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.

AI/ML Overview

This document is a 510(k) summary for the OmniWire Pressure Guide Wire (K202543). It indicates that the device is substantially equivalent to a previously marketed predicate device (OmniWire Pressure Guide Wire, K192886).

Based on the provided information, the device is a pressure guide wire, and the 510(k) is for demonstrating its substantial equivalence. The document explicitly states that no new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission. Therefore, the information regarding acceptance criteria and studies demonstrating that the device meets these criteria is very limited to what is typically found in a clinical study report.

However, the document does contain information about non-clinical testing (bench testing) that was conducted. This bench testing serves as the "study" proving the device meets certain acceptance criteria related to its design, electrical safety, electromagnetic compatibility, and aging.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing)

Acceptance Criteria Category	Reported Device Performance (from "Summary of Non-Clinical Testing")
System Design Verification	Performed, indicated that the subject device performed as intended.
Electrical Safety	Evaluated, indicated that the subject device performed as intended.
Electromagnetic Compatibility	Evaluated, indicated that the subject device performed as intended.
Aging Studies	Evaluated, indicated that the subject device performed as intended.
Physical Properties	"identical design, materials, physical properties, and performance specifications" to the predicate. Example: Wire Diameter: 0.0145", Wire Length: 185 cm, Sterility Assurance Level (SAL): 10^-6

Note: The document states that the subject device and the predicate device have identical design, materials, physical properties, and performance specifications. This implies that the acceptance criteria for these physical and performance specifications are met if they are identical to the already cleared predicate device. Specific numerical acceptance criteria for these physical properties are not listed as distinct "acceptance criteria" but are stated as identical to the predicate's known specifications.

Other Requested Information:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for specific non-clinical tests. The document mentions "Bench testing was completed as part of design verification."
Data Provenance: Not specified, but generally, bench testing data for medical devices originates from the manufacturer's testing facilities (Volcano Corporation in this case). The document is a 510(k) submission, not a detailed test report. The general context suggests lab-based, pre-market non-clinical testing. It is retrospective in the sense that results are reported after testing is completed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this 510(k) submission. For non-clinical bench testing, "ground truth" is typically established by engineering specifications, calibration standards, and established testing methodologies (e.g., ASTM, ISO standards) rather than expert consensus on a test set. This type of analysis (expert review to establish ground truth) is more common in clinical studies, especially those involving image interpretation or diagnostic accuracy by human readers.

4. Adjudication method for the test set:

Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are primarily used in multi-reader studies to resolve discrepancies in expert interpretation, which is not the nature of the non-clinical bench testing described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Special 510(k) submission." This device is a physical medical device (pressure guide wire), not an AI-powered diagnostic tool, so an MRMC study comparing human performance with and without AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device for measuring pressure, not a standalone algorithm.

7. The type of ground truth used:

For the non-clinical testing: The ground truth is engineering specifications, calibrated instruments, and established industry test standards (e.g., for electrical safety, EMC, material properties). The device's performance was compared against these predefined physical and functional requirements.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The "training" for such a device involves its design and manufacturing processes to meet specifications.

9. How the ground truth for the training set was established:

Not applicable. See explanation for #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

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/1 description: The image shows the title of a document. The title is "OmniWire Non-Confidential 510(k) Summary". The text is black and the background is white. The text is centered on the page.

