(27 days)
The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase
Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Simplicity™ System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text primarily focuses on comparative data with a predicate device rather than explicitly stating acceptance criteria as a threshold your device must meet to pass. However, we can infer the acceptance criteria by looking at the performance of the predicate and the modified device's goal to show substantial equivalence.
| Feature / Metric | Acceptance Criteria (Inferred from Predicate/Comparison) | Reported Device Performance (Modified Accu-Chek Simplicity) |
|---|---|---|
| Method Comparison: Capillary Blood | N = 202y = 1.02x + 2.6r = 0.989range = 51 to 490 mg/dL (Predicate) - The modified device should demonstrate similar or improved correlation and agreement with the laboratory method. | N = 297y = 1.02x - 5.2r = 0.977range = 57 to 515 mg/dL (Modified device shows comparable regression statistics and a wider testing range, implying acceptable performance given the predicate's performance.) |
| Method Comparison: Consumer Study | N = 134y = 1.082x - 2.9r = 0.976range = 58 to 357 mg/dL (Predicate) - The modified device should demonstrate similar or improved correlation and agreement with the laboratory method in consumer use. | N = 230y = 1.05x - 7.0r = 0.982range = 57 to 515 mg/dL (Modified device shows comparable regression statistics, particularly a slightly improved 'r' value and wider range, implying acceptable performance.) |
| Precision: Control Level 1 | Predicate: Mean = 84.0 mg/dL, SD = 2.0 mg/dL. The modified device should demonstrate comparable precision. | Mean = 52 mg/dL, SD = 1.6 mg/dL (Note: The mean glucose level for Control Level 1 is different between the modified and predicate devices, so direct comparison of SD might be misleading without a CV for the predicate. However, a low SD indicates good precision.) |
| Precision: Control Level 2 | Predicate: Mean = 196.4 mg/dL, CV = 2.5. The modified device should demonstrate comparable precision. | Mean = 167 mg/dL, SD = 4.7 mg/dL, CV = 2.8 (CV is comparable to the predicate at a different mean level, suggesting acceptable precision for the modified device). |
| Precision: Venous Blood Level 1 | Predicate: Not explicitly stated with full data for comparison. | Mean = 53 mg/dL, SD = 1.7 mg/dL (Indicates good precision, though specific acceptance criteria against a predicate at this level are not delineated). |
| Precision: Venous Blood Level 2 | Predicate: CV = 3.0. The modified device should demonstrate comparable precision. | Mean = 153 mg/dL, SD = 6.3 mg/dL, CV = 4.1 (CV of 4.1 for the modified device is slightly higher than the predicate's 3.0 at a different mean level, but potentially within acceptable limits given the context of substantial equivalence). |
| Precision: Venous Blood Level 3 | Predicate: CV = 3.4. The modified device should demonstrate comparable precision. | Mean = 499 mg/dL, SD = 16.3 mg/dL, CV = 3.3 (CV is comparable to the predicate, suggesting acceptable precision). |
| Maximum Altitude | Predicate: Tested acceptably at elevations up to 9500 feet above sea level. The modified device target was to operate at higher altitude. | Tested acceptably at elevations up to 10,150 feet above sea level (Improved performance and meets the goal of acceptable performance at higher altitude). |
| Acceptable Sample Type | Fresh capillary and heparinized venous whole blood samples (Predicate). The modified device intentionally changed to limit this to capillary whole blood. | Fresh capillary whole blood only (This is a difference from the predicate, and a conscious decision to position the device for consumer testing, implying the performance for capillary blood is acceptable and venous blood claim was removed rather than failing). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Capillary blood study: N = 297
- Consumer study: N = 230
- Precision studies (Control Levels 1 & 2): N = 20/Level
- Precision studies (Venous Blood Levels 1-3): N = Not explicitly stated per level, but the table implies multiple measurements to calculate mean, SD, and CV.
- Altitude study: Not explicitly stated, but mentioned as "The results of the 1999 study confirm the device performs acceptably at 10,150 feet."
Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical investigation sites" for the altitude study. Given the submitter's address (Indianapolis, IN, USA) and the FDA submission, it's highly probable these studies were conducted in the USA. The studies are retrospective in the sense that they are presented as completed data for a submission, but the studies themselves would have been prospective data collection efforts.
