(168 days)
Not Found
No
The summary describes a physical medical device (a pressure guide wire) and its intended use for measuring pressure. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The performance studies focus on physical and electrical properties, not algorithmic performance.
No
The device is a diagnostic tool used to measure pressure in blood vessels to provide hemodynamic information for diagnosis and treatment, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section 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." This directly indicates a diagnostic purpose.
No
The device description clearly states it is a "steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip" and describes physical characteristics like diameter, length, and coatings. This indicates it is a physical medical device with integrated hardware, not software only.
Based on the provided information, 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 OmniWire pressure guide wire is a device that is inserted directly into the body (in vivo) to measure pressure within blood vessels. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it measures pressure in blood vessels and facilitates the placement of other devices in the body.
Therefore, the OmniWire pressure guide wire is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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 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.
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)
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. 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 Study Additionally, simulated-use testing was completed as part of design validation to demonstrate the subject device met user needs and the intended use. The following test was performed: • Signal Drift
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.
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.
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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) |
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3
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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:
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| Description | Subject Device | Predicate Device |
|---|---|---|
| Proprietary Name | OmniWire Pressure Guide | |
| Wire | Verrata PLUS Pressure | |
| Guide Wire (K161887) | ||
| Common Name | Pressure Guide Wire | Pressure Guide Wire |
| Product | ||
| Classification | ||
| Code | DQX | |
| DXO | DQX | |
| 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 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. | The Verrata PLUS Pressure | |
| Guide Wire (hereafter | ||
| referred to as the "Verrata | ||
| PLUS") is a steerable guide | ||
| wire with a pressure | ||
| transducer mounted 3 cm | ||
| proximal to the tip. The | ||
| Verrata PLUS measures | ||
| pressure when used with the | ||
| SmartMap, ComboMap, s5 | ||
| Series, and CORE Series of | ||
| systems. The Verrata PLUS | ||
| has a diameter of 0.014" | ||
| (0.36 mm). | ||
| 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 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. 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. | ||
| Technical | ||
| Specifications | Wire Diameter: 0.0145 | |
| Wire Length: 185 cm | ||
| Sterility Assurance Level | ||
| (SAL): 10-6 | Wire Diameter: 0.0145 | |
| Wire Length: 185 cm and | ||
| 300cm | ||
| Sterility Assurance Level | ||
| (SAL): 10-6 |
5
Appendix 3: OmniWire Non-Confidential 510(k) Summary
| Summary of
Non-Clinical Testing: | 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. 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 Study
Additionally, simulated-use testing was completed as part of design validation to
demonstrate the subject device met user needs and the intended use.
The following test was performed:
• Signal Drift |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Clinical Testing: | No new clinical testing was completed, nor relied upon, in support of this Traditional
510(k) submission. |
| Statement of
Equivalence: | The OmniWire Guide Wire device described in this Traditional 510(k) submission is
substantially equivalent to the currently marketed predicate device, K161887, based
on comparisons of the device classifications, technological characteristics, and
indications for use. The subject device met the pre-determined requirements. |
DH