The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System.

The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Device Description

The Glooko device system for Glooko Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their Android Operating System mobile devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.

The Glooko device system for Glooko Application consists of the following components:

The Glooko MeterSync Cable for Android
The Glooko Application

AI/ML Overview

The provided document describes the Glooko Device System for Glooko Application, which is data management software for individuals with diabetes to download, review, analyze, evaluate, and communicate their blood glucose readings. The submission is a Special 510(k) and demonstrates substantial equivalence to a predicate device (K130886). The primary difference is the operating system platform (Android vs. iOS) and the meters supported.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it states that "All test results fell within the pre-determined specification parameters." The studies focused on confirming that the device performs according to its stated intended use and specifications, particularly regarding data integrity, software features, and error handling.

Acceptance Criteria Category	Reported Device Performance
Functional Performance	- Data Integrity Verification: Passed, all test results within pre-determined specification parameters.- Software Design/features Verification: Passed, all test results within pre-determined specification parameters.- Error Handling Testing: Passed, all test results within pre-determined specification parameters.
Intended Use	- Device performs according to its stated intended use (aid in review, analysis, evaluation, and communication of blood glucose readings, support diabetes management program).
Substantial Equivalence	- Demonstrated substantial equivalence to the predicate device (K130886) in intended use, function, and technology for downloading and analyzing blood glucose data.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "functional testing performed pursuant to Glooko's design verification protocol" and lists categories like "Data Integrity Verification, Software Design/features Verification, and error handling testing." However, it does not specify the sample size used for these test sets (e.g., number of data transfers, number of unique meter readings, etc.).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the data used for testing was retrospective or prospective. Given the nature of a software application for managing blood glucose readings, the "data" would likely refer to simulated or actual blood glucose readings downloaded from various meters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on internal verification protocols and specifications. For a data management system that transfers and displays blood glucose readings, ground truth would typically involve comparing the downloaded data against the original data stored in the blood glucose meters or a reference system. This verification is usually performed by engineers and quality assurance personnel, rather than medical experts, unless the displayed interpretation itself needed clinical validation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set. The testing appears to be based on a pass/fail criteria against pre-determined specifications, implying direct verification rather than a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of device. The Glooko Device System is a data management tool for blood glucose readings; it is not an AI-powered diagnostic or interpretive tool that assists human readers (e.g., radiologists interpreting images). Therefore, there is no "human reader" component to improve or an "AI assistance" to measure an effect size against.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "standalone" performance in this context refers to the Glooko Application and MeterSync Cable's ability to accurately download, store, process (generate graphs, statistics), and display blood glucose data without human intervention beyond initiating the download and viewing the data. The documentation indicates that functional testing, including data integrity verification, software design/features verification, and error handling, was performed. This implies a standalone assessment of the software's functionality in accurately handling the data.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For a device like the Glooko Application, the "ground truth" for the test set would be the actual blood glucose readings stored on the compatible FDA-cleared blood glucose meters. The system's performance is validated by ensuring that the data downloaded, processed, and displayed by the Glooko Application precisely matches the data from the source meters. This is a direct comparison, not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

The Glooko Device System is a deterministic software application for data management, not a machine learning or AI algorithm that requires a "training set." Therefore, there is no training set mentioned or implied in the document.

9. How the Ground Truth for the Training Set Was Established:

Since there is no training set for this device, a method for establishing its ground truth is not applicable.

Summary

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Ki32272

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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 1 of 7

510(k) Summary (21 CFR § 807.92(c))

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter:	Glooko, Inc. 170A University Avenue Palo Alto, CA 94301
Contact:	Shilpa Mydur Director of Regulatory Affairs Phone: 650.720.5310 Email: shilpa@glooko.com
Date Summary Prepared:	16 October 2013
Device Trade Name:	Glooko Device System for Glooko Application
Common Name:	Blood Glucose Meter and Data Management System
Classification Name:	Glucose test system (21 CFR §862.1345) Calculator/data processing module for clinical use (21 CFR §862.2100)
Product Code:	NBW and JQP
Equivalent Device:	Glooko Device System for Glooko Logbook+ Application (K130886)

OCT 17 2013#### Device Description:

Overview

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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 2 of 7

The Glooko device system for Glooko Application consists of the following components

1. The Glooko MeterSync Cable for Android
1. The Glooko Application

Glooko MeterSync Cable

The Glooko MeterSync Cable downloads data from compatible, FDA-cleared, commercial blood glucose meters into an Android operating mobile device by connecting the two components. One end of the Glooko MeterSync Cable plugs directly into the 3.5 mm slot of the Android device. The 3.5mm end of the Glooko MeterSync Cable plugs directly into most compatible meters to allow for the transfer of data. Some meters require an additional 3.5mm to 2.5mm adapter to allow for this connectivity, while other meters transfer data through infrared, and thus require the use of the IR Adapter, which is integrated into the Glooko MeterSync Cable. The IR Adapter is designed to transmit data via infrared from a variety of compatible, FDA-cleared, commercial blood glucose meters that require infrared for data transfer.

