MDILOG, MODEL MDC-512

K990185 · Medtrak Technologies, Inc. · CAF · Apr 1, 1999 · Anesthesiology

Device Facts

• Record ID: K990185
• Device Name: MDILOG, MODEL MDC-512
• Applicant: Medtrak Technologies, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Apr 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed he any The MDILog is intended for use by a single patient under the care of themient of a pirposition of the MDLog can be used by any THC MDIEog is preseribed by as prescribed by a physician. It will be the physician or health care professionality to contact and coordinate with Medirac Technologies to acquire It will be the physician of health care protessonal s responsibility of tonactions. MDIs with attached MDILog and attach the MDILog Titel adapter, sice v adapter bodies and hiscian or health care professional.

Device Story

MDILog (Model MDC-512) is an accessory device for Metered Dose Inhalers (MDIs); attaches to MDI via adapter; intended for single-patient use. Device tracks MDI usage; physician or healthcare professional coordinates acquisition and setup. Output assists healthcare providers in monitoring patient adherence and MDI usage patterns; facilitates clinical decision-making regarding respiratory treatment plans.

Clinical Evidence

No clinical data provided; document is a 510(k) clearance letter.

Technological Characteristics

Accessory device for MDI; includes adapter body for attachment to MDI canisters. Technical specifications and materials not detailed in provided text.

Indications for Use

Indicated for single patient use under the care or treatment of a physician or licensed healthcare professional, as prescribed by a physician, for use with MDIs (Metered Dose Inhalers).

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1999

Ms. Linda Nelson Medtrac Technoloqies, Inc. 6950 Jefferson Avenue, Suite 210 Lakewood, CO 80235

Re: K990185 MDILog, Model MDC-512 Regulatory Class: II (two) Product Code: 73 CAF January 15, 1999 Dated: Received: January 20, 1999

Dear Ms. Nelson:

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 leqally marketed predicate 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 reqistration, 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 - Ms. Linda Nelson

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/dsma/dsmamain.html".

Sincerely yours,

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

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## 510(k) Number (If known): (unknown)

## Device Name: MDILog, model MDC-512

## Indications For Use:

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The MDILog is intended for use by a single patient under the care or treatment of a physician or licensed he any The MDILog is intended for use by a single patient under the care of themient of a pirposition of the MDLog can be used by any THC MDIEog is preseribed by as prescribed by a physician.

It will be the physician or health care professionality to contact and coordinate with Medirac Technologies to acquire It will be the physician of health care protessonal s responsibility of tonactions. MDIs with attached MDILog and attach the MDILog Titel adapter, sice v adapter bodies and hiscian or health care professional.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.H. A. La. Lowsli
(Division Sign or)

liovascular, Respirato

Prescription Use

Over-The-Counter Use _

(Per 21CFR 801.109)

(Optional Format 1-2-96)