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.

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

Device Description

The Endophys Pressure Sensing Sheath Kit is comprised of the Endophys Pressure Sensing Sheath, vessel dilator and guidewire. 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 and a guidewire, 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.

The guidewire is J tipped, 50cm (length), 0.89mm (diameter), and is used to assist in the placement of the dilator/PSS Introducer Sheath through the skin and into the vasculature. Once the dilator and introducer are positioned over the guidewire, the guidewire is removed through the dilator.

AI/ML Overview

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1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative format for each test. Instead, it states that the device "met all specified criteria." Therefore, the table below will broadly indicate "Met all specified criteria" where specific numerical targets are not provided.

Acceptance Criteria (General)	Reported Device Performance
Dimensional Analysis	Met all specified criteria
Guide Wire / Device Compatibility	Met all specified criteria
Flexibility Kink Resistance	Met all specified criteria
Liquid Leak Under Pressure	Met all specified criteria
Liquid Leak through Hemostasis Valve	Met all specified criteria
Separation Force at Break	Met all specified criteria
Dilator to Hemostasis Valve Separation Force	Met all specified criteria
Acute Systemic Injection (Biocompatibility)	Met all specified criteria
Intracutaneous Injection Test (Biocompatibility)	Met all specified criteria
Kligman Maximization (Sensitization) Test (Biocompatibility)	Met all specified criteria
L929 MEM Elution (Biocompatibility)	Met all specified criteria
Rabbit Pyrogenicity Material Mediated (Biocompatibility)	Met all specified criteria
ASTM Hemolysis Complete - Direct / Indirect (Biocompatibility)	Met all specified criteria

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

The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. Given the nature of these tests (design verification and biocompatibility), they are typically conducted in a controlled, prospective manner, often in laboratory settings.

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

This information is not provided in the document. The tests performed are primarily engineering and biocompatibility tests, which do not typically involve human "experts" establishing ground truth in the same way clinical studies do (e.g., for image interpretation). Instead, ground truth is based on established engineering standards and biological assay results.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving multiple human readers, not for the types of engineering and biocompatibility tests described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically associated with AI-driven diagnostic devices where human readers' performance is compared with and without AI assistance. The Endophys Pressure Sensing Sheath Kit is a medical device for facilitating vascular access and measuring blood pressure, not a diagnostic imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study (in the context of AI algorithms) was done. The device itself performs the pressure sensing; it's not an AI algorithm that generates a diagnosis or interpretation without human interaction. The studies performed focused on the physical and biological performance of the device components.

7. Type of Ground Truth Used

The ground truth used for the performance tests appears to be based on:

Established engineering specifications and design requirements: For dimensional analysis, flexibility, kink resistance, liquid leak, and separation forces.
Standard biological assay results and established biocompatibility guidelines: For the biocompatibility tests (acute systemic injection, intracutaneous injection, sensitization, MEM elution, pyrogenicity, hemolysis). These tests have predefined pass/fail criteria based on accepted scientific and regulatory standards.

8. Sample Size for the Training Set

This information is not applicable and is not provided. The Endophys Pressure Sensing Sheath Kit is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on physical and optical principles.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and is not provided, as there is no "training set" for this type of device.

Summary

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October 12, 2018

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

Re: K180620

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: September 10, 2018 Received: September 12, 2018

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 mav, 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 avare 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 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 (Sections 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 mediation-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.

Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson" in a large font. To the right of the name is a digital signature. The signature includes information such as the signer's name, organization, and date of signing, which is "2018.10.12 14:52:48 -04'00'".

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)

K180620

Device Name Endophys Pressure Sensing Sheath Kit

Indications for Use (Describe)

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

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

SUBMITTER I.

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: March 8, 2018

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 (K160272) This predicate has not been subject to a design-related recall

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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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.

V. INDICATION FOR USE

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI. 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	• UV Adhesive
• Device Classification Name	• Pressure Sensor Type
• 21 CFR Regulation Number	• Sensor Location
• Indications for Use	• Pressure Range
• Principle of Operation	• Accuracy of Pressure Reading
• Target Population	• Calibration
• Anatomical Site	• Power Source

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• Where Used	• Sensor Fiber
• Contraindications	• Sensor Diaphragm, Pedestal
• Human Factors	• 2-Part Epoxy
• Placement	• 3-Way Stopcock
• Not Resterilized	• Dilator Sheath Connectivity
• Sterilization Method	• Guidewire length
• Method of Blood Pressure measurement	• Guidewire width
• Components	• Guidewire tip configuration
• Instructions For Use	• Guidewire Source
• Labeling	• Guidewire straightener
• Biocompatibility Test Results	• Guidewire Wire and core material
• Sheath Taper Length	• Guidewire Hoop and Clip
• Suture Ring	• Guidewire Luer Lock
• Radiopaque Marker	• Sterile Barrier System
• Molded Y-Hub	• Primary Barrier Material
• Hemostasis Valve	• Die-Cut Card Material
• Primary Lumen Liner	• Shelf Carton
• Secondary Lumen Liner	• Pouch/Shelf/Shipper Box Label
• Braided Wire (Encapsulated)	• Shipping Carton
• Sheath Size	• Outer Jacket Material
• Inside/Outside Diameter	• Dilator Size
• Overall Length	• Shelf Life
• Effective Length	• Packaged Sterile
• Sterilization Method

The following technological differences exist between the subject and predicate device:

• Hemostasis Valve Adapter• UV Adhesive (proposed device only)• Dilator Hub Ink (proposed device only)	• Dilator Working Length• Dilator Tube/Extrusions• Dilator Hub Resin• Dilator Hub Colorant
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VII. PERFORMANCE DATA

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

' Dimensional Analysis
Guide Wire / Device Compatibility .
Flexibility Kink Resistance ■
Liquid Leak Under Pressure
Liquid Leak through Hemostasis Valve 트
Separation Force at Break 트
Dilator to Hemostasis Valve Separation Force ■

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트 Acute Systemic Injection
Intracutaneous Injection Test
트 Kligman Maximization (Sensitization) Test
트 L929 MEM Elution
트 Rabbit Pyrogenicity Material Mediated
ASTM Hemolysis Complete - Direct / Indirect

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 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.

IX. 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 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).