(71 days)
Verrata® Pressure Guide Wire, K131288
Not Found
No
The summary describes a pressure guide wire and its physical characteristics and performance in bench testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is described as a pressure guide wire used to measure pressure in blood vessels for diagnostic purposes, providing hemodynamic information for the diagnosis and treatment of blood vessel disease. It does not actively treat or provide therapy to the patient.
Yes
The intended use explicitly states that the device is "to measure pressure in blood vessels...during diagnostic angiography and/or any interventional procedures," and that "Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease." This directly indicates its role in providing information for diagnosis.
No
The device description explicitly states it is a "steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip," indicating it is a physical hardware device, not software only.
Based on the provided information, the Verrata® PLUS pressure guide wire 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.
- Verrata® PLUS Function: The Verrata® PLUS is a device that is inserted into the body (specifically, blood vessels) to directly measure pressure in vivo. It is a diagnostic tool used during procedures, but it does not analyze samples taken from the body.
Therefore, while it is a diagnostic device, it falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Verrata® PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product codes
DQX, DXO
Device Description
The Verrata® PLUS Pressure Guide Wire (hereafter referred to as the “Verrata PLUS”) is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata® PLUS measures pressure when used with the SmartMap®, ComboMap®, s5 Series™, and CORE™ Series of systems. The Verrata PLUS has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and also in straight or pre-shaped tips. The Verrata PLUS is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, including both coronary and peripheral vessels
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
Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against the product specification and evaluated the following:
Visual Inspection: Sample wires and connectors were visually inspected to confirm proper routing of the cable out of the connector. Acceptance Criteria: Cable must be routed out the right side of the connector.
Visual Inspection: Sample wires were visually inspected to confirm that the pressure sensor within the pressure housing is properly aligned, positioned and potted in place. Acceptance Criteria: The sensor adhesive is not protruding out of the housing and the sensor is not damaged or misaligned.
Wire Outer Diameter: The maximum diameter of the sensor housing is measured with a micrometer. Acceptance Criteria: The sensor housing outer diameter must meet product specifications.
Zero Test and Connection Durability Test: Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verify that the wire still "zeros". Acceptance Criteria: The wire must successfully zero the first time and after 20 disconnect and re-connect cycles.
Accuracy Test: The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Acceptance Criteria: The pressure measured by the wire must meet product specifications.
Drift Test: The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Acceptance Criteria: The drift over 10 minutes must meet product specifications.
Connector to Cable Tensile Test: The connector to cable connection was pull tested to assess its tensile strength. Acceptance Criteria: The tensile strength must meet product specifications.
Biocompatibility: Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Acceptance Criteria: Per ISO 10993 and test protocols. Direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2016
Volcano Corporation Brian Park Regulatory Affairs Manager 3721 Valley Centre Drive, Suite 500 San Diego, California 92130
Re: K161887
Trade/Device Name: Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 185 cm J-tip; Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip; Verrata PLUS Pressure Guide Wire, 300 cm J-tip Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: August 19, 2016 Received: August 22, 2016
Dear Brian Park:
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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
Sincerelv
Muda Yellman
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) K161887
Device Name Verrata® PLUS Pressure Guide Wire
Indications for Use (Describe)
The Verrata® PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
| 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) SUMMARY
| SPONSOR: | Volcano Corporation
3721 Valley Center Drive Suite 500
San Diego, CA 92130 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Brian Park
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Center Drive Suite 500
San Diego, CA 92130
Tel: (858) 720-4176
Fax: (858) 481-1027 |
| DATE PREPARED: | July 8, 2016 |
| DEVICE: | Volcano Verrata® PLUS Pressure Guide Wire |
| TRADE NAME: | Verrata® PLUS Pressure Guide Wire |
| COMMON NAME: | Pressure Guide Wire |
| CLASSIFICATION: | 21 CFR 870.1330
DQX: Catheter Guide Wire
Class II Device
21 CFR 870.2870
DXO: Catheter Tip Pressure Transducer
Class II Device |
| PREDICATE DEVICE: | Verrata® Pressure Guide Wire, K131288
Model numbers:
10185, Straight Tip, 185 cm long, 0.014" (0.036 mm) dia.
