(209 days)
Not Found
No
The summary mentions "interpretive software" and an "analysis program" for ECGs, but there is no explicit mention of AI, ML, or related terms, nor is there any description of training or test data which would be typical for an AI/ML device submission.
No.
The device is used to record and interpret electrocardiographs, which are diagnostic tools, not therapeutic devices. It assists physicians in diagnosis by providing advisory interpretations of ECG data.
Yes.
The device description states its intention for "acquisition, digitization, display and recording of conventional diagnostic 12 simultaneous lead ECG waveforms." The presence of an optional interpretive software for resting ECGs, even if advisory, further supports its diagnostic capability.
No
The device description explicitly states it is a "portable, multi channel electrocardiograph machine," indicating it includes hardware components for acquiring and processing ECG waveforms.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ArchiMed electrocardiograph products record electrical activity of the heart (ECG waveforms) directly from the patient's body. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use is to record electrocardiographs at patient resting or exercising, and optionally provide interpretation of these recordings. This is a diagnostic tool that analyzes physiological signals from the living patient.
Therefore, the ArchiMed electrocardiograph falls under the category of a medical device used for physiological monitoring and diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74LOS
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.
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
adult populations
Intended User / Care Setting
Not Found
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)
Not Found
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.
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
N/A
0
MAY 1 2 1998
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: (317) 849-1916 Facsimile: (317) 577-9070
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.
1
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
2
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.
3
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.
4
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
Indications For Use
510(k) Number (if known):
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.