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/SubmitterName & Address:	Volcano Corporation3721 Valley Center DriveSuite 500San Diego, CA 92130
Contact Person:	Patrick JuarezRegulatory Affairs SpecialistTelephone: (858) 692-3412E-mail: patrick.juarez@philips.com
Alternative ContactPerson:	Donald EllisDirector Regulatory AffairsTelephone: (858) 209-3574E-mail: donald.ellis@philips.com
Proprietary Name:	OmniWire Pressure Guide Wire
Common/Usual Name:	Pressure Guide Wire
Product ClassificationCode:	DQXDXO
Product RegulationNumber and Name:	870.1330 Wire, Guide, Catheter870.2870 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 sensormounted 3 cm proximal to the tip. The pressure guide wire measures pressurewhen used with the IntraSight and CORE Series of systems and is intended to beused in adult patients eligible for endovascular procedures. The pressure guide wirehas a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straightor pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distalportion to reduce surface friction and enhance lubricity. It is also coated with ahydrophobic coating (146 cm length) on the proximal portion to reduce surfacefriction.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 inblood vessels, including both coronary and peripheral vessels, during diagnosticangiography and/or any interventional procedures. It can also be used to facilitatethe placement of catheters as well as other interventional devices in coronary andperipheral vessels. Blood pressure measurements provide hemodynamicinformation for the diagnosis and treatment of blood vessel disease.
Comparison of Subjectto Predicate Device:	The subject device and the predicate device have identical design, materials,physical properties, and performance specifications. Both the predicate and subjectdevice are .014" (0.36 mm) diameter pressure guide wires. They are both 185 cmin length, use the same pressure sensor, and both utilize a torque device to aid withnavigation through vasculature. There are no differences in technologicalcharacteristics between the devices.The indications for use, and technological characteristics of the OmniWire PressureGuide Wire device that are subject to this Special 510(k) submission are the sameas the predicate, and are summarized in the following table:
Description	Subject Device	Predicate Device
Proprietary Name	OmniWire Pressure GuideWire	OmniWire Pressure GuideWire
Common Name	Pressure Guide Wire	Pressure Guide Wire
Product	DQX	DQX
ClassificationCode	DXO	DXO
ProductRegulation:Number & Name	870.1330, Catheter guidewire and870.2870, Catheter tippressure transducer	870.1330, Catheter guidewire and870.2870, Catheter tippressure transducer
Device Class	II	II
DeviceDescription	The OmniWire PressureGuide Wire is a steerableguide wire with a pressuresensor mounted 3 cmproximal to the tip. Thepressure guide wiremeasures pressure whenused with the IntraSightand Core Series of systemsand is intended to be usedin adult patients eligible forendovascular procedures.The pressure guide wirehas a diameter of 0.014"(0.36 mm), a length of 185cm and is available instraight or pre-shaped tips.	The OmniWire PressureGuide Wire is a steerableguide wire with a pressuresensor mounted 3 cmproximal to the tip. Thepressure guide wiremeasures pressure whenused with the IntraSight andSmartMap systems and isintended to be used in adultpatients eligible forendovascular procedures.The pressure guide wire hasa diameter of 0.014" (0.36mm), a length of 185 cm andis available in straight orpre-shaped tips.
Indications ForUse	The OmniWire pressureguide wire is indicated foruse to measure pressure inblood vessels, includingboth coronary andperipheral vessels, duringdiagnostic angiographyand/or any interventionalprocedures. It can also beused to facilitate theplacement of catheters aswell as other interventionaldevices in coronary andperipheral vessels. Bloodpressure measurementsprovide hemodynamicinformation for thediagnosis and treatment ofblood vessel disease.	The OmniWire pressureguide wire is indicated foruse to measure pressure inblood vessels, includingboth coronary andperipheral vessels, duringdiagnostic angiographyand/or any interventionalprocedures. It can also beused to facilitate theplacement of catheters aswell as other interventionaldevices in coronary andperipheral vessels. Bloodpressure measurementsprovide hemodynamicinformation for the diagnosisand treatment of bloodvessel disease.
Contraindications	The OmniWire pressureguide wire is not intendedfor use with atherectomydevices or for crossing atotal vessel occlusion.	The Verrata PLUS pressureguide wire is not intendedfor use with atherectomydevices or for crossing atotal vessel occlusion.
Compatibilitywith Systems	Compatible with theIntraSight and CORESeries of systems.	Compatible with theIntraSight and SmartMapsystems.
Shelf Life	3 years	2 years
	Technical Specifications	Wire Diameter: 0.0145Wire Length: 185 cmSterility Assurance Level(SAL): 10-6	Wire Diameter: 0.0145Wire Length: 185 cmSterility Assurance Level(SAL): 10-6
Summary ofNon-Clinical Testing:	Bench testing was completed as part of design verification to demonstrate safetyand effectiveness, and that the subject device performed as intended. Tests wereconducted to evaluate the following:• System Design Verification• Electrical Safety• Electromagnetic Compatibility• Aging Studies
Summary ofClinical Testing:	No new clinical testing was completed, nor relied upon, in support of this Special510(k) submission.
Statement ofEquivalence:	The OmniWire Guide Wire device described in this Special 510(k) submission issubstantially equivalent to the currently marketed predicate device, K192886, basedon comparisons of the device classifications, technological characteristics, andindications for use. The subject device met the pre-determined requirements, andraised no new safety or effectiveness concerns.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Volcano Corporation logo. The logo consists of a gray triangle with a blue triangle inside of it on the left. To the right of the triangle is the word "VOLCANO" in large, bold, blue letters. Below the word "VOLCANO" is the phrase "PRECISION GUIDED THERAPY" in smaller, black letters.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "K202543" in a simple, sans-serif font. The text is black and stands out against a white background. The characters are evenly spaced and easily readable. The image appears to be a close-up of the text, with no other elements present.

Image /page/5/Picture/1 description: The image shows the word "VOLCANO" in large, bold, blue letters. To the left of the word is a gray square containing a white triangle, which is likely meant to represent a volcano. The overall design is simple and clean, with a focus on the brand name and a visual representation of its meaning.

OmniWire Non-Confidential 510(k) Summary

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).