The Paladin Carotid PTA Balloon 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 Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.

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 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 quidewire 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

This is a 510(k) premarket notification for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device. As such, it does not typically contain extensive clinical trial data or detailed performance studies in the way a PMA (Premarket Approval) application would. The document explicitly states: "The risk analysis activities for the device changes summarized in this Special 510(k) identified that no additional verification or validation activities are required to establish substantial equivalence with predicate devices." This indicates that the submission relies on the previously established performance of the predicate device (K181128) and demonstrates that the modifications made to the current device do not introduce new risks or alter its fundamental performance.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for the current device's performance study is not available in this document. The submission's conclusion is based on showing that the modified device is substantially equivalent to the predicate device, not on new clinical performance data for the modified device.

However, based on the provided text, I can infer some aspects relevant to substantial equivalence:

Indications for Use (Acceptance Criteria for Device Purpose):

The "acceptance criteria" here relate to the device's intended use and functionality being comparable to the predicate. The Indications for Use for both the modified and predicate device are nearly identical, with minor structural variations in the wording.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) aiming for substantial equivalence based on no change in performance or risk, there isn't a new performance study with specific acceptance criteria that the modified device had to meet and report on in this document. The "performance" being demonstrated is the equivalence to the predicate. The key "acceptance criteria" being highlighted are the equivalence of design and function to the cleared predicate.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Modified Paladin System relative to Predicate)
Indications for Use: Same intended use, patient population, and anatomical site.	SAME as predicate device (K181128). Indicated for PTA in carotid arteries with embolic capture, and post-dilation of self-expanding stents in carotid arteries with embolic capture. Max arterial site diameter for filter deployment of 7.0 mm. Always used with an available embolic protection device for post-dilation of self-expanding stents.
Contraindications: No new contraindications.	SAME as predicate device, including contraindications for coronary arteries, inability to tolerate anticoagulant/anti-platelet therapy, hypersensitivity to nitinol, and unresolved bleeding disorders.
Principle of Operations: Same fundamental mechanism of action.	SAME as predicate device, operating on hydraulic pressurization with an inflatable balloon, 0.014" guidewire compatible, with an adjustable nitinol filter frame and urethane filter for embolic capture.
Sterilization: Same method.	SAME as predicate device (EO gas).
Shelf Life: Same duration.	SAME as predicate device (12 months).
Packaging System: Same components and materials.	SAME as predicate device (balloon/filter protective sheath, HDPE spiral dispenser, PET/G snap-top tray, sterile pouch, outer cardboard carton).
Radiopaque Markers: Same type and placement.	SAME as predicate device (two balloon markers, two marker bands distal and proximal to filter, 6 circumferential marker bands on proximal portion of filter).
Angioplasty Balloon Characteristics: Same material properties and design.	SAME as predicate device (Nylon semi-compliant PTA balloon).
Embolic Capture Mechanism: Same design and function.	SAME as predicate device (Self-expanding nitinol filter frame with urethane membrane (40 micron pores) for capture and removal of embolic material).
Filter Diameter: Same adjustable range.	SAME as predicate device (Adjustable filter fits carotid artery diameters up to 7mm diameter).
Usable Length: Same length.	SAME as predicate device (140 cm).
Introducer Sheath Compatibility: Same size.	SAME as predicate device (6 F).
Guidewire Compatibility: Same size.	SAME as predicate device (0.014").
Balloon Diameter: Same available sizes.	SAME as predicate device (5.0 mm and 5.5 mm).
Balloon Length: Same available sizes.	SAME as predicate device (20 mm and 30 mm).
Balloon RBP (Rated Burst Pressure): Same values.	SAME as predicate device (14 atm for 5.0 mm, 11 atm for 5.5 mm).
No New Risks Introduced: The modifications do not introduce new risks or modify existing risks.	Confirmed by risk analysis.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.

3. 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. No new performance study (test set) for the modified device is documented in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission.

