SPECTRANETICS VISISHEATH DILATOR SHEATH

K092378 · Spectranetics Corp. · DRE · Nov 2, 2009 · Cardiovascular

Device Facts

• Record ID: K092378
• Device Name: SPECTRANETICS VISISHEATH DILATOR SHEATH
• Applicant: Spectranetics Corp.
• Product Code: DRE · Cardiovascular
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

Device Story

Single lumen polymer sheath; used independently or as support for inner sheath to facilitate tissue dilation. Features 45° angle cut at one end and blunt tip at other; metallic radiopaque marker bands at both ends for fluoroscopic visualization; exterior mark for orientation. Available in multiple diameters and lengths. Used by clinicians in clinical settings to dilate tissue around cardiac leads, catheters, or foreign objects, and to support intravascular catheter introduction. Device provides mechanical dilation and access support; radiopaque markers assist physician in positioning under fluoroscopy.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Single lumen polymer sheath; metallic radiopaque marker bands; 45° angle cut and blunt ends; multiple diameter and length options. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, or foreign objects, and for the introduction and support of intravascular catheters.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Submission Summary (Full Text)

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K07237S

510(k) Premarket Notification 510(k) Summary of Substantial Equivalence Visisheath Dilator Sheath

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

NOV - 2 2009

Proprietary Name:

Common Name:

Classification Name:

Device Classification:

Product Classification and Code:

Classification Panel:

Establishment Registration Number: 3007284006

Contact Person:

Cardiovascular Devices Cheryl Hastings Regulatory Affairs

21 CFR 870.1310, DRE

Visisheath™ Dilator Sheath

dilator, vessel, for percutaneous

Dilator sheath

catheterization

Class II

Spectranetics Corporation 9965 Federal Drive Colorado Springs, CO 80921

Telephone: [phone] Facsimile: [phone] E-mail: Cheryl.hastings(a)spnc.com

#### Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

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#### Device Description

The VisiSheath™ Dilator Sheath is a single lumen polymer sheath used independently or as a support for an inner sheath to facilitate tissue dilation. One end is terminated with a 45° angle cut, while the other end is blunt. Both ends contain a metallic radiopaque marker band to enable fluoroscopic identification of tip location and orientation. An additional exterior mark aligned with the tip of the 45° angle cut permits visual identification of sheath orientation. There are multiple diameter and length options available.

#### Indication for Use

The VisiSheath™ Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

### Substantially Equivalent Devices

In Spectranetics' opinion, the VisiSheath™ Dilator Sheath is believed to be substantially equivalent to the predicate device.

#### Summary of Studies

Spectranetics performed device functional testing to support that the VisiSheath™ Dilator Sheath functions as intended. All device functional test results for the VisiSheath™ Dilator Sheath met specified requirements.

#### Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the Spectranetics VisiSheath™ Dilator Sheath through this 510(k) Premarket Notification.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Spectranetics Corp. ATTN: Cheryl Hastings Regulatory Affairs and Compliance Manager 9965 Federal Drive Colorado Springs, CO 80921

NOV - 2 2009

Re: K092378

Trade/Device Name: Spectranetics VisiSheath Dilator Sheath Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: July 24, 2009 Received: August 19, 2009

Dear Ms. Hastings:

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.

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 (reporting of medical

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#### Page 2 - Ms. Hastings

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CentersOffices/CDRH/CDRHOffices/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,

W.M.R.

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number K092378

Device Name: Spectranetics VisiSheath™ Dilator Sheaths

Indications for Use:

The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

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 OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| 510(k) Number | K092378 |
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