The Endophys Pressure Sensing Sheath Kit (Endophys Pressure Sensing Sheath and vessel dilator) 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. Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSAS™).

Device Description

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath and vessel dilator. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO).

The Pressure Sensing Sheath ("PSS") is an introducer sheath with an integrated fiber optic pressure transducer. The PSS is provided with a dilator which together make up the Endophys Pressure Sensing Sheath Kit ("PSS Kit"). The PSS Kit is intended to be used only 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.

The PSS introducer sheath is used to assist vascular access in the same manner as do standard catheter introducers. The PSS introducer sheath has an integrated pressure sensor that provides high resolution, continuous and instantaneous pulse wave hemodynamics to monitor blood pressure.

Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed.

AI/ML Overview

This FDA 510(k) summary for the Endophys Pressure Sensing Sheath Kit (K190098) primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study proving performance against specific acceptance criteria in the manner you've described.

The document emphasizes a comparison of technological characteristics and non-clinical performance data to show that the new device is as safe and effective as the predicate. It does not describe a multi-reader multi-case (MRMC) study, an algorithm-only standalone study, or specific clinical performance metrics with detailed acceptance criteria for a new AI/medical device.

Therefore, many of your specific questions cannot be answered from the provided text because the regulatory pathway chosen (510(k) Substantial Equivalence) does not typically require the level of detailed clinical efficacy testing or AI-specific validation you've outlined.

However, I can extract information related to the device's performance as presented in this 510(k) submission:

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

The document lists "Sensor Accuracy" as a performance data item. While it doesn't provide specific numerical acceptance criteria (e.g., "accuracy > X%"), it states that the device "met all specified criteria." This implies internal design specifications were met.

Acceptance Criterion (Implied)	Reported Device Performance
Sensor Accuracy	Met all specified criteria.
Dimensional Analysis	Met all specified criteria.
Guide Wire / Device Compatibility	Met all specified criteria.
Flexibility - Tip Deflection	Met all specified criteria.
Flexibility - Kink Resistance	Met all specified criteria.
Flexibility - Sensor Functionality	Met all specified criteria.
Pouch Peel Strength	Met all specified criteria.
Dilator to Hemostasis Valve Separation Force	Met all specified criteria.
L929 MEM Elution - ISO	Met all specified criteria.
L929 Neutral Red Uptake Test (4 Concentrations) - ISO	Met all specified criteria.
Rabbit Pyrogen Test (Material Mediated - ISO)	Met all specified criteria.
Rabbit Blood Hemolysis Complete ASTM	Met all specified criteria.

Important Note: These are primarily non-clinical, engineering, and biocompatibility tests, not clinical performance metrics on patient data.

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

Sample Size: Not specified in the document. The tests performed are primarily benchtop and material-based, not clinical trials on patient populations.
Data Provenance: Not specified, but given the non-clinical nature of the tests, it would be laboratory data.

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

Not applicable/Not specified. This type of information is relevant for studies involving human interpretation (e.g., radiologists reading images), which is not detailed here. The "ground truth" for the listed tests would be established by validated measurement techniques and scientific standards for material and mechanical properties.

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

Not applicable/Not specified. Adjudication methods are typically used in clinical studies where expert consensus on subjective findings is required.

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

No. This device is a physical medical device (sheath with a pressure sensor), not an AI algorithm for interpreting medical images or data. Therefore, an MRMC study is not relevant to this submission.

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

No. This is a physical device, and its primary function is to facilitate access and measure blood pressure continuously. It does not appear to employ a standalone AI algorithm that provides diagnostic outputs without human interaction. The pressure sensor's output is displayed on a monitor for human clinicians to use.

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

For the non-clinical tests listed:
- Sensor Accuracy: Likely established against a highly accurate reference pressure measurement system.
- Dimensional, Flexibility, Force, Pouch Peel tests: Established against engineering specifications and industry standards for physical properties.
- Biocompatibility (L929, Rabbit Pyrogen, Hemolysis): Established against ISO and ASTM standards for material safety and biological response.
No "expert consensus," "pathology," or "outcomes data" are mentioned as ground truth for these specific performance tests.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI/machine learning model, so there is no "training set."

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

Not applicable for the reason above.

Summary of Device and Study Context:

The Endophys Pressure Sensing Sheath Kit is an introducer sheath with an integrated fiber optic pressure transducer. It is intended to facilitate device introduction into the vasculature and continuously measure blood pressure. This 510(k) submission demonstrates substantial equivalence to a previously cleared predicate device (K173399). The performance data cited are primarily non-clinical benchtop, engineering, and biocompatibility tests, which confirmed that the modified device met its specified design criteria and is as safe and effective as the predicate. This is a common approach for device modifications under the 510(k) pathway, where extensive new clinical studies are often not required if substantial equivalence can be demonstrated through comparative data.