5. 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 device is a physical medical device (balloon catheter with embolic protection), not an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance study (test set) for the modified device is documented in this 510(k) submission. The "ground truth" for this submission is demonstrating that the modified device has the same fundamental characteristics and performance as the previously cleared predicate device.

8. The sample size for the training set

Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.

9. How the ground truth for the training set was established

Not applicable. Not applicable. No new training set is mentioned as this device is a physical medical device seeking substantial equivalence based on engineering and design comparisons, not a data-driven model.

Summary of the Study (as presented in the 510(k)):

The "study" presented in this 510(k) is a documentary review and comparison of the modified Paladin System against its predicate device (K181128).

Objective: To demonstrate that the modified Paladin System is substantially equivalent to the predicate device.
Methodology: A detailed comparison of the device description, indications for use, fundamental technological characteristics, and performance specifications (as summarized in the table above) between the modified device and the predicate device. A risk analysis was also conducted.
Findings: The comparison concluded that there are "no change to device design, its principles of operation or expected performance." The risk analysis determined that "no additional verification or validation activities are required" as the changes "do not create any new risks, harms nor were any existing risks altered."
Conclusion: The information is sufficient to establish substantial equivalence.

Summary

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June 9, 2022

Contego Medical, LLC. James Clossick Vice President of Regulatory Affairs 3801 Lake Boone Trail, Suite 100 Raleigh, North Carolina 27607

Re: K221339

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: NTE, LIT Dated: May 10, 2022 Received: May 11, 2022

Dear James Clossick:

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. Although this letter refers to your product as a device, please be aware 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221339

Device Name

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

Indications for Use (Describe)

The Paladin Carotid PTA Balloon 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 Palaon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.

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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510(k) - K221339

Date Prepared	May 26, 2022
Applicant:	Contego Medical, Inc.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607
FDA RegistrationNumber	3011471056
Contact Person:	Mr. Jim ClossickContego Medical, Inc.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607Phone: + 1 305 607 1708Email: Jclossick@contegomedical.com
Proprietary Name:	Paladin® System
Common Name:	Paladin Carotid PTA Balloon System with IntegratedEmbolic Protection
Device Classification:	Class II per 21 CFR §870.1250
Classification Name:	Catheter, Angioplasty, Peripheral, TransluminalTemporary Carotid Catheter for Embolic Capture
Product Code:	LIT, NTE
Predicate Device:	Carotid Post-Dilation Balloon System withIntegrated Embolic Protection (K181128)

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Device Description

Indication for Use

"The Paladin Carotid PTA Balloon 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 Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents."

