Comet Pressure Guidewire

K151610 · Boston Scientific Corporation · DXO · Oct 6, 2015 · Cardiovascular

Device Facts

• Record ID: K151610
• Device Name: Comet Pressure Guidewire
• Applicant: Boston Scientific Corporation
• Product Code: DXO · Cardiovascular
• Decision Date: Oct 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2870
• Device Class: Class 2

Intended 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.

Device Story

Comet Pressure Guidewire is a 0.014" guidewire with an integrated distal optical pressure sensor; used to direct catheters and measure blood pressure gradients across coronary and peripheral lesions. Operated by physicians during endovascular procedures. The device connects via a detachable optical cable to a Boston Scientific iLab Polaris Multi-Modality Guidance System. The system processes optical signals to display aortic pressure, distal pressure, and calculated Fractional Flow Reserve (FFR). Output assists clinicians in assessing lesion severity to guide interventional treatment decisions. Benefits include real-time physiological monitoring during vascular navigation and intervention.

Clinical Evidence

Bench testing included dimensional verification, tensile/torque strength, catheter compatibility, fracture, coating integrity, sensing accuracy/drift, and biocompatibility. In vivo testing conducted in GLP porcine models to assess pressure sensing accuracy and device thrombogenicity; additional non-GLP porcine studies evaluated radiodetectability and measurement drift. Results demonstrate performance comparable to the predicate device.

Technological Characteristics

0.014" guidewire with integrated distal optical pressure sensor; radiopaque shapeable tip; includes torque device. Connects to external signal-processing module via optical cable. Sterilized via ethylene oxide (EO).

Indications for Use

Indicated for patients undergoing endovascular procedures requiring catheter guidance and measurement of physiological parameters in coronary and peripheral blood vessels.

Regulatory Classification

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.

Predicate Devices

• St. Jude Medical PressureWire™ Certus™ (K131452)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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<br>(per 21 CFR 870.2870) |
| Device Classification: | Class II |
| Product Classification and Code: | DXO, DQX |
| Classification Panel: | Cardiovascular Devices |
| Contact Person: | James Kleinedler, PhD<br>Sr. Regulatory Affairs Specialist<br>Interventional Cardiology<br>Boston Scientific Corporation<br>47215 Lakeview Boulevard<br>Fremont, CA 94538<br>Telephone: [phone]<br>Facsimile: 763-494-2981<br>E-mail: [e-mail] |
| 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.