(207 days)
The SmartCheck INRTM System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units.
The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.
The SmartCheck INRTM system consists of a hand held battery- powered meter with ROM calibration chip, disposable, dual- chambered, test strips and high and low level external liquid controls. When blood is applied to the strip it migrates by capillary action to the reaction chambers of the strip. The reaction chamber contains a metallic disc and rabbit brain thromboplastin reagent. When blood enters the reaction chamber a magnetic field is applied to the strip to activate disc movement. Upon clot formation, the disc becomes immobilized and clotting is optically detected. Clotting time is calculated and displayed as an INR value.
The provided text describes the SmartCheck INR™ System, a device for quantitative testing of Prothrombin Time in capillary blood. The submission focuses on demonstrating its substantial equivalence to a predicate device through non-clinical and clinical performance evaluations.
Here's an analysis of the acceptance criteria and the study used to prove the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for accuracy and precision. Instead, it presents regression analysis results and aims to show "correlated favourably" and "substantially equivalent" to a venous plasma based PT test and the predicate device.
However, we can infer performance metrics that are implicitly considered for acceptance based on the reported data:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy (Correlation Coefficient) | High correlation to reference method (venous plasma INR) | 0.9235 (recTP), 0.9009 (PTHS+), 0.9036 (PT/Fib) |
| Accuracy (Slope) | Close to 1.0 (indicating proportional agreement) | 1.17 (recTP), 1.48 (PTHS+), 1.31 (PT/Fib) |
| Accuracy (Intercept) | Close to 0 (indicating no systematic bias) | -0.49 (recTP), -1.19 (PTHS+), -0.90 (PT/Fib) |
| Accuracy (Mean Bias) | Close to 0, or within acceptable clinical limits | -0.045 or -1.7% (recTP), 0.036 or 1.4% (PTHS+), -0.062 or -2.3% (PT/Fib) |
| Precision (Standard Deviation) | Low standard deviation | 0.227 INR |
| Precision (Coefficient of Variation - %CV) | Low %CV | 8.70% |
Study Proving Acceptance Criteria:
The study involved two main components:
- Accuracy Study: Comparing SmartCheck INR capillary blood results against venous plasma INR measured by an ACL 10000 laboratory analyzer using three different thromboplastin reagents (recTP, PTHS+, and PT/Fib).
- Precision Study: Measuring SmartCheck INR capillary blood from duplicate finger-sticks to assess within-device variability.
2. Sample sized used for the test set and the data provenance
- Accuracy Test Set Sample Size:
- 315 for recTP reagent
- 310 for PTHS+ reagent
- 314 for PT/Fib reagent
- Precision Test Set Sample Size: 280
- Data Provenance: The document does not explicitly state the country of origin. It indicates the submitter, Unipath Ltd, is based in the UK. The studies are referred to as "non-clinical and clinical performance," implying prospective data collection for the clinical part.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device. The ground truth for INR measurements in this context is established by a reference laboratory method (venous plasma INR on an ACL 10000 analyzer) rather than expert consensus/adjudication of images or clinical assessments.
4. Adjudication method for the test set
This is not applicable (see point 3). The comparison is between the device's measurement and a laboratory reference measurement, not a subjective interpretation requiring adjudication.
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 is not applicable. The SmartCheck INR System is a diagnostic device that measures a biomarker (INR); it is not an AI-assisted diagnostic tool for human readers/interpreters, nor does it involve "readers" in the traditional sense of interpreting images or other complex data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the accuracy and precision studies described represent the standalone performance of the SmartCheck INR system. The device itself provides the INR value, and its performance is evaluated directly against a reference method (accuracy) and internally (precision). There is no "human-in-the-loop" interpretation of the device's primary output. The human interaction is limited to operating the device and applying the blood sample.
7. The type of ground truth used
The ground truth used for the accuracy study was the venous plasma INR results obtained from an ACL 10000 laboratory analyzer using recombinant thromboplastin (recTP), PTHS+ reagent, and PT/Fibrinogen reagent (PT/Fib). This is a well-established, objective laboratory reference method for INR measurement.
8. The sample size for the training set
The document does not report a separate training set sample size. This is typical for a device like the SmartCheck INR, which uses a pre-defined chemical and mechanical detection method rather than a machine learning or AI algorithm that requires a distinct training phase on clinical data. The calibration of the device would likely be done internally and validated through the clinical studies presented here.
9. How the ground truth for the training set was established
As there's no explicitly mentioned training set in the context of machine learning, this question is not directly applicable. For devices that are calibrated, the "ground truth" for calibration would be established by standardized reference materials and methods during manufacturing and internal testing, ensuring accuracy across the device's operating range before clinical evaluation.
