(161 days)
Not Found
No
The description focuses on data download, processing, storage, and report generation. There is no mention of algorithms that learn from data or make predictions/classifications. The "analysis" mentioned in the intended use appears to be standard data aggregation and presentation for clinician review, not automated AI/ML analysis.
No.
The device is described as a data management service that assists in the review, analysis, and evaluation of blood glucose test results. It does not directly treat or prevent a disease.
No
The device is a data management service that assists in the review, analysis, and evaluation of blood glucose test results. It does not provide a diagnosis or new diagnostic information, but rather supports the clinician in managing diabetes based on existing test results.
No
The device description explicitly mentions "dedicated off-the-shelf computer" and "device-specific cable" as components of the data retrieval stations, which are hardware elements. While the service is primarily web-based and uses a SaaS model, the overall system includes hardware components necessary for data retrieval.
Based on the provided information, the SweetSpot Diabetes Data Management Service is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the review, analysis, and evaluation of blood glucose test results by the clinician to support effective diabetes management." It is explicitly stated as an "accessory to blood glucose meters." This indicates it's a tool for managing data generated by an IVD (the blood glucose meter), not a device that performs a diagnostic test itself.
- Device Description: The description focuses on data retrieval, processing, storage, and report generation from existing blood glucose data. It doesn't describe any components or processes that would perform a diagnostic test on a biological sample.
- Lack of Diagnostic Metrics: The performance studies focus on usability, download success rates, and data accuracy compared to manufacturer software. There are no mentions of typical IVD performance metrics like sensitivity, specificity, AUC, etc., which would be expected for a diagnostic device.
- Predicate Device: The listed predicate device, MyCareTeam-Diabetes (K073699), is also a diabetes data management system, not an IVD.
In summary, the SweetSpot Service is a data management tool that works with the results of an IVD (the blood glucose meter), but it does not perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The SweetSpot Diabetes Data Management Service is intended for use in in clinical settings by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.
Product codes
NBW, JQP
Device Description
The SweetSpot Service allows patients or healthcare professionals to download data from blood glucose meters (BGM) and generates a report from the downloaded data. which is delivered to the healthcare professional for use in patient management. The Service is comprised of three different types of data retrieval stations, a Fetch Utility, a data processing and storage platform, report generation software, and an information delivery service.
The first type of data retrieval station is a Front-Office Kiosk - a dedicated off-the-shelf computer that a patient uses to download the data from their devices (if they download from multiple devices the Service will consolidate that data into a single report). A device-specific cable is required to connect the BGM to the Kiosk for data download. Once the data is downloaded, it is processed into a report and delivered according to the specific clinic's needs and workflow.
The second type of data retrieval station is a Back-Office Kiosk - a dedicated off-theshelf computer that healthcare professionals use to download patient devices and/or monitor reports. This kiosk is also configured for the workflow needs of the clinic.
The third type of data retrieval station is a Back-Office Web Application – a standalone application used by healthcare professionals that does not require a dedicated computer. Each customer uses a specific instance of the web application through a unique URL. This launches a proprietary web application configured for that specific clinic's needs and workflows.
The SweetSpot Fetch Utility retrieves data from various BGM manufacturers' devices and includes device drivers for multiple manufacturers. The Fetch Utility is centrally updated and maintained. When any version of the SweetSpot Services retrieval stations - in any setting - is directed to perform data retrieval, the Service ensures the most upto-date version of the Fetch Utility is used.
The SweetSpot Service is primarily web-based and is delivered using a software-as-aservice (SaaS) model. All data storage and processing takes place on remotely hosted virtualized computing resources on the Internet, often referred to as "cloud computing".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical settings by both patients and healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Lay user evaluation:
A lay user evaluation was performed by typical outpatients at two different typical sites of use. A total of 88 respondents completed a user survey after using the SweetSpot Front-Office Kiosk. On a scale of 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree", 98% of the users thought that the SweetSpot Service was easy to use (4.9 average rating at both evaluation sites), and 90% thought that they would be more likely to bring their meters to appointments in the future if the SweetSpot Service was available (ratings of 4.6 and 4.5, respectively, at the user evaluation sites). Meter download success rates were 97.6% and 95.3%, respectively (96.5% overall success rate).
Healthcare professional (HCP) evaluation:
A separate user evaluation of the Back-Office Kiosk was performed by healthcare professionals (HCP) at one typical site of use. A total of 11 respondents completed a user survey after using the SweetSpot Back-Office Kiosk as part of a larger research study. The HCP preferred the consistency, simplicity/ease of use, and speed of the SweetSpot download process to their previous various meter-specific processes, and also preferred the consistency of having one report format for all patients vs. their previous different meter-specific report formats. The HCP thought that these features would improve workflow, decrease meter download time, simplify decision-making, reduce training time, and reduce the chance for mistakes in data management.
Accuracy of Fetch process:
The accuracy of the Fetch process in lay users' hands was evaluated at a typical site of use, where lay users used the Front-Office Kiosk to download data from their BGM, and a SweetSpot employee used the BGM manufacturer's download software to download data from the same BGM. The two download files were compared, and there was 100% agreement between the download files, demonstrating that the lay user does not introduce error into the download process when using the Front-Office Kiosk and the SweetSpot Fetch process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Meter download success rates: 97.6% and 95.3% (96.5% overall success rate).
