Who can help prepare an FDA 510(k) submission like OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

Volcano Corporation filed the 510(k) submission for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip (K202543).

Q: What is the FDA product code for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

OmniWire Pressure Guide Wire (K192886).

K202543 · Volcano Corporation · DQX · Sep 28, 2020 · Cardiovascular

Device Facts

Record ID	K202543
Device Name	OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Applicant	Volcano Corporation
Product Code	DQX · Cardiovascular
Decision Date	Sep 28, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

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 Story

OmniWire is a steerable 0.014" (0.36 mm) diameter guide wire with a pressure sensor mounted 3 cm proximal to the tip. Used in adult patients during endovascular procedures; operated by physicians in clinical settings. Device connects to IntraSight and CORE Series systems to measure intravascular pressure; provides hemodynamic data for diagnosis and treatment of vessel disease. Facilitates placement of catheters and interventional devices. Features hydrophilic distal coating and hydrophobic proximal coating to reduce friction. Packaged with a torque device for navigation. Output displayed on compatible systems to assist clinical decision-making regarding vessel disease.

Clinical Evidence

No clinical testing was completed or relied upon for this submission. Bench testing only.

Technological Characteristics

0.014" (0.36 mm) diameter, 185 cm length steerable guide wire. Features pressure sensor 3 cm from tip. Hydrophilic distal coating (39 cm), hydrophobic proximal coating (146 cm). Compatible with IntraSight and CORE Series systems. Sterilization: SAL 10^-6. Shelf life: 3 years.

Indications for Use

Indicated for adult patients undergoing diagnostic angiography or interventional procedures in coronary and peripheral vessels. Contraindicated for use with atherectomy devices or for crossing total vessel occlusions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

OmniWire Pressure Guide Wire (K192886)

Related Devices

K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip · Volcano Corporation · Mar 26, 2020
K111395 — PRIMEWIRE PRESTIGE PLUS · Volcano Corporation · Aug 1, 2011
K100930 — PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J · Volcano Corporation · Apr 30, 2010
K070487 — SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX · Volcano Corporation · Mar 16, 2007
K031662 — PRESSURE WIRE SENSOR, MODELS 12004/12304 · Radi Medical Systems AB · Jun 6, 2003

Submission Summary (Full Text)

{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) 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. | 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/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. | | | {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