(46 days)
Not Found
Not Found
No
The summary describes a pressure guide wire and its physical characteristics and performance testing, with no mention of AI or ML.
No
The device is used to measure pressure for diagnostic purposes and does not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to measure pressure in blood vessels... during diagnostic angiography... Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip" and mentions physical characteristics like diameter and length, indicating it is a physical medical device with hardware components, not software-only.
Based on the provided information, the Verrata™ Pressure Guide Wire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The Verrata™ Pressure Guide Wire is a device that is inserted into the body (blood vessels) to measure pressure in vivo.
- The intended use clearly states it measures pressure in blood vessels during diagnostic angiography and interventional procedures. This is an in vivo measurement, not an in vitro test on a sample.
Therefore, the Verrata™ Pressure Guide Wire is a medical device used for in vivo measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Verrata™ Pressure Guide Wire device 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™ Pressure Guide Wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata guide wire measures pressure when used with the SmartMap, s5 Family and ComboMap systems. The Verrata guide wire 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 J tips. The Verrata guide wire is packaged pre-connected 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
Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards or product specification and evaluated the following:
- . Visual Inspection
- Dimensional Verification .
- Wire Connection Durability .
- . Tensile Strength
- Connector Resistance .
Biocompatibility testing was not conducted on the device as the direct and indirect blood-contacting materials are identical to those used in the predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Completion of these tests concluded the Verrata™ Pressure Guide Wire is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus Pressure Guide Wire.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire
Reference Device(s)
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
§ 870.1330 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.
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K131288- Page 1 of 2
JUN 2 1 2013
:
510(k) SUMMARY
ﺮ ﺍﻟ
The 510(k) Summary is submitted as required by section 807.92(a)
| SPONSOR: | Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Jwala Jawharkar
Regulatory Affairs Specialist
Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670
Tel: (916) 281-2925
Fax: (916) 638-8112 |
| DATE OF SUBMISSION: | May 3, 2013 |
| DEVICE: | Volcano Verrata™ Pressure Guide Wire |
| Trade Name: | Verrata™ Pressure Guide Wire |
| Common Name: | Pressure Guide Wire |
| Classification: | Class II Device
21 CFR Part 870.1330 Catheter guide wire (DQX)
21 CFR Part 870.2870 Catheter tip pressure transducer
(DX0) |
| PREDICATE DEVICE: | Volcano PrimeWire PRESTIGE® Plus Pressure Guide
Wire |
| DEVICE DESCRIPTION: | The Verrata™ Pressure Guide Wire is a steerable guide
wire with a pressure transducer mounted 3 cm proximal to
the tip. The Verrata guide wire measures pressure when
used with the SmartMap, s5 Family and ComboMap
systems. The Verrata guide wire 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 J tips. The Verrata guide
wire is packaged pre-connected to the connector with a
torque device to facilitate navigation through the
vasculature. |
| INDICATIONS FOR USE: | The Verrata™ Pressure Guide Wire device 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. |
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1
COMPARISON OF CHARACTERISTICS:
... ...
... ... ... ..........................................................................................................................................................
The modified device is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus device. Both devices are Pressure Guide Wires consisting of a wire and connector. The modified Verrata™ Pressure Guide Wire is offered in two lengths and two tip configurations for a total of 4 models, identical to the currently marketed device. The outer diameter and working length are identical for both the predicate and modified devices. The indications for use are identical for both devices. The only difference lies in a modification to the connector.
Non-clinical device testing was conducted to confirm the performance of the device. Bench testing was conducted against known standards or product specification and evaluated the following:
- . Visual Inspection
- Dimensional Verification .
- Wire Connection Durability .
- . Tensile Strength
- Connector Resistance .
Biocompatibility testing was not conducted on the device as the direct and indirect blood-contacting materials are identical to those used in the predicate device.
Completion of these tests concluded the Verrata™ Pressure Guide Wire is substantially equivalent to the currently marketed PrimeWire PRESTIGE® Plus Pressure Guide Wire.
PERFORMANCE DATA:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
Volcano Corporation Jwala Jawharkar Regulatory Affairs Specialist 2870 Kilgore Road Rancho Cordova, CA 95670
Re: K131288
Trade/Device Name: Verrata™ Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX. DXO Dated: May 22, 2013 Received: May 23, 2013
Dear Jwala Jawharkar:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Jwala Jawharkar
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number (if known) K131288
Page | of |
Device Name
Verrata™ Pressure Guide Wire
The Verrata™ Pressure Guide Wire is indicated for use to measure Indications for Use 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.
Prescription Use × (Per 21 CFR 801.109)
OR
Over the Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brar 2013
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