SENTICARE PILLSTATION

K103009 · Senticare, Inc. · NXQ · Jan 28, 2011 · Physical Medicine

Device Facts

• Record ID: K103009
• Device Name: SENTICARE PILLSTATION
• Applicant: Senticare, Inc.
• Product Code: NXQ · Physical Medicine
• Decision Date: Jan 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5050
• Device Class: Class 1

Intended Use

The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healthcare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.

Device Story

SentiCare PillStation is a home-use electronic pillbox for medication management. Device features pill tray, light-up pill bins, alarms, and LCD messaging to alert users of scheduled doses. Integrated scanning system captures static digital images of pill tray contents; images transmitted via internet to PillStation Manager software. Remote 'Call Center Advisors' access software to monitor and verify loaded medications against prescriptions. Device aids in organization, adherence, and self-administration; provides corrective feedback for incomplete/inappropriate medication removal. Does not perform automated image recognition or restrict physical access to medications. Healthcare providers use software to track alerts and verify patient compliance.

Clinical Evidence

Bench testing only. Software design verification and validation were performed to confirm key functions of the PillStation and PillStation Manager software met specifications.

Technological Characteristics

Electronic pillbox with integrated scanning system for digital imaging. Features include light-up indicators, pill alarms, and LCD messaging. Connectivity via wireless communication to central server. Software-based management system for remote monitoring. No automated image recognition or medication access restriction.

Indications for Use

Indicated for individuals requiring assistance with medication organization, self-administration, and adherence. Used by patients and healthcare providers to manage pre-determined medication dosing schedules.

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

• Vocel Pill Phone (K060298)
• e-piller 4 Alarm Vibrating Pill Box (510(k) exempt)

Submission Summary (Full Text)

{0}------------------------------------------------

K103009
JAN 28 2011

## 510(k) Summary

| Submitted by | SentiCare, Inc. |
|-----------------|--------------------------------------------------------|
| Address: | 132 Turnpike Road, Suite 130<br>Southborough, MA 01772 |
| Telephone: | 508-875-2401 |
| Facsimile: | 508-875-2404 |
| Contact Name: | Yogendra Jain, Chief Technical Officer / Co-founder |
| Date Submitted: | January 18, 2011 |
| Trade Name: | SentiCare PillStation |
| Common Name: | Medication reminder |

Product Code / Regulation: 21 C.F.R. 890.5050, Daily Activity Assist Device (Medication Reminder), product code NXQ, class I

Description: The SentiCare PillStation includes an electronic pillbox for home use (the PillStation), and server software for communicating and programming the PillStation (PillStation Manager Software). The SentiCare PillStation is designed to assist individuals with medication organization, self administration, and adherence. Specifically, the PillStation is designed to aid individuals in medication organization and reconciliation: identify incomplete or inappropriate removal of medications with corrective feedback; teach and coach about medications and daily medical procedures; provide alerts of dose times; and ensure timely relills of all medications self-administration. The SentiCare PillStation is a daily assist device with many features to alert users and caregivers of pre-determined scheduled medication times: easy to use pill tray, pill bins highlighted by light-up indicators, pill alarms, and LCD serven messaging. Through PillStation's built in scanning system, high quality, static digital images are sent from the PillStation to PillStation Manager software. Remote monitors, are other alled "Call Center Advisors", monitor and verify PillStation's medication contents with PillStation users' prescriptions in order to keep track of medication aterts and verify that the user and/or caregiver has loaded their prescribed medications into the PillStation pill tray. This monitoring is accomplished through the PillStation Manager software. The SentiCare PillStation is a novel approach to medication organization and may be of great assistance to those individuals and caregivers who look to improve upon their own medication organization, adherence, and self administration.

- Intended Use: The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healtheare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.
- The SentiCare PillStation is similar in intended use and Substantial Equivalence: technological characteristics to predicate devices reviewed as

{1}------------------------------------------------

medication reminders (Daily Activity Assist Devices), including the Vocel Pill Phone (K060298), and the e-piller 4 Alarm Vibrating Pill Box (510(k) exempt).

The capability of the SentiCare PillStation to image the contents of the pill tray and upload the information through the Internet 10 a central server was determined by the FDA to introduce a different fundamental technology requiring the submission of a 510(k). Despite the introduction of this technology into the device, the SentiCare PillStation does not perform image recognition or prohibit access to medications stored in the device. Apart from the additional capability to scan the contents of the pill tray, the SentiCare PillStation is otherwise similar with respect to indications for use and physical characteristics to predicate devices in terms of \$10(k) substantial equivalency.

Applicable tests were carried out as part of the software design process, where the key functions of the SentiCare PillStation (including both the PillStation and the PillStation Manager software) were verified and/or validated. The results of the testing met specifications, and established the device as safe and effective for its intended use, which is comparable to other predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SentiCare, Incorporated C/O Mr. Seth A. Mailhot Nixon Peabody LLP 401 9th Street NW, Suite 900 Washington, District of Columbia 20004

JAN 2 8 25th

Re: K103009

Trade/Device Name: SentiCare PillStation Regulation Number: 21 CFR 890.5050 Regulation Name: Daily Activity Assist Device Regulatory Class: I Product Code: NXQ Dated: January 18, 2011 Received: January 19, 2011

Dear Mr. Mailhot:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equival nt five 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. Please note: CDRH, not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. and the control control of the control of

{3}------------------------------------------------

Page 2- Mr. Mailhot

Enclosure

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 33) -542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ur.v 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go no http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jam 2. Kasia

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): ________________

Device Name: SentiCare PillStation

Intended Use:

The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healthcare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

WE STATE AND WANT OF COLLECT AND A LA COLLECT COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULT

AND/OR

Over-The-Counter Use __ X (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)

Rich C. Chapman 1/26/16

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103009