10185J, J-Tip, 185 cm long, 0.014" (0.036mm) dia.
10300, Straight Tip, 300 cm long, 0.014" (0.036 mm) dia.
10300J, J-Tip, 300 cm long, 0.014" (0.036mm) dia. |
Image /page/3/Picture/5 description: The image contains the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square with a blue triangle inside, resembling a stylized volcano. The overall design is simple and modern, likely representing a company or brand named Volcano.
4
| DEVICE DESCRIPTION: | The Verrata® PLUS Pressure Guide Wire (hereafter
referred to as the “Verrata PLUS”) is a steerable guide wire
with a pressure transducer mounted 3 cm proximal to the
tip. The Verrata® PLUS measures pressure when used with
the SmartMap®, ComboMap®, s5 Series™, and CORE™
Series of systems. The Verrata PLUS has a diameter of
0.014" (0.36 mm) and is available in lengths of 185 cm or
300 cm and also in straight or pre-shaped tips. The Verrata
PLUS is packaged attached to the connector with a torque
device to facilitate navigation through the vasculature. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE: | The Verrata® PLUS pressure guide wire is indicated for
use to measure pressure in blood vessels, including both
coronary and peripheral vessels, during diagnostic
angiography and/or any interventional procedures. Blood
pressure measurements provide hemodynamic information
for the diagnosis and treatment of blood vessel disease. |
| COMPARISON OF
CHARACTERISTICS: | Volcano Corporation made minor revisions to the currently
marketed Verrata Pressure Guide Wire. The pressure
sensor and its encapsulating adhesive was changed, the
routing of the connector cable was changed from exiting the
connector body from the bottom to exiting from the side in
line with the wire, paraffin wax was added to a non-patient
contacting surface inside of the connector drawer and the
non-patient contacting torsion spring inside the connector is
now coated with a soap solution. There are no changes to
any final product or performance specifications as a result
of these changes. |
| PERFORMANCE DATA: | Non-clinical device testing was conducted to confirm the
performance of the device. Bench testing was conducted
against the product specification and evaluated the
following:
Visual Inspection: Sample wires and connectors were
visually inspected to confirm proper routing of the
cable out of the connector. Acceptance Criteria: Cable
must be routed out the right side of the connector. Visual Inspection: Sample wires were visually
inspected to confirm that the pressure sensor within the
pressure housing is properly aligned, positioned and
potted in place. Acceptance Criteria: The sensor
adhesive is not protruding out of the housing and the |
sensor is not damaged or misaligned.
5
- · Wire Outer Diameter: The maximum diameter of the sensor housing is measured with a micrometer. Acceptance Criteria: The sensor housing outer diameter must meet product specifications.
- · Zero Test and Connection Durability Test: Wires with connectors were connected to a Volcano Pressure System and "zeroed". The pressure value on the screen of the System should read "0". Disconnect the wire from the connector and re-connect up to 20 times. After 20 disconnect and re-connects, verify that the wire still "zeros". Acceptance Criteria: The wire must successfully zero the first time and after 20 disconnect and re-connect cycles.
- · Accuracy Test: The wire is connected to a test fixture and is placed in an air pressure chamber at 37℃. The pressure inside the chamber is varied and the pressure reading from the wire is compared to the pressure to which the chamber is set. Acceptance Criteria: The pressure measured by the wire must meet product specifications.
- · Drift Test: The wire is connected to a test fixture and placed in saline at 37℃. The pressure reading is recorded for 10 minutes. Acceptance Criteria: The drift over 10 minutes must meet product specifications.
- · Connector to Cable Tensile Test: The connector to cable connection was pull tested to assess its tensile strength. Acceptance Criteria: The tensile strength must meet product specifications.
- Biocompatibility: Biocompatibility of the raw materials in the Verrata PLUS wire were assessed per ISO 10993. Acceptance Criteria: Per ISO 10993 and test protocols. Direct Contact Hemolysis Acceptance Criteria: The difference between the hemolytic indices of the test article and negative control must be