(74 days)
Designed for testing glucose in whole blood by visually impaired persons with diabetes.
The Accu-Chek Voicemate is a portable blood glucose test system. The Accu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips, and Accu-Chek™ Softclix® Lancet Device. The Accu-Chek Voicemate differs from the currently available devices in that it introduces a new function that will be especially helpful to the visually impaired insulin-using diabetics. We have worked in partnership with Eli Lilly & Company to develop a bar code reader that will reliably read bar codes printed on the insulin vials distributed by Eli Lilly. The bar code reader will help the visually impaired customers distinguish their insulin vials.
The provided text describes the Accu-Chek Voicemate, a self-monitoring blood glucose test system for visually impaired individuals with diabetes. However, the document is a 510(k) summary and approval letter, which primarily focuses on substantial equivalence to a predicate device and regulatory approval.
It does not contain detailed information about the acceptance criteria and the specific study proving the device meets those criteria, as typically found in clinical trial reports or performance evaluation summaries.
Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided text.
I can, however, extrapolate some information based on the context of a medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. For a blood glucose meter, typical acceptance criteria would involve accuracy standards (e.g., ISO 15197 guidelines for blood glucose monitoring systems like accuracy within ±15% or ±0.83 mmol/L for a certain percentage of readings compared to a reference method).
- Reported Device Performance: Not explicitly provided in quantitative terms within this document. The document states "The Accu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips," implying that the glucose measurement aspect relies on previously validated components. The key new feature, the insulin vial label reader, is described as capable of reading bar codes on specific insulin vial types.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective clinical data)
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not specified. This information would typically be relevant for studies evaluating human interpretation, which is not the primary focus of this device's new feature (the barcode reader). For the glucose measurement, the "ground truth" would be established by a laboratory reference method.
4. Adjudication Method for the Test Set
- Not applicable/specified, as there's no mention of a clinical study requiring adjudication of expert interpretations for this specific submission's new features. For glucose measurement, the comparison is typically against a lab reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned. This type of study is more common for diagnostic imaging or interpretation tasks where human readers' performance is being evaluated with or without AI assistance. The Accu-Chek Voicemate is a self-monitoring device, and its primary new feature is an automated barcode reader, not an AI assisting human interpretation of complex medical images.
6. Standalone (Algorithm Only) Performance
- The document implies standalone performance for the glucose measurement component (borrowed from Accu-Chek Advantage Monitor and Comfort Curve Test Strips) and the new insulin vial label reader. However, specific performance metrics (e.g., barcode reading accuracy, false positive/negative rates for the reader) are not provided in this 510(k) summary. The barcode reader itself is an algorithm-only function determining if a barcode is readable and corresponds to a defined insulin vial.
7. Type of Ground Truth Used
- For the core blood glucose measurement, the ground truth would typically be established by a laboratory reference method (e.g., YSI analyzer) for glucose concentration.
- For the new insulin vial label reader, the ground truth would be the actual identity of the insulin vial as confirmed by a human (e.g., visually inspecting the label for the correct insulin type).
8. Sample Size for the Training Set
- Not specified. This would be relevant for the development of any algorithms within the device (e.g., the barcode reader's recognition algorithm).
9. How the Ground Truth for the Training Set Was Established
- Not specified. For a barcode reader, it would involve a dataset of various insulin vial barcodes (and possibly non-barcodes) with their known identities.
Summary of what's provided for acceptance criteria and study in the text:
The provided document is a 510(k) summary, which largely relies on demonstrating substantial equivalence to a predicate device (Accu-Chek II Freedom). The new device, Accu-Chek Voicemate, integrates existing, proven technologies for blood glucose measurement and adds a new function: an insulin vial label reader for visually impaired users.
While it mentions the "incorporation of proven technologies," specific performance data or a dedicated study demonstrating that the entire new device meets predefined acceptance criteria for its combined functionality (especially the new barcode reader) is not detailed in this summary. Regulatory submissions of this nature often reference internal testing or previous submissions for predicate components without fully re-reporting all raw data or detailed study designs in the public 510(k) summary.