The Glooko MeterSync Cable is designed to attach to a variety of compatible, FDAcleared, commercial blood glucose meters. The users simply connect the supported meters to their Android mobile device and transfer the blood glucose meter data into the Glooko Android Application.

The Glooko Application:

The Glooko Application is one component of the Glooko data monitoring system used to aid individuals with diabetes in the review, analysis, evaluation, and communication of their blood glucose readings.

The Glooko Application collects and stores historical blood glucose data that has been downloaded from blood glucose meters. The Glooko Application also lets the user sync and view data from any supported compatible device when using the appropriate login information.

The Glooko Application keeps an organized log of the users blood glucose readings and allows for the addition of user-generated notes and meal tags. The Glooko Application also shows graphs, provides statistics, and allows for the sharing and viewing of blood glucose data across multiple supported devices running on Android.

The Glooko Application is compatible with the following FDA-cleared blood glucose meters:

. Abbott: FreeStyle Freedom Lite®, FreeStyle Lite®
Bayer: Bayer's BREEZE®2, Bayer's CONTOUR®, Bayer's CONTOUR® NEXT EZ .
LifeScan: OneTouch® Ultra®2, OneTouch® UltraLink®, OneTouch® UltraMini® ●
Nipro: Nipro TRUEbalance™ (K090495), Nipro TRUEread ™ (K042080), Nipro . TRUEresult (K080641), Nipro TRUEtrack™(K040670)
Roche: ACCU-CHEK® Aviva, ACCU-CHEK® Compact Plus, ACCU-CHEK® Nano .
USB Meters: Bayer's Contour USB (K091820), Bayer's Contour Next USB . (K121087)

COMPANY CONFIDENTIAL DO NOT COPY

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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 3 of 7

The Glooko Application can be operated on the following mobile devices, each supporting Android OS 2.3.3 and higher:

HTC Desire HD (A9191), HTC Evo (PC36100), HTC Incredible S S710e ●
LG Nexus 4, LG Optimus 2X (LG-P990) .
. Motorola DROID X
Samsung Ace (GT-S5830T), Samsung Galaxy Nexus, Samsung Galaxy Note o (GT-N7000), Samsung Galaxy Note II (GT-N7100), Samsung Galaxy S+ (GT-19001), Samsung Galaxy S II (GT-19100), Samsung Galaxy S II (SGH-1757M), Samsung Galaxy S III (GT-19300), Samsung Galaxy SIIII (GT-I9500)

The USB OTG Cable can be operated on the following Android devices, each supporting OS 3.1 and higher:

Samsung Galaxy Nexus .
. Samsung Note II (GT-N7100)
. Samsung Galaxy SII (SGH-1757M)
Samsung Galaxy SIII (GT-19300) .
Samsung Galaxy SIIII (GT-19500) .

The Glooko Application is compatible with the following web browsers:

Internet Explorer- v8.0 and above .
Firefox- v3.0 and above .
Chrome- v14.0 and above .
. Safari-v4.0 and above
iOS (Safari)- v3.0 and above .

Software Requirements:

The Glooko Application performs the following functions:

Sync with compatible meters ●
Allow users to annotate readings with notes ●
Provide multiple view options for the data ●
.Share the collected data .
Transmit and view readings, graphs, statistics and notes across supported . multiple devices and web browsers when using consistent authentication credentials (username and password)
Ability to connect to USB supported blood glucose meters using an off the shelf . micro USB cable

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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 4 of 7

Technological Characteristics:

The table below provides the comparison of technological characteristics between the subject and predicate device ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Product	Glooko Device System for GlookoLogbook+ ApplicationK130886(Predicate Device)	Glooko Device System forGlooko ApplicationK132272(Subject Device)
Indications for Use	The Glooko device system forGlooko Application is datamanagement software intended foruse in home and professionalsettings to aid individuals withdiabetes and their health careprofessionals in review, analysisand evaluation of blood glucosereadings to support an effectivediabetes management program. TheGlooko device system for GlookoApplication connects to compatibleFDA cleared meters and allowsusers to transfer their blood glucosemeter results to their mobiledevices.The Glooko device system forGlooko Application is not intendedto provide treatment decisions or tobe used as a substitute forprofessional healthcare advice.	Same
Software	Glooko Logbook+ Application(iOS platform)	Glooko Application (Androidoperating system platform)
Hardware	MeterSync CableIR Adapter	MeterSync Cable with integrated IRAdapter

Table 1: Summary of Technological Characteristics

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Glooko Device system for Glooko Application
Special 510(k) Submission

