DPILOG, MODEL DPC-512

K062811 · Life Outcomes, Inc. · CAF · Dec 20, 2006 · Anesthesiology

Device Facts

• Record ID: K062811
• Device Name: DPILOG, MODEL DPC-512
• Applicant: Life Outcomes, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2

Intended Use

The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician. It will be the physician or healthcare professional's responsibility to contact and coordinate with Life Outcomes to acquire and attach the DPILog electronics module, disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog electronic modules and disposable sleeve bodies will be distributed to patients by a physician or healthcare professional.

Device Story

DPILog DPC-512 is an accessory for Dry Powder Inhalers (DPIs) consisting of a reusable electronics module and disposable battery sleeve that attaches to a DPI actuator. Device monitors and records DPI usage data; data is transferred via infrared docking station to a computer for analysis by researchers or clinicians. Used in clinical trials and patient training to improve disease management and statistical analysis of inhaler usage. Healthcare professionals manage device acquisition, attachment, and distribution to patients. Output provides objective usage data to clinicians to inform treatment decisions and patient training.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and compliance with international standards (IEC 60601 series, ISO 14971, ISO 10993).

Technological Characteristics

Reusable electronics module with disposable battery sleeve; infrared docking station for data communication; complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 14971, and ISO 10993.

Indications for Use

Indicated for patients under physician care who require detailed monitoring of Dry Powder Inhaler (DPI) usage.

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.

Predicate Devices

• MedTrac MDILog MDC-512 (K990185)
• MedTrac MDILog MDC-511 (K970344)
• NewMed Doser (K935955)

Submission Summary (Full Text)

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K062811

Life Outcomes, Incorporated 510(k) Premarket Notification

| Summary of Safety and Effectiveness | | | | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|-------------|
| Submitted by: | Life Outcomes, Inc.<br>5696 Peachtree Parkway, Suite A<br>Norcross, GA 30092 USA<br>Telephone: [phone]<br>Facsimile: [phone]<br>Website: www.lifeoutcomes.com | | | | DEC 20 2006 |
| Contact Person: | Thomas Taccini<br>Director, Research & Development<br>Westmed, Inc.<br>109 Inverness Drive East, Suite A<br>Englewood, CO 80112 USA<br>Telephone: [phone] ext. 1132<br>Facsimile: [phone]<br>Email: [e-mail] | | | | |
| Date Prepared: | September 15, 2006 | | | | |
| Proprietary Name: | DPILog DPC-512 | | | | |
| Common Name: | Accessory to Metered Dose Inhalers | | | | |
| Classification Name: | Anesthesiology 21 CFR 868.5630 73 CAF | | | | |
| Predicate Device: | MedTrac MDILog MDC-512, K990185, cleared April 1, 1999<br>MedTrac MDILog MDC-511, K970344, cleared August 6, 1997<br>NewMed Doser, K935955, cleared September 516, 1994 | | | | |

Device Description: The DPILog DPC-512 is comprised of a reusable electronics module and a disposable battery sleeve that snaps together around an already cleared/marketed dry power inhaler. The device utilizes previously cleared/marketed accessories, i.e., an infrared docking station to communicate the collected data to a computer via an interface cable and software. The DPILog System has direct application to physicians involved in clinical trial disease management and training patients in proper use of DPIs. The objective data collected by the DPILog allows researchers improved quality of information in clinical trials and increased precision of statistical analysis.

lntended Use of Device: The DPILog DPC-512 is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPLLog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.

ll will be the physician or healthcare professional's responsibility to contact and coordinate with Life Outcomes to acquire and attach the PPLog electronics module, disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog electronic modules and disposable sleeve bodies will be distributed to patients by a physician or healthcare professional.

Technological Characteristics: The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of International Electrotechnical Commission Standards for Medical Devices, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8 plus International Standards Organization Standards for Risk Management ISO 14971 and Biocompatibility ISO 10993.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 0 2006

Life Outcomes. Incorporated C/O Mr. Charles M. Hart Principle Consultant HART Consulting 3957 Blue Pine Circle Highlands Ranch, Colorado 80126-8077

Re: K062811

Trade/Device Name: DPILog, Model DPC-512 Regulation Number: 868.5630 Regulation Name: Nebulizer Anesthesiology Regulatory Class: II Product Code: CAF Dated: December 7, 2006 Received: December 8, 2006

Dear Mr. Hart:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 -Mr. Hart

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

11 062811

DPILog DPC-512 Device Name:

Indications for Use:

The DPILog is intended for use by a single patient under the care or treatment of a physician or licensed healthcare professional. The DPILog is prescribed by the doctor when detailed Dry Powder Inhaler (DPI) usage monitoring is indicated. The DPILog can be used by any patient who regularly uses DPIs as prescribed by a physician.

It will be the physician or healthcare professional's responsibility to contact and coordinate with Life Outcomes to acquire and attach the DPILog electronics module, disposable sleeve bodies onto the DPI actuator. DPIs with attached DPILog electronic modules and disposable sleeve bodies will be distributed to patients by a physician or healthcare professional.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter

**OR**
(Per 21 CFR 801.109)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________