(113 days)
Not Found
No
The description focuses on the hardware (pressure sensor, guidewire, optical cable) and the calculation of FFR based on a ratio of measured pressures, which is a standard physiological calculation, not an AI/ML algorithm. There is no mention of AI, ML, or related concepts in the text.
No
The device is indicated to direct a catheter and to measure physiological parameters; it does not directly treat or diagnose a disease.
Yes
The device is described as measuring "physiological parameters" and "blood pressure gradient changes," and displaying "various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value." These measurements and calculations are used to assess the patient's physiological state, which is indicative of a diagnostic function.
No
The device description clearly details a physical guidewire with an integrated pressure sensor, optical cable, and torque device, indicating it is a hardware device with a software component for display and calculation.
Based on the provided information, the Comet™ Pressure Guidewire is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Comet™ Function: The Comet™ Pressure Guidewire is used inside the body (in vivo) to measure physiological parameters (blood pressure) directly within blood vessels. It is a tool used during a medical procedure, not for analyzing a specimen in a lab.
The device description and intended use clearly indicate its function is to facilitate a procedure and measure parameters within the patient's body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Comet™ Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
DXO, DQX
Device Description
Comet™ is a coronary and peripheral guidewire 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" guidewire 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 signalprocessing 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 remains within the scope of the predicate intended use. The subject device features a narrower intended use (i.e., FFR) as compared to the PressureWire Certus (i.e., any physiological parameters). Narrower intended use does not raise new questions of safety and/or effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral blood vessels
coronary and peripheral lesions
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)
In Vitro Testing: Dimensional Verification, Surface Evaluation, Tensile Strength, Torque Strength, Torqueability, Tip Stiffness, Catheter Compatibility, Fracture, Flexing Test, Coating Adherence/Integrity, Particulate Evaluation, Corrosion Resistance, Tracking Force, Tip Shape Retention, Sensing Accuracy, Sensing Drift, Interface Challenge, Package Integrity, Sterility and EO Residuals, Biocompatibility, Endotoxin.
In Vivo Testing: Acute performance in a vascular application, pressure sensing accuracy, device thrombogenicity, radiodetectability, and measurement drift were evaluated in GLP and non-GLP porcine models.
Key Results: The results from these in vitro and in vivo tests demonstrate that the technological characteristics and performance criteria of the Comet Pressure Guidewire are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
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
§ 870.2870 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Boston Scientific Corporation James Kleinedler Senior Regulatory Affairs Specialist 47215 Lakeview Boulevard Fremont, California 94538
Re: K151610
Trade/Device Name: Comet Pressure Guidewire Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, DQX Dated: October 1, 2015 Received: October 2, 2015
Dear Dr. Kleinedler:
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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known)
Device Name Comet™ Pressure Guidewire
Indications for Use (Describe)
The Comet™ Pressure Guidewire is indicated to direct a catheter through a blood vessel and to 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Boston Scientific Corporation 47215 Lakeview Boulevard Fremont, CA 94538 763-494-1700 Tel www.bostonscientific.com
510(k) SUMMARY
| Proprietary Name: | Comet™ Pressure Guidewire |
|---|---|
| Common Name: | Pressure Guidewire |
| Classification Name: | Transducer, Pressure, Catheter Tip |
| (per 21 CFR 870.2870) | |
| Device Classification: | Class II |
| Product Classification and Code: | DXO, DQX |
| Classification Panel: | Cardiovascular Devices |
| Contact Person: | James Kleinedler, PhD |
| Sr. Regulatory Affairs Specialist | |
| Interventional Cardiology | |
| Boston Scientific Corporation | |
| 47215 Lakeview Boulevard | |
| Fremont, CA 94538 | |
| Telephone: 763-494-1249 | |
| Facsimile: 763-494-2981 | |
| E-mail: James.Kleinedler@bsci.com | |
| Date Prepared: | June 15, 2015 |
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Performance Standards
Performance standards do not currently exist for this device. None are established under Section 514.
Device Description
Comet™ is a coronary and peripheral guidewire 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" guidewire 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 signalprocessing 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 remains within the scope of the predicate intended use. The subject device features a narrower intended use (i.e., FFR) as compared to the PressureWire Certus (i.e., any physiological parameters). Narrower intended use does not raise new questions of safety and/or effectiveness.
Intended Use
The Comet™ Pressure Guidewire measures blood pressure gradient across coronary and peripheral lesions during endovascular procedures. FFR (Fractional Flow Reserve) pressure guidewire may also be used as a coronary or peripheral guidewire for interventional treatments.
Indications for Use
The Comet™ Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.
Substantially Equivalent Devices
The following predicate device is substantially equivalent to the subject device:
- St. Jude Medical PressureWire™ Certus™ K131452 (cleared September 5, 2013) .
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Brief Comparison Summary
To demonstrate substantial equivalence of the Boston Scientific Comet Pressure Guidewire to the predicate device, technological characteristics and performance criterion were evaluated using in vitro and in vivo testing as indicated below:
In Vitro Testing
Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:
- Dimensional Verification ●
- Surface Evaluation o
- Tensile Strength ●
- Torque Strength ●
- Torqueability
- Tip Stiffness ●
- Catheter Compatibility ●
- Fracture ●
- Flexing Test ●
- Coating Adherence/Integrity ●
- o Particulate Evaluation
- Corrosion Resistance o
- Tracking Force o
- Tip Shape Retention ●
- Sensing Accuracy ●
- Sensing Drift ●
- Interface Challenge ●
- Package Integrity ●
- Sterility and EO Residuals ●
- Biocompatibility ●
- Endotoxin 0
In Vivo Testing
To assess the acute performance of the Comet Pressure Guidewire in a vascular application, in vivo studies were conducted in GLP porcine model to assess pressure sensing accuracy and device thrombogenicity. Additionally, radiodetectability and measurement drift were evaluated in non-GLP porcine models.
The results from these in vitro and in vivo tests demonstrate that the technological characteristics and performance criteria of the Comet Pressure Guidewire are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusion (Statement of Equivalence)
As the indications for use and fundamental scientific technology have not changed, non-clinical performance data supports a determination that the subject device is substantially equivalent to the predicate device, and that it is at least as safe and effective for its intended use.