Liberator Beacon Tip Locking Stylet

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 18, 2017 Cook Incorporated Steven Lawrie Regulatory Affairs Manager 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402 Re: K170298 Trade/Device Name: Liberator Beacon Tip Locking Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: September 13, 2017 Received: September 14, 2017 Dear Steven Lawrie: 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 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. {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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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, M.A. Wilhelm for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### Device Name Liberator® Beacon® Tip Locking Stylet Indications for Use (Describe) The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen. | Type of Use (Select one or both, as applicable) | <div> <span> <input type="checkbox"/> </span> </div> | <div> <span> <input type="checkbox"/> </span> </div> | |-------------------------------------------------|------------------------------------------------------|------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------|------------------------------------------------------| X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white letters on the top half. The word "MEDICAL" is in white letters on the bottom half of the rectangle. The bottom left corner of the rectangle is cut off at an angle. #### 510(k) Summary ## Liberator® Beacon® Tip Locking Stylet 21 CFR §870.1380 Date Prepared: January 30, 2017 Cook Incorporated Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104518 Steven Lawrie (812) 332-0281 #### Submitted By: Applicant: Contact: Applicant Address: Contact Phone Number: Contact Fax Number: tact Fax Number: #### Device Information: Trade Name: Common Name: Classification Name: Classification Regulation: Device Class/Classification Panel: Liberator® Beacon® Tip Locking Stylet Locking Stylet Stylet, Catheter 21 CFR §870.1380, Product Code DRB Class II, Cardiovascular ### Predicate Device: - Locking Stylet 2 (K970690) ### Device Description: The Liberator® Beacon® Tip Locking Stylet is a specialized stylet that can be inserted through a cardiac lead's inner conductor lumen, once the proximal connector has been removed. The stylet can then be locked into position within the lead's distal portion allowing for the delivery of tractional forces helpful during the extraction procedure. The Liberator Beacon® Tip Locking Stylet has a braided Nickel-Chromium integral extender (handle). The locking mechanism that is located at the distal end of the stylet is comprised of a uniquely shaped stainless steel wire-locking coil segment attached to a central stainless steel stylet wire. This locking stylet is activated through the forward advancement of a stainless steel cannula that surrounds the central stainless steel stylet wire. Upon activation by the cannula. the wire-locking coil segment at the distal end of {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half of the rectangle. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red trapezoid. The trapezoid is slightly darker than the rest of the red rectangle. the stylet is advanced forward and is compressed. This compression causes the stacking of successive helices of the wire-locking coil. This stacking results in the outward radial displacement of a number of the wire-locking coil's helices against and into the lead conductor coil through which it has been inserted. This outward radial displacement creates the locking engagement of the Liberator® Beacon® Tip Locking Stylet to the lead conductor central or inner lumen. The device is available in a single size compatible with the internal diameter dimensions of many leads and catheters with a central lumen. Stylet wires for checking lead patency are available separately; they consist of a molded plastic handle on a 0.038 cm (0.015 inches) stainless steel wire, with a wire length of 65 cm. ### Intended Use: The Liberator® Beacon® Tip Locking Stylet is intended for use in patients requiring the percutaneous removal of cardiac leads, indwelling catheters and foreign objects, with a central lumen. ### Comparison to Predicate: The subject device is substantially equivalent to the predicate in that it has the same intended use as the predicate. They also have similar technological characteristics, methods of operation, and materials of construction. The substantial equivalence comparison is provided below. | | PREDICATE DEVICE | SUBJECT DEVICE | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Locking Stylet 2 (K970690) | Liberator® Beacon® Tip Locking<br>Stylet (Subject of this Submission) | | Regulation | 21 CFR §870.1330, Catheter Guide Wire | 21 CFR §870.1380, Catheter Stylet | | Product Code | DQX | DRB | | Classification | II | II | | Indications<br>for Use | The Locking Stylet 2 is intended for use<br>during the percutaneous removal of<br>cardiac leads, indwelling catheters and<br>foreign objects having a central lumen. | The