(564 days)
Medisign MM1000 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1100 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1200 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (invitro diagnostic use only) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly).
The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Glucose Control Solutions are intended for use with Smart Diabetes Bluetooth meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only autodisabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes, and may be used for testing multiple patients in a professional healthcare setting. It is intended for use outside the body (invitro diagnostic use) and not for the diagnosis of or screening for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this system.
The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use with fingertip, forearm, and palm testing. The system is intended for use for multiple patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system. The strips are not for the diagnosis of or screening for diabetes or for neonatal use.
Smart Diabetes Glucose Control Solutions are for use with the Smart Diabetes Bluetooth Pro meter and Smart Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.
Medisign® Blood Glucose Monitoring System measures the glucose in the fresh capillary whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips.
Medisign® MM 1000 BT Blood Glucose Monitoring System, Medisign® MM 1100 BT Blood Glucose Monitoring System, Medisign® MM1200 BT and Smart Diabetes Bluetooth Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual and log book. Blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), lancing device, lancets, batteries (CR2032), diabetes management software, and data transporting cable are sold separately.
Medisign® MM1000 BT MULTI Blood Glucose Monitoring System, Medisign® MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign® MM1200 BT MULTI and Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System are basically provided with a blood glucose meter and a carrying bag including user manual, quick reference manual. Disposable lancing device, blood glucose test strips (10T, 25T, 50T), blood glucose control solutions (Level 1, Level 3), batteries (CR2032) diabetes management software, and data transporting cable are sold separately.
Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3 µg and buffer & non-reactant - 50.5µg
Each box of control solutions (Level 1, Level 2 and Level 3) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL), Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).
The system contains Bluetooth wireless technology. This device complies with U.S. federal guidelines, Part 15 of the FCC Rules for devices with RF capability. Operation is subject to the following two conditions:
- This device may not cause harmful interference.
- · This device must accept any interference received, including interference that may cause undesirable operation.
The Bluetooth wireless technology is used to transfer meter test results to a mobile APP.
The provided text describes several Medisign and Smart Diabetes Bluetooth Blood Glucose Monitoring Systems, all under K152534. The submission claims substantial equivalence to a predicate device (K111456 Medisign® Blood Glucose Monitoring System) and includes performance testing of the modified device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text explicitly states that the modified devices aim to demonstrate substantial equivalence to the predicate device, implying that the performance of the modified device should align with that of the predicate. It then lists "Similarities" and "Differences" between the candidate device (the various Medisign and Smart Diabetes systems) and the predicate device (K111456). While it doesn't present a formal acceptance criteria table with numerical targets, it lists the characteristics that are considered "Same" as the predicate device.
| Feature / Acceptance Criteria (Implied: Same as Predicate) | Reported Device Performance (as stated in "Similarities") |
|---|---|
| Intended Use | Same |
| Enzyme | Same (Glucose Oxidase (Aspergillus Niger)) |
| Test Principle | Same (Electrochemical reaction) |
| Test Sample | Same (Fresh capillary whole blood) |
| Electrode Material | Same (Carbon) |
| Coding of Test Strip | Same (Auto coding) |
| Calibration | Same (Plasma equivalent) |
| Operating Temperature | Same (50 - 104°F) |
| Operating Humidity | Same (10 - 90%RH) |
| Hematocrit Range | Same (30 - 55%) |
| Alternate Site Testing Site | Same (Palm, Forearm) |
| Measuring Time | Same (5 seconds) |
| Sample Volume | Same (Minimum 0.5 microliter) |
| Measuring Range | Same (20 - 600 mg/dL) |
| Pre/Post-meal flagging | Same (Available) |
| Battery Life | Same (Approximately more than 1,000 tests) |
| Battery | Same (Two (2) 3.0V Lithium batteries (CR2032)) |
| Test Strip Ejector | Same (Available) |
| Memory Capacity | Same (300 results with date, time and flags) |
| Averaging Results | Same (14 days) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "verification tests were conducted" (page 16) but does not provide any specific details about the sample sizes used for these tests. There is also no explicit mention of data provenance (country of origin) or whether the studies were retrospective or prospective.
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)
For a blood glucose monitoring system, the "ground truth" is typically an established laboratory reference method (e.g., using a YSI glucose analyzer) rather than expert consensus on images or clinical assessments. The document does not mention the involvement of experts for establishing ground truth in the context of radiologists or similar clinical reviewers. The ground truth for glucose measurements would be provided by a highly accurate laboratory instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Given that the device measures a quantitative value (glucose concentration) against an established reference method, an adjudication method like 2+1 or 3+1 (which are typically used for qualitative or subjective assessments in imaging or pathology) is not applicable or mentioned in the context of this device. The comparison would be a direct quantitative comparison between the device reading and the reference method reading.
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
This type of study (MRMC, measuring improvement with AI assistance) is not relevant to a blood glucose monitoring system, which is a standalone diagnostic device, not an AI-assisted diagnostic imaging tool. Therefore, no such study was done or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance testing described implicitly as "verification tests" (page 16) would be a standalone performance evaluation of the device (meter and test strip system) measuring glucose concentrations. The device itself (the algorithm within the meter) provides the result without human interpretation of raw data, beyond operating the device. While "algorithm only" implies a pure software evaluation, this would be the closest analogue for a medical device that produces a direct numerical output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood glucose monitoring system, the ground truth is established by a reference laboratory method for glucose measurement, typically a highly accurate and precise enzymatic method often run on a laboratory analyzer (e.g., YSI glucose analyzer). While not explicitly stated, this is the standard for validating such devices. The document mentions "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood equivalent test strips," which further indicates a comparison to a standardized laboratory method that often reports plasma glucose.
8. The sample size for the training set
The document describes a 510(k) submission for modified devices, claiming substantial equivalence. It refers to "verification tests" for the modified device based on its similarity to a predicate device. No mention is made of a "training set" as would be used for machine learning. The device operates based on established electrochemical principles, not a learnable algorithm that requires training data in the AI sense.
9. How the ground truth for the training set was established
As there is no mention of a training set in the context of an AI/machine learning model, this question is not applicable. The device's operation relies on chemical reactions and electrical current measurements, calibrated against reference glucose values derived from a laboratory method.
§ 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.