(31 days)
Not Found
No
The device description focuses on mechanical components (balloon, filter, catheter) and standard medical imaging guidance (fluoroscopy). There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device control.
Yes.
The device's intended use is for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries, which is a therapeutic procedure to open narrowed arteries and restore blood flow. Additionally, it is used for post-dilation of self-expanding stents, another therapeutic intervention.
No
Explanation: The device description and intended use clearly state that the Paladin Carotid PTA Balloon System is designed for percutaneous transluminal angioplasty (PTA) and post-dilation of self-expanding stents in the carotid arteries, with an integrated embolic protection system. These are therapeutic, interventional procedures, not diagnostic ones. Its purpose is to treat conditions, not to identify or characterize them.
No
The device description clearly outlines physical components such as a catheter, balloon, filter, and handle, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) and post-dilation of stents in the carotid arteries, with the capture and removal of embolic material. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a catheter with a balloon and a filter designed for mechanical intervention within the carotid arteries.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the human body. This device is used for a surgical/interventional procedure within the body.
N/A
Intended Use / Indications 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.
Product codes
NTE, LIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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) | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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) |
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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.