Parameters	Contego Medical PaladinSystem(modified device)	Contego Medical PaladinSystem(predicate device K181128)
Indications foruse	The Paladin Carotid PTA	The Paladin System with
	Balloon System with	Integrated Embolic Protection
	Integrated Embolic Protection	(IEP) is indicated for
	(IEP), is indicated for	Percutaneous Transluminal
	Percutaneous Transluminal	Angioplasty (PTA) in the carotid
	Angioplasty (PTA) in the	arteries with capture and removal
	carotid arteries with capture	of embolic material. This device
	and removal of embolic	is also indicated for post-dilation
	material. This device is also	of self-expanding stents in the
	indicated for post-dilation of	carotid arteries with capture and
	self-expanding stents in the	removal of embolic material. The
	carotid arteries with capture	diameter of the arterial site for
Parameters	Contego Medical PaladinSystem(modified device)	Contego Medical PaladinSystem(predicate device K181128)
	and removal of embolicmaterial. The diameter of thearterial site for filterdeployment should be nomore than 7.0 mm. ThePaladin Carotid PTA BalloonSystem with IntegratedEmbolic Protection (IEP)should always be used inconjunction with an availableembolic protection devicewhen used for post-dilation ofself-expanding stents.	filter deployment should be nomore than 7.0 mm. The PaladinSystem with IEP should alwaysbe used in conjunction with anavailable embolic protectiondevice.
Common name	Carotid PTA Balloon Systemwith Integrated EmbolicProtection	Carotid Post-Dilation BalloonSystem with Integrated EmbolicProtection
Classification	SAME as 510(k) clearedPaladin System	Class II (21 CFR 870.1250)
Classificationname	SAME as 510(k) clearedPaladin System	Catheter, Angioplasty,Peripheral, TransluminalTemporary Carotid Catheter forEmbolic Capture
Product code	SAME as 510(k) clearedPaladin System	LIT, NTE
Contraindications	SAME as 510(k) clearedPaladin System	Contraindicated for use incoronary arteries.Contraindicated for use inpatients who cannot tolerateanticoagulant or anti-platelettherapyContraindicated for use inpatients with knownhypersensitivity to nitinol.Contraindicated for use inpatients with unresolved bleedingdisorders.
Principle ofoperations	SAME as 510(k) clearedPaladin System	Device operates on the principleof hydraulic pressurizationapplied through an inflatableballoon attached to the distalend.0.014" guidewire compatiblecatheter based platform with
Parameters	Contego Medical PaladinSystem(modified device)	Contego Medical PaladinSystem(predicate device K181128)
		adjustable nitinol filter frame andurethane filter used to captureand remove embolic materialduring the carotid angioplasty /post-dilation procedure. Platformis advanced to the carotid lesion,filter is expanded via turning thefilter deployment knob on thehandle. PTA, or post-dilation ofstent, in the carotid is performed,where after the filter is collapsedby turning the knob and thedevice is removed.
Sterilization	SAME as 510(k) clearedPaladin System	EO gas
Shelf life	SAME as 510(k) clearedPaladin System	12 months
Packagingsystem	SAME as 510(k) clearedPaladin System	Balloon and filter have aprotective sheath. Catheter isprotected by a HDPE spiraldispenser, placed in a PET/Gsnap-top tray, sealed in a sterilepouch. Product is packed in anouter cardboard carton.
Radiopaquemarkers	SAME as 510(k) clearedPaladin System	Two balloon markers - distal andproximal to balloon.Two marker bands distal andproximal to the filter, and 6circumferential marker bands onthe proximal portion of the filter.
AngioplastyBalloonCharacteristics	SAME as 510(k) clearedPaladin System	Nylon semi-compliant PTAballoon
Embolic CaptureMechanism	SAME as 510(k) clearedPaladin System	Self-expanding nitinol filter framewith urethane membrane (40micron pores) for capture andremoval of embolic material fromthe body
Filter diameter	SAME as 510(k) clearedPaladin System	Adjustable filter fits carotid arterydiameters up to 7mm diameter
Usable length[cm]	SAME as 510(k) clearedPaladin System	140
Introducer	SAME as 510(k) clearedPaladin System	6 F
Parameters	Contego Medical PaladinSystem(modified device)	Contego Medical PaladinSystem(predicate device K181128)
sheathcompatibility	Paladin System
Guide wirecompatibility	SAME as 510(k) clearedPaladin System	0.014"
Balloon diameter[mm]	SAME as 510(k) clearedPaladin System	5.0 mm and 5.5 mm
Balloon length[mm]	SAME as 510(k) clearedPaladin System	20 mm and 30 mm
Balloon RBP[atm]	SAME as 510(k) clearedPaladin System	14 atm (5.0 mm)11 atm (5.5 mm)

Table 4-1. Substantial Equivalency Table

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Performance Data:

The risk analysis activities for the device changes summarized in this Special 510(k) identified that no additional verification or validation activities are required to establish substantial equivalence with predicate devices.

The changes highlighted for the Paladin System do not create any new risks, harms nor were any existing risks altered. No additional risk control measures or mitigations are required.

Conclusion:

The information provided is sufficient to establish the substantial equivalency of the Paladin System (modified device) to the predicate device (Contego Medical, Paladin System 510(k) K181128).

There is no change to device design, its principles of operation or expected performance. The information provided in this submission demonstrates that modified Paladin System is equivalent to the currently cleared Paladin system.

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).