K Number

Device Name

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

Manufacturer

Volcano Corporation

Date Cleared

2020-09-28

(26 days)

Product Code

DXQ DQX DXO

Regulation Number

870.1120

Intended Use

The OmniWire 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 facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

Device Description

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192886

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a pressure guide wire and its physical characteristics and intended use for measuring pressure. There is no mention of AI, ML, image processing, or any algorithms that would suggest the use of such technologies. The performance studies focus on bench testing of the device's physical and electrical properties.

Therapeutic

The device is purely diagnostic, as it is used to measure pressure for the purpose of diagnosis and treatment planning. It does not actively treat or alleviate any condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "measure pressure in blood vessels...during diagnostic angiography" and that "Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease."

SaMD (Software as a Medical Device)

The device description clearly describes a physical guide wire with a pressure sensor, coatings, and a connector, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
This device, the OmniWire pressure guide wire, is used in vivo (inside the body) to measure pressure directly within blood vessels. It is an invasive device used during diagnostic and interventional procedures.

The intended use and device description clearly indicate its function is to measure pressure within the body, not to analyze samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DQX, DXO

Device Description

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction.
The pressure guide wire is packaged attached to the connector with an OmniWire-specific 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

adult patients

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)

Bench testing was completed as part of design verification to demonstrate safety and effectiveness, and that the subject device performed as intended. Tests were conducted to evaluate the following: • System Design Verification • Electrical Safety • Electromagnetic Compatibility • Aging Studies
No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission.

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.

K192886

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

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).

Summary

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September 28, 2020

Volcano Corporation Patrick Juarez Regulatory Specialist 3721 Valley Centre Drive, Ste 500 San Diego, California 92130

Re: K202543

Trade/Device Name: OmniWire Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DXO Dated: September 1, 2020 Received: September 2, 2020

Dear Patrick Juarez:

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 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 (OS) 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 Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known)

K202543

Device Name OmniWire Pressure Guide Wire

Indications for Use (Describe)

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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Image: Volcano logo	VOLCANO
PRECISION GUIDED THERAPY

OmniWire Pressure Guide Wire Non-Confidential 510(k) Summary
510(k) Number:	K202543
Date Prepared:	September 22, 2020
Owner/Submitter
Name & Address:	Volcano Corporation
3721 Valley Center Drive
Suite 500
San Diego, CA 92130
Contact Person:	Patrick Juarez
Regulatory Affairs Specialist
Telephone: (858) 692-3412
E-mail: patrick.juarez@philips.com
Alternative Contact
Person:	Donald Ellis
Director Regulatory Affairs
Telephone: (858) 209-3574
E-mail: donald.ellis@philips.com
Proprietary Name:	OmniWire Pressure Guide Wire
Common/Usual Name:	Pressure Guide Wire
Product Classification
Code:	DQX
DXO
Product Regulation
Number and Name:	870.1330 Wire, Guide, Catheter
870.2870 Catheter Tip Pressure Transducer
Device Class:	II
Predicate Device:	OmniWire Pressure Guide Wire (K192886)
Device Description:	The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor
mounted 3 cm proximal to the tip. The pressure guide wire measures pressure
when used with the IntraSight and CORE Series of systems and is intended to be
used in adult patients eligible for endovascular procedures. The pressure guide wire
has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight
or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal
portion to reduce surface friction and enhance lubricity. It is also coated with a
hydrophobic coating (146 cm length) on the proximal portion to reduce surface
friction.
The pressure guide wire is packaged attached to the connector with an OmniWire-
specific torque device to facilitate navigation through the vasculature.
Indications for Use:	The OmniWire 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 facilitate
the placement of catheters as well as other interventional devices in coronary and
peripheral vessels. Blood pressure measurements provide hemodynamic
information for the diagnosis and treatment of blood vessel disease.
Comparison of Subject
to Predicate Device:	The subject device and the predicate device have identical design, materials,
physical properties, and performance specifications. Both the predicate and subject
device are .014" (0.36 mm) diameter pressure guide wires. They are both 185 cm
in length, use the same pressure sensor, and both utilize a torque device to aid with
navigation through vasculature. There are no differences in technological
characteristics between the devices.
The indications for use, and technological characteristics of the OmniWire Pressure
Guide Wire device that are subject to this Special 510(k) submission are the same
as the predicate, and are summarized in the following table:
Description	Subject Device	Predicate Device
Proprietary Name	OmniWire Pressure Guide
Wire	OmniWire Pressure Guide
Wire
Common Name	Pressure Guide Wire	Pressure Guide Wire
Product	DQX	DQX
Classification
Code	DXO	DXO
Product
Regulation:
Number & Name	870.1330, Catheter guide
wire and
870.2870, Catheter tip
pressure transducer	870.1330, Catheter guide
wire and
870.2870, Catheter tip
pressure transducer
Device Class	II	II
Device
Description	The OmniWire Pressure
Guide Wire is a steerable
guide wire with a pressure
sensor mounted 3 cm
proximal to the tip. The
pressure guide wire
measures pressure when
used with the IntraSight
and Core Series of systems
and is intended to be used
in adult patients eligible for
endovascular procedures.
The pressure guide wire
has a diameter of 0.014"
(0.36 mm), a length of 185
cm and is available in
straight or pre-shaped tips.	The OmniWire Pressure
Guide Wire is a steerable
guide wire with a pressure
sensor mounted 3 cm
proximal to the tip. The
pressure guide wire
measures pressure when
used with the IntraSight and
SmartMap systems and is
intended to be used in adult
patients eligible for
endovascular procedures.
The pressure guide wire has
a diameter of 0.014" (0.36
mm), a length of 185 cm and
is available in straight or
pre-shaped tips.
Indications For
Use	The OmniWire 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 facilitate the
placement of catheters as
well as other interventional
devices in coronary and
peripheral vessels. Blood
pressure measurements
provide hemodynamic
information for the
diagnosis and treatment of
blood vessel disease.	The OmniWire 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 facilitate the
placement of catheters as
well as other interventional
devices in coronary and
peripheral vessels. Blood
pressure measurements
provide hemodynamic
information for the diagnosis
and treatment of blood
vessel disease.
Contraindications	The OmniWire pressure
guide wire is not intended
for use with atherectomy
devices or for crossing a
total vessel occlusion.	The Verrata PLUS pressure
guide wire is not intended
for use with atherectomy
devices or for crossing a
total vessel occlusion.
Compatibility
with Systems	Compatible with the
IntraSight and CORE
Series of systems.	Compatible with the
IntraSight and SmartMap
systems.
Shelf Life	3 years	2 years
	Technical Specifications	Wire Diameter: 0.0145
Wire Length: 185 cm
Sterility Assurance Level
(SAL): 10-6	Wire Diameter: 0.0145
Wire Length: 185 cm
Sterility Assurance Level
(SAL): 10-6
Summary of
Non-Clinical Testing:	Bench testing was completed as part of design verification to demonstrate safety
and effectiveness, and that the subject device performed as intended. Tests were
conducted to evaluate the following:
• System Design Verification
• Electrical Safety
• Electromagnetic Compatibility
• Aging Studies
Summary of
Clinical Testing:	No new clinical testing was completed, nor relied upon, in support of this Special
510(k) submission.
Statement of
Equivalence:	The OmniWire Guide Wire device described in this Special 510(k) submission is
substantially equivalent to the currently marketed predicate device, K192886, based
on comparisons of the device classifications, technological characteristics, and
indications for use. The subject device met the pre-determined requirements, and
raised no new safety or effectiveness concerns.

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OmniWire Non-Confidential 510(k) Summary