(336 days)
The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) 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 person and should not be shared.
The OneTouch Verio Sync BGMS 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 Sync BGMS should not 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The OneTouch® Verio™ Sync 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™ Sync 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 an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for OneTouch Verio Sync Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against the requirements of ISO 15197:2003(E) for system accuracy. The provided text details two levels of accuracy checks: against a laboratory reference method (YSI) and a user performance evaluation with fingertip blood samples.
System Accuracy (Against Laboratory Reference - YSI)
| Glucose Concentration Range | Acceptance Criteria (Implied by ISO 15197:2003(E) - General Guidance) | Reported Device Performance (Number and Percent of Meter Results Matching Laboratory Test) |
|---|---|---|
| <75 mg/dL | For < 75 mg/dL, at least 95% of all results shall be within ±15 mg/dL of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003) | Within ±15 mg/dL: 57/57 (100%) |
| Within ±5 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5 mg/dL: 40/57 (70%) | |
| Within ±10 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10 mg/dL: 55/57 (96%) | |
| ≥75 mg/dL | For ≥ 75 mg/dL, at least 95% of all results shall be within ±20% of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003) | Within ±20%: 243/243 (100%) |
| Within ±5%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5%: 174/243 (72%) | |
| Within ±10%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10%: 235/243 (97%) | |
| Within ±15%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±15%: 242/243 (99.59%) |
Total Precision (Based on Control Solution Tests)
| Glucose Level Ranges (mg/dL) | Acceptance Criteria (Typically CV < 5% for control solutions, but not explicitly stated as such in filing. The reported values are generally acceptable for devices of this type.) | Reported Device Performance (Coefficient of Variation (%)) |
|---|---|---|
| Low (38-62) | No explicit threshold for acceptance stated in the document. | 2.27 |
| Mid (102-138) | No explicit threshold for acceptance stated in the document. | 1.70 |
| High (298-403) | No explicit threshold for acceptance stated in the document. | 1.86 |
User Performance Evaluation (Subject Fingertip Results)
| Glucose Concentration Range | Acceptance Criteria (Implied by ISO 15197:2003(E) - General Guidance for lay-user testing) | Reported Device Performance (Number and Percent of Meter Results Matching Laboratory Test) |
|---|---|---|
| <75 mg/dL | For < 75 mg/dL, at least 95% of all results shall be within ±15 mg/dL of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003 for user performance testing) | Within ±15 mg/dL: 22/23 (96%) |
| Within ±5 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5 mg/dL: 5/23 (22%) | |
| Within ±10 mg/dL: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10 mg/dL: 15/23 (65%) | |
| ≥75 mg/dL | For ≥ 75 mg/dL, at least 95% of all results shall be within ±20% of the reference method. (While not explicitly stated as "acceptance criteria" in this document, this is the standard for ISO 15197:2003 for user performance testing) | Within ±20%: 248/250 (99%) |
| Within ±5%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±5%: 141/250 (56%) | |
| Within ±10%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±10%: 219/250 (88%) | |
| Within ±15%: No explicit threshold for acceptance in this range, but often reported for context. | Within ±15%: 242/250 (97%) |
Note: The document states that the testing was performed in accordance with ISO 15197:2003(E). While the specific acceptance thresholds (e.g., "95% of results within...") are not explicitly listed in the provided text as "acceptance criteria," they are inherent to meeting the ISO standard. The reported performance values demonstrate that the device met or exceeded these implicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size for System Accuracy (Against Lab Reference):
- Glucose <75 mg/dL: 57 samples
- Glucose ≥75 mg/dL: 243 samples
- Total for System Accuracy: 300 samples (57 + 243)
- Test Set Sample Size for User Performance Evaluation:
- Glucose <75 mg/dL: 23 samples
- Glucose ≥75 mg/dL: 250 samples
- Total for User Performance: 273 samples (23 + 250)
- Test Set Sample Size for Total Precision: 600 control solution tests.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device cleared in the US (FDA), it is highly probable that the studies were conducted in accordance with good clinical practice and likely involved prospective data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this device. The ground truth for glucose measurements is established by a laboratory reference method, specifically the Yellow Springs Instrument (YSI).
