PILL PHONE

K060298 · Vocel · NXQ · Mar 29, 2006 · Physical Medicine

Device Facts

• Record ID: K060298
• Device Name: PILL PHONE
• Applicant: Vocel
• Product Code: NXQ · Physical Medicine
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5050
• Device Class: Class 1
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.

Device Story

PILL PHONE is a software-based medication reminder system operating on cell phones or wireless devices. It functions by storing a programmed dosing schedule and delivering automated reminders to the user. The system provides medication-related information, including indications, dosing, side effects, and pill imagery. It also supports the delivery of surveys from a central server. Used by patients or caregivers to improve medication adherence. The software is classified as a Minor Level of Concern.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based medication reminder system; operates on standard cell phones or wireless communication devices; utilizes wireless network connectivity; Minor Level of Concern software.

Indications for Use

Indicated for individuals requiring medication adherence support, including patients, children, or elderly parents, via cell phone or wireless device reminders and medication information delivery.

Regulatory Classification

Identification

A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.

Predicate Devices

• ONCELLRX
• MEDPARTNER
• E-Pill, LLC medication reminder systems

Submission Summary (Full Text)

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## MAR 2 9 2006

## 510(k) SUMMARY

### Vocel

# PILL PHONE Medication Reminder Software Device 510(k) Premarket Notification

#### Submitter

Vocel 13400 Sabre Springs Parkway Suite 255 San Diego, CA 92128

Contact Person: Mr. Chris Nelson Date Prepared: January 27, 2006

#### Name and Classification of Device

Trade or Proprietary Name: PILL PHONE Common Name: Classification Name: Product Code :

medication reminder system daily assist device unknown

#### Predicate Devices

The PILL PHONE is substantially equivalent to the ONCELLRX, the MEDPARTNER, and various medication reminder systems marketed by E-Pill, LLC.

#### Description of the PILL PHONE

The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and four horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 y 2006

Vocel C/O Mr. Keith A. Barritt Fish & Richardson, Professional Corporation 1425 K Street, N.W. Suite 1100 Washington, DC 20005

Re: K060298

Trade/Device Name: Pill Phone Regulation Number: 890.5050 Regulation Name: Daily activity assist device Regulatory Class: I Product Code: NXQ Dated: February 3, 2006 Received: February 7, 2006

Dear Mr. Barritt:

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 (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 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. Keith A. Barritt

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 continue 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/dsma/dsmamain.html

Sincerely yours,

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

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# Indications for Use

K060298 510(k) Number (if known):

Device Name: PILL PHONE

Indications For Use:

The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. Watts

whilegy, General Huspin Dental Dovices

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