PRIMEWIRE PRESTIGE PLUS

K111395 · Volcano Corporation · DQX · Aug 1, 2011 · Cardiovascular

Device Facts

• Record ID: K111395
• Device Name: PRIMEWIRE PRESTIGE PLUS
• Applicant: Volcano Corporation
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device 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.

Device Story

Steerable 0.014" guide wire with pressure transducer mounted 3 cm proximal to tip; used to measure intravascular blood pressure. Operates by connecting to SmartMap®, s5™ Family, or ComboMap® systems to provide hemodynamic data. Used in clinical settings (e.g., cath lab) by physicians during diagnostic or interventional procedures. Enhancements include hydrophilic coating for improved torqueability and lubricity compared to predicate. Output displayed on compatible systems to assist clinicians in diagnosing and treating blood vessel disease.

Clinical Evidence

Bench testing only. Performance verified via design verification plan including biocompatibility (ISO 10993-1), particulate testing (USP 788), tensile strength, and torqueability. No clinical data presented.

Technological Characteristics

0.014" diameter guide wire; 185 cm or 300 cm lengths; pressure transducer 3 cm from tip. Features hydrophilic coating. Biocompatibility per ISO 10993-1. Connectivity via preconnected cable to Volcano console systems. Sterilization method leveraged from predicate.

Indications for Use

Indicated for patients undergoing diagnostic angiography or interventional procedures requiring blood pressure measurement in coronary or peripheral vessels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PrimeWire PRESTIGE® Pressure Guide Wire (K100930)

Submission Summary (Full Text)

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K111395

Volcano Corporation July 25, 2011

PrimeWire PRESTIGE®Plus Pressure Guide Wire Special 510(k)

#### 510 (K) Summary

AUG - 1 2011

# PrimeWire PRESTIGE® Plus Pressure Guide Wire

| Date Prepared: | July 7, 2011 | |
|----------------------|-----------------------------------------------------------------------------------|-------------|
| Submitted by: | Volcano Corporation<br>3661 Valley Centre Dr.<br>Suite 200<br>San Diego, CA 92130 | |
| Contact person: | Marilyn Pourazar<br>Senior Director of Regulatory Affairs | |
| Phone number: | [phone] | |
| Facsimile number: | [phone] | |
| Device Name: | PrimeWire PRESTIGE® Plus Pressure Guide Wire | |
| Classification name: | > 870.1330 Catheter guide wire | Class<br>II |
| | > 870.2870 Catheter tip pressure transducer | II |

#### Predicate Device:

The Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire is substantially equivalent to the following:

| 510(k) Number | Product Name | Clearance Date |
|---------------|-----------------------------------------|----------------|
| K100930 | PrimeWire PRESTIGE® Pressure Guide Wire | April 30, 2010 |

#### Device Description:

The PrimeWire PRESTIGE® Plus pressure guide wire is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The PrimeWire PRESTIGE® Plus guide wire measures pressure when used with the SmartMap®, s5™ Family, and ComboMap® systems. The PrimeWire PRESTIGE® Plus guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm, and also in straight or pre-shaped tips. The PrimeWire PRESTIGE® Plus guide wire is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.

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#### Intended Use:

The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device 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.

### Device Technological Characteristics and Comparison to Predicate Device:

The Volcano Corporation PrimeWire PRESTIGE® Plus Pressure Guide Wire Device is substantially equivalent to the predicate device, PrimeWire PRESTIGE® Pressure Guide Wire.

The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device uses the same fundamental scientific technology and has the same intended use as that of the predicate device.

#### Performance Data:

Applicable testing was performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of enhancements to the device and components. The test results indicate the PrimeWire PRESTIGE® Plus Pressure Guide Wire is comparable to the predicate device.