- Qualifications of Experts: Not applicable. The YSI is a highly accurate and standardized laboratory instrument used for reference glucose measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth is established by a quantitative laboratory reference method (YSI), which does not typically involve human expert adjudication for determining values. The comparison is directly between the device's reading and the YSI's reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret images. For a blood glucose monitoring system, the focus is on the accuracy and precision of the numerical measurement provided by the device, both in a lab setting and by a single lay user. The "user performance evaluation" assesses accuracy and usability, not reader improvement with AI assistance.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable as it wasn't an MRMC study with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The "System Accuracy" section (Page 4) directly compares the OneTouch® Verio™ Sync Blood Glucose Monitoring System's results to a laboratory reference method (YSI). This is a standalone assessment of the device's (meter, strips, and control solutions) accuracy without direct human interpretation influencing the measurement itself, beyond applying the blood sample and following test procedure.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for glucose concentrations was established using a laboratory reference method, specifically the Yellow Springs Instrument (YSI). This is a highly accurate and precise method for determining glucose levels in blood samples.
8. The Sample Size for the Training Set
- The document does not explicitly state a separate sample size for a training set. For a blood glucose monitoring system, particularly one cleared via 510(k) as "substantially equivalent," the focus is on verification and validation testing rather than large-scale training of an artificial intelligence algorithm in the way a machine learning device would require. The system's underlying electrochemical reaction and algorithms are inherent to its design and calibrated during manufacturing. Therefore, there isn't a "training set" in the sense of a dataset used to train a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- As mentioned in point 8, a distinct "training set" for a machine learning algorithm is not detailed or implied in the submission. The device's operational principles are based on established electrochemical sensing technology. Any internal calibration or algorithm development would have relied on highly controlled glucose standards and reference methods during the device's engineering and design phases. The "ground truth" for the device's development and calibration would similarly be laboratory reference methods, but the specific details and dataset sizes for this are not provided in the 510(k) summary.
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(510(k) Summary (as required by section 807.92(c).
FEB 7 2013
| Sponsor | LifeScan Europe, a Division of Cilag GmbHInternationalLandis and Gyr Strasse 1Zug, Switzerland 6300 |
|---|---|
| Correspondent | Nadine Nasr, Regulatory Project ManagerLifeScan, Inc.1000 Gibraltar DriveMilpitas, California 95035Phone: 408-956-4079, 408-942-5906Email: nnasr@its.jnj.comAlternate 510(k) Contact:Yvonne Middlefell, Director Regulatory AffairsLifeScan Scotland LtdBeechwood Business Park NorthInverness, Scotland IV2 3EDUnited KingdomPhone: 44 01463 721250Mobile: 44 (0) 7900 138 650Fax: 44 01463 722000Email: ymiddlef@its.jnj.com |
| Date Prepared | 07th Feb 2013 |
| Device Trade Name | OneTouch Verio Sync Blood Glucose MonitoringSystem |
| Common Name | Glucose Test System |
LifeScan Europe, a Div. of Cilag GmbH International
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| Classification | OneTouch Verio Sync Blood Glucose Meters andOneTouch Verio Test Strips are Class II devices (21CFR § 862.1345), Product Code NBW, LFR | |
|---|---|---|
| System Description | The OneTouch® Verio™ Sync Blood GlucoseMonitoring System consists of the OneTouch® Verio™Sync Blood Glucose Meter, OneTouch® Verio™ TestStrips, OneTouch® Verio™ Level 3 and Level 4Control Solutions, Lancing Device and SterileLancets. The OneTouch® Verio™ Sync Blood GlucoseMonitoring System measures the glucose content of ablood sample by means of an electrical currentproduced in the test strip and sent to the meter formeasurement. | |
| Predicate Device | OneTouch Verio Blood Glucose Monitoring System(K093745, cleared on February 11, 2011) | |
| Intended Use/Indications for Use | The OneTouch Verio Sync Blood GlucoseMonitoring System (BGMS) is intended to be usedfor the quantitative measurement of glucose (sugar) infresh capillary whole blood samples drawn from thefingertip. The system is intended to be used by asingle person and should not be shared.The OneTouch Verio Sync BGMS is intended for selftesting outside the body (in vitro diagnostic use) bypeople with diabetes at home as an aid to monitor theeffectiveness of diabetes control. The OneTouchVerio Sync BGMS should not be used for thediagnosis of or screening of diabetes or for neonataluse.The OneTouch Verio Test Strips are for use with theOneTouch Verio Sync Blood Glucose Meter toquantitatively measure glucose (sugar) in fresh | |
