 · Biosound Esaote, Inc. · LOS · May 12, 1998 · CV

Device Facts

• Record ID: K973922
• Device Name: ARCHIMED 4210 AND 4220
• Applicant: Biosound Esaote, Inc.
• Product Code: LOS · CV
• Decision Date: May 12, 1998
• Decision: SESE
• Submission Type: Traditional

Indications for Use

The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.

Device Story

ArchiMed 4210/4220 are portable, multi-channel electrocardiographs for acquisition, digitization, display, and recording of 12-lead ECG waveforms. Used in clinical settings by healthcare professionals. Inputs include 10 buffered leads with RL drive; device performs signal amplification, filtering (50/60Hz adaptive, 30/45Hz low-pass), and digitization. Model 4220 includes optional interpretive software for adult resting ECGs and exercise stress testing capabilities. Output is displayed on a backlit LCD and recorded via thermal printer; 4220 supports laser printing and network connectivity. Interpretive software provides advisory analysis; physicians must validate all interpretations. Benefits include automated measurement and diagnostic support for cardiac assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Portable 12-lead ECG system. 10 buffered leads with RL drive. 500 Hz sampling frequency. 50/60 Hz adaptive digital filter; 30/45 Hz digital low-pass filter. Thermal print head (8 dots/mm). LCD display (480x640). Connectivity: RS232, network (4220). Power: 12V Ni-Cd battery or mains. Defibrillation protected. Fully floating and isolated patient input.

Indications for Use

Indicated for recording standard resting or exercise ECGs in adult patients. Includes optional automated measurement and interpretation of resting ECGs.

Predicate Devices

• Esaote P210 (K902368)

Submission Summary (Full Text)

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MAY 1 2 1998

K973922

Safety and Effectiveness Summary 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 8000 Castleway Drive Indianapolis, IN 46250 Phone: [phone] Facsimile: [phone]

Contact Person: Colleen Hittle

Date: October 3, 1997

807.92(a)(2)

Trade Name: ArchiMed

Electrocardiograph data analysis firmware Common Name:

Classification Name(s): System, ECG Analysis 870.2340

Classification Number: 74LOS

807.92(a)(3)

#### Predicate Device(s)

P210 K902368 Esaote

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

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#### Safety and Effectiveness Summary ArchiMed Biosound Esaote

#### ESAOTE P210 ESAOTE 4210 - 4220 General Characteristics (K#902368) 310x350x75 Dimensions (1.w.h) in mm 328x254x75 3.3 kg Weight 3.8 kg (4210) 4.8 kg (4220) SAME 12V Ni-Cd rechargeable battery Power Supply Mains supply 100 - 240 V. SAME 20-60Hz LCD, backlit, 480x640 pixels, SAME Display adjustable viewing angle ECG storage RAM Cards Floppy Disks Digital device . HardDisk (Mod.4220) Yes (RS232) (RS232, Network for Yes ● Remote data storage Mod.4220) Up to 500 Hz ● Digital storage resolution 500 Hz Environmental Conditions SAME +10 / + 40°C Operating temperature ● SAME 25 to 95% RH . Relative humidity Standard, Cabrera SAME Leads 10 buffered leads with RL drive SAME ECG patient cable SAME Defibrillation protected Patient Input Fully floating and isolated SAME ECG amplifier 8 leads simultaneously acquired, SAME . Number of signals recorded 4 mathematically derived 200 Hz . Sampling frequency 1000 Hz ± 300 mV Max. DC polarization ±450 mV ● SAME . > 100 dB Common mode rejection 0.05 to > 150 Hz SAME . Frequency response 50/60 Hz adaptive digital filter SAME Filters 30/45 Hz digital low-pass filter, SAME programmable Recorder Thermal print head (8 dots/mm) SAME Paper speed 5, 12.5, 25, 50 mm/s SAME . A4 or Letter (Z folded) SAME. but Paper size . with half length 6 channels Recording tracks 12 channels .

#### Comparison Chart for Substantial Equivalence

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Safety and Effectiveness Summary ArchiMed Biosound Esaole

807.92(a)(4)

#### Device Description

The ArchiMed product line represents two (4210, 4220) versions of a portable, multi channel electrocardiograph machine. These units are intended for acquisition, digitization, display and recording of conventional diagnostic 12 simultaneous lead ECG waveforms. The 4220 model can be equipped with a resting interpretation program covering adult populations. This analysis program is offered to the physician on an advisory basis only and physician is asked to over-read and validate (or change) the ECG interpretation. Moreover, the 4220 may be equipped with a software package to be used for exercise stress testing, has wider connectivity characteristics and can print to a laser printer.

807.92(a)(5)

## Intended Use(s)

The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | 2 |998

Biosound Esaote, Inc. c/o Ms. Colleen J. Hittle 8000 Castleway Drive Indianapolis, IN 46250

Re: K973922 ArchiMed Electrocardiographs Models 4210 and 4220 Requlatory Class: III (three) Product Code: 74 LOS Dated: February 10, 1998 Received: February 11, 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 requlations 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 regulatory action. In addition, FDA may publish further announcements 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 requlations.

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#### Page 2 - Ms. Colleen J. 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 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 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

Thomas J. 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):

K973922

Device Name: ArchiMed

Indications for Use:

The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.

(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 _________________________________________________________________________________________________________________________________________________________

Mr. Puye

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number.