(270 days)
The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The Didget Blood Glucose Monitoring System consists of:
- Didget Blood Glucose Monitor
- Contour Blood Glucose Test Strips
- Contour Control Solution
The provided text describes a 510(k) summary for the Didget Blood Glucose Monitoring System. It outlines the device, its intended use, and a performance assessment, but does not specify numerical acceptance criteria or detail the study results required to prove these criteria were met. The document states that "The studies showed equivalent performance with the current Contour system." and "The results of clinical evaluations... demonstrated that the device can produce blood glucose results that are substantially equivalent to results obtained on the predicate device." However, specific metrics, thresholds, and statistical analyses are not provided.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a summary of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Equivalent performance with the current Contour system (predicate device). |
| Substantially equivalent to results obtained on the predicate device. |
- Note: The document does not provide specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) or the detailed numerical results from the Didget system's performance. It broadly states "equivalent performance".
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document states "a clinical setting using persons with diabetes, ages 5 through 24," but does not give a number of participants.
- Data Provenance:
- Country of origin of the data: Not specified.
- Retrospective or prospective: Not specified, but "studied in the laboratory and in a clinical setting" suggests a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This study is for a blood glucose meter, which typically uses a highly accurate laboratory reference method (e.g., YSI analyzer) as the "ground truth" rather than expert interpretation of images or other data. The text mentions "compared to a laboratory method."
4. Adjudication method for the test set:
- Not applicable. (See point 3)
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:
- No. This is not relevant to a blood glucose meter study. This type of study is typically done for diagnostic imaging or interpretation tasks involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The performance assessment of a blood glucose meter is inherently a standalone assessment of the device's accuracy against a reference method. The Didget system's performance was compared to the Contour system and "a laboratory method."
7. The type of ground truth used:
- Laboratory Method: The document states the results were "compared to... a laboratory method." This typically refers to a highly accurate and precise analytical instrument considered the gold standard for glucose measurement.
8. The sample size for the training set:
- Not applicable / Not specified. Blood glucose meters are not typically "trained" in the same way machine learning algorithms are. Their performance is based on the chemical and electrochemical reactions of the test strip and the meter's electronics.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. (See point 8)
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KC090628
DEC - 4 2009
Image /page/0/Picture/2 description: The image shows the Bayer HealthCare logo. The logo consists of the Bayer company symbol on the left and the text "Bayer HealthCare" and "Diabetes Care Division" on the right. The Bayer company symbol is a circle with the word "BAYER" written vertically inside.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
The assigned 510(k) number is: K090628
| Prepared: | November 30, 2009 |
|---|---|
| Submitter: | Bayer Healthcare Diabetes Care |
| Address: | Bayer Healthcare, Diabetes Care777 Old Saw Mill River RoadTarrytown, NY 10591Phone (914) 333-6736 FAX (914) 333-6160 |
| Contact: | Susan BrocchiRegulatory Affairs Specialist |
| Device: | Trade/ Proprietary Name: DidgetCommon/Usual Name: Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Regulation - 21CFR 862.1345Product Code - 75 LFR (Glucose Dehydrogenase, Glucose) |
| Predicate Devices: | Contour Blood Glucose Meter (K062058, K060470) |
| Device Description: | The Didget Blood Glucose Monitoring System consists of:1. Didget Blood Glucose Monitor2. Contour Blood Glucose Test Strips3. Contour Control Solution |
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Bayer Healthcare Didget Blood Glucose Monitoring System
,
| Intended Use: | The Didget blood glucose monitoring system (meter, strips, and controls)is intended for self-testing by people with diabetes to monitor glucoseconcentrations in fresh capillary whole blood samples drawn from thefingertip only. It is intended for those ages four and older, with adultsupervision as needed. The Didget blood glucose monitoring system isnot intended for the diagnosis of or screening for diabetes mellitus and isnot intended for use on neonates. |
|---|---|
| TechnologicalCharacteristics: | There were no changes to the fundamental scientific technology |
| Comparison toPredicate Device: | The modifications to the device encompass meter size/shape designchanges. There has been no change to the operating principle. Aninterface for a Nintendo gaming system was added. The indication wasmodified. |
| Assessment ofPerformance: | An evaluation of the Didget Blood Glucose Monitoring Systemwas studied in the laboratory and in a clinical setting using persons withdiabetes, ages 5 through 24. The results were compared to results fromthe currently marketed Contour system and to a laboratory method. Thestudies showed equivalent performance with the current Contour system. |
| Conclusion: | The results of clinical evaluations of the Didget Blood GlucoseMonitoring System demonstrated that the device can produce bloodglucose results that are substantially equivalent to results obtained on thepredicate device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wave-like lines beneath it.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 4 2009
Bayer HealthCare Diabetes Care c/o Ms. Susan Brocchi Regulatory Affairs Specialist 777 Old Saw Mill River Road Tarrytown, NY 10591
K090628 Re:
Trade Name: Didget Blood Glucose Monitoring System Regulation Number: 21 CFR 8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: November 03, 2009 Received: November 04, 2009
Dear Ms. Brocchi:
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 (OS) 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 Vitro 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): 090628
Device Name: Didget
Indication for Use:
The Didget blood glucose monitoring system (meter, strips, and controls) is intended for self-testing by people with diabetes to monitor glucose concentrations in fresh capillary whole blood samples drawn from the fingertip only. It is intended for those ages four and older, with adult supervision as needed. The Didget blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K0910628
Page 1 of 1
§ 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.