(174 days)
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 data processing or interpretation.
No
The device is a blood pressure monitor used for diagnostic purposes, not for therapeutic intervention.
Yes
The device continuously provides systolic, diastolic, and mean blood pressure based on the output of a pressure sensing sheath, which are measurements used in diagnostic procedures.
No
The device description explicitly states it is a "blood pressure computer" that "obtains an optical signal from the Endophys Pressure Sensing Sheath," "converts the optical transducer data to electrical signals," and is "powered by a standard AC power adapter." These are descriptions of hardware components and their functions, not solely software.
Based on the provided information, the Endophys Blood Pressure Monitor Model 651 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endophys Blood Pressure Monitor Model 651 measures blood pressure directly within the patient's vascular system using a pressure sensing sheath inserted percutaneously. It does not analyze a sample taken from the body.
- Intended Use: The intended use clearly states it's for continuously providing blood pressure based on the output of a pressure sensing sheath in patients undergoing procedures involving percutaneous vascular access. This is a direct physiological measurement, not an in vitro analysis.
Therefore, the Endophys Blood Pressure Monitor Model 651 is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Endophys Blood Pressure Monitor Model 651 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
DSK
Device Description
The Endophys Blood Pressure Monitor 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 standalone 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.
The Endophys Blood Pressure Monitor Model 651 is powered by a standard AC power adapter. The Endophys Blood Pressure Monitor Model 651 is used outside of the sterile environment and has standard alerts and alarms.
The Endophys Blood Pressure Monitor Model 651 has an operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.
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)
Functional Testing
Electrical Safety (IEC 60601-1)
Electromagnetic compatibility (IEC 60601-1-2)
Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34)
The modified Endophys Blood Pressure Monitor Model 651 met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.
Predicate Device(s)
Endophys Blood Pressure Monitor (K141615)
Reference Device(s)
IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 (K141015)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked one behind the other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2016
Endophys Holdings, LLC Rebecca Pine Official Correspondent 1601 Elm Street Dallas, Texas 75201
Re: K160945
Trade/Device Name: Endophys Blood Pressure Monitor, Model 651 Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II Product Code: DSK Dated: August 23, 2016 Received: August 24, 2016
Dear Rebecca Pine:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 vours.
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160945
Device Name
Endophys Blood Pressure Monitor (Model 651)
Indications for Use (Describe)
The Endophys Blood Pressure Monitor Model 651 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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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6. 510(k) Summarv
I. SUBMITTER
Endophys Holdings, LLC Thanksgiving Tower, Suite 1930 1601 Elm Street Dallas, TX 75201
Contact person: Rebecca K Pine Phone: (760) 809-5178 Date prepared: March 30, 2016
II. DEVICE
Name of the device: Endophys Blood Pressure Monitor, Model 651 Common of usual name: Blood Pressure Monitor Classification name: Computer, Blood Pressure Regulatory Class: 2 Product Code: DSK
- III. PREDICATE DEVICE Endophys Blood Pressure Monitor (K141615) This predicate has not been subject to a design-related recall IntelliVue Patient Monitors MX400, MX450, MX500 and MX550 (K141015) [ reference predicate] This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION
The Endophys Blood Pressure Monitor 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 standalone 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.
The Endophys Blood Pressure Monitor Model 651 is powered by a standard AC power adapter. The Endophys Blood Pressure Monitor Model 651 is used outside of the sterile environment and has standard alerts and alarms.
4
The Endophys Blood Pressure Monitor Model 651 has an operating pressure range of 0-300 mmHg with an accuracy of ±2mmHg or ±4% of the reading, whichever is greater.
V. INDICATIONS FOR USE
The Endophys Blood Pressure Monitor Model 651 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 ..
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Blood Pressure Monitors, by nature, are instruments intended to provide clinicians with the physiological blood pressure of patients reported in milligrams of mercury (mmHg). Specialized computer based instruments have been developed which allow active monitoring of blood pressure during interventional procedures. Blood pressure monitoring using a fiber optic communication is the technological principle for both the subject and predicate devices. The technology requires use of a compatible intravascular pressure sensing sheath to provide this data to the clinician.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Calculates and displays hemodynamic (invasive blood pressure) ■ data when attached to a compatible intravascular pressure sensing device (Endophys Pressure Sensing Sheath)
- Optical signal (fiber optic) measurement of blood pressure
- l Pressure measurement range 0-300 mmHg
- I Pressure accuracy: System accuracy:± 2 mmHg or ± 4% of the reading, whichever is greater
The following technological differences exist between the subject and predicate devices:
- Plastic mode mixer ■
- USB Port feature
- Patient Monitor Interface port
PERFORMANCE DATA VII.
5
The following performance data were provided in support of the substantial equivalence.
- Functional Testing ■
- Electrical Safety (IEC 60601-1)
- I Electromagnetic compatibility (IEC 60601-1-2)
- 트 Safety and Essential Performance for Invasive blood pressure monitoring equipment (IEC 60601-2-34)
The modified Endophys Blood Pressure Monitor Model 651 met all specified criteria and did not raise new safety or performance questions. Based on the design verification performance the modified Endophys Blood Pressure Monitor was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
The testing performed for the modified Endophys Blood Pressure Monitor Model 651 demonstrated that the performance of the modified device is equal to the legally marketed Endophys Blood Pressure Monitor.