(205 days)
Not Found
No
The description focuses on converting optical signals to electrical signals and displaying blood pressure measurements, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is a blood pressure monitor intended for diagnostic purposes and does not directly provide therapy. It measures physiological parameters rather than treating a condition.
Yes
The device is intended to continuously provide systolic, diastolic, and mean blood pressure values based on the output of a pressure sensing sheath, which are diagnostic measurements for patients undergoing procedures involving percutaneous vascular access.
No
The device description explicitly states that the device is a "blood pressure computer" that "obtains an optical signal from the Endophys Pressure Sensing Sheath" and "converts the optical transducer data to electrical signals and displays blood pressure measurements." This indicates the presence of hardware components (computer, signal converter) that are integral to the device's function, making it more than just software.
Based on the provided information, the Endophys Blood Pressure Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device measures blood pressure in vivo (within the patient's body) using a pressure sensing sheath inserted percutaneously. IVDs are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples.
- Device Description: The device processes an optical signal from a sheath inserted into the patient's vascular system to determine blood pressure. This is a direct physiological measurement, not an analysis of a biological sample.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, reagents, or any of the typical components associated with IVD devices.
Therefore, the Endophys Blood Pressure Monitor is a medical device used for in vivo physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.
Product codes (comma separated list FDA assigned to the subject device)
DSK
Device Description
The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
catheterization laboratory
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing was conducted on the BPM to support a determination of substantial equivalence to the predicate devices. Testing of the BPM included design verification testing, electrical safety testing, and electromagnetic compatibility testing. The collective results of the testing demonstrate that the BPM meets the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the BPM does not raise new questions of safety or effectiveness when compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).
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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 Experien Group, LLC 755 N. Mathilda, Ave, Suite 100 Sunnyvale, California 94085
Re: K141615
Trade/Device Name: Endophys Blood Pressure Monitor Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II Product Code: DSK Dated: December 5, 2014 Received: December 9, 2014
Dear 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)
Page 1 of 1
Device Name
Endophys Blood Pressure Monitor
Indications for Use (Describe)
The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) SUMMARY
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: June 13, 2014
DEVICE INFORMATION
Trade Name: Endophys Blood Pressure Monitor
Generic/Common Name: Blood Pressure Computer
Classification: Class II, 21 CFR§870.1110
Product Code: DSK, Computer, Blood Pressure
PREDICATE DEVICES
- Radi Medical Systems AB (now St. Jude Medical AB) RadiAnalyzer Xpress (K092105)
- Acist Medical Systems Rapid Exchange (RXi) System and Navvus Catheter ● (K132474)
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510(k) SUMMARY
INDICATIONS FOR USE
The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.
PRODUCT DESCRIPTION
The Endophys Blood Pressure Monitor ("BPM") Model 651 is a blood pressure computer that computes and continuously displays systolic, diastolic, and mean blood pressure values. The BPM obtains an optical signal from the Endophys Pressure Sensing Sheath, which is a stand-alone catheterization sheath that is inserted percutaneously during intravascular diagnostic or interventional procedures. The BPM converts the optical transducer data to electrical signals and displays blood pressure measurements.
SUBSTANTIAL EQUIVALENCE
The indications for use for the Endophys Blood Pressure Monitor are substantially equivalent to the indications for use for the predicate devices. The Endophys Blood Pressure Monitor has the same intended use and similar technological characteristics as those of the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Endophys Blood Pressure Monitor is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary testing was conducted on the BPM to support a determination of substantial equivalence to the predicate devices. Testing of the BPM included design verification testing, electrical safety testing, and electromagnetic compatibility testing. The collective results of the testing demonstrate that the BPM meets the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates that the BPM does not raise new questions of safety or effectiveness when compared to the predicate devices.
CONCLUSION
The BPM has the same intended use and similar technological characteristics as do the predicate devices. The differences in technological characteristics have been analyzed and addressed through performance testing. As such, the BPM is substantially equivalent to the predicate devices.
SUMMARY
The Endophys Blood Pressure Monitor is substantially equivalent to the predicate devices.