The VeriCor is indicated for use in estimating non-invasively, left ventricular end-diastolic (LVEDP) pressure. This estimate, when used along with clinical signs and other patient test results. including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected.

The device has been clinically validated in males only. Use of the device in females has not been investigated. Certain patient conditions should be considered as a basis for excluding individual patients for testing based on a possible risk to them of the Valsalva maneuver, such as the following:.

Weight <88 pounds (40 kilograms)* 1.
Atrial flutter or atrial fibrillation with irregular ventricular response
Significant atrial or ventricular ectopy 3
Hypertrophic obstructive cardiomyopathy 4.
History of paradoxical emboli 5.
Known intracardiac shunt 6.
Significant aortic valvular disease 7.
1. Unstable angina
History of embolic CVA
1. Myocardial infarction within one week of intended VeriCor testing
1. Uncontrolled hypertension (systolic BP > 160mmHg or diastolic BP > 100mmHg)
1. Hypotension (systolic BP<90mmHg)
1. Symptomatic bradycardia
1. Known cholesterol emboli
1. Poor LV function with LV thrombus

*Colin tonometer recommendation

Device Description

The VeriCor device is intended to be used as one of several tools that will assist the cardiologist in assessment of the volume status of a patient, i.e., when the questions of either volume overload or volume depletion arises. A principal measure of intravascular volume status is the filling pressure in the left ventricle as best reflected by the left ventricular enddiastolic pressure (LVEDP). Measurement of the left ventricular enddiastolic pressure requires the placement of a catheter in the left ventricle of the heart to measure the pressures directly. This procedure involves a moderate risk to the patient but could result in arterial hemorrhage, stroke and death. Accordingly, it cannot be used as a routine procedure for patient assessment or for monitoring over time.

An estimate of LVEDP may be obtained with somewhat less risk to the patient by catheterization of the pulmonary artery as described above. The resulting measurement, called the Pulmonary Capillary Wedge Pressure (PCWP), correlates well with LVEDP. PCWP is widely used as an alternative to direct measurement of LVEDP, even though it has potential for complications and limitations in accuracy that are recognized.

The proposed device, the VeriCor, is intended to provide another point on the risk/benefit curve for assessment tools. The VeriCor is non-invasive, so it involves much less risk than catheterization of either the left ventricle or the pulmonary artery. The VeriCor device provides measurements that are well correlated with PCWP measurements.

The Colin CBM7000 Pulse Tonometer and the W. E. Collins Airway Pressure Monitor each have an interface connection for a computer to read data from the devices. In the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure.

The digital manometer is used to measure the airway strain of the patient blowing into the mouthpiece. The pulse tonometer provides an instantaneous and continuous measure of non-invasive blood pressure before, during and after the Valsalva manuever. Data are recorded from both devices so as to provide a baseline followed by a minimum of eight and a maximum of 15 seconds of modest expiratory strain which is followed by 15 to 20 seconds of post-strain recording. The computer controller acquires the data from the devices and provides a dialog with the health-professional user. The user coaches the patient to perform the necessary actions, and one or more practice sessions are used to ensure that the patient can perform those actions correctly.

AI/ML Overview

The provided text describes the VeriCor device, its intended use, and its substantial equivalence to predicate devices, but it does not contain detailed acceptance criteria or a specific study proving the device meets those criteria, nor does it provide a performance table with reported device performance against acceptance criteria.

The document states: "The performance testing carried out on the device assures substantial equivalence" and "The results from clinical studies of the device are presented in the 510(k)." However, the content of these studies or the specific performance metrics and acceptance thresholds are not included in the provided snippets.

Therefore, I cannot populate the table or answer most of the questions directly. However, based on the available information, I can infer some details.

Here's an attempt to answer the questions based on the limited information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a performance table are provided in the given text. The document only mentions that the device provides measurements "well correlated with PCWP measurements" and that "performance testing carried out on the device assures substantial equivalence." Specific numerical thresholds for this correlation or other performance metrics are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document mentions "clinical studies" but does not provide details on sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document does not describe how ground truth was established for the clinical studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

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. The VeriCor is described as a device that aids clinicians in assessing intravascular volume status by non-invasively estimating LVEDP. It's not an AI-based interpretation tool for human readers in the sense of image analysis. It provides an estimate, which is then used "along with clinical signs and other patient test results." Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described.

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

The device itself is a "standalone" system in the sense that it generates the LVEDP estimate. The description states: "the VeriCor, a computer reads data from these devices during a sequence of procedures with the patient, including the Valsalva maneuver, and, using a proprietary algorithm, converts the data to estimates of the left ventricular pressure." This suggests an algorithm-only component for the estimation. However, the output is intended to be used by a clinician, implying a human-in-the-loop is essential for diagnosis and therapeutic planning. The clinical validation would have assessed the performance of this algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the device aims to estimate Left Ventricular End-Diastolic Pressure (LVEDP), and it's stated that "PCWP [Pulmonary Capillary Wedge Pressure] is widely used as an alternative to direct measurement of LVEDP," it is highly probable that Pulmonary Capillary Wedge Pressure (PCWP) measurements, obtained via catheterization, were used as the ground truth or a strong reference standard for validating the VeriCor's estimates. The document states: "The VeriCor device provides measurements that are well correlated with PCWP measurements."

