(133 days)
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Not Found
No
The description mentions "proprietary software algorithms" for signal processing and data handling, but there is no mention of AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML models. The focus is on standard signal processing and data management functions.
No
The device is an electrocardiograph used for detection, recording, and display of ECG signals, which are diagnostic functions, not therapeutic.
Yes
The device is an electrocardiograph that detects, records, and displays ECG signals, which are used to assess heart function and diagnose cardiac conditions. This aligns with the definition of a diagnostic device.
No
The device description explicitly states it includes a "Biolog™ 3000 unit" and has a "built-in LCD screen," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Biolog™ 3000 electrocardiograph is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Biolog™ 3000 function: The Biolog™ 3000 electrocardiograph detects and records electrical signals from the heart (ECG) directly from the patient's body surface using electrodes. It does not analyze samples taken from the body.
The device is a medical device used for physiological monitoring and recording, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Biolog™ 3000 electrocardiograph is intended to detect an ECG using a single lead patient cable or a 12 Lead Simultaneous Cable. The Biolog 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECT data to a PC running CardioView™ software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.
Product codes
74 DPS
Device Description
The proposed device is an electrocardiograph that can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View7M 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer. The device includes a Biolog™ 3000 unit, a User's Manual, and accessories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Nonclinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device.
Key Metrics
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Predicate Device(s)
MAX 1 Exercise Testing System
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
510(k) SUMMARY
Submitted by:
APR - 1 1998
Malcom Castle, President Micromedical, Inc. 255 Revere Drive Suite 111 Northbrook, IL 60062
Date Prepared:
November 6, 1997
Proposed Device:
Biolog™ 3000 electrocardiograph
Predicate Device:
MAX 1 Exercise Testing System
Proposed Device Description:
The proposed device is an electrocardiograph that can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View7M 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer.
Statement of Intended Use:
The Biolog™ 3000 electrocardiograph is intended to detect an ECG using a single lead patient cable or a 12 Lead Simultaneous Cable. The Biolog 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECT data to a PC running CardioView™ software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Nonclinical testing was performed to compare the device to the predicate device. Testing showed the proposed device to be substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Mr. Malcom Castle President Micromedical, Inc. 255 Revere Drive, Suite 111 Northbrook, IL 60062
Re : K974351 Biolog™ 3000 Electrocardiograph Requlatory Class: II (two) Product Code: 74 DPS November 4, 1997 Dated: Received: November 19, 1997
Dear Mr. Castle:
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, 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulations.
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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 requlation 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use
510(k) Number: Not Available
Device Name: Biolog™ 3000 Electrocardiograph
Indication for Use:
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices. The device includes a Biolog™ 3000 unit, a User's Manual, and accessories. Additional device description information is presented in Attachment 5.0 - Device Description.
Prescription Use
(Per 21 CFR 801.109)
Darlene Heller
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 97435 510(k) Number _