(236 days)
No
The summary describes a device for measuring blood pressure using a fiber optic transducer and displaying the results. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is described as an introducer sheath that continuously measures blood pressure. Its primary function is to facilitate the introduction of other devices and monitor a physiological parameter (blood pressure), not to treat a disease or condition.
No
The device is primarily an introducer sheath that measures blood pressure, which is a physiological parameter, but its intended use is to "facilitate the introduction of diagnostic and interventional devices" and "continuously measure blood pressure," not to provide a diagnosis itself. It monitors blood pressure, which is a type of measurement, but does not interpret that measurement to generate a diagnosis.
No
The device description explicitly states that the device is a "Pressure Sensing Sheath" which is an "introducer sheath with an integrated fiber optic pressure transducer." This indicates the device includes physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Endophys Pressure Sensing Sheath Kit is an invasive medical device used to facilitate access to the vasculature and directly measure blood pressure within the body. It does not analyze samples taken from the body.
The device's function and intended use clearly place it outside the scope of in vitro diagnostics. It is an in vivo (within the living body) diagnostic and interventional device accessory.
N/A
Intended Use / Indications for Use
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.
Product codes
DYB, DXO
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
K052557, K120212, K093111, K132474
Reference Device(s)
Not Found
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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
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
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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
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.
PRODUCT 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.
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.