The Paladin System with Integrated Embolic Protection (IEP) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin System with IEP should always be used in conjunction with an available embolic protection device.

Device Description

The Paladin System is a sterile, single use, rapid exchange (RX) PTA catheter with a nitinol-based filter between the PTA balloon and the distal tip of the catheter. The balloon has radiopaque markers to aid in accurate positioning under fluoroscopic guidance. The dilation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Paladin has balloon diameters Ø of 5.0 mm and 5.5 mm and balloon lengths of 20 mm and 30 mm. The embolic protection filter is composed of a nitinol braid chassis with an overlying polyurethane membrane with radiopaque markers on either end and radiopaque markers on the filter. The catheter has a guidewire lumen, an inflation/deflation lumen, and a filter activation wire lumen. The guidewire lumen permits the passage of a guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal end of the catheter has a handle that controls activation. The filter is identical across all sizes of balloons and can be expanded to a maximum diameter of 7 mm. The Paladin System is designed to be introduced through a 6 French vascular sheath.

AI/ML Overview

The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets those criteria in a format applicable to evaluating AI/ML models (e.g., performance metrics like accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, or ground truth establishment).

The document is a 510(k) summary for the "Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection." It focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Instead of acceptance criteria and a study proving their fulfillment, the document provides:

Indications for Use: The Paladin System is indicated for Percutaneous Transluminal Angioplasty (PTA) in carotid arteries and post-dilation of self-expanding stents in carotid arteries, with integrated embolic protection.
Summary of Non-Clinical Data: This includes design verification in-vitro testing (e.g., dimensional verification, torque response, balloon burst pressure, embolic capture efficiency), biocompatibility testing, and animal testing (acute and chronic studies in swine). These tests are designed to demonstrate the device's physical and biological safety and performance characteristics, but they are not presented as numerical acceptance criteria against reported device performance in the context of an AI/ML system's evaluation.
Summary of Clinical Data: A multi-center study in Germany with 106 subjects assessing acute safety and clinical performance.
- Primary Outcome: Combined major adverse event (MAE) rate at 30 days (stroke, myocardial infarction, death) was 0.98%.
- Related Events: One major stroke at day 12 (antiplatelet non-compliance), attributed to patient non-compliance, not the device.
- Procedural Success Rate: 100%
- Technical Success Rate: 99%
- Patient Demographics: Age, gender, diabetes, hypertension, hyperlipidemia, smoking status, symptomatic status, lesion length, and percent diameter stenosis.

Therefore, it is not possible to generate the requested table and information as the provided text pertains to a medical device's 510(k) submission, not an AI/ML model's performance evaluation.

The document describes the traditional regulatory process for a medical device (a physical system) and its clinical trial outcomes, not the validation of an algorithmic device with respect to specific performance metrics like those typically outlined for AI/ML.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

September 6, 2018

Contego Medical, LLC % Debra Cogan Regulatory Consultant QRAC, LLC 14906 Conway Avenue San Jose, California 95124

Re: K181128

Trade/Device Name: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, NTE Dated: August 7, 2018 Received: August 9, 2018

Dear Debra Cogan:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/6 description: The image shows the name "Finn E. Donaldson -S" in large, bold font on the left side. On the right side, there is a digital signature block that includes information such as the signer's name, organizational details (DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People), and a date and time stamp (Date: 2018.09.06 08:00:46 -04'00'). The signature block indicates that the document was digitally signed by Finn E. Donaldson -S.

for

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K181128

Device Name

Paladin® Carotid Post-Dilation Balloon System with Integrated Embolic Protection

Indications for Use (Describe)

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)

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}------------------------------------------------

510(k) Summary [per 21 CFR 807.92]

Date Prepared:	April 27, 2018
Applicant:	Contego Medical, LLC3921 Sunset Ridge Rd., Suite 102Raleigh, NC 27607
Contact Person:	Debra CoganRegulatory Affairs Consultant toContego Medical, LLCPhone: (408) 515-0820Fax: (408) 273-6047dcogan@contegomedical.com
Proprietary Name:	Paladin Carotid Post-Dilation Balloon System with Integrated EmbolicProtection
Common Name:	Carotid Post-Dilation Balloon System with Integrated EmbolicProtection
Device Classification:	Class II
Regulation Number:	870.1250
Classification Name:	Percutaneous Catheter
Product Code:	LIT, NTE
Device Description:	The Paladin System is a sterile, single use, rapid exchange (RX) PTAcatheter with a nitinol-based filter between the PTA balloon and thedistal tip of the catheter. The balloon has radiopaque markers to aid inaccurate positioning under fluoroscopic guidance. The dilation balloonis designed to inflate to a known diameter and length at a specificinflation pressure. Paladin has balloon diameters Ø of 5.0 mm and 5.5mm and balloon lengths of 20 mm and 30 mm.
	The embolic protection filter is composed of a nitinol braid chassis withan overlying polyurethane membrane with radiopaque markers oneither end and radiopaque markers on the filter. The catheter has aguidewire lumen, an inflation/deflation lumen, and a filter activation wirelumen. The guidewire lumen permits the passage of a guidewire tofacilitate advancement of the catheter to and through the stenosis to bedilated. The proximal end of the catheter has a handle that controlsactivation.
	The filter is identical across all sizes of balloons and can be expandedto a maximum diameter of 7 mm.
	The Paladin System is designed to be introduced through a 6 Frenchvascular sheath.

