(77 days)
Not Found
No
The summary describes a pressure guide wire and its associated systems for measuring blood pressure. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical device and its pressure measurement capabilities.
No.
The device is used for diagnostic purposes (measuring pressure) and for guiding other interventional devices, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states, "Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease," directly indicating a diagnostic purpose.
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.
No, this device 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.
- Device Function: The Verrata PLUS pressure guide wire is an invasive medical device that is inserted directly into blood vessels to measure pressure in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it measures pressure in blood vessels during procedures, not on samples outside the body.
Therefore, based on the provided information, the Verrata PLUS pressure guide wire is a medical device used for in vivo measurement and guidance, not an In Vitro Diagnostic.
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. It can also be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
Product codes (comma separated list FDA assigned to the subject device)
DQX, DXO
Device Description
The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing completed for a determination of substantial equivalence included the following:
- EMC and Electrical Safety Testing
- . Design Verification
- . Self Life Studies
- Drift Performance Testing ●
- System Verification ●
All device acceptance criteria were met. Results of testing show that the proposed Verrata PLUS Pressure Guide Wire with alternate sensor meets its intended use. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed Verrata PLUS Pressure Guide Wire with alternate sensor is substantially equivalent to the predicate Verrata PLUS Pressure Guide Wire.
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.
Verrata PLUS Pressure Guide Wire, K161887
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
§ 870.1330 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 15, 2020
Volcano Corporation Leilani Taylor Sr. Regulatory Affairs Specialist 3721 Valley Centre Drive, Ste 500 San Diego, California 92130
Re: K210235
Trade/Device Name: Verrata PLUS Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: March 15, 2021 Received: March 16, 2021
Dear Leilani Taylor:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. 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) |
CONTINUE ON SEPARATE PAGE IF NEEDED
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a blue triangle inside, followed by the word "VOLCANO" in large, blue, sans-serif letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black, sans-serif letters.
This 510(k) Summary was prepared in accordance with 21 CFR 807.92 (c)
510(k) SUMMARY
| SUBMITTER: | Volcano Corporation
3721 Valley Centre Drive, Ste 500
San Diego, CA 92130 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Leilani Taylor
Regulatory Affairs Specialist
Volcano Corporation
3721 Valley Centre Drive, Suite
500 San Diego, CA 92130
Tel: (858) 720-4121 |
| DATE PREPARED: | April 02, 2021 |
| DEVICE NAME: | Verrata PLUS Pressure Guide Wire |
| COMMON NAME: | Wire, guide, catheter
Catheter Tip Pressure Transducer |
| CLASSIFICATION: | 870.1330 Catheter guide wire / DQX
870.2870 Catheter Tip Pressure Transducer /DXO
CLASS II |
| PREDICATE DEVICE: | Verrata PLUS Pressure Guide Wire, K161887 |
DEVICE DESCRIPTION:
The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.
4
Image /page/4/Picture/0 description: The image contains the logo for Volcano Corporation. The logo features a stylized mountain graphic to the left of the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the text "PRECISION GUIDED THERAPY" in a smaller font.
INDICATION FOR USE:
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
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. It can also be used to guide the positioning of a balloon dilatation catheter, as well as other interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.
