For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.

Device Description

• The CoaguChek test strip contains reagent and iron particles. Blood mixes with these reagents and particles on the test strip. At the same time, the meter starts a timer. The iron particles move in response to an oscillating magnetic field. When the blood clots, the particles stop moving. The meter stops the timer and displays the result.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the CoaguChek® PST System. It mainly focuses on demonstrating substantial equivalence to a predicate device and studies related to the new user group (patients) rather than establishing specific quantitative acceptance criteria or a detailed clinical study for the device's accuracy against a ground truth.

Therefore, many of the requested sections (like explicit acceptance criteria values, multi-reader multi-case studies, effect size, standalone algorithm performance, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets with ground truth methods for training) cannot be fully populated from this document. The document highlights a correlation study for the new user group.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in a quantitative, pass/fail manner. The document focuses on demonstrating substantial equivalence to a predicate device and showing that trained patients can achieve results comparable to healthcare professionals.
Correlation between trained patients and healthcare professionals using CoaguChek PST System:	N = 315 observations Slope = 0.973 Intercept = 0.05 Correlation Coefficient = 0.966

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (for the patient vs. professional comparison): 315 observations.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved a comparison between "trained patients" and "health care professionals," suggesting this was likely a prospective study conducted for the purpose of this submission. It is implicitly prospective as it compares results from different user groups using the "new" device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The study described compares measurements by "trained patients" with measurements by "health care professionals." The "health care professionals" are acting as a reference group or a proxy for a high-quality measurement.
Number of Experts: Not specified. It refers to "health care professionals" in general, not a specific number of adjudicated experts providing a 'ground truth' in the traditional sense of a diagnostic interpretation.
Qualifications of Experts: Assumed to be "health care professionals trained in the use of the CoaguChek System." Specific qualifications (e.g., medical degrees, years of experience) are not detailed.

4. Adjudication Method (for the test set)

Not applicable. The study is a direct comparison of measurements between two user groups (patients vs. professionals) using the same device, not an adjudication process to establish a definitive ground truth from multiple expert interpretations.

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

Not applicable. This is not an AI-based device, nor is it an MRMC study in the typical sense comparing human readers with and without AI assistance. The study compares patient performance with professional performance.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) study was done

Not applicable, as this is a medical device that requires human interaction (patient or professional) for operation and specimen collection. The device itself (the meter and test strip system) is a standalone measurement tool, and its internal performance characteristics were previously established (under K930454) and are asserted as unchanged. The focus of this submission is on the new user group.

7. The type of ground truth used

The "ground truth" in the comparative study described here is represented by the test results obtained by "health care professionals trained in the use of the CoaguChek PST System." This acts as the reference for evaluating whether trained patients can achieve comparable accuracy. It is a comparative ground truth rather than an independent gold standard like pathology or long-term outcomes.

8. The sample size for the training set

Not explicitly mentioned in the context of algorithm training. The device does not appear to be an AI/machine learning device that would have a distinct training set for an algorithm. The "training" referred to in the document is the training of patients on how to use the device.

9. How the ground truth for the training set was established

Not applicable, as there's no mention of an algorithm training set or associated ground truth establishment in this document. The document refers to the "training of patients" to use the device, not a machine learning model.

Summary

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Boehringer Mannheim Corporation

CoaguChek® PST System 510(k) Premarket Notification

K962571

510(k) Summary

APR 2 2 1997

Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1) Submitter name, address, contact	Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000
	Contact Person: Mike Flis
	Date Prepared: June 28, 1996
2) Device name	Proprietary name: CoaguChek™ PST System
	Common name: prothrombin time test
3) Predicate device	We claim substantial equivalence to Boehringer Mannheim's CoaguChek™ System.
4) Device Description	• The CoaguChek test strip contains reagent and iron particles. Blood mixes with these reagents and particles on the test strip. At the same time, the meter starts a timer. The iron particles move in response to an oscillating magnetic field. When the blood clots, the particles stop moving. The meter stops the timer and displays the result.

Continued on next pagei

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Boehringer Mannheim Corporation

510(k) Summary, Continued
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5) Intended use	For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.
6) Comparison to predicate device	The Boehringer Mannheim CoaguChek PST System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim CoaguChek System. The following tables compare the CoaguChek PST with the predicate device.

A study was conducted comparing test results obtained by trained patients with those obtained by health care professionals, when both were using the CoaguChek PST System. The correlation was very good, as indicated by the following statistics: N = 315 observations, Slope = 0.973, Intercept = 0.05, and Correlation Coefficient = 0.966. This study shows that trained patients are able to obtain results that are as accurate as those obtained by health care professionals trained in the use of the CoaguChek System.

