(44 days)
No reference devices were used in this submission.
No
The summary describes a device that measures blood pressure using a fiber optic sensor and displays it on a monitor. There is no mention of AI, ML, or any form of algorithmic processing beyond basic signal acquisition and display. The performance studies focus on physical and biological compatibility, not algorithmic performance.
No
The device is described as facilitating the introduction of diagnostic and interventional devices and continuously measuring blood pressure. It is not used for treating a condition, but rather for measurement and access.
Yes
The device is explicitly stated to be intended to "facilitate the introduction of diagnostic and interventional devices into the vasculature". Additionally, it "continuously measure[s] blood pressure during the procedure", and blood pressure monitoring can be a diagnostic function.
No
The device description clearly states it includes physical components like a sheath, dilator, and an integrated fiber optic pressure transducer, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the introduction of diagnostic and interventional devices into the vasculature and to continuously measure blood pressure during the procedure". This describes a device used in vivo (within the body) for access and physiological monitoring.
- Device Description: The description details an introducer sheath with an integrated pressure sensor for measuring blood pressure in the vessel. This is a direct measurement of a physiological parameter within the patient's body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices and accessories used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform tests on samples taken from the body.
The device is used within the body to facilitate access and measure a physiological parameter (blood pressure). This falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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™).
Product codes
DYB, DXO
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 (PSASA). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data was provided in support of the substantial equivalence.
- Dimensional Analysis ■
- Sensor Accuracy
- Guide Wire / Device Compatibility ■
- Flexibility - Tip Deflection
- Flexibility - Kink Resistance
- Flexibility - Sensor Functionality
- Pouch Peel Strength
- Dilator to Hemostasis Valve Separation Force
- L929 MEM Elution - ISO
- L929 Neutral Red Uptake Test (4 Concentrations) - ISO
- Rabbit Pyrogen Test (Material Mediated - ISO)
- 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 effective, and performs as well as or better than the legally marketed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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)
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™).
| 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).
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.
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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
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").
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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5
| • 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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6
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.