(50 days)
The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Vita™ Blood Glucose Monitoring System is a modification of existing predicate devices (OneTouch® Select™ and OneTouch® Ultra®2 meters and OneTouch® Ultra® test strip). The acceptance criteria and performance are based on the ISO 15197:2003(E) standard for in vitro diagnostic test systems for self-testing in managing diabetes mellitus.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only explicitly mentions that the device was tested in accordance with ISO 15197:2003(E). It does not provide a detailed table of specific acceptance criteria values (e.g., specific percentage agreement within a certain range) or the exact reported performance metrics from the study. Therefore, the table below will list the categories of performance characteristics evaluated based on the ISO standard and the general statement of performance presented in the summary.
| Acceptance Criteria Category (based on ISO 15197:2003(E)) | Reported Device Performance |
|---|---|
| System Accuracy (comparison to laboratory reference method) | Demonstrated substantial equivalence to currently marketed predicate devices (OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems). |
| Repeatability | Evaluated as part of analytical performance testing. (No specific numerical results provided in the summary). |
| Intermediate Precision | Evaluated as part of analytical performance testing. (No specific numerical results provided in the summary). |
| User Performance Evaluation (Human Factors) | Assessed usability and validated comprehension of product labeling in the hands of intended users. (No specific numerical results or pass/fail criteria provided in the summary). |
| Design Verification (including software V&V) | Confirmed that the performance, safety, and effectiveness is equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally states that "analytical performance testing included system accuracy, repeatability and intermediate precision testing" and "A user performance evaluation assessed usability of the device (human factors) in the hands of intended users."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth. For blood glucose monitoring systems, the "ground truth" for system accuracy is typically established by comparative measurements against a laboratory reference method, which is itself calibrated and controlled rather than relying on expert consensus in the same way an imaging device might.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is not applicable here as the ground truth for blood glucose measurements is established through a laboratory reference method, not through consensus read by experts.
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 relevant for diagnostic devices where human interpretation of images or data is involved. For a blood glucose monitoring system, the performance is measured by the device's accuracy in autonomously measuring glucose levels.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation for the OneTouch® Vita™ Blood Glucose Monitoring System is inherently a "standalone" evaluation. The device (meter and test strip) itself measures glucose concentration independently of human interpretation of the reading. The "user performance evaluation" described is to assess usability and comprehension by human users, not to assess human interpretation of the device's output.
7. The Type of Ground Truth Used
The ground truth for system accuracy is established through comparison to a laboratory reference method. The document states that "A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems." This implies that the device's measurements were compared against highly accurate laboratory glucose measurements.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For medical devices like blood glucose monitors, the development process involves extensive testing and refinement rather than a distinct "training set" in the machine learning sense. The performance characteristics described are from verification and validation testing, which would involve a test set.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit mention of a "training set" in the context of this device's regulatory submission, the establishment of ground truth for a training set is not described. The ground truth for the performance evaluation (test set) is established via a laboratory reference method.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the LifeScan logo, which includes the word "LIFESCAN" in bold, sans-serif font. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in a smaller, lighter font. To the left of the word "LIFESCAN" is a graphic element that appears to be a stylized representation of a blood drop or a similar shape. The logo has a sleek and modern design.
OCT 2 2 2008
OneTouch® Vita™ Blood Glucose Monitoring System
510(k) Summary
| Sponsor | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035 U.S.A. |
|---|---|
| Correspondent | Primary 510(k) Contact (submitter):Oyinkan DonaldsonLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: 011-44-1463-721259e-mail: odonalds@its.jnj.comSecondary 510(k) Contact:Mary Ellen HoldenLifeScan Inc.1000 Gibraltar DriveMilpitas, CA 95035 U.S.A.Phone: 408 942 3589e-mail: mholden@lfsus.jnj.com |
| Device Name andClassification | OneTouch® Vita™ Blood Glucose Monitoring SystemCommon name: Glucose test systemClassification:(1) OneTouch® Vita™ Blood Glucose Meters andOneTouch® Vita ™ Test Strips are Class IIdevices(21 CFR § 862.1345)(2) OneTouch® Vita™ Control Solutions are a Class Idevice (21 CFR § 862.1660)(3) OneTouch® Lancing Device with OneTouch® ASTClearCap™, OneTouch® UltraSoft® AdjustableBlood Sampler with OneTouch® UltraClear® Capand OneTouch® UltraSoft® Sterile Lancets areClass I (exempt) devices (21 CFR § 878.4800) |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font. Below the word is the text "johnson johnson company" in a smaller, cursive font. To the left of the word is a graphic of a globe with a curved line extending from the bottom left to the top right.
System Description
The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Vita™ meter is a modification of the OneTouch® Select™ and OneTouch® Ultra®2 meters. The OneTouch® Vita™ test strip is a modification of the OneTouch® Ultra® test strip (component of the OneTouch® Ultra®2 Blood Glucose Monitoring System).
There are no changes to other system testing components compared to the predicate devices.
Predicate Devices - OneTouch® Select™ Blood Glucose Monitoring System (K072543, cleared 4th Oct 2007)
- OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529, cleared 17 Jan 2006)
Intended Use
The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Comparison to Predicate Devices
The device modifications encompass:
- Meter ergonomic/physical design and software/firmware changes . including removal of user coding step
- Test Strip changes to electrode layout and cosmetic appearance .
The OneTouch® Vita™ Blood Glucose Monitoring System has the same intended use, material composition and operating principle as the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, stylized letters. Below the company name, in smaller font, is the text "Johnson & Johnson company". To the left of the company name is a graphic element that appears to be a stylized globe or sphere with an arc extending from it.
Technological Characteristics
The OneTouch® Vita™ Blood Glucose Monitoring System has the same
fundamental scientific technology as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.
Summary of Performance Characteristics
The OneTouch Vita™ Blood Glucose Monitoring System has the same performance characteristics as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra 2 Blood Glucose Monitoring System predicate devices.
A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems.
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Vita™ Blood Glucose Monitoring System is equivalent to that of the predicate devices.
The modified blood glucose monitoring system (meter and test strip) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability and intermediate precision testing. A user performance evaluation assessed usability of the device (human factors) in the hands of intended users and validated comprehension of the proposed product labeling.
Conclusion
The OneTouch® Vita™ Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure in black, with three distinct lines forming its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 0 6 2008
LifeScan Inc. c/o Mrs. Ovinkan Donaldson 1000 Gibraltar Dr. Milpitas. CA 95035
K082513 Re: Trade Name: OneTouch Vita Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 18, 2008 Received: September 22, 2008
Dear Mrs. Donaldson:
This letter corrects our substantially equivalent letter of October 22, 2008.
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): __<< 8 2s / 3
Device Name: OneTouch® Vita™ Blood Glucose Monitoring System
Indications For Use:
The OneTouch® Vita™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch® Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) 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.