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Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection

Q: Who is the manufacturer of Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

Contego Medical, Inc. filed the 510(k) submission for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K221339).

Q: What is the FDA product code for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

LIT. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection?

510(k) clearance (submission type: Special).

K221339 · Contego Medical, Inc. · LIT · Jun 9, 2022 · Cardiovascular

Device Facts

Record ID	K221339
Device Name	Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Applicant	Contego Medical, Inc.
Product Code	LIT · Cardiovascular
Decision Date	Jun 9, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Sterile, single-use, rapid exchange (RX) PTA catheter; features nitinol-based filter between PTA balloon and distal tip. Operates via hydraulic pressurization for balloon inflation; filter deployed/collapsed via handle-mounted activation knob. Used in carotid arteries under fluoroscopic guidance; physician-operated. Captures embolic material during angioplasty or stent post-dilation. Filter consists of nitinol braid chassis with polyurethane membrane (40-micron pores). Radiopaque markers on balloon and filter aid positioning. Device introduced via 6F vascular sheath; compatible with 0.014" guidewires. Benefits patient by reducing risk of distal embolization during carotid interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence established via risk analysis and comparison of technological characteristics to the predicate device.

Technological Characteristics

Nitinol-based filter frame; polyurethane membrane (40-micron pores); nylon semi-compliant PTA balloon. Rapid exchange (RX) catheter platform. Radiopaque markers on balloon and filter. 6F sheath compatibility; 0.014" guidewire compatibility. EO gas sterilization. 12-month shelf life. Mechanical activation via handle knob. No software or electronic components.

Indications for Use

Indicated for patients undergoing Percutaneous Transluminal Angioplasty (PTA) or post-dilation of self-expanding stents in carotid arteries requiring embolic material capture. Contraindicated for coronary artery use, patients unable to tolerate anticoagulant/anti-platelet therapy, patients with nitinol hypersensitivity, or patients with unresolved bleeding disorders.

Regulatory Classification

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.

Predicate Devices

Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K181128)

Related Devices

K052454 — THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM · Abbott Vascular Devices · Sep 14, 2005
K181128 — Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) · Contego Medical, LLC · Sep 6, 2018
K081523 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM · Abbott Vascular-Vascular Solutions · Sep 11, 2008
K121015 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM · Abbott Vascular · May 4, 2012
K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM · Guidant Corporation · Aug 16, 2005

Submission Summary (Full Text)

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {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/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 {2}------------------------------------------------ # 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) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ✓ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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) - K221339 | Date Prepared | May 26, 2022 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Contego Medical, Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 | | FDA RegistrationNumber | 3011471056 | | Contact Person: | Mr. Jim Clossick Contego Medical, Inc. 3801 Lake Boone Trail, Suite 100 Raleigh, NC 27607 Phone: + 1 305 607 1708 Email: Jclossick@contegomedical.com | | Proprietary Name: | Paladin® System | | Common Name: | Paladin Carotid PTA Balloon System with Integrated Embolic Protection | | Device Classification: | Class II per 21 CFR §870.1250 | | Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal Temporary Carotid Catheter for Embolic Capture | | Product Code: | LIT, NTE | | Predicate Device: | Carotid Post-Dilation Balloon System with Integrated Embolic Protection (K181128) | {4}------------------------------------------------ ## 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. ## 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 Paladin System (modified device) | Contego Medical Paladin System (predicate device K181128) | |-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | 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 Paladin System (modified device) | Contego Medical Paladin System (predicate device K181128) | | | 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. | 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. | | Common name | Carotid PTA Balloon System with Integrated Embolic Protection | Carotid Post-Dilation Balloon System with Integrated Embolic Protection | | Classification | SAME as 510(k) cleared Paladin System | Class II (21 CFR 870.1250) | | Classification name | SAME as 510(k) cleared Paladin System | Catheter, Angioplasty, Peripheral, Transluminal Temporary Carotid Catheter for Embolic Capture | | Product code | SAME as 510(k) cleared Paladin System | LIT, NTE | | Contraindications | SAME as 510(k) cleared Paladin System | Contraindicated for use in coronary arteries. Contraindicated for use in patients who cannot tolerate anticoagulant or anti-platelet therapy Contraindicated for use in patients with known hypersensitivity to nitinol. Contraindicated for use in patients with unresolved bleeding disorders. | | Principle of operations | SAME as 510(k) cleared Paladin System | Device operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. 0.014" guidewire compatible catheter based platform with | | Parameters | Contego Medical Paladin System (modified device) | Contego Medical Paladin System (predicate device K181128) | | | | adjustable nitinol filter frame and urethane filter used to capture and remove embolic material during the carotid angioplasty / post-dilation procedure. Platform is advanced to the carotid lesion, filter is expanded via turning the filter deployment knob on the handle. PTA, or post-dilation of stent, in the carotid is performed, where after the filter is collapsed by turning the knob and the device is removed. | | Sterilization | SAME as 510(k) cleared Paladin System | EO gas | | Shelf life | SAME as 510(k) cleared Paladin System | 12 months | | Packaging system | SAME as 510(k) cleared Paladin System | Balloon and filter have a protective sheath. Catheter is protected by a HDPE spiral dispenser, placed in a PET/G snap-top tray, sealed in a sterile pouch. Product is packed in an outer cardboard carton. | | Radiopaque markers | SAME as 510(k) cleared Paladin System | Two balloon markers - distal and proximal to balloon. Two marker bands distal and proximal to the filter, and 6 circumferential marker bands on the proximal portion of the filter. | | Angioplasty Balloon Characteristics | SAME as 510(k) cleared Paladin System | Nylon semi-compliant PTA balloon | | Embolic Capture Mechanism | SAME as 510(k) cleared Paladin System | Self-expanding nitinol filter frame with urethane membrane (40 micron pores) for capture and removal of embolic material from the body | | Filter diameter | SAME as 510(k) cleared Paladin System | Adjustable filter fits carotid artery diameters up to 7mm diameter | | Usable length [cm] | SAME as 510(k) cleared Paladin System | 140 | | Introducer | SAME as 510(k) cleared Paladin System | 6 F | | Parameters | Contego Medical Paladin System (modified device) | Contego Medical Paladin System (predicate device K181128) | | sheath compatibility | Paladin System | | | Guide wire compatibility | SAME as 510(k) cleared Paladin System | 0.014" | | Balloon diameter [mm] | SAME as 510(k) cleared Paladin System | 5.0 mm and 5.5 mm | | Balloon length [mm] | SAME as 510(k) cleared Paladin System | 20 mm and 30 mm | | Balloon RBP [atm] | SAME as 510(k) cleared Paladin System | 14 atm (5.0 mm) 11 atm (5.5 mm) | # Table 4-1. Substantial Equivalency Table {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ### 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.