t சிக் கல்வுகளையு கடலத்தல்வர்கள்
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
| Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure
Guide Wire (K161887) and Subject Devices Volcano Verrata
PLUS Pressure Guide Wire Alternate Sensor |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | SAME |
| Materials (Guide Wire) | |
| Tip Coil | SAME |
| Tip Coil Solder | SAME |
| Proximal Coil | SAME |
| Distal Coating | SAME |
| Sensor Housing | SAME
SAME
SAME |
| Pressure Transducer | SAME
SAME, except for Silicon Nitride, which is identified in the subject
device, but not specified in the predicate device. See table below. |
| Conductor Wire | SAME
SAME |
| Contact Pad | Different, see table below. |
| Hypotube | SAME |
| Hypotube Coating | SAME |
| Core Wire | SAME |
| Retaining Sleeve | SAME |
| Conductive Bands | SAME |
| Insulator Sleeve | SAME |
| Locking Core | SAME |
| Insulator Sleeve,
conductive band | SAME |
| Adhesive, UV Cured | SAME
SAME |
| Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor |
| Adhesive, UV Cured | SAME |
| Materials (Connector) | |
| Connector Shell | SAME |
| Contact | SAME |
| Locking Clip | SAME |
| Torsional Spring | SAME |
| Cable | SAME |
| Cable 10 pin connector assembly | SAME |
| Materials (Torque Device) | |
| Body | SAME |
| Cap | SAME |
| Collet | SAME |
| Design | |
| Core Design | SAME |
| Tip Design | SAME |
| Tip Joint Design | SAME |
| Transducer Location | SAME |
| Tip Coil to Core Wire | SAME |
| Core Wire to Housing | SAME |
| Proximal Locking | SAME |
| Core tensile strength | SAME |
| Turns to Failure | SAME |
| Connector Cable Routing | SAME |
| Sensor | |
| Sensor | Different sensor but same performance specifications |
| Accuracy | SAME |
| Drift | SAME |
| Operating Range | SAME |
| Dimensions | |
| Overall Outer Diameter | SAME |
| Working Length (Distal tip of the wire to the distal end of the connector) | SAME |
| Attribute/Feature | Comparison of the Predicate Volcano Verrata PLUS Pressure Guide Wire (K161887) and Subject Devices Volcano Verrata PLUS Pressure Guide Wire Alternate Sensor |
| Length | |
| Sensor Housing Length | SAME |
| Core Wire Diameter | SAME |
| Flexible Distal Section | SAME |
| Packaging Materials | |
| Carton | SAME |
| Spiral Dispenser with Clips | SAME |
| Wire Tray | SAME |
| Pouch | SAME |
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟ
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
5
Image /page/5/Picture/0 description: The image contains the logo for "VOLCANO". To the left of the word, there is a gray square with a white triangle inside. The triangle has a blue triangle inside of it. The word "VOLCANO" is in blue.
PRECISION GUIL
6
Image /page/6/Picture/0 description: The image shows the logo for Volcano Corporation. The logo consists of a gray square with a white triangle inside, followed by the word "VOLCANO" in large, blue, bold letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, gray letters.
PRECISION GUIDE
| Wire Tray | SAME |
|---|---|
| Pouch | SAME |
| RJ50 Cap | SAME |
| Sterilization and Shelf Life | |
| Sterilization Method | SAME |
| Sterilization | SAME |
| Sterilization Assurance Level (SAL) | |
| Shelf Life | SAME |
The following table describes the differences between the two sensors:
| Sensor Part | Predicate Volcano
Verrata PLUS
Pressure Guide
Wire (K161887)
Sensor Material | Subject Volcano
Verrata PLUS
Pressure Guide
Wire Alternate
Sensor | Rationale |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bond Pads
(Metallization)
(Not blood
Contacting) | Base: Tantalum
Top Layer: Platinum | Base: Niobium -
Titanium-
Tungsten
Top Layer: Gold | Sensor Manufacturer
driven. Alternate
Supplier does not have
capability to metalize
platinum. Gold Pads
are beneficial for the
Trifilar to Sensor Bond
(Compatible with gold
plated trifilar) |
| Base (Handle
Layer)
(Blood
Contacting) | Silicon | Silicon | No Change |
| Device Layer and | Silicon | Silicon | No Change |
| Diaphragm
(Blood
Contacting) | Silicon Oxide
(silicon naturally
oxidizes when | Silicon Oxide | Passivation layer 1
(adherence, 2nd
protection) |
| | exposed to air) | Silicon Nitride | Passivation Layer 2
(Protective). Silicon
Nitride is widely used
in semi conductor
industry for its
insulation properties.
Biocompatibility
studies were executed
to verify material
impact. All
biocompatibility
requirements were
effectively met per
ISO10993. There were
no new biological
hazards or risks
identified compared to
predicate device. |
| Adhesive Marker
(Distal Marker
aka Dielectric
marker)
(Blood
Contacting) | NA | Silicon Dioxide | Dielectric material
added For
manufacturing Purposes
(Indicator for maximum
amount of adhesive and
positioning of die in
protective housing,
yield improvement,
cosmetic feature) |
| Trifilar Insulator
(Blood
Contacting) | NA | Silicon Dioxide | Dielectric material
added for
manufacturing purposes
(to avoid the Trifilar to
short with the Handle
Layer, yield
improvement). |
| Electrical Circuit
(inside) (Not
blood Contacting) | Unknown | Traces of Boron
and Phosphorous
(