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 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Family Healthware™". It focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics.

Therefore, the provided text does not contain the information required to answer your request about acceptance criteria, detailed device performance, study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set details.

The document discusses the following:

Device Name: Family Healthware™
Regulatory Number: 21 CFR 870.2910 (Radiofrequency Physiological Signal Transmitter and Receiver)
Regulatory Class: Class II
Product Code: DRG
Intended Use: 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.
Predicate Device: Wellaho Personalized Outpatient Management System (K123671)
Basis for Substantial Equivalence: Comparison of intended use, indications for use, and technological characteristics (e.g., Internet data collection platform, proprietary software, wireless RF protocol, Wi-Fi, SSL via HTTPS for communication, patient feedback via on-screen display, encrypted patient data on servers).

The primary purpose of a 510(k) submission, as seen here, is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or different technological characteristics that do not raise new questions of safety or effectiveness. This process usually does not involve a clinical performance study with the level of detail you're asking for regarding AI algorithm performance (e.g., sensitivity, specificity, AUC) and its associated validation studies. These types of detailed performance studies are more typical for novel devices or those undergoing PMA (Premarket Approval) pathways, or for AI/ML devices where specific performance claims are made and need to be validated.

In summary, the document does not provide the information to populate the requested table or answer the specific questions about device performance validation studies.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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.

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

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 (800) 638-2041 or (301) 796-7100 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

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

4 Indications for Use Statement

510(k) Number:

K132173

Device Name:

Family Healthware™

Indications For Use:

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)

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

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: 858 945 0660 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: 858 485 8584 Fax: 858 753 1801 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:

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.

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

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 implementand maintain healthy life changes.	To motivate patients to implement andmaintain healthy life changes.
Disease focus	Six specific chronic conditions	Chronic conditions
Advice provided	Healthy lifestyle changes linked tohereditary diseases	Healthy lifestyle changes
Rx or OTC?	OTC	OTC
Browser function available?	Yes	Yes
Smart phone app available?	No	Yes

{5}------------------------------------------------

Sanitas, Inc.

Data collectionplatform	Internet	Internet
Data CollectionSoftware	Proprietary software	Proprietary software
Data collectionsoftwarefunctionality	Transmit data from device to centraldatabase	Transmit data from device to centraldatabase
CommunicationTechnology	Wireless RF protocol, Internet	Wireless RF protocol, Internet
CommunicationMethods	Wi-Fi	Cellular modem, Wi-Fi
InternalCommunication	Secure sockets Layer (SSL) viaHTTPS	Secure sockets Layer (SSL) via HTTPS
Patient Feedback	Provides patient health reinforcementmessages	Provides patient health reinforcementmessages
Communicationfrequency	2.4 gHz	2.4 gHz

Communicationvia?	cellular modem, wifi	cellular modem, wifi
Communicationwith patients	On screen display	On screen display
Patient data onservers	Encrypted	Encrypted
Server to Browsercommunication	Encrypted	Encrypted

SE Discussion.

Product Classification

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

{6}------------------------------------------------

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.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).