(25 days)
AutoSure Voice II Blood Glucose Monitoring System: The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Blood Glucose Test Strips: The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for selftesting by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Voice II blood glucose monitoring system consists of a meter and AutoSure test strips. It is used for testing of blood glucose by self-testers at home and for professional testers in healthcare facilities.
The provided document does not contain the level of detail required to fulfill all aspects of the request. Specifically, it is lacking information about the quantitative acceptance criteria, the specific study design for clinical testing, the sample sizes for the test set, the number and qualifications of experts, the adjudication method, details about a multi-reader multi-case study, the type of ground truth used for the test set, and how ground truth for the training set was established.
However, based on the limited information available in the 510(k) summary, here's what can be inferred and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. It broadly claims "Results demonstrate substantial equivalence to the predicate device." for both non-clinical and clinical testing. For blood glucose monitoring systems seeking 510(k) clearance, the typical acceptance criteria for accuracy involve specific percentages of measurements falling within ±X% or ±Y mg/dL of a reference method. This document does not provide those specific numbers.
| Acceptance Criteria (Not explicitly stated, but typically expected for blood glucose monitors) | Reported Device Performance (Generalized adherence) |
|---|---|
| e.g., X% of results within ±Y mg/dL or ±Z% of reference (specific values not provided in document) | "Results demonstrate substantial equivalence to the predicate device." |
| e.g., Clinical Accuracy for healthcare professionals and lay users (specific values not provided) | "An accuracy study was performed with blood testing by healthcare professionals." and concluded "substantially equivalent." |
| Ease-of-use and user manual comprehension. | "A user study was conducted to evaluate ease-of-use of the system and ease-of-understanding of the User's Manual." and concluded "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The summary only mentions "An accuracy study was performed" and "A user study was conducted."
- Data Provenance: The document implies the data is likely prospective clinical data collected for the purpose of the 510(k) submission, as it describes "An accuracy study was performed with blood testing...". No country of origin for the clinical study data is specified beyond the submitter's location in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided document.
4. Adjudication method for the test set
Not specified in the provided document.
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
Not applicable. This is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements. The "human readers" in this context would be users performing the blood glucose test, not interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the "accuracy study" performed is a standalone assessment of the device's numerical output against a reference method. The device (meter and test strips) is an algorithm/system generating a quantitative glucose value. The study compared this quantitative output to a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy study would have been established using a laboratory reference method for glucose measurement, such as a YSI glucose analyzer, which is the standard for such device comparisons. While not explicitly named, this is the accepted "ground truth" for blood glucose monitor accuracy claims.
8. The sample size for the training set
Not applicable/Not specified. This device is not described as utilizing a machine learning algorithm that requires a distinct "training set" in the conventional sense. Its "algorithm" refers to the electrochemical principles and calculations for glucose measurement, which are established rather than "trained" on data for pattern recognition.
9. How the ground truth for the training set was established
Not applicable, as there's no mention of a machine learning training set. The underlying principles and calibration were established through engineering and analytical validation.
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K102037 AUG 1 3 2010
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6 510(k) Summary
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| Submitter: | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
|---|---|
| Contact Person: | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
| Date Prepared: | July 2, 2010 |
| Trade Names: | AutoSure Voice II Blood Glucose Monitoring System,AutoSure Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | AutoSure Voice meter and test strips |
| Device Description: | The AutoSure Voice II blood glucose monitoring system consists of ameter and AutoSure test strips. It is used for testing of blood glucose byself-testers at home and for professional testers in healthcare facilities. |
| Intended Use: | System: The AutoSure Voice II Blood Glucose Monitoring Systemintended for the quantitative measurement of glucose in fresh capillary whblood samples drawn from the fingertips, forearm, or palm. Testing is dooutside the body (In Vitro diagnostic use). The meter includes vofunctionality to assist visually impaired users. It is indicated for both layby people with diabetes and in a clinical setting by healthcare professionaas an aid to monitoring levels in Diabetes Mellitus. It is not indicated fordiagnosis or screening of diabetes or for neonatal use.Test Strip: The AutoSure Blood Glucose Test Strips are to be used withAutoSure Voice II Blood Glucose Meter to quantitatively measure glucosecapillary whole blood taken from fingertips, palm, or forearm. The AutoSVoice II Blood Glucose Monitoring System is plasma-calibrated for eacomparison to lab results. It is intended for self-testing by persons wdiabetes and by health care professionals. It is not indicated for the diagnoor screening of diabetes or for neonatal use. |
| Comparison ofTechnologicalCharacteristics: | The AutoSure Voice II meter uses the same test algorithm as the predicaThe meter has been modified by relocating the 3 operating buttons. Mesoftware has been changed to accommodate the new autocoding feature. Ttest strip and test strip holder have been modified to allow automadetection of the calibration code upon insertion of the test strip. The tstrip is otherwise unchanged from the predicate test strip. |
| Non-ClinicalTesting: | Testing was conducted as follows: Software verification and validaticsoftware integration, linearity, Lo/Hi detection, strip holder reliability, drtesting, EMC and Electrical Safety, autocode manufacturing qualificatioand verification of strip noninterchangeability between new and predicadevices. Results demonstrate substantial equivalence to the predicate devic |
| Clinical Testing | An accuracy study was performed with blood testing by healthcaprofessionals. A user study was conducted to evaluate ease-of-use of tsystem and ease-of-understanding of the User's Manual. Resudemonstrate substantial equivalence to the predicate device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure Voicemeter and AutoSure test strips perform in a substantially equivalent manrto that of the predicate device. We conclude that the AutoSure Voicemeter and AutoSure test strips are substantially equivalent to the predicadevice |
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510(k) Summary (Continued)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Apex BioTechnology Corp. c/o Hsue-mei Lee Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, 30078 China (Taiwan)
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 13 2000
K102037 Re:
Trade Name: AutoSure Voice II Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW Dated: July 2, 2010 Received: July 19, 2010
Dear Mr. Lee:
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 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 yours.
Signature
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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AUG 1 3 2010
Indications for Use Statement 5
510(k) Number (if known): 16 102203
Device Name: AutoSure Voice II Blood Glucose Monitoring System
Indications for Use:
AutoSure Voice II Blood Glucose Monitoring System:
The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.
AutoSure Blood Glucose Test Strips:
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for selftesting by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use,
Prescription Use Over-The-Counter Use X AND/OR (Part 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 In Vitro Diagnostic Devices (01VD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102037
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.