Product	Glooko Device System for GlookoLogbook+ ApplicationK130886(Predicate Device)	Glooko Device System forGlooko ApplicationK132272(Subject Device)
Blood glucose metercompatibility	Abbott: FreeStyle Freedom Lite®,FreeStyle Lite®Bayer: Bayer's BREEZE®2, Bayer'sCONTOUR®, Bayer's CONTOUR®NEXT EZ.LifeScan: OneTouch® Ultra®2,OneTouch® UltraLink®,OneTouch® UltraMini®Roche: ACCU-CHEK® Aviva,ACCU-CHEK® Compact Plus,ACCU-CHEK® Nano	Abbott: FreeStyle Freedom Lite®,FreeStyle Lite®Bayer: Bayer's BREEZE® 2,Bayer's CONTOUR®, Bayer'sCONTOUR® NEXT EZ, Bayer'sLifeScan:OneTouch® Ultra®2,OneTouch® UltraLink®, andOneTouch® UltraMini®Roche: ACCU-CHEK® Aviva,ACCU-CHEK® Compact Plus,ACCU-CHEK® Nano
Meters not supportedby the predicate devicebut supported bycurrent device		Nipro TRUEbalance™ (K090495),Nipro TRUEread ™ (K042080),Nipro TRUEresult (K080641),Nipro TRUEtrack™(K040670)Bayer's Contour USB (K091820)Bayer's Contour Next USB(K121087)
Meters supported bythe predicate devicebut not by the currentdevice	GLUCOCARD: GLUCOCARD® 01,GLUCOCARD® VitalTMReliOn: ReliOn® Confirm, ReliOn®PrimeiSENS: CareSens N and CareSensN POP
Operating System	iOS 5.0 and higher	Android OS 2.3.3 or higher
Product	Glooko Device System for GlookoLogbook+ ApplicationK130886(Predicate Device)	Glooko Device System forGlooko ApplicationK132272(Subject Device)
Hardware	• iPod touch®: 3rd and 4thgenerations• iPhone®: 3GS, 4, 4S• iPad®: iPad 1, iPad 2, and iPad(3rd generation) -(Accessed in 2xmode)• iPod touch 5th generation, iPhone5, iPad mini, and iPad 4thgeneration (These devices requireApple's off-the-shelf Lightning to 30-pin adapter for connection.)*	• HTC Desire HD (A9191), HTCEvo (PC36100), HTC IncredibleS S710e• LG Nexus 4, LG Optimus 2X(LG-P990)• Motorola DROID X• Samsung Ace (GT-S5830T),Samsung Galaxy Nexus,Samsung Galaxy Note (GT-N7000), Samsung Galaxy NoteII (GT-N7100); SamsungGalaxy S+ (GT-I9001),Samsung Galaxy S II (GT-I9100), Samsung Galaxy S II(SGH-I757M), SamsungGalaxy S III (GT-I9300),Samsung Galaxy SIIII (GT-I9500)
Syncs with compatiblemeters	Yes	Yes
Allow users to annotatereadings with notes	Yes	Yes
Provide multiple viewoptions for the data	Yes	Yes
Share the collecteddata	Yes	Yes
Provide statistics	Yes, across multiple devices andsupported web browsers.	Yes, across multiple devices andsupported web browsers.
Graph the glucosereadings	Yes, across multiple devices andsupported web browsers.	Yes, across supported webbrowsers.
Allow goals to be set	Yes	No
Transmit and view dataacross supportedmultiple devices andweb browsers usingconsistentauthenticationcredentials(username/password)	Yes	Yes

COMPANY CONFIDENTIAL DO NOT COPY

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Glooko Device system for Glooko Application
Special 510(k) Submission
K132272
Page 6 of 7

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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 7 of 7

Intended Use:

The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android operating system.

The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Summary of Testing:

The Glooko Application underwent verification and validation testing. A brief summary of the tests performed is described below. These studies demonstrated that the Glooko Device System for Glooko Application performed according to the specifications and the intended use.

Software Verification and Validation

The Glooko Device system (Glooko Application, and Cable) was validated pursuant to the moderate level of concern requirements. Design validation testing confirmed that the Glooko device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol, which referenced FDA's guidance document for medical devices containing software. Such testing included Data Integrity Verification, Software Design/features Verification, and error handling testing. All test results fell within the pre-determined specification parameters.

Statement of Equivalence:

The Glooko Device System for Glooko Application is substantially equivalent to the predicate device with regards to its intended use and function. Both the subject and predicate devices use the exact same technology to download data from compatible FDA cleared blood glucose meters. Both the subject and predicate device are able to analyze blood glucose meter data producing basic statistics and graphs.

Summary:

Based on the information provided in this premarket notification, the Glooko device system for Glooko Application is substantially equivalent to the predicate device and is suitable for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

October 17, 2013

Glooko, Inc. c/o Shilpa Mydur 170A University Avenue PALO ALTO CA 94301

Re: K132272

Trade/Device Name: Glooko Device System for Glooko Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: September 16, 2013 Received: September 17, 2013

Dear Shilpa Mydur:

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.

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 Parts 801 and 809); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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/MedicalDeviccs/Resourcesfor You/Industry/default.htm.

Sincerely yours.

CarolGBenson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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K132212

510(k) Number if Known: N/A

Device Name: Glooko Device System for Glooko Application

Indications for Use:

The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

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

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Stayce Beck

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.