The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.

Device Description

The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Endophys Blood Pressure Monitor" (K141615). However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a recognized standard). This document is a regulatory approval letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study against specific acceptance metrics.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document for the device	Not specified in document for the device

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document mentions "design verification testing" and "performance testing" but does not provide details on sample sizes for any test sets that would typically assess clinical performance.
Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The document focuses on performance relative to predicate devices and general safety/effectiveness, not on a ground truth established by experts for a specific diagnostic task.

4. Adjudication method for the test set

Not applicable/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. This device is a blood pressure monitor, not an AI/ML diagnostic aid for human readers.

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

Not explicitly detailed as a distinct 'standalone' study for an algorithm in the AI/ML sense. However, the device itself "computes and continuously displays systolic, diastolic, and mean blood pressure values" based on an optical signal. The "design verification testing" and "performance testing" would assess this standalone measurement capability. No specific metrics are provided.

7. The type of ground truth used

The document states the device "continuously provide[s] systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath." The "ground truth" would implicitly be the established accuracy of pressure measurements against a recognized standard (e.g., an invasive catheter-based pressure measurement device or laboratory-calibrated pressure sensors), but this is not explicitly detailed with specific metrics or methodologies in the provided summary.

8. The sample size for the training set

Not applicable/Not specified. This is not an AI/ML device in the modern sense that involves a separate training phase with a distinct dataset.

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

Not applicable. No training set is mentioned for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 7, 2015

Endophys, Inc. % Ronald Warren Regulatory Consultant for Endophys, Inc Experien Group, LLC 755 N. Mathilda, Ave, Suite 100 Sunnyvale, California 94085

Re: K141615

Trade/Device Name: Endophys Blood Pressure Monitor Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II Product Code: DSK Dated: December 5, 2014 Received: December 9, 2014

Dear Ronald Warren,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting (reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Page 1 of 1

K141615

Device Name

Endophys Blood Pressure Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

510(k) Notification K

GENERAL INFORMATION

Applicant:

Endophys, Inc. Thanksgiving Tower, Suite 300 1601 Elm Street Dallas, TX 75201 U.S.A. Phone: 1-214-871-3320

Contact Person:

Ronald S. Warren Regulatory Consultant for Endophys, Inc. Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 1-408-505-3926 FAX: 1-408-400-0865

Date Prepared: June 13, 2014

DEVICE INFORMATION

Trade Name: Endophys Blood Pressure Monitor

Generic/Common Name: Blood Pressure Computer

Classification: Class II, 21 CFR§870.1110

Product Code: DSK, Computer, Blood Pressure

PREDICATE DEVICES

Radi Medical Systems AB (now St. Jude Medical AB) RadiAnalyzer Xpress (K092105)
Acist Medical Systems Rapid Exchange (RXi) System and Navvus Catheter ● (K132474)

{4}------------------------------------------------

510(k) SUMMARY

INDICATIONS FOR USE

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The indications for use for the Endophys Blood Pressure Monitor are substantially equivalent to the indications for use for the predicate devices. The Endophys Blood Pressure Monitor has the same intended use and similar technological characteristics as those of the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Endophys Blood Pressure Monitor is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary testing was conducted on the BPM to support a determination of substantial equivalence to the predicate devices. Testing of the BPM included design verification testing, electrical safety testing, and electromagnetic compatibility testing. The collective results of the testing demonstrate that the BPM meets the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the BPM does not raise new questions of safety or effectiveness when compared to the predicate devices.

CONCLUSION

The BPM has the same intended use and similar technological characteristics as do the predicate devices. The differences in technological characteristics have been analyzed and addressed through performance testing. As such, the BPM is substantially equivalent to the predicate devices.

SUMMARY

The Endophys Blood Pressure Monitor is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1110 Blood pressure computer.

(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).