(129 days)
Not Found
No
The device description focuses on the mechanical components and function of a PTA catheter with an integrated embolic protection filter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies evaluate clinical outcomes and device success rates, not the performance of an AI/ML algorithm.
Yes
The device is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries and post-dilation of self-expanding stents, which are medical procedures used to treat and modify a physiological function or anatomical structure, thereby classifying it as a therapeutic device.
No
The device is a therapeutic device (PTA catheter with embolic protection) used for angioplasty and stenting, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device consisting of a catheter, balloon, filter, and handle, with no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Paladin System is a medical device used for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries. This is a surgical procedure performed directly on the patient's body to widen narrowed arteries. It also includes an embolic protection filter to capture debris during the procedure.
- Lack of Specimen Analysis: The description of the device and its intended use does not involve the analysis of any specimens taken from the human body. It is a tool used for a therapeutic intervention within the body.
Therefore, the Paladin System falls under the category of a therapeutic medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, NTE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
carotid arteries
Indicated Patient Age Range
adults
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)
Design Verification in-vitro testing: The following in-vitro bench tests were completed on the Paladin System in accordance with the requirements of Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010, and Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions, February 15, 2008, which verify that it meets the required performance specifications. 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 was tested 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 in accordance with the recommendations of Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Issued June 16, 2016, for an external communicating device with limited exposure (i.e. whose contact with circulating blood is ≤ 24 hours).
Animal Testing: Two animal studies were conducted in the swine model. The first was an acute study in one animal which assessed the ability to deploy the Paladin device through a pre-deployed stent. A second GLP study involved 12 animals treated with the Paladin platform through deployed stents. Animals were survived to 30 days and six months to assess histological safety. Both studies found the device to be well tolerated and safe based on local and dependent tissue response in the healthy swine model.
Clinical Data: A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of the Paladin System was conducted at five centers in Germany to assess the safety and clinical performance of the device in adults requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis. A total of 106 subjects were followed through 30 days to evaluate safety, device performance and clinical endpoints. A primary embolic protection device was used distal to and in conjunction with the Paladin System for this study. The combined major adverse event (MAE) rate at 30 days for all stroke, myocardial infarction and death was 0.98%. There was one major stroke caused by acute stent thrombosis at day 12 (antiplatelet non-compliance). The MAE rate at discharge was 0%. No events were related to the use of the Paladin System. The procedural success rate was 100%, and the technical success was 99%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The combined major adverse event (MAE) rate at 30 days for all stroke, myocardial infarction and death was 0.98%.
The MAE rate at discharge was 0%.
The procedural success rate was 100%, and the technical success was 99%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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)
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.
| 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) Summary [per 21 CFR 807.92]
| Date Prepared: | April 27, 2018 |
|---|---|
| Applicant: | Contego Medical, LLC |
| 3921 Sunset Ridge Rd., Suite 102 | |
| Raleigh, NC 27607 | |
| Contact Person: | Debra Cogan |
| Regulatory Affairs Consultant to | |
| Contego Medical, LLC | |
| Phone: (408) 515-0820 | |
| Fax: (408) 273-6047 | |
| dcogan@contegomedical.com | |
| Proprietary Name: | Paladin Carotid Post-Dilation Balloon System with Integrated Embolic |
| Protection | |
| Common Name: | Carotid Post-Dilation Balloon System with Integrated Embolic |
| Protection | |
| 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) 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. |
4
| Indications for Use: | 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. |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device(s): | Boston Scientific Corp. Sterling Monorail Balloon Dilatation Catheter
(K141150) - Primary predicate
Abbott Vascular RX ACCUNET Embolic Protection System (K153086) |
| Comparison of
Technological
Characteristics | Paladin has the same intended use as the predicate devices. The
materials, design, and performance characteristics are similar. Balloon
lengths and diameters are within the same range as the Sterling
Monorail Balloon Dilatation Catheter. The filter element is intended to
capture and remove embolic material while performing angioplasty and
stenting procedures in the carotid arteries, which is the same as the RX
ACCUNET 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 Paladin
System in accordance with the requirements of Guidance for Industry
and FDA Staff - Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters, September 8, 2010, and Coronary and Carotid Embolic
Protection Devices - Premarket Notification [510(k)] Submissions,
February 15, 2008, which verify that it meets the required performance
specifications.
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 was
tested 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 in
accordance with the recommendations of Guidance for Industry and
FDA Staff - Use of International Standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process" - Issued June 16, 2016, for an external
communicating device with limited exposure (i.e. whose contact with
circulating blood is ≤ 24 hours).
Animal Testing:
Two animal studies were conducted in the swine model. The first was
an acute study in one animal which assessed the ability to deploy the
Paladin device through a pre-deployed stent. A second GLP study
involved 12 animals treated with the Paladin platform through deployed
stents. Animals were survived to 30 days and six months to assess
histological safety. Both studies found the device to be well tolerated
and safe based on local and dependent tissue response in the healthy
swine model. |
| Summary of Clinical
Data: | A Multi-Center Study to Evaluate Acute Safety and Clinical
Performance of the Paladin System was conducted at five centers in
Germany to assess the safety and clinical performance of the device in
adults requiring percutaneous intervention of an asymptomatic (> 70%)
or symptomatic (>50%) internal carotid artery stenosis. A total of 106
subjects were followed through 30 days to evaluate safety, device
performance and clinical endpoints. A primary embolic protection
device was used distal to and in conjunction with the Paladin System
for this study. Patient demographics for age, gender and disease are
presented in Table 1. Carotid stents post-dilated with the Paladin
System include the Roadsaver® Carotid Stent (Terumo), the Xact®
Carotid Stent (Abbott Vascular), the Cristallo Ideale™Carotid Self-
Expanding Stent (Medtronic), the Wallstent® Endoprosthesis (Boston
Scientific), the Precise® Stent (Cordis) and the Adapt™ Monorail
(Boston Scientific). The combined major adverse event (MAE) rate at
30 days for all stroke, myocardial infarction and death was 0.98%.
There was one major stroke caused by acute stent thrombosis at day
12 (antiplatelet non-compliance). The MAE rate at discharge was 0%.
No events were related to the use of the Paladin System. The
procedural success rate was 100%, and the technical success was
99%.
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.