LLD EZ

K142116 · Spectranetics, Inc. · DRB · Aug 12, 2014 · Cardiovascular

Device Facts

• Record ID: K142116
• Device Name: LLD EZ
• Applicant: Spectranetics, Inc.
• Product Code: DRB · Cardiovascular
• Decision Date: Aug 12, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1380
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

Device Story

LLD EZ is a lead locking device designed to facilitate the transvenous extraction of chronically implanted pacing or defibrillator leads. The device is inserted into the inner lumen of the lead to provide mechanical stability and locking, allowing the physician to apply traction during the extraction procedure. Used in a clinical setting (e.g., OR or cath lab) by physicians specializing in lead management. The device acts as a mechanical tool to assist in the removal of leads that have become fibrosed or otherwise difficult to extract, potentially reducing the risk of lead fragment retention and improving procedural outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Mechanical lead locking device designed for insertion into the inner lumen of pacing or defibrillator leads. The device provides a locking mechanism to facilitate traction during lead extraction. It is a non-powered, manual surgical instrument.

Indications for Use

Indicated for patients requiring transvenous removal of chronically implanted pacing or defibrillator leads with an inner lumen via a superior venous approach.

Regulatory Classification

Identification

A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.

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

August 12, 2014

Spectranetics, Inc. Pharoah Garma Regulatory Affairs Manager 9965 Federal Drive Colorado Springs, Colorado 80921

Re: K142116 Trade/Device Name: LLD EZ Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: August 1, 2014 Received: August 4, 2014

Dear Pharoah Garma,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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.

Arthel Stein

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

Enclosure

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## Indications for Use

510(k) Number (if known) K142116

Device Name LLD EZ

Indications for Use (Describe)

The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach.

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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## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.08.12
12:05:09 -04'00'

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