(109 days)
The OneTouch® Verio® 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 system is intended to be used by a single patient and should not be shared.
The OneTouch® Verio® 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 OneTouch® Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's a breakdown of the acceptance criteria and study information for the OneTouch Verio Blood Glucose Monitoring System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document specifically refers to ISO 15197:2003(E) as the standard for performance testing. While ISO 15197:2003(E) has specific accuracy criteria (e.g., a certain percentage of results within ±X mg/dL or ±Y%), the summary text reports the device's performance against those criteria rather than explicitly stating the criteria as acceptance thresholds separate from the results. However, we can infer the acceptance criteria from the reported performance, as reaching 100% within certain thresholds implies these were the targets.
| Performance Metric | Acceptance Criteria (Inferred from 100% achievement) | Reported Device Performance (1st Replicate for System Accuracy) |
|---|---|---|
| System Accuracy (Glucose < 75 mg/dL) | ||
| Within ±5 mg/dL | N/A (Not 100%) | 50.7% (35/69) |
| Within ±10 mg/dL | N/A (Not 100%) | 89.9% (62/69) |
| Within ±15 mg/dL | 100% of results | 100% (69/69) |
| System Accuracy (Glucose ≥ 75 mg/dL) | ||
| Within ±5% | N/A (Not 100%) | 62.3% (144/231) |
| Within ±10% | N/A (Not 100%) | 89.2% (206/231) |
| Within ±15% | N/A (Not 100%) | 97.8% (226/231) |
| Within ±20% | 100% of results | 100% (231/231) |
| User Performance (Glucose < 75 mg/dL) | ||
| Within ±5 mg/dL | N/A (Not 100%) | 35% (7 of 20) |
| Within ±10 mg/dL | N/A (Not 100%) | 90% (18 of 20) |
| Within ±15 mg/dL | N/A (Not 100%)* | 95% (19 of 20) |
| User Performance (Glucose ≥ 75 mg/dL) | ||
| Within ±5% | N/A (Not 100%) | 56.2% (95 of 169) |
| Within ±10% | N/A (Not 100%) | 85.2% (144 of 169) |
| Within ±15% | N/A (Not 100%) | 95.3% (161 of 169) |
| Within ±20% | N/A (Not 100%)* | 98.8% (167 of 169) |
Note: While the results are high, the table does not explicitly state 100% for these user performance categories, so we cannot infer 100% as the acceptance criterion from the provided text for user performance.
2. Sample Size Used for the Test Set and Data Provenance:
- System Accuracy Test Set Sample Sizes:
- Glucose < 75 mg/dL: 69 samples
- Glucose ≥ 75 mg/dL: 231 samples
- User Performance Evaluation Test Set Sample Sizes:
- Glucose < 75 mg/dL: 20 samples
- Glucose ≥ 75 mg/dL: 169 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were conducted as part of design verification and validation testing for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document mentions comparison to a "laboratory reference method, the Yellow Springs Instrument (YSI)". This indicates that the ground truth was established by a validated laboratory method, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" does not apply in this context.
4. Adjudication Method for the Test Set:
- Not applicable, as the ground truth was established by a laboratory reference instrument (YSI), which provides a quantitative measurement, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted with human readers improving with AI vs without AI assistance. This device is a blood glucose meter, and its performance is evaluated against a reference laboratory method, not against human interpretation of images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance:
- Yes, the "System Accuracy" section reports the performance of the device (meter) directly against the laboratory reference method, which is a standalone assessment of the algorithm/device. The "User Performance Evaluation" also assesses the device, but in the hands of intended users, which is slightly different but still focuses on the device's accuracy.
7. Type of Ground Truth Used:
- The type of ground truth used was a laboratory reference method (Yellow Springs Instrument - YSI). This is a quantitative, highly accurate measurement system often considered the gold standard for glucose concentration.
8. Sample Size for the Training Set:
- The document does not explicitly state a separate "training set" sample size. For in vitro diagnostic devices like blood glucose meters, the development and calibration typically involve extensive data, but the 510(k) summary focuses on the performance verification using a distinct test set. The precision data (Within Run Precision with 300 venous blood tests per glucose level, and Total Precision with 600 control solution tests at each level) could be considered part of the data used for device development and characterization, but not explicitly as a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established:
- As a dedicated "training set" is not explicitly mentioned in the context of machine learning model training, this question is not directly applicable. However, the overall development and calibration of the glucose meter would rely on a robust ground truth established by laboratory reference methods (like the YSI) to ensure accurate measurements across various glucose concentrations, similar to how the test set ground truth was established.