| capillary whole blood samples drawn from the fingertips. | ||
| Comparison to Predicate Device | The Subject device is different from the predicate device for the following aspects:• Meter: shape/size, ergonomic design,simplified user interface, wireless communication with the OneTouch Reveal Diabetes Management Application and a rechargeable battery.There have been no changes to the OneTouch® Verio™ Test Strip principle of operation, materials of construction, design of strip or electrodes, and they are identical to the test strips in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. The OneTouch® Verio™ Control Solutions composition and functional performance are also the same as those cleared in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. However, changes were made to the labeling provided with those components of the system at the request of the Food and Drug Administration during review of the OneTouch Verio IQ 510(k) Submission, K110637. There are some differences in the intended use, specifically around alternate site testing and the removal of the indication for forearm or palm testing. The OneTouch Verio Sync Blood Glucose Monitoring System is not validated for alternate site testing. Only | |
| fingertip testing is indicated for this system. | ||
| Technological Characteristics | There has been no change to the fundamental scientific | |
| technology, which is amperometric detection. The | ||
| operating principle remains electrochemical reaction. | ||
| Summary of Performance | The OneTouch® Verio™ Sync Blood Glucose | |
| Characteristics | 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™ Sync 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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LifeScan Europe, a Div. of Cilag GmbH International
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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" Sync Blood Glucose Monitoring System and the OneTouch® Verio™ Blood Glucose Monitoring System are substantially equivalent.
System Accuracy Results for Glucose Concentrations <75 mg/dL
Number (and percent) of meter results that match the laboratory test
| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---|---|---|
| 40/57 (70%) | 55/57 (96%) | 57/57 (100%) |
System Accuracy Results for Glucose Concentrations ≥75 mg/dL
Number (and percent) of meter results that match the laboratory test
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|
| 174/243 (72%) | 235/243 (97%) | 242/243 (99.59%) | 243/243 (100%) |
LifeScan Europe, a Div. of Cilag GmbH International
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Total Precision
(600 Control Solution Tests)
| Glucose LevelRanges(mg/dL) | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| Low (38-62) | 38.63 | 0.88 | 2.27 |
| Mid (102-138) | 117.39 | 2.00 | 1.70 |
| High (298-403) | 335.91 | 6.25 | 1.86 |
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 | 5/23 (22%) | 15/23 (65%) | 22/23 (96%) |
Subject Fingertip Results for Glucose Concentrations ≥75 mg/dL
| Tester | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|---|
| Subject | 141/250 (56%) | 219/250 (88%) | 242/250 (97%) | 248/250 (99%) |
LifeScan Europe, a Div. of Cilag GmbH International
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Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch® Verio" Sync Blood Glucose Monitoring System was equivalent to that of the predicate device. The OneTouch® Verio" Sync Meter also met recognized electrical and safety standards.
Conclusions
The OneTouch Verio Sync Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles used to the predicate, the OneTouch Verio Blood Glucose Monitoring System (K093745, 2/11/11).
LifeScan Europe, a Div. of Cilag GmbH International
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Image /page/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2013
Cilag GMBH International c/o Nadine Nasr, Regulatory Project Manager Lifescan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035
Re: K120708
Trade/Device Name: OneTouch Verio Sync Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: January 09, 2013
Received: January 30, 2013
Dear Ms. Nasr:
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 Part 801); 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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Page 2—Ms. Nasr
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you usille speeffice aov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson 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): K120708
Device Name: OneTouch Verio Sync Blood Glucose Monitoring System
Indications for Use:
The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) 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 person and should not be shared.
The OneTouch Verio Sync BGMS 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 Sync BGMS should not 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
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 Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)_k120708
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.