(26 days)
Not Found
No
The description focuses on the hardware (pressure sensor, guidewire, optical cable) and the calculation of FFR based on a simple ratio of measured pressures. There is no mention of AI/ML algorithms for data processing, interpretation, or decision support.
No
The device is indicated to direct a catheter and measure physiological parameters, specifically blood pressure gradient changes and fractional flow reserve (FFR). These are diagnostic measurements used to assess the severity of lesions, not to treat them.
Yes.
The device measures physiological parameters (blood pressure gradient, aortic pressure, distal pressure, and FFR value) to assess changes across lesions, which serves a diagnostic purpose.
No
The device description clearly details a physical guidewire with an integrated pressure sensor, optical cable, and torque device. It is a hardware device with a software component for displaying physiological parameters, but it is not solely software.
Based on the provided information, the Comet II Pressure Guidewire is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Comet II Pressure Guidewire is used within the human body to measure physiological parameters (blood pressure) directly in blood vessels. It does not analyze samples taken from the body.
- The intended use describes a device for directing a catheter and measuring physiological parameters in vivo. This is a clear indication of an invasive medical device used within the body, not for testing samples outside the body.
- The device description details a guidewire with a pressure sensor inserted into blood vessels. This further reinforces its function as an in-vivo measurement tool.
Therefore, the Comet II Pressure Guidewire falls under the category of an invasive medical device used for diagnostic and interventional procedures within the cardiovascular system, not an IVD.
N/A
Intended Use / Indications for Use
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.
Intended Use
The Comet II Pressure Guidewire measures the blood pressure gradient across coronary and peripheral lesions during endovascular procedures. The Comet II Pressure Guidewire may also be used as a coronary or peripheral guidewire for interventional treatments.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DQX
Device Description
Comet™ II is a coronary and peripheral quidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" quidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signal processing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet II remains within the scope of the predicate intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral blood vessels
Indicated Patient Age Range
Not Found
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)
Non-clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data.
Bench Testing
Bench testing was performed to evaluate physical integrity, functionality, and performance of the Comet II Pressure Guidewire. Performance criteria includes dimensional requirements, pressure gradient measurement (sensor) requirements, and interface with compatible devices.
Clinical Testing
Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II.
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.
Comet™ Pressure Guidewire K151610
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
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 23, 2019
Boston Scientific Corporation Kimberly Berg Sr. Regulatory Affairs Specialist Three Scimed Place Maple Grove, Minnesota 55311-1566
Re: K193279
Trade/Device Name: Comet™ II Pressure Guidewire Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQX Dated: November 25, 2019 Received: November 27, 2019
Dear Kimberly Berg:
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 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
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Indications for Use
510(k) Number (if known)
Device Name Comet™ II Pressure Guidewire
Indications for Use (Describe)
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.
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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510(k) Summary per 21 CFR §807.92
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Kimberly Berg
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2701
Fax: 763-494-2981
e-mail: Kimberly.Berg@bsci.com |
| Prepared by | Kimberly Berg
November 25, 2019 |
| Proprietary Name | Comet™ II Pressure Guidewire |
| Common Name | Transducer, Pressure, Catheter Tip |
| Product Code | DXO, DQX |
| Classification | Class II, 21 CFR Part 870. 2870 |
| Predicate Device | Comet™ Pressure Guidewire
K151610 October 6, 2019 |
4
300 Boston Scientific Way Marlborough, MA 01752-1234 508-683-4000 www.bostonscientific.com
Device Description
Comet™ II is a coronary and peripheral quidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" quidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signal processing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet II remains within the scope of the predicate intended use.
Indications for Use / Intended Use
Intended Use
The Comet II Pressure Guidewire measures the blood pressure gradient across coronary and peripheral lesions during endovascular procedures. The Comet II Pressure Guidewire may also be used as a coronary or peripheral guidewire for interventional treatments.
Indications for Use
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.
Comparison of Technological Characteristics
The Comet II Pressure Guidewire incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate, Comet Pressure Guidewire, K151610.
Non-clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data.
Bench Testing
Bench testing was performed to evaluate physical integrity, functionality, and performance of the Comet II Pressure Guidewire. Performance criteria includes dimensional requirements, pressure gradient measurement (sensor) requirements, and interface with compatible devices.
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Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
300 Boston Scientific Way Marlborough, MA 01752-1234 508-683-4000 www.bostonscientific.com
Clinical Testing
Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II.
Conclusion
Based on the indications for use, technological characteristics, and performance testing the Comet II Pressure Guidewire has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Comet Pressure Guidewire, K151610.