Accuracy of Fetch process in lay users' hands: 100% agreement between download files.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV - 9 2011
SweetSpot Diabetes Care, Inc. SweetSpot Diabetes Data Management Service Response to Request for Additional Information dated July 17, 2011
510(k) Summarv
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ _ K111509
| A. Submitter | SweetSpot Diabetes Care, Inc. |
|---|---|
| Contact: | Christopher Logan, CEO |
| Telephone: | 503-893-2448 |
| Email: | chris@sweetspotdiabetes.com |
Date Prepared: September 28, 2011
B. Device Names
Classification names
- System, Test, Blood Glucose, Over the Counter, Class II at 862.1345, NBW 2) Calculator/data processingmodule for clinical use, Class I at 862.2100, JQP
Common/usual names
-
Blood glucose meter
-
Data management software
Proprietary names
-
Various, from various manufacturers
-
SweetSpot Diabetes Data Management Service
C. Predicate Device
MyCareTeam-Diabetes, K073699, NBW/JQP
D. Device Description
The SweetSpot Service allows patients or healthcare professionals to download data from blood glucose meters (BGM) and generates a report from the downloaded data. which is delivered to the healthcare professional for use in patient management. The Service is comprised of three different types of data retrieval stations, a Fetch Utility, a data processing and storage platform, report generation software, and an information delivery service.
The first type of data retrieval station is a Front-Office Kiosk - a dedicated off-the-shelf computer that a patient uses to download the data from their devices (if they download from multiple devices the Service will consolidate that data into a single report). A device-specific cable is required to connect the BGM to the Kiosk for data download. Once the data is downloaded, it is processed into a report and delivered according to the specific clinic's needs and workflow.
The second type of data retrieval station is a Back-Office Kiosk - a dedicated off-theshelf computer that healthcare professionals use to download patient devices and/or monitor reports. This kiosk is also configured for the workflow needs of the clinic.
1
The third type of data retrieval station is a Back-Office Web Application – a standalone application used by healthcare professionals that does not require a dedicated computer. Each customer uses a specific instance of the web application through a unique URL. This launches a proprietary web application configured for that specific clinic's needs and workflows.
The SweetSpot Fetch Utility retrieves data from various BGM manufacturers' devices and includes device drivers for multiple manufacturers. The Fetch Utility is centrally updated and maintained. When any version of the SweetSpot Services retrieval stations - in any setting - is directed to perform data retrieval, the Service ensures the most upto-date version of the Fetch Utility is used.
The SweetSpot Service is primarily web-based and is delivered using a software-as-aservice (SaaS) model. All data storage and processing takes place on remotely hosted virtualized computing resources on the Internet, often referred to as "cloud computing".
ய் Intended Use
The SweetSpot Diabetes Data Management Service is intended for use in in clinical settings by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.
ட் Comparison with the Predicate Device
The SweetSpot Service is substantially equivalent to the MyCareTeam (MCT-Diabetes product), K073699. Both devices are intended to provide access to BGM data to assist in the monitoring of an individual's blood glucose levels. Both devices are designed for use by patients and by healthcare professionals. Both devices support the most commonly used blood glucose meters. The SweetSpot Service has the same technological characteristics as the predicate device with minor exceptions (e.g., the predicate device operates only on PC operating systems while the SweetSpot Service operates on both PC and Mac OS; report contents and data presentation are slightly different), but the exceptions do not affect safety or effectiveness. Any differences in technology have been addressed by software validation and verification testing, and usability testing (conducted in accordance with ISO15197: 2003).
G. Nonclinical Data
Software verification and validation testing showed that the SweetSpot Service performs as designed.
Clinical Data - User Evaluations H.
・・
A lay user evaluation was performed by typical outpatients at two different typical sites of use. A total of 88 respondents completed a user survey after using the SweetSpot Front-Office Kiosk. On a scale of 1 to 5, with 1 being "Strongly Disagree" and 5 being "Strongly Agree", 98% of the users thought that the SweetSpot Service was easy to use (4.9 average rating at both evaluation sites), and 90% thought that they would be more likely to bring their meters to appointments in the future if the SweetSpot Service was available (ratings of 4.6 and 4.5, respectively, at the user evaluation sites). Meter download success rates were 97.6% and 95.3%, respectively (96.5% overall success rate).
2
A separate user evaluation of the Back-Office Kiosk was performed by healthcare professionals (HCP) at one typical site of use. A total of 11 respondents completed a user survey after using the SweetSpot Back-Office Kiosk as part of a larger research study. The HCP preferred the consistency, simplicity/ease of use, and speed of the SweetSpot download process to their previous various meter-specific processes, and also preferred the consistency of having one report format for all patients vs. their previous different meter-specific report formats. The HCP thought that these features would improve workflow, decrease meter download time, simplify decision-making, reduce training time, and reduce the chance for mistakes in data management.
The accuracy of the Fetch process in lay users' hands was evaluated at a typical site of use, where lay users used the Front-Office Kiosk to download data from their BGM, and a SweetSpot employee used the BGM manufacturer's download software to download data from the same BGM. The two download files were compared, and there was 100% agreement between the download files, demonstrating that the lay user does not introduce error into the download process when using the Front-Office Kiosk and the SweetSpot Fetch process.
Conclusions Drawn from Testing .
Software verification and validation testing and user evaluations showed that the SweetSpot Service performs as designed and meets the users' needs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SweetSpot Diabetes Care, Inc. c/o Chris Logan CEO 2538 Ne 48th Ave. Portland, OR 97213-1924
NOV - 9 2011
Re: K111509
Trade/Device Name: SweetSpot Diabetes Data Management Service Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: September 30, 2011 Received: October 3, 2011
Dear Mr. Logan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ( 30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Response to Request for Additional Information dated July 17, 2011
Indications for Use Form
510(k) Number (if known): K111509 Device Name: SweetSpot Diabetes Data Management Service
Indications for Use:
The SweetSpot Diabetes Data Management Service is intended for use in clinical settings by both patients and healthcare professionals, to assist in the review, analysis, and evaluation of blood glucose test results by the clinician to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.
| Prescription Use | X |
|---|---|
| (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
్ ప్ర
510(k) K 11150 9
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