(227 days)
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Accu-Chek Guide Me Blood Glucose Monitoring System makes use of the Accu-Chek Guide Me meter, and the Accu-Chek Guide test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System consists of the following:
- Accu-Chek Guide Me meter
- Accu-Chek Guide test strips (previously cleared in K160944)
The provided text describes the Accu-Chek Guide Me Blood Glucose Monitoring System, a device intended for quantitative measurement of glucose in fresh capillary whole blood. The submission is a Special 510(k), indicating a modification to a previously cleared device (Accu-Chek Guide Blood Glucose Monitoring System, K160944).
Here's an analysis of the acceptance criteria and study information, based solely on the provided text. Many of the requested details about the study are not present in this 510(k) summary, as it largely focuses on demonstrating substantial equivalence through comparison to a predicate device rather than presenting full clinical study results.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabulated format with corresponding reported performance for the Accu-Chek Guide Me system related to analytical accuracy. Instead, it highlights that the Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified. System claims and performance have not changed. This implies that the performance of the Accu-Chek Guide Me system is expected to be identical to the predicate device (Accu-Chek Guide) because the core measurement technology is the same.
The similarities table (Table 1) however, provides specifications that could be considered performance parameters.
| Parameter | Acceptance Criteria (Implied from Predicate/Similarities) | Reported Device Performance (Accu-Chek Guide Me) |
|---|---|---|
| Alternative Site Testing | Palm and Upper arm | Same |
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometric Detection | Same |
| Sample Volume | 600 nanoliters | Same |
| Measurement Range | 20 - 600 mg/dL | Same |
| Hematocrit Range | 10 - 65% | Same |
| Operating Temperature Range | 6 - 45 °C | Same |
| Operating Relative Humidity Range | 10 - 90% | Same |
| Auto Control Solution Identification | Yes | Same |
| Connectivity | USB for PC connectivity and BLE for wireless connectivity | Same |
| Maximum Altitude | 10,150 feet | Same |
| Underdose Detection | Yes | Same |
| Coding | No (no manual coding required) | Same |
| Averages | 7, 14, 30, and 90 Day Average | Same |
| System Integrity Fail-safe checks | Present | Same |
| Strip Handling / Dosing | Same as predicate | Same |
The key takeaway is that for the significant analytical performance aspects (test strip, measurement engine, principle, measurement range, hematocrit range), the device performance is stated to be "Same" as the predicate because these components were not modified. The document does not provide new analytical accuracy data for the Accu-Chek Guide Me system, relying on the predicate's performance.
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 does not provide details on specific sample sizes for a "test set" or data provenance (country of origin, retrospective/prospective) for the Accu-Chek Guide Me system. Since it's a Special 510(k) focusing on modifications that did not change the core measurement technology, new extensive analytical or clinical studies for the modified device are not detailed here. The submission relies on the established performance of the predicate device.
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)
This information is not provided in the document. The device is a blood glucose monitoring system, and ground truth for such devices is typically established against laboratory reference methods (e.g., YSI analyzer), not by human expert consensus in the way medical imaging might require.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments by multiple human readers (e.g., in radiology studies), not for objective measurements by a blood glucose meter.
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 information is not applicable and not provided. An MRMC study is relevant to AI/CAD systems that assist human readers in interpreting medical images. The Accu-Chek Guide Me is a standalone blood glucose meter and does not involve human readers for interpretation in this context, nor does it feature AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone glucose monitoring system. The document implies that because the "Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified," its standalone performance is considered identical to the predicate device (Accu-Chek Guide, K160944). No new standalone performance study data regarding analytical accuracy is presented for the Accu-Chek Guide Me in this document. The submission focuses on demonstrating that the modifications (user interface, physical design, connectivity details) do not impact the established standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. However, for blood glucose meters, the ground truth for analytical accuracy studies is invariably established using laboratory reference methods, such as a YSI glucose analyzer, which is considered the gold standard for glucose measurement in clinical laboratory settings.
8. The sample size for the training set
This information is not provided. The document highlights that the core measurement technology was not changed, implying that extensive re-training or new studies for the "Guiding Me" version was not deemed necessary for the 510(k) submission as a Special 510(k). For blood glucose meters, "training sets" are usually associated with the initial development and calibration of the electrochemical measurement system and algorithms, which happened for the predicate device.
9. How the ground truth for the training set was established
This information is not provided. As with point 7, ground truth for the underlying measurement technology (if considered a "training set" for the original Accu-Chek Guide system) would have been established using laboratory reference methods like a YSI glucose analyzer.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 13, 2018
Roche Diabetes Care Ginger Emrich Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250
Re: K181131
Trade/Device Name: Accu-Chek Guide Me Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 12, 2018 Received: November 13, 2018
Dear Ginger Emrich:
We have reviewed vour 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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Kellie B. Kelm -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) K181131
Device Name
Accu-Chek Guide Me Blood Glucose Monitoring System
Indications for Use (Describe)
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue, enclosed within a blue hexagon. The hexagon is horizontally oriented, with the word "Roche" centered inside it.
