(85 days)
The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of the information that is and is not present, based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document states that Biotest Medical Corp. "has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements." However, it does not detail what those acceptance criteria were (e.g., accuracy standards like ISO 15197) or present specific performance data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present. The document mentions "Performance Studies" in a very general way, but does not provide any specifics about sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not present. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation), where expert consensus establishes ground truth. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by expert consensus interpreting images. The document does not describe how ground truth was established for any performance studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not present. Similar to point 3, adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for a blood glucose meter's performance assessment.
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/Not present. MRMC studies are used to evaluate the impact of AI on human reader performance, particularly in diagnostic imaging. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in the way an imaging AI would.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. While the device itself is a "standalone" system for measuring glucose, the concept of "standalone (algorithm only without human-in-the-loop performance)" is usually applied to AI algorithms that process data independently. This device is a physical diagnostic tool; its performance is inherently a standalone measurement. The document does not describe any specific "algorithm-only" performance study in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but inferred to be a laboratory reference method. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., hexokinase method). The document does not explicitly state this, but it's the standard for such devices.
8. The sample size for the training set:
- Not applicable/Not present. This device is not described as involving machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on its electrochemical measurement technology.
9. How the ground truth for the training set was established:
- Not applicable/Not present. As there's no mention of a training set for an AI/ML model, this information is not provided.
In summary:
The provided 510(k) summary for the SoloV2™ Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to a predicate device (SuperCheck 1 Blood Glucose Monitoring System) by listing modifications and asserting that "necessary verification and validation activities" were performed. It does not include detailed performance data, specific acceptance criteria, or study methodologies that would address most of your requested points, which are more typically found in documents for AI/ML-based medical devices or more comprehensive clinical study reports.
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510(k) Summary (Per 21 CFR 807.92)
Updated on February 18, 2010
MAR - 2 2010
1. Submitter Information
| Company name | Biotest Medical Corporation |
|---|---|
| Contact person | Maggie Chu, President |
| Address | No. 3-2, Chien-Kuo Road, TEPZ, TantzuTaichung 427, TaiwanRepublic of China |
| Phone | 886-919099431 |
| Fax | 886-425326593 |
2. Name of Device
| Trade Name | SoloV2TM Blood Glucose Monitoring System |
|---|---|
| Common Name | Blood Glucose Meter |
| Classifications | NBW, Over the Counter Blood Glucose Test, 862.1345CGA, Glucose Oxidase, 862.1345Class II device |
3. Predicate Device
| Trade name | SuperCheck 1 Blood Glucose Monitoring System (SuperCheck 1). |
|---|---|
| Model 6268 | |
| Common name | Blood Glucose Meter |
| Submitter | Biotest Medical Corporation |
| 510(k) number | K091815 |
4. Device Description
The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
5. Intended Use
The SoloV2TM Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
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The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
6. Comparison to Predicate Device
Modifications to the cleared device include additional buttons for volume and language adjustment, additional pre-meal and post-meal Logging Flags, substitution of a USB connection for the previous RS232 cable, addition of an insufficient blood error message, and the removal of the test strip ejector mechanism. The size and shape of the device have also been modified to differentiate from the predicate. The SoloV240 Blood Glucose Monitoring System has the same indented use and fundamental scientific technology as the previous version, the SuperCheck 1 Blood Glucose Monitoring System, Model 6268.
7. Performance Studies
Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.
8. Conclusion
In summary, the modified SoloV2TM Blood Glucose Monitoring System has the same intended use and fundamental scientific technology as the previous version of the device, which received 510(k) clearance (K091815). Therefore, the subject device is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing segments.
Biotest Medical Corp. c/o Maggie Chu No.3-2, Chien-Kuo Road, Tepz, Tantzu Taichung, 427 China (Taiwan)
MAR - 2 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K093764
Trade/Device Name: SoloV2™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: January 26, 2010 Received: February 1, 2010
Dear: Ms. Chu:
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/Resourcesfor You/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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Indications for Use
510(k) Number (if known): K093764
Device Name: SoloV2TM Blood Glucose Monitoring System
Indications for Use:
The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use . X (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093764
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.