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.

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 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.

AI/ML Overview

The Liberator® Beacon® Tip Locking Stylet (and its associated stylet wires) underwent several tests to ensure reliable design and performance and to demonstrate substantial equivalence to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided text does not explicitly state the specific numerical acceptance criteria for each test (e.g., "minimum pull strength force of X Newtons"). It only confirms that "The acceptance criterion was met" for each test. Therefore, the table below reflects what is verbally stated as acceptance criteria and how the device performed against them.

Test Name	Acceptance Criteria (Stated)	Reported Device Performance
Complete Device Test	Withstood the established minimum pull strength force.	Met
Collar Tubing Test	Collar tubing materials and solder joints withstood the established minimum pull strength force.	Met
Collar Cable Test	Collar cable materials and solder joints withstood the established minimum pull strength force.	Met
Mechanical Pull Test	Device locked into a simulated cardiac lead withstood the established minimum pull strength force.	Met
Radiopacity Test	Distal end of the locking stylet is radiopaque.	Met
Biocompatibility Testing	Passed tests for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, hemolysis, partial thromboplastin time, complement activation, and material mediated pyrogenicity.	Met (Determined to be biocompatible per ISO 10993-1 and FDA guidance)
Stylet Wires - Pull Strength	Stylet wire withstood the established minimum pull strength force.	Met
Stylet Wires - Cardiac Lead Insertion / Retraction	Stylet wires can pass in and out of a "wet" lead coil a total of two cycles.	Met
Stylet Wires - Biocompatibility Testing	Applicable testing for the main device confirmed biological compatibility.	Met

The provided document describes physical and biological performance tests, not a clinical study involving human patients or ground truth consensus among experts. Therefore, several requested categories are not applicable to this type of submission.

Here's the breakdown:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes used for each test.
- The data provenance is not explicitly mentioned, but these are typically in-house testing results from the device manufacturer (Cook Incorporated, in Bloomington, IN, USA). The studies are prospective in nature, as they are conducted specifically for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This submission involves engineering and biocompatibility testing, not clinical data requiring expert human interpretation or "ground truth" establishment in a medical context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3. Testing results are typically evaluated against pre-defined engineering specifications.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a hardware device (a stylet) and not an AI/software as a medical device (SaMD). No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm. The "stand-alone" performance refers to the device's inherent physical and material characteristics as tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests are pre-defined engineering specifications and widely accepted international standards (e.g., ISO 10993-1 for biocompatibility) and FDA guidance for medical device testing. For example, a "minimum pull strength force" would be a specific numerical value derived from design requirements and clinical needs for the device's function.
The sample size for the training set
- Not applicable. No training set is used as this is not a machine learning or AI device.
How the ground truth for the training set was established
- Not applicable. No training set is used.

Summary

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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.

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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 (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

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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)
-------------------------------------------------	------------------------------------------------------	------------------------------------------------------

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

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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 LockingStylet (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
Indicationsfor Use	The Locking Stylet 2 is intended for useduring the percutaneous removal ofcardiac leads, indwelling catheters andforeign objects having a central lumen.	The Liberator® Beacon® Tip LockingStylet is intended for use in patientsrequiring the percutaneous removal ofcardiac leads, indwelling catheters andforeign objects, with a central lumen
Method ofactivation	Handle Slide Mechanism	Identical
Stylet Wire	304 Stainless Steel	Identical
Cannula	304 Stainless Steel	Identical
Lockingmechanism	Wire and Collar - 304 Stainless Steel	Wire Bundle - 304 Stainless Steel
RadiopaqueMarker	N/A	Platinum clad Tantalum
Solder	Silver Bearing(6% Ag / 94% Sn)	Identical
Latch Clip	304 Stainless Steel	302 Stainless Steel
Cable	N/A	304 Stainless Steel
Wire(Handle)	Nickel-Chromium	Identical
Method ofoperation	The Locking Stylet 2 is inserted into thecentral lumen of a cardiac lead or catheterand advanced to the distal end. Thelatchpin, which is inserted into the pinhole on the tubular handle keeping thedevice in the disengaged position, isremoved. To engage, the tubular handleportion of the Locking Stylet 2 is pushedforward while holding the loop handlestationary. This causes the wire exitingthe proximal end of the distal cannula toprotrude and engage into the inner surfaceof the central lumen. The capturedindwelling object is then withdrawn withthe Locking Stylet 2 by gently pulling onthe loop handle while maintaining tensionbetween the tubular handle portion andloop handle.	The Liberator® Beacon® Tip LockingStylet is inserted into the central lumenof a cardiac lead or catheter andadvanced to the distal end. The latchpin,which is inserted into the pin hole on thetubular handle keeping the device in thedisengaged position, is removed. Toengage, the tubular handle portion of theLiberator® Beacon® Tip Locking Styletis pushed forward while holding theintegral wire extender stationary. Thiscauses the wire bundle exiting theproximal end of the distal cannula toprotrude and engage into the innersurface of the central lumen. Thecaptured indwelling object is thenwithdrawn with the Liberator® Beacon®Tip Locking Stylet by gently pulling onthe loop handle while maintainingtension between the tubular handleportion and loop handle.
Activationmechanism	Advance cannula to lock stylet	Identical
WorkingLength (cm)	65 cm	70 cm
OverallLength (cm)	72 cm	140 cm
LockingMechanism	Engagement wire	Wire bundle
OperatingRange	.017 to .032 inches	.016 to .032 inches
Othercomponents	None	Stylet wires (available separately)

Substantial Equivalence Table

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Technological Characteristics:

The following tests have been conducted to ensure reliable design and performance under the specified design requirements:

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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.

Regulation Number and Section

§ 870.1380 Catheter stylet.

(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(b)
Classification. Class II (performance standards).