The Micromedical Printer Interface is used to download ECG data from a Micromedical ECG monitor and print ECG recordings on standard letter-sized paper by using one of a number of standard commercially available Canon or Hewlett Packard ink jet printers.

Device Description

The Micromedical Printer Interface receives data from a Micromedical ECG monitor and transmits it through a parallel cable to one of a number of commonly available Canon or H-P bubble jet printers to print the ECG tracing on standard-sized paper.

AI/ML Overview

This 510(k) pertains to a hardware device (Printer Interface) rather than an AI/ML powered software device. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable here.

The provided document describes the Micromedical Printer Interface as a device that receives data from a Micromedical ECG monitor and transmits it to a standard ink jet printer to print ECG tracings. The basis for clearance is substantial equivalence to an existing predicate device, the Ralin CorFax.

Here's why the AI/ML-specific questions are not applicable:

Device Type: This is a hardware interface for printing, not an algorithm or software that processes or interprets medical data.
Substantial Equivalence: The clearance is based on comparing the new device to a legally marketed predicate device, demonstrating that it's as safe and effective. This typically involves performance bench testing, electrical safety, EMC testing, and ensuring the output is clinically equivalent to the predicate, rather than clinical studies with human readers or specific statistical performance metrics against a ground truth as would be done for an AI/ML algorithm.
Lack of AI/ML Component: The submission explicitly mentions "proprietary algorithms to receive the data from ECG monitors and transmit it to a printing device," but this refers to the internal software/firmware necessary for device function (e.g., data formatting, communication protocols), not AI/ML algorithms for medical diagnosis or interpretation.

Therefore, the requested table and detailed study information for AI/ML devices cannot be extracted from this 510(k) submission.

Summary

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K970305

AUG 1 5 1997

ATTACHMENT 3

510(k) SUMMARY

The Printer Interface is substantially equivalent to the Ralin CorFax, which receives ECG data from a Ralin ECG monitor and transmits it through telephone lines for printing on a Group III compatible facsimile machine.

Both devices use proprietary algorithms to receive the data from ECG monitors and transmit it to a printing device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

AUG 15 1997

Mr., Malcom Castle Micromedical, Inc. -255 Revere Drive, Suite 111 ~ Northbrook, Illinois 60062

Re: K970305 Printer Interface Regulatory Class: II (two) Product Code: 74 DXH Dated: May 20, 1997 Received: May 28, 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 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. Tn addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect anv 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 - Mr. Malcom Castle

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 leqally 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. Callehan

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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ATTACHMENT 4

STATEMENT OF INTENDED USE

510(k) Number: K

Device Name: Micromedical Printer Interface

Indication For Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

At. A. Lidd.

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

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).