(30 days)
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.
Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving device performance:
Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with performance metrics. The document is a 510(k) summary for the INRatio® 2 PT Monitoring System, primarily focusing on its substantial equivalence to a predicate device. It defines the device, its intended use, and presents the FDA's clearance letter.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document explicitly states that the INRatio 2 PT Monitoring System is a "hardware and software modification of the INRatio System" and that "The INRatio 2 and the INRatio have the same intended use and use the same operating principle." This suggests that the substantial equivalence claim relies heavily on the prior clearance of the original INRatio System (K020679) and that extensive new clinical studies to establish new performance criteria were likely not performed as part of this 510(k) submission.
To illustrate what a full answer would look like if the information were present, I'll provide a template with placeholders and explanations for each requested section.
Acceptance Criteria and Device Performance Study Analysis (Based on Hypothetical Data)
As the provided 510(k) summary for the INRatio® 2 PT Monitoring System (K072727) does not explicitly detail acceptance criteria or a specific study proving it meets them beyond a claim of substantial equivalence to its predicate, the following information is presented as a template for what would be expected in such a description. If a detailed study was included, it was not part of the publicly available summary provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|---|
| Accuracy (vs. Lab Reference Method) | Mean difference between INRatio 2 PT and central lab PT <= 0.5 INR units for INR 1.5-4.5 | Mean difference: 0.3 INR units |
| Precision (repeatability) | Coefficient of Variation (CV) <= 5% for PT results | CV: 3.8% |
| Linearity | R-squared >= 0.98 compared to reference at various PT levels | R-squared: 0.995 |
| User Agreement (for point-of-care) | >= 95% of user-performed tests produce valid results | 98% |
| Inter-device agreement | Difference between devices <= 0.2 INR units | Average difference: 0.15 INR units |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: (Hypothetical) 500 patient samples
- Data Provenance: (Hypothetical) Prospective study conducted at 3 clinical sites in the United States and Canada.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: (Hypothetical) 2 board-certified clinical pathologists
- Qualifications: Each pathologist had at least 15 years of experience in coagulation testing interpretation and laboratory oversight, specifically with PT/INR assays.
4. Adjudication Method for the Test Set
- Adjudication Method: (Hypothetical) For any discrepancies in ground truth determination between the two primary pathologists (e.g., if a reference result was borderline or technically challenging), a third, equally qualified pathologist would independently review the data, and their decision would serve as the tie-breaker (2+1 method).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was it done? No.
- Effect Size: N/A (The INRatio 2 PT Monitoring System is an in-vitro diagnostic device for quantitative measurement rather than an interpretive AI tool. MRMC studies are typically for AI-assisted image interpretation or similar diagnostic tasks where human readers' performance is directly enhanced by AI.)
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Was it done? Yes.
- Details: (Hypothetical) The core analytical algorithm for Prothrombin Time calculation was evaluated in a standalone manner by comparing its output on blood samples with known PT values against a gold-standard laboratory reference method, without human intervention in the calculation process.
7. Type of Ground Truth Used
- Type of Ground Truth: (Hypothetical) Central laboratory reference method (e.g., automated coagulometer using a World Health Organization (WHO) traceable thromboplastin reagent) performed by qualified laboratory personnel, with results cross-verified by expert consensus for ambiguous cases.
8. Sample Size for the Training Set
- Sample Size: (Hypothetical) The device's underlying algorithm (which is a modification of a previously cleared device) did not utilize a "training set" in the machine learning sense. Its calibration and parameter optimization might have been based on historical data or engineering studies (e.g., 1,000 samples for initial parameter tuning).
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: (Hypothetical, assuming no machine learning training set) For any historical data or engineering studies used for parameter optimization, ground truth would have been established through a similar process as the test set: comparison to a validated central laboratory reference method.
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510(k) Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K072727
UCT 2 6 2007
| A. | Submitter: | HemoSense, Inc. |
|---|---|---|
| 651 River Oaks Parkway | ||
| San Jose, CA 95134 |
Contact: Doug Rundle, VP, OA/RA Phone: (408) 240-3791 Fax (408) 719-1184 Email: drundle@hemosense.com
Date Prepared: October 18, 2007
B. Device Names:
Classification name Common/usual name Proprietary name
Prothrombin Time Test Prothrombin Time Test INRatio® 2 PT Monitoring System
- ﻥ Predicate Device:
INRatio® System, K020679
Device Description: D.
Like the predicate device, the INRatio 2 PT Monitoring System performs a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor. disposable test strips, instruction manual, quick reference guide, training video/DVD, and testing supplies. The monitor measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The Test Strips have not been modified from the design described in K020679.
E. Intended Use:
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.
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F. Comparison with the Predicate Device:
The INRatio 2 PT Monitoring System is a hardware and software modification of the INRatio System. The INRatio 2 and the INRatio have the same intended use and use the same operating principle.
Based on the data and information presented here, the modified INRatio 2 PT Monitoring System is substantially equivalent to the INRatio System currently manufactured and distributed by HemoSense, Inc.
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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, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
OCT 26 2007
Hemosense, Inc. C/O Doug Rundle 651 River Oaks Parkway San Jose, California 95134
Re: K072727
Trade/Device Name: INRatio® 2 PT Monitoring System Regulation Number: 21 CFR 864.7750 Regulation Name: Prothrombin Time Test Regulatory Class: Class II Product Code: GJS Dated: September 24, 2007 Received: September 26, 2007
Dear Mr. Rundle:
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. Ilsting 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 will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 – Doug Rundle
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.
Robert M. Booker/
Robert L. Becker, Jr., M.D., Ph.L 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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Additional Information: K072727 HemoSense INRatio 2 PT Monitoring System (Professional Use)
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ INRatio® 2 PT Monitoring System
Indications for Use:
The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oruphine Bautista
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072727
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§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).