FAMILY HEALTHWARE

K132173 · Sanitas, Inc. · DRG · May 30, 2014 · Cardiovascular

Device Facts

• Record ID: K132173
• Device Name: FAMILY HEALTHWARE
• Applicant: Sanitas, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: May 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.

Device Story

Family Healthware is a web-based telemedicine tool for home use; collects user-reported health behaviors, screening test results, and family health history (first/second-degree relatives). Software algorithms analyze familial risk for six chronic diseases; second algorithm set generates personalized prevention plans/lifestyle recommendations. Output displayed on-screen for user; intended to increase risk perception and improve chronic disease management. Operates via internet/Wi-Fi; data transmitted to central database using SSL/HTTPS encryption. Does not provide real-time or emergency monitoring; intended as adjunct to, not replacement for, professional healthcare oversight.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to the predicate device.

Technological Characteristics

Web-based software tool; utilizes proprietary algorithms for risk assessment and recommendation generation. Connectivity via Wi-Fi; data transmission secured via SSL/HTTPS. Data stored on encrypted servers. Operates on standard web browsers. No hardware components described beyond standard internet-connected devices.

Indications for Use

Indicated for individuals seeking assessment of familial risk for coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer; provides personalized lifestyle and screening recommendations.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Wellaho Personalized Outpatient Management System (K123671)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 2, 2015

Sanitas. Inc. c/o Mr. Alan Donald, MS, MBA, FRAPS President Matrix Medical Consulting, Inc. 11440 W. Bernardo Court, Suite 300 San Diego, CA 92127

Re: K132173

Trade/Device Names: Family Healthware™ Regulatory Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: April 27, 2014 Received: April 30, 2014

Dear Mr. Donald:

This letter corrects our letter of May 30, 2014.

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. Please note: CDRH does 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.

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Page 2 - Mr. Alan Donald, MS, MBA, FRAPS

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 531-542 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/ucm115809.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 to

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4 Indications for Use Statement

510(k) Number:

K132173

Device Name:

Family Healthware™

Indications For Use:

Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.

Prescription Use

AND/OR

Over-The-Counter Use XX

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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#### 5 510(k) Summary of Safety and Effectiveness

Device / trade name: Family Healthware™ Device type / Common Name: Telemedicine System 510(k) owner: Sanitas, Inc. 1640 El Camino Del Teatro La Jolla, CA 92037 Phone: [phone] Contact: Mr. Naser Partovi, CEO

Establishment registration number: 3010209421 Authorized Contact Person: Mr. Alan Donald, MS, MBA, FRAPS Matrix Medical Consulting, Inc. 11440 West Bernardo Court, Suite 300 San Diego, California 92127-1644 Phone: [phone] Fax: [phone] Recommended regulation: 21 CFR 870.2910 Device classification name: Radiofrequency physiological signal transmitter and receiver Device class: Class II device Panel: Cardiovascular Devices Product code: DRG Predicate device: Wellaho Personalized Outpatient Management System Predicate Device Pro Code DRG Predicate K 123671 Date Summary Prepared: May 25, 2014 Device Description:

Family Healthware™ is a Web-based software tool that can be used to assess a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:

- Health behaviors (e.g., smoking and exercise), .
- Screening tests (e.g., blood cholesterol and mammography), ●
- Health history among his or her first- and second-degree relatives. .

One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk. health behaviors, and screening results to generate personalized prevention messages.

The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.

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K132173

### Indications for Use:

Family Healthware is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides a "prevention plan" with personalized recommendations for lifestyle changes and screening.

### Substantial Equivalency

Comparison Table of New and Predicate Device

A summary of the equivalence between the Sanitas Family Healthware and the Wellaho Personalized Outpatient Management System predicate device is given in the following table.

| Parameter | Family Healthware (new) | Wellaho (predicate) |
|-----------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Intended Use | Telemedicine System | Telemedicine System |
| Intended Users | Home users and healthcare providers | Home users and healthcare providers |
| Site of Use | Any place with remote internet access | Any place with remote internet access |
| Purpose | To motivate patients to implement<br>and maintain healthy life changes. | To motivate patients to implement and<br>maintain healthy life changes. |
| Disease focus | Six specific chronic conditions | Chronic conditions |
| Advice provided | Healthy lifestyle changes linked to<br>hereditary diseases | Healthy lifestyle changes |
| Rx or OTC? | OTC | OTC |
| Browser function available? | Yes | Yes |
| Smart phone app available? | No | Yes |

© Copyright 2013 Sanitas, Inc.

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Sanitas, Inc.

| Data collection<br>platform | Internet | Internet |
|----------------------------------------------|---------------------------------------------------|---------------------------------------------------|
| Data Collection<br>Software | Proprietary software | Proprietary software |
| Data collection<br>software<br>functionality | Transmit data from device to central<br>database | Transmit data from device to central<br>database |
| Communication<br>Technology | Wireless RF protocol, Internet | Wireless RF protocol, Internet |
| Communication<br>Methods | Wi-Fi | Cellular modem, Wi-Fi |
| Internal<br>Communication | Secure sockets Layer (SSL) via<br>HTTPS | Secure sockets Layer (SSL) via HTTPS |
| Patient Feedback | Provides patient health reinforcement<br>messages | Provides patient health reinforcement<br>messages |
| Communication<br>frequency | 2.4 gHz | 2.4 gHz |

| Communication<br>via? | cellular modem, wifi | cellular modem, wifi |
|------------------------------------|----------------------|----------------------|
| Communication<br>with patients | On screen display | On screen display |
| Patient data on<br>servers | Encrypted | Encrypted |
| Server to Browser<br>communication | Encrypted | Encrypted |

# SE Discussion.

## Product Classification

Both devices have the same product classification (§870.2910).

© Copyright 2013 Sanitas, Inc.

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K132173

### Sanitas, Inc.

#### Product Code

Both devices have the same Product Code (DRG).

#### Intended Use

Both devices have the same intended use (as telemedicine systems).

#### Indications for Use

Both devices have nearly the same indications for use.

#### User Safety

In terms of user safety, similar devices have been utilized for many years with a good record of safety. The technologies used within the Family Healthware software and the Wellaho Personalized Outpatient Management System are the same as those in other legally marketed risk assessment devices, and they are used for similar reasons in similar manners. There are no new additional safety concerns raised by these technologies. In addition, neither device is intended as a replacement for the oversight of healthcare professionals nor does either provide "real-time" or emergency monitoring.

#### Conclusions

The Family Healthware software uses the same fundamental technologies as the predicate device and has the same intended use and indications for use. The fundamental purpose of both devices is as outpatient risk assessment/management systems.

The Family Healthware software is substantially equivalent to the predicate device, the Wellaho Personalized Outpatient Management System, since their intended uses are the same, their indications for use are essentially the same, and they utilize similar technologies.

Based on the comparison of intended use, indications for use, and technological characteristics, the Family Healthware software is substantially equivalent to the Wellaho Personalized Outpatient Management System (K123671), with respect to intended use, indications for use, performance and technological characteristics. The Wellaho Personalized Outpatient Management System raises no new safety or effectiveness issues.