Summary

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March 7, 2019

Endophys Holdings LLC % Gregory Sachs President Sachs & Associates, Inc 5116 Birch Road Minnetonka, Minnesota 55345

Re: K190098

Trade/Device Name: Endophys Pressure Sensing Sheath Kit - 8F Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DXO Dated: January 18, 2019 Received: January 22, 2019

Dear Gregory Sachs:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shawn W. Forrest -S 2019.03.07 22:26:06 -05'00' 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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Indications for Use

510(k) Number (if known) K190098

Device Name Endophys Pressure Sensing Sheath Kit- 8F

Indications for Use (Describe)

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)

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510(k) Summarv Endophys Pressure Sensing Sheath Kit

I. SUBMITTER

Endophys Holdings, LLC Thanksgiving Tower, Suite 3500 1601 Elm Street Dallas, TX 75201

Contact person: Phillip D. Purdy, M.D. Phone: 214-801-0578 Fax: 214-377-0709 Date prepared: January 18, 2019

II. DEVICE

Name of the device: Endophys Pressure Sensing Sheath Kit Common of usual name: Introducer Catheter and accessories Classification name: Catheter Introducer Regulatory Class: 2 Product Code: DYB (classification); DXO (subsequent)

III. PREDICATE DEVICE

Endophys Pressure Sensing Sheath Kit (K173399) This predicate has not been subject to a design-related recall

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath and vessel dilator. The Endophys Pressure Sensing Sheath and accessories are provided sterile (EO).

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Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSASTM).

The vessel dilator is used to facilitate insertion of the PSS, and is packaged with the Endophys PSS Kit. Once the PSS has been properly positioned in the vessel, the dilator is removed.

V. INDICATION FOR USE

Together, the Pressure Sensing Sheath and the Blood Pressure Monitor comprise the Endophys Pressure Sensing Access System (PSAS").

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Introducer catheters, by nature, are tubular structures intended to provide a pathway for therapeutic and/or diagnostic devices into the human vasculature. Specialized introducer catheters have been developed which incorporate sensors into these devices to allow active monitoring of blood pressure during interventional procedures. Blood pressure monitoring using a fiber optic transducer is the technological principle for both the subject and predicate devices. The technology requires use of a compatible blood pressure monitor to provide this data to the clinician.

At a high level, the subject and predicate device are based on the following same technological elements:

• Product Code	• Pressure Sensor Type
• Device Classification Name	• Sensor Location
• 21 CFR Regulation Number	• Pressure Range
• Principle of Operation	• Accuracy of Pressure Reading
• Target Population	• Calibration
• Anatomical Site	• Power Source
• Where Used	• Sensor Fiber
• Contraindications	• Sensor Diaphragm, Pedestal
• Human Factors	• 2-Part Epoxy
• Placement	• Hemostasis Valve Adapter Assembly
• Not Resterilized	• 3-Way Stopcock
• Sterilization Method	• Dilator Sheath Connectivity
• Method of Blood Pressure measurement	• Dilator Size

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• Instructions For Use	• Dilator Tube/Extrusions
• Labeling	• Dilator Hub Resin
• Biocompatibility Test Results	• Dilator Hub Ink
• Sheath Taper Length	• Dilator Hub Colorant
• Inside/outside diameter	• Sterile Barrier System
• Suture Ring	• Pouch/Shelf/Shipper Box Label
• Radiopaque Marker	• Outer Jacket
• Molded Y-Hub	• Packaged Sterile
• Hemostasis Valve	• Braided Wire (Encapsulated)
• Primary Lumen Liner	• Sheath Size
• Secondary Lumen Liner	• UV Adhesive

The following technological differences exist between the subject and predicate device. Please note that a guidewire is not supplied with the proposed device.

• Indications for Use	• Guidewire Wire and Core Material
• Components	• Guidewire Hoop and Clip
• Sheath Overall Length	• Guidewire Luer Lock
• Sheath Working Length	• Shelf Life
• Dilator Working Length	• Primary Barrier Height
• Guidewire length	• Die-Cut Card Height
• Guidewire width/diameter	• Shelf Carton Height
• Guidewire tip configuration	• Shipping Carton Width
• Guidewire Source
• Guidewire Straightener

VII. PERFORMANCE DATA

The following performance data was provided in support of the substantial equivalence.

Dimensional Analysis ■
트 Sensor Accuracy
Guide Wire / Device Compatibility ■
Flexibility - Tip Deflection
트 Flexibility - Kink Resistance
" Flexibility - Sensor Functionality
Pouch Peel Strength
트 Dilator to Hemostasis Valve Separation Force
L929 MEM Elution - ISO
L929 Neutral Red Uptake Test (4 Concentrations) - ISO
I Rabbit Pyrogen Test (Material Mediated - ISO)
트 Rabbit Blood Hemolysis Complete ASTM

The modified Endophys Pressure Sensing Sheath met all specified criteria and based on the design verification performance, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as

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effective, and performs as well as or better than the legally marketed device.

SUBSTANTIAL EQUIVALENCE VIII.

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

CONCLUSION IX.

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

X. SUMMARY

The PSS Kit is substantially equivalent to the predicate device.

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).