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5.0 510(k) Summary
| Submitted by: | Unipath LtdPriory Business ParkBedfordMK44 3UPUK+44 1234 835530Contact Person: Lesley Moore | NOV 3 0 2007 |
|---|---|---|
| Date Prepared: | 30th October 2007 | |
| Device Name: | SmartCheck INRTM System | |
| ClassificationName: | Multipurpose System for in vitro Coagulation Studies21 CFR Part 864.5425 | |
| Predicate Device: | Roche Diagnostics Corporation CoaguChek® S System clearedunder 510(k) Numbers K020831 and K994349. | |
| Description: | The SmartCheck INRTM system consists of a hand held battery-powered meter with ROM calibration chip, disposable, dual-chambered, test strips and high and low level external liquidcontrols. When blood is applied to the strip it migrates by capillaryaction to the reaction chambers of the strip. The reaction chambercontains a metallic disc and rabbit brain thromboplastin reagent.When blood enters the reaction chamber a magnetic field is appliedto the strip to activate disc movement. Upon clot formation, the discbecomes immobilized and clotting is optically detected. Clottingtime is calculated and displayed as an INR value. | |
| Intended Use: | The SmartCheck INRTM System is intended for quantitative testingof Prothrombin Time in capillary blood. Results are given inInternational Normalized Ratio (INR) units. | |
| PredicateComparison: | The SmartCheck INRTM System and the predicate system bothuse a hand held meter and disposable strips for the determination ofclotting time in capillary whole blood. The Systems havecomparable test strip reagents and clot detection technology. Bothuse external liquid controls. The systems differ in the blood volumeneeded to carry out a test, the time to result, strip and ROMkey | |
| Testing and Conclusion: | The SmartCheck INRTM System was evaluated for non-clinicaland clinical performance. SmartCheck INR passed all tests andcorrelated favourably to a venous plasma based PT test with respectto accuracy and precision. A summary of the results is presentedbelow for combined site calculations and support the conclusion thatthe SmartCheck INRTM System is substantially equivalent to thepredicate CoaguChek S System. |
:
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Accuracy: SmartCheck INR Capillary Blood v. Venous Plasma INR ACL 10000 with recombinant thromboplastin (recTP), PTHS+ reagent and PT/Fibrinogen reagent (PT/Fib).
| Parameter | recTP | PTHS+ | PT/Fib |
|---|---|---|---|
| n | 315 | 310 | 314 |
| Regression Curve | $y = 1.17x - 0.49$ | $y = 1.48x - 1.19$ | $y = 1.31x - 0.90$ |
| Correlation Coefficient | 0.9235 | 0.9009 | 0.9036 |
| Slope(95% CI) | 1.17(1.07 to 1.27) | 1.48(1.32 to 1.63) | 1.31(1.21 to 1.42) |
| Intercept(95% CI) | -0.49(-0.73 to -0.25) | -1.19(-1.57 to -0.81) | -0.90(-1.16 to -0.65) |
| Range x | 1.2 to 6.2 | 1.2 to 6.6 | 1.1 to 6.2 |
| Range y | 0.9 to 7.2 | 0.9 to 7.2 | 0.9 to 7.2 |
| Sy,x | 0.250 | 0.247 | 0.263 |
| Mean Bias: Units or %(95% CI) | -0.045 or -1.7%-0.78 to 0.70 | 0.036 or 1.4%-0.87 to 0.94 | -0.062 or -2.3%-0.91 to 0.79 |
Precision: SmartCheck INR Capillary Blood Measurement On Duplicate Finger Sticks
| n | 280 |
|---|---|
| Mean INR | 2.61 |
| Standard Deviation | 0.227 |
| %CV | 8.70 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 3 0 2007
Inverness Medical Innovations, Inc. C/O Lesley Moore 51 Sawyer Road Suite 200 Waltham, Massachusetts 02453
Re: K071265
Trade/Device Name: Smartcheck INR System Regulation Number: 21 CFR 864.5425 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: JPA Dated: May 3, 2007 Received: May 7, 2007
Dear Ms. Moore:
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). This letter
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Page 2 - Inverness Medical Innovations, Inc.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
lole W. Bote
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071265
Device Name: The Inverness Medical Innovations, Inc. SmartCheck INR™ System
Indications For Use: The SmartCheck INR™ System is intended for quantitative testing of Prothrombin Time in capillary blood. Results are given in International Normalized Ratio (INR) units.
The SmartCheck INR System is indicated for use by trained medical professionals in a point of care setting for monitoring the INR of patients on oral anticoagulant therapy.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071265
Page 1 of
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.