(388 days)
The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The eBchek Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired.
eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Based on an electrochemical biosensor technology and the principle of capillary action, eBchek Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed on the meter. This system contains some speaking functions, but is not intended for use by the visually impaired.
The eBchek Blood Glucose Monitoring System consists of the eBchek Meter, eBchek test strips with instruction, lancing device, lancets, code card, two AAA Batteries, users manual, carrying case. eB-series control solutions (previously cleared in K062555 as eBsensor control solution) with two different glucose concentration ranges (Level 1 and Level 2) are available but sold separately.
The original text describes a medical device, the eBchek Blood Glucose Monitoring System, and its performance studies. However, the document does not include detailed acceptance criteria or a comprehensive study report with specific data provenance, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way typically expected for AI/ML device descriptions.
The document states that the Performance Studies are "based on ISO 15197: In vitro diagnostic test systems- Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus." It concludes that "Performance on the eBchek Blood Glucose Monitoring System demonstrated that the device meets the requirements for its intended use" and "replicates the predicate device."
Without the full ISO 15197 study report, I cannot provide all the requested details. However, I can infer some information based on typical requirements for blood glucose monitoring systems and the provided text.
Based on the provided information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for blood glucose monitoring systems generally follow ISO 15197. While the specific ISO 15197 table is not provided, the general performance criteria for accuracy typically involve comparing the device's readings to a laboratory reference method. The document states that the device "meets the requirements for its intended use" and "demonstrated that the device is substantially equivalent to the predicate."
A typical summary of accuracy for a blood glucose monitor under ISO 15197 would involve percentage of results within certain deviation ranges from a reference method. For self-testing devices, common accuracy criteria at the time this submission was made were:
- For glucose concentrations < 75 mg/dL (4.2 mmol/L): At least 95% of results must be within ±15 mg/dL (±0.83 mmol/L) of the reference value.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): At least 95% of results must be within ±20% of the reference value.
Since the document states the device "meets the requirements for its intended use" and "is substantially equivalent to the predicate," it implies that the device achieved these (or similar) ISO 15197 specified accuracy targets.
| Acceptance Criteria (Inferred from ISO 15197 for accuracy) | Reported Device Performance (Inferred) |
|---|---|
| For glucose < 75 mg/dL: ≥95% results within ±15 mg/dL | Device "meets the requirements for its intended use" and is "substantially equivalent to the predicate," implying these ISO 15197 criteria are met. |
| For glucose ≥ 75 mg/dL: ≥95% results within ±20% | Device "meets the requirements for its intended use" and is "substantially equivalent to the predicate," implying these ISO 15197 criteria are met. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. ISO 15197 typically requires a minimum number of subjects (e.g., 100 for user performance accuracy) and a certain number of data points across the measurable range.
- Data Provenance: Not explicitly stated. The manufacturer is Visgeneer Inc. from Hsinchu City, Taiwan. The study was conducted based on ISO 15197. It is highly likely the data was collected in Taiwan, but this is not confirmed. It is a prospective study as it's a performance study for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a blood glucose monitoring system, not an imaging AI device requiring expert adjudication for ground truth. The "ground truth" would be established by a highly accurate laboratory reference method (e.g., YSI analyzer).
4. Adjudication method for the test set
Not applicable. Ground truth for blood glucose measurements is established by a reference laboratory method, not expert adjudication.
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 standalone diagnostic device (blood glucose monitor), not an AI assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this is a standalone performance study. The eBchek Blood Glucose Monitoring System is a device that provides a direct measurement, and its performance is evaluated on its own ability to accurately measure glucose.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method (e.g., YSI Glucose Analyzer) due to its high precision and accuracy, rather than expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device in the modern sense that it requires a training set of data to learn from. Its electrochemical biosensor technology is pre-programmed, not "trained" on data.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.
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K 122181
Image /page/0/Picture/1 description: The image shows a black and white drawing of a winged lion. The lion is in a leaping position, with its front paws raised and its back paws on the ground. The wings are spread out behind the lion. The drawing is simple and stylized, with thick lines and minimal detail. The lion appears to be a heraldic symbol or emblem.
Visgeneer Inc. No. 188 Sec.3, Gongdao 5th Rd., Hsinchu City 30069, Taiwan Fax: +886-3-5160161 Tel: +886-3-5160111
Section V 510(K) Summary
This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of (Per 21 CFR 807.92)
Submitter's Name
Visgeneer Inc. No.188, Sec.3, Gongdao 5th Rd., Hsinchu City 30069, Taiwan Fax: +886-5160161 Tel: +886-5160111 Contact Person: Jack Yang Date prepared: June 14th, 2013
AUG 1 5 2013
Name of Device
Trade Name: eBchek Blood Glucose Monitoring System Common Name: Blood Glucose Monitoring System
| RegulationSection | Classification | Product Code | Panel |
|---|---|---|---|
| 21 CFR § 862.1345 | Class II | CGA, glucose oxidase, glucose | ClinicalChemistry |
| (75) | |||
| 21 CFR § 862.1345 | Class II | NBW, system, test, blood glucose,over the counter | ClinicalChemistry(75) |
| 21 CFR § 862.1660 | Class I.reserved | JJX, single (specified) analytecontrols (assayed and unassayed) | ClinicalChemistry(75) |
Predicate Device:
Visgeneer Inc., eBsensor Blood Glucose Monitoring System (K062555)
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Image /page/1/Picture/0 description: The image shows a logo with the letters "VAS" stacked on top of each other. The letters are stylized and appear to be hand-drawn or custom-designed. Below the letters, there is some smaller text that is difficult to read due to the image quality. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look.