In a previous Premarket Notification (#K930454) Boehringer Mannheim demonstrated the CoaguChek System was compared against Boehringer Mannheim's CoaguChek Plus System and the MLA 700 Analyzer. In August, 1993, FDA determined the CoaguChek System was substantially equivalent to those test systems.

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510(k) Summary, Cont'd

SIMILARITIES

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Feature Feature	CoaguChek System(the Predicate Device)	CoaguChek PST System (the NewDevice)
Principle of Operation	The CoaguChek test strip contains reagent and ironparticles. Blood mixes with these reagents and particleson the test strip. At the same time, the meter starts atimer. The iron particles move in response to anoscillating magnetic field. When the blood clots, theparticles stop moving. The meter stops the timer anddisplays the result.	Same. Principle of operation is noteffected by introduction of new usergroup.
Meter CalibrationProcedure	Test strip package insert and Meter User's Manualinstruct the user to change the Code Chip with each newpackage of test strips.	Same. A Code Chip is provided in eachpackage of test strips. The metercalibration procedure is not effected byintroduction of new user group.
Meter Cleaning	Meter User's Manual describes the cleaning procedurewhich consists of wiping strip guide and other surfaceswith a cloth dampened with 10% household bleachsolution.	Same. Meter cleaning procedure is noteffected by introduction of new usergroup.
Hematocrit Range	Hematocrit ranges between 32-52% do not significantlyaffect test results.	Same. Test strip and meter design werenot effected by the proposed modification(i.e., new user group).
Fail-Safe Mechanisms	Fail-safe mechanisms built into meter and error codemessages were described in 510(k) file #K930454.	Same. The meter was initially designedfor use by patients so no redesign wasrequired.

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CoaguChek® PST System 510(k) Premarket Notification

510(k) Summary, Cont'd

SIMILARITIES, Cont'd

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Feature	CoaguChek System(the Predicate Device)	CoaguChek PST System (the NewDevice)
Storage and OperatingCondition Limits	Test Strips & Liquid Controls: Store strips and liquidcontrols in refrigerator at +35°F to +45°F until ready touse. Do not freeze. Test strips are stable for 60 days orthe expiration date, whichever comes first, when stored atroom temperature (below 86°F). Remove test strip foilpouch and control vial from refrigerator for at least fiveminutes before performing test. The strip pouch andcontrol vial should be at room temperature (65°F - 90°F)before opening.Meter: 65°F - 90°F, 10-85% relative humidity (withoutcondensation).	Same. The recommended storage andoperating conditions are not effected bythe introduction of the new user group.
Measuring Range	The CoaguChek system has a PT measuring range of 9.6to 36.9 seconds (NAS) and 0.64 to 9.5 INR.	Same.
Sensitivity	The CoaguChek System is sensitive to deficiencies ofFactor II, V, VII, and X.	Same.
Meter Size	2.2 x 5.5 x 8.8 inches1.5 lb.	Same.
Meter Memory	30 tests with time and date	Same.

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510(k) Summary, Cont'd

DIFFERENCES

Feature	CoaguChek System(the Predicate Device)	CoaguChek PST System (the New Device)
Recommended QualityControl Strategy	Health care professionals are directed to perform dailycontrol testing as required by CLIA '88. A two-levelElectronic Quality Control cartridge is available fromBoehringer Mannheim as well as two liquid controls tomeet the regulatory requirements.	Two levels of control should be testedupon receipt of each test strip cartonand each day of use.
User Environment andQualifications	Cleared for use by health care professionals, includingHome Health Care nurses, within operating conditionsspecified in User's manual. As noted on previous page,the recommended storage and operating conditions arenot effected by the introduction of the new user group.	Intended for use by health careprofessionals and properly selected andsuitable trained patients withinoperating conditions specified in devicelabeling.

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510(k) Summary, Cont'd

DIFFERENCES, Cont'd

Feature	CoaguChek System(the Predicate Device)	CoaguChek PST System (the NewDevice)
Test System Labeling	510(k) cleared labeling intended for health careprofessional. Labeling for predicate device is provided inattachment 8.	Labeling content intended for patientrewritten to 7th grade reading level orlower.Additional labeling created to assistprofessionals with suitable selection andproper training of patients.Labeling for proposed test kit is providedin attachment 7.
Specimen Collection	Test procedure is described in the package insert and theMeter User's Manual. The labeling describes dosing teststrips with either fresh capillary or venous bloodsamples.	Patient is limited to testing only freshcapillary whole blood samples. All otheraspects of test procedure (e.g., stripinsertion into meter before dosing strip)are not effected by introduction of newuser group.

Regulation Number and Section

§ 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).