(28 days)
The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and 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 LifeScan blood glucose monitoring systems with data management capabilities.
The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management. The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account. The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side. The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.
Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch® Zoom™ Diabetes Management Program:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit acceptance criteria mentioned. | "Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device." |
| No change to the intended use. | Confirmed, as stated. |
| No change to the operating principle. | Confirmed, as stated. |
| No change to the functionality. | Confirmed, as stated. |
| No change to the material composition. | Confirmed, as stated. |
| No change to the fundamental scientific technology. | Confirmed, as stated. |
| No change to the performance characteristics. | Confirmed, as stated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document refers to "Design Verification testing" but does not give specific numbers for test cases or datasets.
- Data Provenance: Not explicitly stated. The testing is described as design verification and software verification/validation, implying internal testing, but details on the origin of data used for this testing (e.g., country, retrospective/prospective) are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The device is a software program for diabetes management data analysis; there is no mention of human expert-established ground truth in the context of diagnostic accuracy for the device itself. The "ground truth" would likely relate to the accuracy of data retrieval, processing, and display, rather than clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this type of adjudication is typically for diagnostic accuracy studies with human readers, which is not the nature of this device's testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No. An MRMC comparative effectiveness study was not performed. The device is a data management program, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The "Design Verification testing (including software verification and validation testing)" would assess the standalone performance of the software in its intended functions (data retrieval, trending, reporting). The focus is on the software's ability to accurately process and present the blood glucose data.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established by:
- Conformance to requirements: Ensuring the software correctly implements its specified functions (e.g., retrieves data accurately, generates reports as defined, performs calculations correctly).
- Predicate device equivalence: The primary "ground truth" or benchmark is the predicate device. The testing aimed to confirm that the new device's performance characteristics were equivalent to the already approved predicate.
- The accuracy of the blood glucose data itself, which originates from LifeScan blood glucose meters, is assumed as established by the prior approval of those meters.
8. The Sample Size for the Training Set
Not applicable. This device is a data management program, not a machine learning model that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of software device.
{0}------------------------------------------------
Special 510(k)
JUN - 9 2008
OneTouch® Zoom™ Diabetes Management Program
510(k) Summary
Sponsor LifeScan, Inc. 1000 Gibraltar Drive
Milpitas, CA 95035 U.S.A.
Correspondent
Primary 510(k) Contact: Frank Peralta LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Phone: 408.942.3588 e-mail: fperalta@lfsus.jnj.com
Alternate 510(k) Contact: Mary Ellen Holden LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
Phone: 408.942.3589 E-mail: mholden@lfsus.jnj.com
Device Name and Classification
OneTouch® Zoom™ Diabetes Management Program Common name: Glucose test system Classification: OneTouch® Zoom™ Diabetes Management Programa Class II device (21 CFR § 862.1345)
{1}------------------------------------------------
Product Description
The OneTouch® Zoom™ Diabetes Management Program is a web-based application that is designed to retrieve blood glucose data from the Microsoft® HealthVault™ and provide trending and reports in order to assist people with diabetes management.
The program also includes a stand-alone software driver, branded as OneTouch® Meter Drivers for use with Microsoft® HealthVault™ that downloads blood glucose data from Lifescan Brand blood glucose meters with data management capabilities to Microsoft® HealthVault™ Connection Center, which subsequently upload the data to the user's online Microsoft® HealthVault™ account.
The OneTouch® Zoom™ Diabetes Management Program is a .NET based client/server application that runs on Windows 2003 server and supports Internet Explorer 6.0 and higher on the client side.
The OneTouch® Meter Drivers for use with Microsoft® HealthVault™ run on Windows XP Service Pack 2 and Windows Vista platforms.
Predicate Device
OneTouch® Diabetes Management Software
Intended Use
The ONE TOUCH® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and 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 LifeScan blood glucose monitoring systems with data management capabilities.
Comparison to Predicate Device
The modifications to the device encompass:
- . Reports: a reduction in the number of reports from eleven to two.
- . Data Storage: a change in data storage on a local database stored on the user's PC to a remote database hosted by Microsoft Corporation. connected via the Internet.
{2}------------------------------------------------
OneTouch® Zoom™ Diabetes Management Program
There has been no change to the intended use, operating principle, functionality, or material composition of the device.
Technological Characteristics
There has been no change to the fundamental scientific technology.
Summary of Performance Characteristics
There has been no change to the performance characteristics of the product.
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Zoom™ Diabetes Management Program was equivalent to that of the predicate device.
Conclusion
The OneTouch® Zoom™ Diabetes Management Program is substantially equivalent to the predicate OneTouch Diabetes Management Software.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 9 2008
LifeScan, Inc. Mr. Frank Peralta Senior Regulatory Submissions Specialist 1000 Gibraltar Drive Milpitas, CA, 95035-6312
Re: K081318
Trade/Device Name: OneTouch® Zoom™ Diabetes Management Program Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: May 9, 2008 Received: May 12, 2008
Dear Mr. Peralta:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
ONE TOUCH® Zoom™ Diabetes Management Program Device Name:
Indications for Use:
The ONE Touch® Zoom™ Diabetes Management Program is intended for use in home and clinical settings to aid people with diabetes and 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 LifeScan blood glucose monitoring systems with data management capabilities.
| Prescription Use | |
|---|---|
| (Per 21 CFR 801 Subpart D) |
AND/OR
Over-the-Counter Use__
×
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| LifeScan, Inc. | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) |
|---|---|
| Page 1 of 1 | |
| Confidential |
| Division Sign-Off | |
|---|---|
| 2 of 2 | |
| Office of In Vitro Diagnostic Device Evaluation and Safety |
| 510(k) | K081318 |
|---|---|
| -------- | --------- |
§ 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.