Description of Device:
Based on an electrochemical biosensor technology and the principle of capillary action, eBchek Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed on the meter. This system contains some speaking functions, but is not intended for use by the visually impaired.
The eBchek Blood Glucose Monitoring System consists of the eBchek Meter, eBchek test strips with instruction, lancing device, lancets, code card, two AAA Batteries, users manual, carrying case. eB-series control solutions (previously cleared in K062555 as eBsensor control solution) with two different glucose concentration ranges (Level 1 and Level 2) are available but sold separately.
Intended Use:
The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The eBchek Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired.
eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
5-2
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Visgeneer Inc.
No. 188 Sec.3, Gongdao 5th Rd., Hsinchu City 30069, Taiwan
Tel: +886-3-5160111 Fax: +886-3-5160161
Comparison to Predicate Device
| Similarities | ||
|---|---|---|
| Item | Device | Predicate Device(K062555) |
| Device name | eBchek | eBsensor (Model : eB-G) |
| Test Principle | Electrochemical biosensorwith carbon electrodes | Same |
| Specimen Type | capillary whole blood | Same |
| Measurement unit | mg/dL or mmol/L | Same |
| Enzyme | Glucose oxidase | Same |
| Control Solution | eB-series control solution(contains D-glucose, twodifferent concentrations areused, ie. Level 1:100 mg/dLand Level 2:300 mg/dL) | Same composition and mixture, but underlabeling of eBsensor control solution |
| A Code card | Code card(for each batch oftest strip) | Same |
| Strip Dimension | 7.9mm*32mm | Same |
| Battery Power | Two 1.5 V AAA batteries | Same |
| Operating Temp. | 4 to 42 ℃ | Same |
| OperatingHumidity | 10 to 85% | Same |
| Meter Storage | 0~50℃ | Same |
| Differences | ||
|---|---|---|
| Item | Device | Predicate Device |
| Intended use | Single patient | Single patient and Healthcare Professionals |
| Sample Volume | 0.5 uL | 2.5 uL |
| Measuring Time | 5 sec | 10 sec |
| HCT Range | 20~60% | 30 ~ 55 % |
| Detecting Range | 20 ~ 600 mg/dL(1.1~33.3mmol/L) | 30 ~ 600 mg/dL(1.6~33.3mmol/L) |
| Slot location | Bottom | Top |
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Image /page/3/Picture/0 description: The image shows a logo with the letters "VTS" stacked on top of each other. Below the letters, there is a stylized image of a body of water with a horizon line. Underneath the water image, there is some text that is difficult to read due to the image quality. The logo appears to be for an organization or company with the initials VTS.
ec.3, Gongdao 5th Rd., Hsinchu City 30069, Taiwan Fax: +886-3-5160161 el: +886-3-5160111
| Meter Check | Autocheck | Check Strip |
|---|---|---|
| Average Display | 7, 14 and 28 days | - |
| Memory Storage | 450 blood glucose result | 70 blood glucose results |
| Alarm Function | Alarm clock | - |
| Talking Function | English/Chinese | - |
| Meter DimensionLength X Width X Height | 95 mm X 55 mm X 18.5 mm | 87 mm X 60 mm X 21 mm |
| Meter Weight | 85 g | 75 g |
The Subject device is different from the predicate device in the following aspects: *Meter: ergonomic/physical design, hardware, slight modification of firmware and electronics to include talking function.
*Strips: Modifications in GOD enzyme dosage and the reaction chamber on the eBchek test strips was made to fill blood samples according to the specified volume. *Control Solution: There are no changes to the ingredients of Normal and High Control Solutions from the predicate. Proposed labeling is changed from previously cleared k number K062555, eBsensor control solution to eB-series control solution. There have been no changes to the operating principle or general scientific technology from the predicate.
Performance Studies
Study is based on ISO 15197: In vitro diagnostic test systems- Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. Performance on the eBchek Blood Glucose Monitoring System demonstrated that the device meets the requirements for its intended use. The data demonstrates that the device is substantially equivalent to the predicate and raises no safety or effectiveness issues.
Conclusion
The modification of eBchek Blood Glucose Monitoring System does not affect the safety and effectiveness of the device. The submitted information in this premarket notification supports a substantial equivalence decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2013
Visgeneer, Inc. C/O Jack Yang No. 188, Sec. 3, Gongdao 5th Rd. Hsinchu City 30069, Taiwan
Re: K122181
Trade/Device Name: eBchek Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: July 31, 2013 Received: August 8, 2013
Dear Mr. Yang:
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. Please note: CDRH does not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for.
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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulations repording by reference to premarket notification'' (21CFR Par 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go lo
http://www.fda.gov/MedicalDevices/Safetw/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may oblain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122181
Device Name: eBchek Blood Glucose Monitoring System
Indications for Use:
The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The eBchek Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired.
eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use _ X . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122181
§ 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.