(168 days)
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 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 preshaped 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.
The provided text describes the OmniWire Pressure Guide Wire and its substantial equivalence to a predicate device (Verrata PLUS Pressure Guide Wire, K161887). The information regarding acceptance criteria and the study proving the device meets them is primarily found in the "Summary of Non-Clinical Testing" section.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Performance bench testing was completed as part of design verification to establish Substantial Equivalence with the predicate device, and that the subject device performs as intended." It then lists the types of tests conducted. However, it does not explicitly state the specific acceptance criteria (e.g., numerical thresholds, pass/fail rates) or the numerical results of each test. It only indicates that the device met these requirements.
| Acceptance Criteria (What was measured) | Reported Device Performance (Result/Outcome) |
|---|---|
| Guidewire Tensile Strength | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Torque Strength | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Rotational Accuracy | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Kink Resistance | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Conformance to Electrical safety standards | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Electromagnetic Compatibility | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| GLP Animal Study | Met the pre-determined requirements for substantial equivalence with the predicate device. |
| Signal Drift (simulated-use testing/design validation) | Demonstrated the subject device met user needs and the intended use by meeting pre-determined requirements. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each of the non-clinical tests (e.g., number of guidewires tested for tensile strength, number of animals in the GLP study). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) beyond stating they were "performance bench testing" and a "GLP Animal Study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The non-clinical tests described are primarily engineering and performance evaluations, and do not necessarily involve expert "ground truth" in the same way a diagnostic AI might. For the GLP Animal Study, expert veterinarians or researchers would have been involved, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given the nature of the non-clinical tests, a formal adjudication method like those used for clinical image interpretation studies is unlikely to be applicable or necessary.
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 comparative effectiveness study was done. The document explicitly states: "No new clinical testing was completed, nor relied upon, in support of this Traditional 510(k) submission." This device is a pressure guide wire, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a physical medical device (pressure guide wire) used to measure pressure. It is not an algorithm or AI that operates "standalone" in the typical sense of AI performance evaluation. Its performance is inherent in its physical and pressure-sensing capabilities, which were evaluated through the non-clinical tests mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests (tensile strength, torque strength, etc.), the "ground truth" would be established by physical measurements against engineering specifications and industry standards. For the GLP Animal Study, the "ground truth" would be the physiological measurements and observations recorded by trained personnel, likely assessed against expected physiological responses. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.
8. The sample size for the training set:
This information is not applicable/not provided. This device is not an AI algorithm that undergoes a "training set" in the machine learning sense. Its design and performance are based on engineering principles and materials science.
9. How the ground truth for the training set was established:
This information is not applicable/not provided for the same reason as point 8.
{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.
March 26, 2019
Volcano Corporation Jenny Fu Senior Regulatory Specialist 3721 Vallev Centre Drive. Ste 500 San Diego, California 92130
Re: K192886
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: February 25, 2020 Received: February 27, 2020
Dear Jenny Fu:
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 medical devices and radiation-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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K192886
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 word "PHILIPS" in blue, with each letter in a bold, sans-serif font. The letters are evenly spaced and aligned horizontally. The color of the text is a bright, saturated blue, which contrasts with the white background.
OmniWire Pressure Guide Wire Non-Confidential 510(k) Summary 510(k) Number: K192886 Date Prepared: March 25, 2020 Philips Image Guided Therapy Corporation (formerly Volcano Corporation) Owner/Submitter 3721 Valley Center Drive Name & Address: Suite 500 San Diego, CA 92130 Contact Person: Jenny Fu Senior Regulatory Affairs Specialist Telephone: (858) 720-4094 E-mail: jenny.fu@philips.com Donald Ellis Alternative Contact Director Regulatory Affairs Person: Telephone: (858) 209-3574 E-mail: donald.ellis@philips.com OmniWire Pressure Guide Wire Proprietary Name: Common/Usual Name: Pressure Guide Wire Product Classification DQX DXO Code: Product Regulation 870.1330 Wire, Guide, Catheter 870.2870 Catheter Tip Pressure Transducer Number and Name: Device Class: ll Verrata PLUS Pressure Guide Wire (K161887) Predicate Device: The OmniWire pressure quide wire is a steerable quide wire with a pressure sensor Device Description: 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 preshaped 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 quide wire is packaged attached to the connector with an OmniWirespecific 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 The subject device and the predicate device have similar design, materials, physical properties, and performance specifications. Both the predicate and subject device to Predicate Device: are 0.014" (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. Therefore, there are no significant 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 Traditional 510(k) submission are substantially equivalent as the predicate, and are summarized in the following table:
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are a bright blue color, and the word is underlined with a thin black line. The logo is simple and modern, and the blue color is eye-catching.
| Description | Subject Device | Predicate Device |
|---|---|---|
| Proprietary Name | OmniWire Pressure GuideWire | Verrata PLUS PressureGuide Wire (K161887) |
| Common Name | Pressure Guide Wire | Pressure Guide Wire |
| ProductClassificationCode | DQXDXO | DQXDXO |
| 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 SmartMap 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 Verrata PLUS PressureGuide Wire (hereafterreferred to as the "VerrataPLUS") is a steerable guidewire with a pressuretransducer mounted 3 cmproximal to the tip. TheVerrata PLUS measurespressure when used with theSmartMap, ComboMap, s5Series, and CORE Series ofsystems. The Verrata PLUShas a diameter of 0.014"(0.36 mm). |
| 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 Verrata PLUS pressureguide wire is indicated foruse to measure pressure inblood vessels, includingboth coronary andperipheral vessels, duringdiagnostic angiographyand/or any interventionalprocedures. Blood pressuremeasurements providehemodynamic informationfor the diagnosis andtreatment of blood vesseldisease. |
| 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. |
| TechnicalSpecifications | Wire Diameter: 0.0145Wire Length: 185 cmSterility Assurance Level(SAL): 10-6 | Wire Diameter: 0.0145Wire Length: 185 cm and300cmSterility Assurance Level(SAL): 10-6 |
{5}------------------------------------------------
Appendix 3: OmniWire Non-Confidential 510(k) Summary
| Summary ofNon-Clinical Testing: | Performance bench testing was completed as part of design verification to establishSubstantial Equivalence with the predicate device, and that the subject deviceperforms as intended. Tests were conducted to evaluate the following:• Guidewire Tensile Strength• Torque Strength• Rotational Accuracy• Kink Resistance• Conformance to Electrical safety standards• Electromagnetic Compatibility• GLP Animal StudyAdditionally, simulated-use testing was completed as part of design validation todemonstrate the subject device met user needs and the intended use.The following test was performed:• Signal Drift |
|---|---|
| Summary ofClinical Testing: | No new clinical testing was completed, nor relied upon, in support of this Traditional510(k) submission. |
| Statement ofEquivalence: | The OmniWire Guide Wire device described in this Traditional 510(k) submission issubstantially equivalent to the currently marketed predicate device, K161887, basedon comparisons of the device classifications, technological characteristics, andindications for use. The subject device met the pre-determined requirements. |
DH
§ 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.