PRINTER INTERFACE

K970305 · Micromedical, Inc. · DXH · Aug 15, 1997 · Cardiovascular

Device Facts

• Record ID: K970305
• Device Name: PRINTER INTERFACE
• Applicant: Micromedical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

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 Story

Device acts as interface between Micromedical ECG monitor and standard Canon or HP bubble jet printers; receives ECG data from monitor; transmits data via parallel cable to printer; enables printing of ECG tracings on standard-sized paper; used in clinical settings; facilitates hard-copy documentation of cardiac signals for physician review and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Interface hardware; parallel cable connectivity; compatible with standard Canon or HP bubble jet printers; proprietary algorithm for data transmission.

Indications for Use

Indicated for use by clinicians to download and print ECG data from Micromedical ECG monitors onto standard letter-sized paper using compatible Canon or Hewlett Packard ink jet printers.

Regulatory Classification

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.

Predicate Devices

• Ralin CorFax

Submission Summary (Full Text)

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AUG-06-1997 10:49 DEAN E SNYDER 8474461309 P.02
K970305
AUG 15 1997

# ATTACHMENT 3

## 510(k) SUMMARY

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.

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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TOTAL P.02

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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. 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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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 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. 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:

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.

Con

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

AH Lall

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K970305