Liberator® Beacon® Tip Locking<br>Stylet is intended for use in patients<br>requiring the percutaneous removal of<br>cardiac leads, indwelling catheters and<br>foreign objects, with a central lumen | | Method of<br>activation | Handle Slide Mechanism | Identical | | Stylet Wire | 304 Stainless Steel | Identical | | Cannula | 304 Stainless Steel | Identical | | Locking<br>mechanism | Wire and Collar - 304 Stainless Steel | Wire Bundle - 304 Stainless Steel | | Radiopaque<br>Marker | N/A | Platinum clad Tantalum | | Solder | Silver Bearing<br>(6% Ag / 94% Sn) | Identical | | Latch Clip | 304 Stainless Steel | 302 Stainless Steel | | Cable | N/A | 304 Stainless Steel | | Wire<br>(Handle) | Nickel-Chromium | Identical | | Method of<br>operation | The Locking Stylet 2 is inserted into the<br>central lumen of a cardiac lead or catheter<br>and advanced to the distal end. The<br>latchpin, which is inserted into the pin<br>hole on the tubular handle keeping the<br>device in the disengaged position, is<br>removed. To engage, the tubular handle<br>portion of the Locking Stylet 2 is pushed<br>forward while holding the loop handle<br>stationary. This causes the wire exiting<br>the proximal end of the distal cannula to<br>protrude and engage into the inner surface<br>of the central lumen. The captured<br>indwelling object is then withdrawn with<br>the Locking Stylet 2 by gently pulling on<br>the loop handle while maintaining tension<br>between the tubular handle portion and<br>loop handle. | The Liberator® Beacon® Tip Locking<br>Stylet is inserted into the central lumen<br>of a cardiac lead or catheter and<br>advanced to the distal end. The latchpin,<br>which is inserted into the pin hole on the<br>tubular handle keeping the device in the<br>disengaged position, is removed. To<br>engage, the tubular handle portion of the<br>Liberator® Beacon® Tip Locking Stylet<br>is pushed forward while holding the<br>integral wire extender stationary. This<br>causes the wire bundle exiting the<br>proximal end of the distal cannula to<br>protrude and engage into the inner<br>surface of the central lumen. The<br>captured indwelling object is then<br>withdrawn with the Liberator® Beacon®<br>Tip Locking Stylet by gently pulling on<br>the loop handle while maintaining<br>tension between the tubular handle<br>portion and loop handle. | | Activation<br>mechanism | Advance cannula to lock stylet | Identical | | Working<br>Length (cm) | 65 cm | 70 cm | | Overall<br>Length (cm) | 72 cm | 140 cm | | Locking<br>Mechanism | Engagement wire | Wire bundle | | Operating<br>Range | .017 to .032 inches | .016 to .032 inches | | Other<br>components | None | Stylet wires (available separately) | ## Substantial Equivalence Table {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif letters. Below the word "COOK", the word "MEDICAL" is written in smaller, white letters. # Technological Characteristics: The following tests have been conducted to ensure reliable design and performance under the specified design requirements: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Cook Medical logo. The logo consists of the word "COOK" in white, with a registered trademark symbol, on a red background. Below the word "COOK" is the word "MEDICAL" in white, also on a red background. # Liberator® Beacon® Tip Locking Stylet - Complete Device Test – Testing demonstrated that the complete device withstood the established minimum pull strength force. The acceptance criterion was met. - . Collar Tubing Test – Testing demonstrated that the collar tubing materials and solder joints withstood the established minimum pull strength force. The acceptance criterion was met. - . Collar Cable Test – Testing demonstrated that the collar cable materials and solder joints withstood the established minimum pull strength force. The acceptance criterion was met. - . Mechanical Pull Test – Testing demonstrated that the device locked into a simulated cardiac lead withstood the established minimum pull strength force. The acceptance criterion was met. - Radiopacity Test – Testing demonstrated that the distal end of the locking stylet is radiopaque. The acceptance criterion was met. - . Biocompatibility testing - Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, hemolysis, partial thromboplastin time, complement activation, and material mediated pyrogenicity were performed to ensure the biocompatibility of the subject device. ### Stylet Wires - Pull strength Testing demonstrated that the stylet wire withstood the established ● minimum pull strength force. The acceptance criterion was met. - Cardiac Lead Insertion / Retraction Testing demonstrated that the stylet wires ● can pass in and out of a "wet" lead coil a total of two cycles. The acceptance criterion was met. - Biocompatibility testing Testing performed for the Liberator® Beacon® Tip ● Locking Stylet is also applicable to this component. The results of these tests show that the subject device meets the design input requirements based on the intended use and support the determination that this device is substantially equivalent to the predicate device.