{4}------------------------------------------------

Indications for Use:	The Paladin System with Integrated Embolic Protection (IEP), isindicated for Percutaneous Transluminal Angioplasty (PTA) in thecarotid arteries with capture and removal of embolic material. Thisdevice is also indicated for post-dilation of self-expanding stents in thecarotid arteries with capture and removal of embolic material. Thediameter of the arterial site for filter deployment should be no more than7.0 mm. The Paladin System with IEP should always be used inconjunction with an available embolic protection device.
Predicate Device(s):	Boston Scientific Corp. Sterling Monorail Balloon Dilatation Catheter(K141150) - Primary predicateAbbott Vascular RX ACCUNET Embolic Protection System (K153086)
Comparison ofTechnologicalCharacteristics	Paladin has the same intended use as the predicate devices. Thematerials, design, and performance characteristics are similar. Balloonlengths and diameters are within the same range as the SterlingMonorail Balloon Dilatation Catheter. The filter element is intended tocapture and remove embolic material while performing angioplasty andstenting procedures in the carotid arteries, which is the same as the RXACCUNET Embolic Protection System. All devices are provided sterile,for single use only.
Summary of Non-Clinical Data	Design Verification in-vitro testing:The following in-vitro bench tests were completed on the PaladinSystem in accordance with the requirements of Guidance for Industryand FDA Staff - Class II Special Controls Guidance Document forCertain Percutaneous Transluminal Coronary Angioplasty (PTCA)Catheters, September 8, 2010, and Coronary and Carotid EmbolicProtection Devices - Premarket Notification [510(k)] Submissions,February 15, 2008, which verify that it meets the required performancespecifications.Dimensional Verification Simulated Use Torque Response Balloon Rated Burst Pressure / Balloon Compliance Balloon Fatigue Inflation / Deflation time Catheter Bond Strength / Tip Tensile Strength Flexibility and Kink Testing Torque Strength Embolic Capture Efficiency and Retrieval Ability Stent Compatibility (the Paladin System wastested with the Cordis Precise Stent) Filter Capacity Resistance to Filter Rupture Flow Characteristics Balloon Rated Burst Pressure (in-stent) Balloon Fatigue (in-stent) Shelf Life
	Biocompatibility Testing:Biocompatibility testing for the Paladin System has been completed inaccordance with the recommendations of Guidance for Industry andFDA Staff - Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing within arisk management process" - Issued June 16, 2016, for an externalcommunicating device with limited exposure (i.e. whose contact withcirculating blood is ≤ 24 hours).Animal Testing:Two animal studies were conducted in the swine model. The first wasan acute study in one animal which assessed the ability to deploy thePaladin device through a pre-deployed stent. A second GLP studyinvolved 12 animals treated with the Paladin platform through deployedstents. Animals were survived to 30 days and six months to assesshistological safety. Both studies found the device to be well toleratedand safe based on local and dependent tissue response in the healthyswine model.
Summary of ClinicalData:	A Multi-Center Study to Evaluate Acute Safety and ClinicalPerformance of the Paladin System was conducted at five centers inGermany to assess the safety and clinical performance of the device inadults requiring percutaneous intervention of an asymptomatic (> 70%)or symptomatic (>50%) internal carotid artery stenosis. A total of 106subjects were followed through 30 days to evaluate safety, deviceperformance and clinical endpoints. A primary embolic protectiondevice was used distal to and in conjunction with the Paladin Systemfor this study. Patient demographics for age, gender and disease arepresented in Table 1. Carotid stents post-dilated with the PaladinSystem include the Roadsaver® Carotid Stent (Terumo), the Xact®Carotid Stent (Abbott Vascular), the Cristallo Ideale™Carotid Self-Expanding Stent (Medtronic), the Wallstent® Endoprosthesis (BostonScientific), the Precise® Stent (Cordis) and the Adapt™ Monorail(Boston Scientific). The combined major adverse event (MAE) rate at30 days for all stroke, myocardial infarction and death was 0.98%.There was one major stroke caused by acute stent thrombosis at day12 (antiplatelet non-compliance). The MAE rate at discharge was 0%.No events were related to the use of the Paladin System. Theprocedural success rate was 100%, and the technical success was99%.Table 1. Patient demographics
	Daladin Study (n-106)Darsmator

{5}------------------------------------------------

Parameter	Paladin Study (n=106)
Age, SD	69.6, 8.3
(min, max)	(47, 88)
Gender Male	74.5
Diabetics %	37.1
Hypertension %	82.1
Hyperlipidemia %	84
Current Smoker %	33
Symptomatic %	19.8
Lesion Length, SD	14.8,6.3
(Min, Max)	(3.4, 40.0)
% diameter stenosis, SD	83.6, 8.6
(min, max)	(50, 99)
History of Neck Radiation %	5.7

{6}------------------------------------------------

The Paladin System is substantially equivalent to the predicate Conclusion: devices with respect to indications for use, labeling, materials, mode of operation and technological characteristics.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).