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K13/363
510(k) Summary
(as required by section 807.92(c).)
| Sponsor | LifeScan Europe, a Div. of Cilag GmbH InternationalGubelstrasse 34Zug, Switzerland 6300 |
|---|---|
| Correspondent | Oyinkan Donaldson,Regulatory Affairs ManagerLifeScan Scotland LtdBeechwood Business Park NorthInverness, Scotland IV2 3EDUnited KingdomPhone: +44(0) 1463 721259Mobile: 44 (0) 7909 935151Fax: 44 01463 722000Email: odonalds@its.jnj.com |
| 510(k) Author | Fiona Leeper,Senior Regulatory Affairs SpecialistLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3ED, UK |
| Date Prepared | 9th May 2013 |
| Device Trade Name | OneTouch Verio Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | OneTouch Verio Blood Glucose Meters andOneTouch Verio Test Strips are Class II devices (21CFR § 862.1345), Product Code NBW, LFR |
| System Description | The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. |
| Predicate Device | OneTouch® Verio® IQ Blood Glucose Monitoring System (K110637, cleared on Sept 07, 2011) |
| Intended Use/Indications for Use | The OneTouch Verio® 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 system is intended to be used by a single patient and should not be shared.The OneTouch Verio® 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 OneTouch Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips. |
| Comparison to Predicate Device | The Subject device is different from the predicate device for the following aspects: |
| Meter: ergonomic/physical design, user interface, hardware, electronic and software changes. There are no changes to the OneTouch® Verio® Test Strips or the OneTouch® Verio® Level 3 and Level 4 Control Solutions as a result of this 510(k) submission. | |
| Technological Characteristics | There have been no changes to the intended use, operating principle or scientific technology.There has been no change to the fundamental scientific technology, which is amperometric detection. The operating principle remains electrochemical reaction. |
| Summary of PerformanceCharacteristics | The OneTouch® Verio® Blood Glucose Monitoring System (meter, strips, and control solutions) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability, intermediate precision and linearity testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The OneTouch® Verio® Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI). |
LifeScan Europe, a Div. of Cilag GmbH International
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System Accuracy
A comparison of system accuracy performance demonstrated that the OneTouch® Verio® Blood Glucose Monitoring System and the OneTouch® Verio®IQ Blood Glucose Monitoring System are substantially equivalent.
System Accuracy Results for Glucose Concentrations <75 mg/dL (1st Replicate) Number (and percent) of meter results that match the laboratory test
| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---|---|---|
| 50.7% | 89.9% | 100% |
| (35/69) | (62/69) | (69/69) |
System Accuracy Results for Glucose Concentrations ≥75 mg/dL (1* Replicate) Number (and percent) of meter results that match the laboratory test
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|
| 62.3% | 89.2% | 97.8% | 100% |
| (144/231) | (206/231) | (226/231) | (231/231) |
LifeScan Europe, a Div. of Cilag GmbH International
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Precision
| Target Glucose(mg/dL) | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| 40 | 51.50 | 1.26 | 2.44 |
| 100 | 108.59 | 1.91 | 1.76 |
| 130 | 145.72 | 2.91 | 2.00 |
| 200 | 206.92 | 4.30 | 2.08 |
| 350 | 382.27 | 7.69 | 2.01 |
Within Run Precision (300 Venous Blood Tests per glucose level)
Results show that the greatest variability observed between test strips when tested with blood is 2.44% or less.
Total Precision
(600 Control Solution Tests at each control solution level)
| Glucose LevelRanges(mg/dL) | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| Level 2 (38-62) | 39.45 | 0.82 | 2.08 |
| Level 3 (102-138) | 117.81 | 2.22 | 1.88 |
| Level 4 (298-403) | 342.56 | 6.55 | 1.91 |
LifeScan Europe, a Div. of Cilag GmbH International
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User Performance Evaluation
Subject Fingertip Results for Glucose Concentrations <75 mg/dL
| Tester | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---|---|---|---|
| Subject | 7 of 20 (35%) | 18 of 20 (90%) | 19 of 20 (95%) |
Subject Fingertip Results for Glucose Concentrations ≥75 mg/dL
| Tester | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|---|
| Subject | 95 of 169(56.2%) | 144 of 169(85.2%) | 161 of 169(95.3%) | 167 of 169(98.8%) |
Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch® Verio® Blood Glucose Monitoring System was equivalent to that of the predicate device. The OneTouch® Verio® Meter met recognized electrical and safety standards.
Conclusions
The OneTouch® Verio® Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate OneTouch® Verio®IQ Blood Glucose Monitoring System (K110637).
LifeScan Europe, a Div. of Cilag GmbH International
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
Cilag GmbH International C/O Oyinkan Donaldson Regulatory Affairs Manager LifeScan Europe Gubelstrasse 34 ZUG, SWITZERLAND 6300
Re: K131363
Trade/Device Name: OneTouch Verio Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: July 25, 2013 Received: July 29, 2013
Dear Ms. Donaldson:
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 warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (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.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/ReportalProblem/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Form
510(k) Number (if known): K131363
Device Name: OneTouch® Verio® Blood Glucose Monitoring System
Indications for Use:
The OneTouch® Verio® 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 fingertip. The system is intended to be used by a single patient and should not be shared.
The OneTouch® Verio 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 OneTouch® Verio Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole drawn from the fingertips.
AND/OR Over-The-Counter Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
<PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR) Katherine Serrano -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k) K131363
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§ 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.