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 or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set results. The ground truth appears to be based on an established laboratory reference method.
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
An MRMC study was not done. This device is a blood glucose monitoring system, not an imaging diagnostic device that typically involves human "readers" or "interpreters" in the same way an AI-assisted diagnostic might. Therefore, the concept of "human readers improve with AI" does not apply to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The performance characteristics reported (method comparison, precision data) represent the standalone performance of the Accu-Chek Simplicity™ System itself when used as intended. While it's used by humans (persons with diabetes or healthcare professionals), the performance data reflects the device's accuracy in measuring glucose values against a reference standard. There isn't an "AI" component or "human-in-the-loop" interaction in the typical sense for this device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for method comparison studies was recognized laboratory methods:
- Hitachi glucose plasma (for the modified device's capillary and consumer studies)
- Hitachi glucose hexokinase whole blood (for the predicate device's studies)
For precision studies, the ground truth would be the known concentration of the control materials or pooled blood samples, or the mean value derived from repeated measurements by a highly accurate reference method.
8. The Sample Size for the Training Set
The document does not mention a training set because this device is a chemical-photometric measurement system, not a machine learning or AI-based device that would require explicit training data for an algorithm. The "training" for such a device would be its engineering and calibration during manufacturing.
9. How the Ground Truth for the Training Set was Established
As there is no explicit training set for an algorithm in this context, the concept of establishing ground truth for a training set does not apply. The device's calibration and performance are established through rigorous manufacturing processes and quality control using known reference standards.
{0}------------------------------------------------
DEC - 9 1999
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000 |
| Contact Person: Mike Flis | |
| Date Prepared: November 09, 1999 | |
| 2) Device name | Proprietary name: Accu-Chek Simplicity™ SystemCommon name: whole blood glucose test systemClassification name: Glucose dehydrogenase, glucose |
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed version ofthe same device. |
| 4) DeviceDescription | Instrument Operating Principle -- photometricReagent Test Principle -- glucose deoxy reductase |
| 5) Intended use | The test strips are to be used with the Accu-Chek Simplicity meter. TheAccu-Chek Simplicity system is designed for testing glucose in whole bloodby persons with diabetes or by health care professionals in the home or inhealth care facilities. |
| 6) Comparisonto predicatedevice | The Roche Diagnostics Accu-Chek Simplicity System is substantiallyequivalent to the current legally marketed version of the same device. |
{1}------------------------------------------------
Comparison to Predicate Device - .
Similarities
| Feature/Claim | Detail |
|---|---|
| Intended use | The test strips are to be used with the Accu-Chek Simplicity meter.The Accu-Chek Simplicity system is designed for testing glucosein whole blood by persons with diabetes or by health careprofessionals in the home or in health care facilities. |
| Test principle | Glucose dehydrogenase chemical reaction. The instrumentmeasures the chemical reaction by detecting photometric changes. |
| Monitor codingprocedure | Code chip is provided with each carton of test strips. |
| Minimum samplevolume | 3 µL |
| Test strip storageconditions | Store the strips at room temperature between +36° F and +86° F.Do not freeze. |
| Test strip operatingconditions | Use at temperatures between 50° and 104° F and less than 85%humidity. |
| Quality controlprocedure | Tests should be run with liquid quality control materials whenevera new vial of test strips is opened or an unusual blood test result isobtained. |
| Labeling instructionsregarding expectedresults | The normal fasting adult blood glucose range for a non-diabetic is70-105 mg/dL. One to two hours after meals, normal bloodglucose levels should be less than 140 mg/dL. Doctors willdetermine the range that is appropriate for the patients. |
| Labeling instructionsregarding response tounusual results | Run a quality control test, if the result is outside the acceptable QCrecovery range contact Roche Diagnostics's Accu-Chek CustomerCare center; if result is within the acceptable range, review propertesting procedure and repeat blood glucose test with a new teststrip. |
| Hematocrit range | 30 to 57% |
| Reportable range | 10-600 mg/dL |
| Warnings andprecautions | For in vitro diagnostic use only. |
| Reagent stability | 18 months |
Continued on next page
{2}------------------------------------------------
Comparison to Predicate Device, Continued
Similarities, Contd.
