(27 days)
The InDuo™ Blood Glucose Meter is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The InDuo™ meter is intended for use outside the body ( in vitro diagnostic use) by healthcare professionals and by diabetics at home as an aid to monitor the effectiveness of diabetes control.
The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.
The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per 21 CFR § 862.1345. The changes made to the meter were done under design controls, and include ergonomic changes to allow for inclusion of the InDuo™ Insulin Doser to form a single unit for user convenience. The modified device has the same technological characteristics as the legally marketed predicate. The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™ Insulin Doser. The two devices fit together to form a single unit for user convenience.
The provided 510(k) summary for the InDuo™ Blood Glucose Meter states that "Laboratory and clinical studies demonstrate that the InDuo™ Blood Glucose Meter provides equivalent performance to the ONE TOUCH® Ultra™ Blood Glucose Meter." However, it does not explicitly detail the acceptance criteria or the specific results from these studies. It only makes a general claim of equivalence to a predicate device (K002134).
Therefore, based solely on the provided text, many of the requested details cannot be extracted as they are not present.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: Not explicitly stated in the provided text. The submission claims "equivalent performance" to the predicate device, but the specific metrics for this equivalence (e.g., accuracy percentages, standard deviations) are not provided.
Reported Device Performance: Not explicitly stated in the provided text. The submission claims "equivalent performance" to the ONE TOUCH® Ultra™ Blood Glucose Meter, but no specific performance statistics (e.g., accuracy, precision, bias) are given for the InDuo™ meter.
2. Sample Size Used for the Test Set and Data Provenance
Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. It mentions "Laboratory and clinical studies," which implies prospective data collection, but no details on country of origin are given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not specified in the provided text. For a blood glucose meter, the "ground truth" would likely come from a reference laboratory method (e.g., YSI analyzer), not expert consensus.
4. Adjudication Method for the Test Set
Not applicable/specified in the provided text. Adjudication methods are typically used in studies where human interpretation of medical images or other subjective data is involved. For a blood glucose meter, the "ground truth" is typically an objective lab measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. MRMC studies are relevant for medical imaging devices where multiple readers interpret cases. This is a blood glucose meter.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device (blood glucose meter). Its performance would inherently be "standalone" in how it measures glucose from a blood sample. The "human-in-the-loop" aspect would be the user performing the test, but the device's measurement function is automated. The document implies a standalone performance comparison to a predicate device.
7. The Type of Ground Truth Used
Not explicitly stated in the provided text. For blood glucose meters, the ground truth is typically established by reference laboratory methods (e.g., YSI glucose analyzer) that are considered the gold standard for glucose measurement.
8. The Sample Size for the Training Set
Not applicable/specified. This type of device (blood glucose meter) does not typically have a "training set" in the context of machine learning algorithms. Its design and calibration are based on established chemical and electrical engineering principles, not adaptive learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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JUN 2 1 2001
7.0 510(k) Summary
510(k) Summary
(As required by 21 C.F.R. § 807.92)
| Submitted By: | Inverness Medical Technology, Inc.51 Sawyer RoadSuite 200Waltham, MA 02453-3448Phone: (781) 647-3900Fax: (781) 647-3939 |
|---|---|
| Contact Person: | Carol A. Adiletto, M.S.Director of Clinical and Regulatory AffairsPhone: (781) 314-4002Fax: (781) 647-3939e-mail: carol.adiletto@usa.invernessmedical.com |
| Date Summary Prepared: | May 24, 2001 |
| Device Name: | InDuo™ Blood Glucose Meter |
| Classification Name: | The InDuo™ Blood Glucose Meter is a Class II Device for home use, as per21 CFR § 862.1345. |
| Substantial Equivalence: | The InDuo™ Blood Glucose Meter is substantially equivalent to thepreviously cleared predicate device (K002134). |
| Description of Changes: | The changes made to the meter were done under design controls, andinclude ergonomic changes to allow for inclusion of the InDuo™ InsulinDoser to form a single unit for user convenience. |
| Statement of Intended Use: | The InDuo™ Blood Glucose Meter is intended to be used for thequantitative measurement of glucose in fresh capillary whole blood. TheInDuo™ meter is intended for use outside the body ( in vitro diagnostic use)by healthcare professionals and by diabetics at home as an aid to monitorthe effectiveness of diabetes control. |
| The InDuo™ Blood Glucose Meter also functions as the cap for the InDuo™Insulin Doser. The two devices fit together to form a single unit for userconvenience. | |
| TechnologicalCharacteristics: | The modified device has the same technological characteristics as thelegally marketed predicate. |
| Summary of PerformanceData: | Laboratory and clinical studies demonstrate that the InDuo™ Blood GlucoseMeter provides equivalent performance to the ONE TOUCH® Ultra™Blood Glucose Meter. |
:
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2001
Ms. Carol A. Adiletto, M.S. Director of Clinical and Regulatory Affairs Inverness Medical Technology, Inc. 51 Sawyer Road - Suite 200 Waltham, MA 02453
510(k) Number: K011616 Re: Trade/Device Name: LifeScan InDuo™ Blood Glucose Meter Regulation Number: 862.1345, 880.5860 Regulatory Class: II Product Code: NBW, CGA, FMF Dated: May 24, 2001 Received: May 25, 2001
Dear Ms. Adiletto:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to 1 coord 1 ood, Drag, and sions of the Act. The general controls provisions of the Act include the general of 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 (1 remancer ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such periodio GMP insposited on one with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Dri may packet 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 any obligation you imganian Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to ocgin mansaling , quivalence of your device to a legally marketed notification. The FDA inding of succeantal requence and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do to revices), please contact the Office of Compliance at additionally 609.10 for in True diagnestions on the promotion and advertising of your device, (201) 594-4588. Additionally, for questions of Compliance at (301) 594-4639. Also, please of Complex prease conact the Office or Compilance en premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes and use and more (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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3.0 ODE Indications for Use Statement
Indications for Use Statement
LifeScan InDuo™ Blood Glucose Meter Device Name:
Indications for Use:
The InDuo™ Blood Glucose Meter is intended to be used for the quantitative The InDuo Blood Gracose Meter is intenate is blood. The InDuo" Blood Glucose measurent of gracose in noon capinary (in vitro diagnostic use) by healthcare Meter is intended for use outside the body (in This Chapter in and to monitor the effectiveness of diabetes control.
The InDuo™ Blood Glucose Meter also functions as the InDuo™ Insulin Doser.
The InDuo™ Blood Columnit Same as sensessiones The two devices fit together to form a single unit for user convenience.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
10(k) Number K 011616
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
§ 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.