ENDOPHYS BLOOD PRESSURE MONITOR

K141615 · Endophys, Inc. · DSK · Jan 7, 2015 · Cardiovascular

Device Facts

• Record ID: K141615
• Device Name: ENDOPHYS BLOOD PRESSURE MONITOR
• Applicant: Endophys, Inc.
• Product Code: DSK · Cardiovascular
• Decision Date: Jan 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1110
• Device Class: Class 2

Intended 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.

Device Story

Endophys Blood Pressure Monitor (BPM) Model 651 is a blood pressure computer used in catheterization laboratories. It receives optical signals from an Endophys Pressure Sensing Sheath inserted percutaneously during intravascular procedures. The device converts these optical transducer inputs into electrical signals to compute and continuously display systolic, diastolic, and mean blood pressure values. Operated by clinical staff, the monitor provides real-time hemodynamic data to assist in monitoring patients during diagnostic or interventional procedures. The output allows healthcare providers to track blood pressure trends, facilitating clinical decision-making during vascular access procedures.

Clinical Evidence

Bench testing only. Testing included design verification, electrical safety, and electromagnetic compatibility testing to demonstrate that the device meets established specifications for consistent performance.

Technological Characteristics

Blood pressure computer (Model 651). Inputs optical signals from a pressure sensing sheath; converts to electrical signals for display. Standalone device for catheterization lab use. Class II, 21 CFR 870.1110.

Indications for Use

Indicated for patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access in a catheterization laboratory.

Regulatory Classification

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.

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)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

K141615

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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: [phone]

#### 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: [phone] FAX: [phone]

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.