The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure when used with the Endophys Blood Pressure Monitor.

Device Description

The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator and a guidewire, which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used with the Endophys Blood Pressure Monitor ("BPM"), which connects to the PSS and displays the blood pressure measurements. Together with the BPM, the PSS is used to continuously monitor patient blood pressure during procedures requiring vascular access.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets them. The text primarily consists of an FDA 510(k) clearance letter and a summary of the device, its indications for use, and a general statement about testing to support substantial equivalence.

Specifically, the text does not include:

A table of acceptance criteria and reported device performance.
Details on the sample size for the test set or data provenance (country, retrospective/prospective).
Number or qualifications of experts used for ground truth.
Adjudication method.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
Information on a standalone algorithm performance study.
Specifics on the type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The text generally states that "All necessary testing was conducted on the PSS Kit to support a determination of substantial equivalence" and lists types of testing like "Design verification testing," "Sterilization validation," "Biocompatibility testing," "Shelf life and packaging testing," and "In vivo testing." However, it does not provide any specific results, acceptance criteria, or methodological details for these studies.

Summary

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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. 755 N. Mathilda, Ave. Suite 100 Sunnyvale, California 94085

Re: K141275
Trade/Device Name: Endophys Pressure Sensing Sheath Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DXO Dated: December 5, 2014 Received: December 9, 2014

Dear Mr. 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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141275

Device Name

Endophys Pressure Sensing Sheath Kit

Indications for Use (Describe)

The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath, vessel dilator and guidewire) is intended to facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure during the procedure when used with the Endophys Blood Pressure Monitor.

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

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)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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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: May 15, 2014

DEVICE INFORMATION

Trade Name: Endophys Pressure Sensing Sheath Kit

Generic/Common Name:

Catheter Introducer and Accessories

Classification:

Class II, 21 CFR§870.1340, Catheter Introducer and Accessories

Product Code:

DYB, Catheter Introducer, DXO, Transducer, Pressure, Catheter tip

PREDICATE DEVICES

Togo Medikit Co., Ltd. Super Sheath Introducer Sheath (K052557) ●
Endologix AFX Introducer System (K120212) ●
Millar Instruments, Inc. Mikro-Cath (K093111)
Acist Medical Systems Rapid Exchange (RXi) System and Navvus Catheter ● (K132474)

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510(k) SUMMARY

INDICATION FOR USE

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the indications for use for the PSS Kit. Furthermore, the PSS Kit has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as do the predicate devices. The differences in technological characteristics have been analyzed and addressed through testing. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Endophys Pressure Sensing Sheath Kit is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary testing was conducted on the PSS Kit to support a determination of substantial equivalence to the predicate devices. Testing of the PSS Kit included the following:

Design verification testing ●
Sterilization validation
Biocompatibility testing ●
Shelf life and packaging testing ●
. In vivo testing

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the PSS Kit meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the PSS Kit does not raise new questions of safety or effectiveness when compared to the predicate devices.

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510(k) SUMMARY

CONCLUSION

The PSS Kit contains a catheter introducer sheath with an integrated fiber optic pressure transducer, a dilator, and a guidewire for standard interventional procedures. The PSS Kit has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as do the predicate devices. The differences in technological characteristics have been analyzed and addressed through testing. As such, the PSS Kit is substantially equivalent to the predicate devices.

SUMMARY

The PSS Kit is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).