| Reagent composition | Copied from test strip carton label (qty/cm2): | |
|---|---|---|
| Glucose-dye-oxidoreductaseBis-(2-hydroxyethyl)-(4-hydroxminocyclohexa-2,5-dienylidene)-ammonium chloride2,18-Phosphomolybdic acidStabilizerNonreactive substances. | ||
| Minimum at time of manufacture. |
Differences
| Feature | Accu-Chek SimplicityTest Strip(modified) | Accu-Chek SimplicityTest Strip(predicate) |
|---|---|---|
| Values equivalent to... | plasma lab method | whole blood method |
| Maximum altitude | Tested acceptably atelevations up to 10,150feet above sea level1 | Tested acceptably atelevations up to 9500feet above sea level. |
| Acceptable sample type | Fresh capillary wholeblood only2 | Fresh capillary andheparinized venouswhole blood samples |
-
- The effect of altitude was examined at a different clinical investigation site than K971876. The site selected for the most recent examination was higher than the prior site. The results of the 1999 study confirm the device performs acceptably at 10,150 feet.
-
- The proposed modification does not adversely effect the product's performance with heparinized whole blood samples. The removal of the venous sample claim from the product's labeling is triggered by our desire to position this device as a test best suited for consumer testing. The draft labeling only includes references to capillary fingerstick testing procedures and summaries of results obtained in capillary blood clinical studies.
Continued on next page
{3}------------------------------------------------
Comparison to Predicate Device, Continued
Performance Characteristics Method Comparison
| Feature | Accu-Chek SimplicityTest Strip PackageInsert(modified) | Accu-Chek SimplicityTest Strip PackageInsert(predicate) |
|---|---|---|
| Laboratory method | Hitachi glucose plasma | Hitachi glucose hexokinasewhole blood |
| Capillary blood study | N = 297$y = 1.02x - 5.2$$r = 0.977$$range = 57 to 515 mg/dL$ | N = 202$y = 1.02x + 2.6$$r = 0.989$$range = 51 to 490 mg/dL$ |
| Physician's OfficeVenous blood study | Not applicable | N = 104$y = 1.029x + 2.7$$r = 0.995$$range = 35 to 483 mg/dL$ |
| Consumer study | N = 230$y = 1.05x - 7.0$$r = 0.982$$range = 57 to 515 mg/dL$ | N = 134$y = 1.082x - 2.9$$r = 0.976$$range = 58 to 357 mg/dL$ |
Continued on next page ﭘﺎ
r
{4}------------------------------------------------
Comparison to Predicate Device, Continued
Performance Characteristics,
Contd.
Precision
| Parameter | Accu-ChekSimplicityTest StripPackage Insert(modified) | Accu-ChekSimplicityTest Strip PackageInsert(predicate) |
|---|---|---|
| N = 20/Level | N = 20/Level | |
| Control Level 1 | ||
| •Mean (mg/dL) | 52 | 84.0 |
| •Standard Deviation (SD) (mg/dL) | 1.6 | 2.0 |
| Control Level 2 | ||
| •Mean (mg/dL) | 167 | 196.4 |
| •Standard Deviation (SD) (mg/dL) | 4.7 | |
| •CV | 2.8 | 2.5 |
| Venous Blood Level 1 | ||
| •Mean (mg/dL) | 53 | 28.7 |
| •Standard Deviation (SD) (mg/dL) | 1.7 | 1.2 |
| Venous Blood Level 2 | ||
| •Mean (mg/dL) | 153 | 129.4 |
| •Standard Deviation (SD) (mg/dL) | 6.3 | |
| •CV | 4.1 | 3.0 |
| Venous Blood Level 3 | ||
| •Mean (mg/dL) | 499 | 335.0 |
| •Standard Deviation (SD) (mg/dL) | 16.3 | |
| •CV | 3.3 | 3.4 |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 9 1999
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K993829
Trade Name: Accu-Chek Simplicity™ System Regulatory Class: II Product Code: LFR Dated: November 10, 1999 Received: November 12, 1999
Dear Mr. Flis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{6}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): Device Name: Accu-Chek Simplicity™ System
Indications for Use:
The test strips are to be used with the Accu-Chek Simplicity meter. The Accu-Chek Simplicity system is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973629
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.