8. The sample size for the training set

Not specified. The document mentions clinical studies for validation but does not separate training and test sets or provide their sizes.

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

Not specified. (See point 7 for the likely nature of the ground truth if it were described).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three intertwined human profiles or figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 - 2004

CVP Diagnostics c/o Dr. T. Whit Athey The Health Policy Resources Group, LLC Senior Consultant 2305 Gold Mine Road, Suite 200 Brookeville, MD 20833-2233

Re: K031327 Trade Name: VeriCor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: 74 DXN Dated: March 31, 2004 Received: March 31, 2004

Dear Dr. Athey:

This letter corrects our substantially equivalent letter of May 12, 2004 regarding the classification of the subject device.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. T. Whit Athey

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Megacmype

). Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K031327

510(k) Number (if known):

Device Name:

Indications For Use:

Weight <88 pounds (40 kilograms)* 1.
Atrial flutter or atrial fibrillation with irregular ventricular response
Significant atrial or ventricular ectopy 3
Hypertrophic obstructive cardiomyopathy 4.
History of paradoxical emboli 5.
Known intracardiac shunt 6.
Significant aortic valvular disease 7.
1. Unstable angina
History of embolic CVA ത
1. Myocardial infarction within one week of intended VeriCor testing
1. Uncontrolled hypertension (systolic BP > 160mmHg or diastolic BP > 100mmHg)
1. Hypotension (systolic BP<90mmHg)
1. Symptomatic bradycardia
1. Known cholesterol emboli
1. Poor LV function with LV thrombus

*Colin tonometer recommendation

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Duna R. LaClune
(Division Sign Off)

Page 1 of

Division of Cardiovascular Device

510(k) Number

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K031327

510(k) Summary

MAY 1 2 2004

VeriCor

Catheter, 21 CFR Common/Classification Name: Diagnostic Intravascular 870.1200

CVP Diagnostics 160 Commonwealth Ave; Suite 801 Boston, MA 02116

Contact: Kevin McIntyre, Prepared: September 9, 2003

A. LEGALLY MARKETED PREDICATE DEVICES

The VeriCor is substantially equivalent to the Arrow Balloon Wedge Pressure Catheter, which is a pre-Amendments device. The VeriCor device incorporates two independent medical devices that were previously cleared by FDA: The W. E. Collins Airway Pressure Monitor was cleared by FDA as K912946, and the Colin CBM7000 Pulse Tonometer was cleared by FDA as K900247. The VeriCor is substantially equivalent to these two devices in regard to many of its technological characteristics.

B. DEVICE DESCRIPTION

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potential for complications and limitations in accuracy that are recognized.

C. INTENDED USE

The VeriCor is indicated for use in estimating non-invasively, left ventricular enddiastolic (LVEDP) pressure. This estimate, when used along with clinical signs and symptoms and other patient test results, including weights on a daily basis, can aid the clinician in the selection of further diagnostic tests in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of intravascular volume are suspected.

1. Weight <88 pounds (40 kilograms)*
1. Atrial flutter or atrial fibrillation with irregular ventricular response
1. Significant atrial or ventricular ectopy
1. Hypertrophic obstructive cardiomyopathy
1. History of paradoxical emboli

000059

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1. Known intracardiac shunt
1. Significant aortic valvular disease
1. Unstable angina
1. History of embolic CVA
1. Myocardial infarction within one week of intended VeriCor testing
1. Uncontrolled hypertension (systolic BP >160mmHg or diastolic BP ≥ 100mmHg)
1. Hypotension (systolic BP<90mmHg)
1. Symptomatic bradycardia
1. Known cholesterol emboli
1. Poor LV function with LV thrombus

*Colin tonometer recommendation

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The VeriCor is a medical device, and it has similar indications for use and target population as the legally marketed predicate device. The differences in indications statements do not change the intended diagnostic effect. The VeriCor has the same technological characteristics as two of the predicate devices, the W. E. Collins Airway Pressure Monitor (K912946), and the Colin CBM7000 Pulse Tonometer (K900247), though it has different technological characteristics from the primary predicate device. The different technological characteristics could affect the tradeoff between safety and effectiveness compared to the primary predicate device. However, no new safety and effectiveness issues are raised by the VeriCor device, and there are established scientific techniques for assessing the safety and effectiveness of the device. The performance testing carried out on the device assures substantial equivalence.

E. TECHNOLOGICAL CHARACTERISTICS

The VeriCor device incorporates the technological characteristics of the two previously cleared component devices, the W. E. Collins Airway Pressure Monitor (K912946), and the Colin CBM7000 Pulse Tonometer (K900247)

TESTING F.

The results from clinical studies of the device are presented in the 510(k).

G. CONCLUSIONS

This 510(k) has demonstrated "substantial equivalence" as it is defined in the Federal Food, Drug, and Cosmetic Act and related requlations and guidance documents issued by FDA.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).