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| AUG 28 1998 | |
|---|---|
| 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/Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(800) 428-5074Contact Person: Mike FlisDate Prepared: June 12, 1998 |
| 2) Device name | Proprietary name: Accu-Chek VoicemateCommon name: self-monitoring blood glucose test systemClassification name: glucose test system |
| 3) Predicatedevice | Boehringer Mannheim Accu-Chek II Freedom |
| 4) DeviceDescription | The Accu-Chek Voicemate is a portable blood glucose test system. TheAccu-Chek Voicemate incorporates proven technologies, such as the Accu-Chek® Advantage® Monitor, Accu-Chek™ Comfort Curve™ Test Strips,and Accu-Chek™ Softclix® Lancet Device.The Accu-Chek Voicemate differs from the currently available devices in thatit introduces a new function that will be especially helpful to the visuallyimpaired insulin-using diabetics. We have worked in partnership with EliLilly & Company to develop a bar code reader that will reliably read barcodes printed on the insulin vials distributed by Eli Lilly. The bar code readerwill help the visually impaired customers distinguish their insulin vials. |
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510(k) Summary, Continued
Designed for testing glucose in whole blood by visually impaired persons 5) Intended use with diabetes.
6) Comparison to predicate device
... ...
| Function | Accu-Chek Voicemate(new device) | Accu-Chek II Freedom(predicate device) |
|---|---|---|
| IntendedUse/Indications forUse | Designed for testing glucose in wholeblood by visually impaired persons withdiabetes | Accu-Chek II Freedom Audio SBGMSystem for the Visually Impaired is arechargeable, battery operated system forvisually impaired people with diabetes thatwill accurately measure blood glucose levels |
| Incorporate whichSelf-MonitoringBlood GlucoseSystem | Accu-Chek Advantage MeterAccu-Chek Comfort Curve Test Strips | Accu-Chek II MeterChemstrip bG Test Strips |
| Blood CollectionDevice | None required. The test strips permit theuser to dose by applying a drop of blood tothe edge of the test strips. A "curve" is cutinto the test strip so that the exact locationof the dose is discernable through touch.The patient may also touch the test stripwhile dosing the test strip withoutdamaging the strips' reagent orcompromising the test result. | Accu-Drop™. The Chemstrip bG test stripsrequired the user to dose the test strips usingthe Accu-Drop device (which guided theblood sample to the test strips' reagent pad). |
| Preanalytic test strippreparation | None required. Accu-Chek Comfort CurveTest Strips do not require the user to timeany of the procedural steps, blot awayblood, or intervene in any manner once thestrip has been dosed. The test strip isinserted into the meter before the blooddrop is applied. | The Chemstrip bG Test Strip required theusers to time the first step of the procedure,wipe away excess blood from the strip andthen insert the test strip into the meter. |
| Insulin vial labelreader | Device is capable of reading bar codesprinted on specific insulin vial types. Thedevice's embedded software defines whichinsulin vial labels may be read. | Function not available |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 28 1998
Mike Flis Regulatory Affairs Specialist Boehringer Mannheim 9115 Hague Road P.O. Box 50457 46250-0457 Indianapolis, Indiana
K982079 Re : Accu-Chek™ Voicemate™ System Regulatory Class: II Product Code: LFR Dated: June 12, 1998 Received: June 15, 1998
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 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, Druq, 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 aqainst 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 Requlations, 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 (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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.
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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 entifiled, "Misbranding by reference bo
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/dsmamain.html".
Sincerely yours,
Steven Litman
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
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510(k) Number (if known): Device Name: Accu-Chek™ Voicemate™ System Indications for Use:
Designed for testing glucose in whole blood by visually impaired persons with diabetes.
The product will be marketed over-the-counter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE-ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 20 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (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.