510(k) SUMMARY: K181131
INTRODUCTION
According to the requirements of 21 CFR 807.92, the following information is intended to introduce the Accu-Chek Guide Me Blood Glucose Monitoring System, and provide sufficient detail to support a determination of substantial equivalence for K181131.
| Submission Number | K181131 |
|---|---|
| Submission Type | Special 510(k) |
| Submitter Name | Roche Diabetes Care |
| Address | 9115 Hague RoadIndianapolis, IN 46250 |
| Contact | Primary: Ginger EmrichPhone: (317) 521-4037Email: ginger.emrich@roche.comSecondary: Susan HollandbeckPhone: (317) 521-3380Email: susan.hollandbeck@roche.com |
| Date Prepared | November 12, 2018 |
| Proprietary Names | Accu-Chek Guide Me Blood Glucose Monitoring System |
| Common Names | Glucose test system |
| Classification Names /Product Codes | Blood Glucose Test System, Over the Counter(21 C.F.R. § 862.1345, Product Code NBW); Class II |
| Predicate Device | Accu-Chek Guide Blood Glucose Monitoring System(K160944), clearance received on August 31, 2016. |
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Image /page/4/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue font, enclosed within a blue hexagon. The hexagon is horizontally oriented.
DEVICE DESCRIPTION
The Accu-Chek Guide Me Blood Glucose Monitoring System makes use of the Accu-Chek Guide Me meter, and the Accu-Chek Guide test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System consists of the following:
- Accu-Chek Guide Me meter
- Accu-Chek Guide test strips (previously cleared in K160944) ●
INTENDED USE
The Intended Use is identical to the predicate device with the exception of the device name. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s).
The Accu-Chek Guide Me Blood Glucose Monitoring System is comprised of the Accu-Chek Guide Me meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Me Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
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Image /page/5/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue, enclosed within a blue hexagon. The hexagon is horizontally oriented, with the word "Roche" centered inside.
TECHNOLOGICAL CHARACTERISTICS
The Accu-Chek Guide test strip, measurement engine, and measurement principle used with the Accu-Chek Guide Me system have not been modified. System claims and performance have not changed.
The Accu-Chek Guide Me meter reflects the following modifications of the cleared Accu-Chek Guide meter:
- Updated user interface -
- -Fixed segment display
- -3 button interface
- -Modified meter housing - design / materials
- No strip eject, strip port light, target range indicator or beeper / reminders -
- -No pattern detection or meal indicator
- BLE pairing with fixed PIN (on meter backlabel); only supports one pairing at a time -
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Image /page/6/Picture/0 description: The image features the Roche logo, which consists of the word "Roche" in a blue, sans-serif font. The word is enclosed within a blue hexagon shape. The logo is simple and clean, with the blue color providing a sense of trust and reliability. The hexagon shape adds a modern and corporate feel to the overall design.
Similarities to Predicate Device
The following table shows the similarities of the modified device to the predicate device.
| Accu-Chek GuidePredicate (K160944) | Accu-Chek Guide MeModified Device | |
|---|---|---|
| Indications for Use | Quantitatively measure glucose in fresh capillary whole blood from the finger, palm, and upper arm as an aid in monitoring the effectiveness of glucose control | Same |
| Alternative Site Testing | Palm and Upper arm | Same |
| Enzyme | FAD-GDH | Same |
| Test Principle | Amperometric Detection | Same |
| Primary Container (Vial) | Black, flip top oval vial, holds up to 50 stripsClosed vial height: 51 mmWidth at widest point: 18.3 mmWidth at narrowest point: 15.3 mm | Same |
| Sample Volume | 600 nanoliters | Same |
| Measurement Range | 20 - 600 mg/dL | Same |
| Hematocrit Range | 10 - 65% | Same |
| Operating TemperatureRange | 6 - 45 °C | Same |
| Operating RelativeHumidity Range | 10 - 90% | Same |
| Auto Control SolutionIdentification | Yes | Same |
| Connectivity | USB for PC connectivity and BLE (Bluetooth Low Energy) for wireless connectivity | Same |
| Maximum Altitude | 10,150 feet | Same |
| Underdose Detection | Yes | Same |
| Coding | No | Same |
| Averages | 7, 14, 30, and 90 Day Average | Same |
| System Integrity Fail-safechecks | Same | Same |
| Strip Handling / Dosing | Same | Same |
Table 1: Similarities to Predicate Device
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Image /page/7/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in blue, enclosed in a blue hexagon. The hexagon has a thick blue border. The word "Roche" is written in a simple, sans-serif font.
Differences to Predicate Device
The following table shows the differences of the modified device to the predicate device.
| Table 2: Differences to Predicate Device | ||
|---|---|---|
| Accu-Chek GuidePredicate (K160944) | Accu-Chek Guide MeModified Device | |
| Target RangeIndication | Yes | No |
| Pattern Detection | Yes | No |
| Meal Indication | Yes | No |
| Beeper / Reminders | Yes | No |
| Strip Light | Yes | No |
| Strip Ejector | Yes | No |
| BLE Pairing | BLE pairing with variablePIN (new PIN generatedelectronically at each pairing);able to pair with 5 devices at atime | BLE pairing with fixed PIN (onmeter backlabel); only supportsone pairing at a time |
| Screen / Display | Dot Matrix LCD Displaywith Backlight | Fixed Segment LCD Displaywithout Backlight |
| Meter Buttons | Hard cap front button4-way rocker design includingOK/Power, back, andup/down functions | One Hard cap OK/Power buttonon the side2 soft buttons for memoryrecall, and forwards /backwards functions |
| Meter HousingMaterials | PET, IMD, PC,TPF, and ABS/PC | PET, IMD, PC,and Silicone Rubber |
Table 2: Differences to Predicate Device
SUBSTANTIAL EQUIVALENCE
The submitted information in this premarket notification supports a substantial equivalence decision. The differences between predicate and modified devices do not impact the indications for use or fundamental scientific technology.
§ 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.