| Design Input Description | Design Change | Required Testing,<br>Leveraged or<br>Justification |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Working Length - product shall come<br>in 185cm and 300 cm lengths | No change from predicate device. | Testing |
| Flexible Distal Length - length of<br>flexible section shall be ~ 30 cm in<br>length | No change from predicate device. | Testing |
| Distal Radiopaque Length - length<br>of distal tip shall be 3.0 cm | No change from predicate device. | Testing |
| Design Input Description | Design Change | Required Testing,<br>Leveraged or<br>Justification |
| Maximum outer diameter of .0145" | No change from predicate device. | Justification –<br>100% verified in<br>manufacturing |
| The distal 1.0 cm of the wire shall be<br>equivalent stiffness to the predicate<br>device tip. | No change from predicate device. | Testing |
| Better torqueability than predicate<br>device in distal or tortuous anatomy. | Replaced silicon-based coating with<br>hydrophilic coating | Testing |
| Maintain lubricity within the body<br>throughout procedure (approx. 60<br>minutes). | Replaced silicon-based coating with<br>hydrophilic coating | Testing |
| Particulate generation in simulated use<br>shall meet USP 788: Maximum of 3000<br>particles $\ge$ 10 microns; maximum of<br>300 particles $\ge$ 25 microns. | Replaced silicon-based coating with<br>hydrophilic coating | Testing |
| Sensor Housing to Core Tensile shall<br>be $\ge$ 1.0 pounds. | No change from predicate device. | Testing |
| Tip Tensile $\ge$ 1.0 pounds. | No change from predicate device. | Testing |
| Turns to Failure $\ge$ 10 turns | No change from predicate device. | Testing |
| Wire connector must withstand 10<br>insertions in connector. | No change from predicate device. | Testing |
| Sensor shall have same accuracy as<br>predicate device | No change from predicate device. | Leveraged from<br>previously cleared<br>predicate device |
| Sensor drift shall not exceed 5 mmHG<br>in 10 minutes | No change from predicate device. | Leveraged from<br>previously cleared<br>predicate device and<br>100% verified in<br>manufacturing |
| Subjecting PLUS to clinically relevant<br>tortuosity shall not cause erratic output | No change from predicate device. | |
| 3 year shelf life | Replaced silicon-based coating with<br>hydrophilic coating | Testing |
| Biocompatibility | Replaced silicon-based coating with<br>hydrophilic coating | Testing |
| Packaging | No change from predicate device. | Leveraged from<br>previously cleared<br>predicate device |
| Sterilization | No change from predicate device. | Leveraged from<br>previously cleared<br>predicate device |

## Summary of Performance Characteristics

#### K111395 2

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# Biocompatibility Studies:

The biocompatibility of the PrimeWire PRESTIGE® Plus was verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices and FDA Memorandum # G95-1. Test results confirmed biocompatibility of the pressure wire was tested as an external communicating, circulating blood contact, limited exposure (<24 hrs) device.

The following table summarizes biocompatibility test results on the following PrimeWire PRESTIGE® Plus materials:

| Test Description | Results |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Cytotoxicity Study using the Colony Assay Extraction Method | Pass |
| ISO Intracutaneous Study (Irritation Test), Extract 0.9% NaCl | Pass |
| ISO Intracutaneous Study (Irritation Test), Extract Sesame Oil | Pass |
| ISO Systemic Toxicity Study, Sesame Oil | Pass |
| ISO Systemic Toxicity Study, 0.9% NaCl | Pass |
| ISO Maximum Sensitization Study, Extract Sesame Oil | Pass |
| ISO Maximum Sensitization Study, Extract 0.9% NaCl | Pass |
| Pyrogen Study, Material Mediated, 0.9% NaCl | Pass |
| ASTM Partial Thromboplastin Time - Plasma Extract | Pass |
| ASTM Hemolysis CMF PBS Extract | Pass |
| C3a Complement Activation (Hemocompatibility), Normal<br>Human Serum Extract | Pass |
| SC5b-9 Complement Activation (Hemocompatibility), Human<br>Serum Extract | Pass |
| In Vivo Thromboresistance Study, Peripheral Vessel / Jugular<br>Vein (vessel to be determined based on device evaluation)<br>(Note: the control device will be identified in the NAMSA<br>protocol before test execution) | Pass |
| Preliminary Extraction, Japanese MHLW | Pass |
| Exaggerated Extraction Method 1 or 2, Japanese MHLW (test<br>type depends on preliminary extraction results) | Pass |
| Maximum Sensitization Study, Method 1 or 2, MHLW (test<br>type depends on preliminary extraction results) | Pass |

Image /page/3/Picture/6 description: The image contains a sequence of digits and a letter. The sequence starts with the letter 'K', followed by four instances of the digit '1', and then the digits '395'. There is also a small superscript '4' to the right of the number.

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Volcano Corporation July 25, 2011

# Conclusion:

The Volcano PrimeWire PRESTIGE® Plus Pressure Guide Wire Device has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, PrimeWire PRESTIGE® Pressure Guide Wire. The design enhancements to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the modified device to the predicate device.

\$\qquad K11139\overline{5}^{5}\$

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines representing the eagle's body. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Volcano Corporation c/o Ms. Marilyn Pourazar Senior Director, Regulatory Affairs 3661 Valley Centre Drive Suite 200 San Diego, CA 92130

AUG - 1 2011

Re: K111395 Trade/Device Name: PrimeWire PRESTIGE® Plus Pressure Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQX Dated: July 12, 2011 Received: July 13, 2011

Dear Ms. Pourazar:

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, Dr re 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 contractly and i warranties. We remind you, however, that device labeling must be truthful and not much you

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 if 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Marilyn Pourazar

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutfDA/CentersQffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

K

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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510(k) Number (if known): K11395

Device Name: PrimeWire PRESTIGE® Plus Pressure Guide Wire Device

Indications for Use:

The PrimeWire PRESTIGE® Plus Pressure Guide Wire Device 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.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Division of Cardiovascular Devices

510(k) Numbe

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