(85 days)
Not Found
No
The description mentions a "resting interpretation program" but explicitly states it's an "analysis program" offered on an "advisory basis only" and requires physician overread. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with such technologies.
No
The device is described as an electrocardiograph machine intended for analyzing cardiac performance through acquiring, digitizing, displaying, and recording ECG waveforms. Its function is diagnostic (analysis and interpretation of cardiac performance), not therapeutic (treating or alleviating a condition).
Yes
The device is described as a multi-channel electrocardiograph machine intended for "acquisition, digitization, display and recording of conventional diagnostic twelve (12) simultaneous lead ECG waveforms," and includes a "resting interpretation program." These functions are characteristic of a diagnostic device used to analyze cardiac performance.
No
The device description explicitly states it is a "multi-channel electrocardiograph machine equipped with an SVGA monitor, a PC keyboard and a trackball," indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "analyze cardiac performance" by acquiring, displaying, and recording ECG waveforms. This is a direct measurement of physiological signals from the patient's body.
- Device Description: The device is an electrocardiograph machine. Electrocardiography is a non-invasive method of measuring electrical activity of the heart.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not process or analyze such specimens.
The device is a diagnostic tool, but it falls under the category of in vivo diagnostic devices as it directly measures physiological signals from the patient.
N/A
Intended Use / Indications for Use
The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance.
Product codes
74DPS
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.
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
a physician
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
8000 Castleway Drive
Indianapolis, IN 46250
Phone: (317) 849-1916
Facsimile: (317) 577-9070 | | | | JAN 22 1998 | | FDA/CDRH/ODE/DMC | | OCT 29
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
/
II
1
Safety and Effectiveness Summary Formula for ArchiMed Biosound Esaote
Comparison Chart for Substantial Equivalence
| General Characteristics | ESAOTE 4230
Formula for ArchiMed | ESAOTE ACTA
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.
2
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.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three profiles facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
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.
4
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 (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
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:
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