(26 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Comet™ II Pressure Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report for a new device's performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop study, is not present in the provided text.
Specifically, the text states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This indicates that a comprehensive clinical trial with human subjects to prove the device meets specific acceptance criteria typical of an AI-driven medical device (like those involving multi-reader multi-case studies, expert consensus on ground truth, or analysis of human reader improvement with AI assistance) was not performed or not required for this 510(k) clearance.
The study described is primarily non-clinical performance bench testing.
Here's a breakdown of the requested information based only on the provided text, with clear indications where the information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Performance criteria includes dimensional requirements, pressure gradient measurement (sensor) requirements, and interface with compatible devices." However, specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) and the corresponding reported performance values from these bench tests are not detailed in the provided text.
| Performance Criterion | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Dimensional Requirements | Not specified (e.g., within X mm) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Pressure Gradient Measurement (Sensor) Requirements | Not specified (e.g., accuracy +/- X mmHg, drift within Y%) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Interface with Compatible Devices | Not specified (e.g., successful connection X% of time) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Overall Performance | "Shown to be appropriate for its intended use" and "substantially equivalent to the Comet Pressure Guidewire, K151610." | "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench testing" which would involve a sample size of devices, but the number is not provided.
- Data Provenance: Not specified. As it's bench testing, country of origin related to patient data is not applicable. The data would be newly generated from the bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for bench testing of a pressure guidewire would be established by calibrated instruments and established engineering standards, not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth for bench testing is objectively measured by instruments, not subject to human interpretation or adjudication methods.
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, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This type of study would be relevant for devices involving AI assistance to human readers, which this guidewire is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an AI algorithm. This device is a physical pressure guidewire that measures physiological parameters. Its "performance" is its ability to accurately measure pressure and direct a catheter, relying on its internal sensor and physical properties, not a standalone AI algorithm. The text states it interfaces with a "Boston Scientific iLab Polaris™ Multi-Modality Guidance System" which "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." While this system performs calculations, it's not described as a standalone AI algorithm whose performance needs to be evaluated independently of the device's physical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "pressure gradient measurement (sensor) requirements," the ground truth would typically be established by reference standard measurements from highly accurate and calibrated pressure transducers used in a controlled laboratory setting (bench testing).
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI models. Its performance is based on its physical design, manufacturing, and calibration, not learned from data.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this device.
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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
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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 Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Name andInformation | Kimberly BergThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-2701Fax: 763-494-2981e-mail: Kimberly.Berg@bsci.com |
| Prepared by | Kimberly BergNovember 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 GuidewireK151610 October 6, 2019 |
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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.
§ 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).