(141 days)
The NC Gallant PTCA Catheter is indicated for:
• Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
• Post-deployment stent expansion.
The NC Gallant is a sterile, single-use, intravascular medical device. The NC Gallant is a double lumen catheter comprising an expandable non-compliant (NC) coronary balloon on a rapid exchange (RX) catheter.
Here's a breakdown of the acceptance criteria and the study information for the Medinol Ltd. NC Gallant PTCA Catheter, based on the provided FDA 510(k) summary:
This device is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is typically subject to bench testing and biocompatibility testing to establish substantial equivalence. It's important to note that for this type of device, the "acceptance criteria" are generally met by demonstrating that the device performs comparably to legally marketed predicate devices across a series of established engineering and biocompatibility tests. There isn't typically a "performance metric" in the same way an AI/ML device would have for diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Completed |
| Sensitization | Completed | |
| Intracutaneous Toxicity | Completed | |
| Material Mediated Pyrogenicity | Completed | |
| In Vitro Hemolysis | Completed | |
| Partial Thromboplastin Time | Completed | |
| In Vivo Thromboresistance | Completed | |
| Bacterial Reverse Mutation | Completed | |
| Mouse Lymphoma Assay | Completed | |
| Mouse Peripheral Blood Micronucleus Study | Completed | |
| C3a Complement Activation Assay | Completed | |
| SC5b-9 Complement Activation Assay | Completed | |
| In-Vitro Performance | Visual and Handling Performance | Completed |
| Dimensional Verification | Completed | |
| Crossing Profile | Completed | |
| Simulated Use | Completed | |
| Kissing Balloon Technique (KBT) | Completed | |
| Balloon Rated Burst Pressure | Completed | |
| Balloon Fatigue (Repeat Balloon Inflations) | Completed | |
| Balloon Diameter vs. Balloon Pressure (Compliance), Balloon Diameter at NIP, Balloon Diameter at RBP, Markers Positioning, Balloon Working Length | Completed | |
| Catheter Bond Strength | Completed | |
| Tip Pull Test | Completed | |
| Flexibility and Kink Resistance | Completed | |
| Torque Strength | Completed | |
| Catheter Radiopacity | Completed | |
| Particulate Evaluation | Completed | |
| Coating Integrity | Completed | |
| Balloon Rated Burst Pressure (in Stent) | Completed | |
| Balloon Fatigue (Repeat Balloon Inflations; in Stent) | Completed | |
| Catheter corrosion resistance | Completed | |
| Packaging Integrity | Completed | |
| Environmental & Shipping & Accelerated Shelf-Life | Completed | |
| In-Vivo Performance | GLP Acute Performance Study of Novel NC PTCA Balloons in Porcine Model | Completed |
Overall Conclusion: The document states, "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, the NC Gallant may be considered substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance
The document describes bench testing, biocompatibility testing, and a GLP acute performance study in a porcine model. These types of studies use manufactured devices and animal models, not human patient data in the way an AI/ML diagnostic device would. Therefore, the concept of "sample size for the test set" concerning human patient data or "data provenance" (country of origin, retrospective/prospective) is not directly applicable here.
- Bench Testing: Involves testing multiple units of the manufactured device to various physical and mechanical specifications. The specific number of units tested for each in-vitro test is not detailed in this summary but would be part of the full submission.
- Biocompatibility Testing: Involves testing materials and components according to established standards. The sample sizes for these tests are dictated by the specific ISO standards (e.g., ISO 10993 series) applied.
- Porcine Model Study: This is an animal study. The specific number of animals used is not provided in this summary but would be part of the GLP (Good Laboratory Practice) study report. The document states it's a "Porcine Model."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of medical device submission. Ground truth, in the context of an AI/ML device, refers to a definitive diagnosis or assessment made by human experts or pathology. For a PTCA catheter, performance is evaluated against engineering specifications, biocompatibility standards, and observable outcomes in animal models or clinical trials (though a clinical trial is not described as the primary method for substantial equivalence here beyond the porcine model). The "ground truth" is typically defined by regulatory standards and established scientific methods for testing medical device properties.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert opinions are resolved to establish a single ground truth, which is relevant for AI/ML diagnostic performance studies. For physical devices like catheters, performance is evaluated by measurable outcomes from tests, not subjective interpretations.
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
This question is not applicable. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI. The NC Gallant PTCA Catheter is a physical interventional device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This refers to the performance of an AI algorithm independently. The NC Gallant PTCA Catheter is a physical device.
7. The type of ground truth used
For this device, the "ground truth" is established through:
- Engineering specifications and standards: Performance metrics like burst pressure, flexibility, and dimensions are compared against predetermined valid ranges and the performance of predicate devices.
- Biocompatibility standards (e.g., ISO 10993 series): These define acceptable levels of biological response to materials.
- Observations from the GLP acute performance study in a porcine model: This would involve evaluating the device's function, safety, and any tissue reactions in a living system according to predefined criteria for successful deployment and physiological response.
8. The sample size for the training set
This question is not applicable. This refers to AI/ML development. The NC Gallant PTCA Catheter is a physical medical device; it does not involve a training set as an AI algorithm would.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Medinol Ltd. % Semih Oktay President Cardiomed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228
Re: K162434
Trade/Device Name: NC Gallant PTCA Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: December 12, 2016 Received: December 20, 2016
Dear Semih Oktay:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel-S
Fernando Aguel
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162434
Device Name NC Gallant PTCA Catheter
Indications for Use (Describe)
The NC Gallant PTCA Catheter is indicated for:
- · Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
- · Post-deployment stent expansion.
| 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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Image /page/3/Picture/0 description: The image contains the logo for Medinol. The logo consists of a blue and green abstract shape on the left, followed by the word "Medinol" in green, and the phrase "Ingenuity for life" in a smaller font below it. The logo is clean and modern, with a focus on the company name and tagline.
| Medinol LTD's NC Gallant PTCA Catheter | |
|---|---|
| Submitter'sName andAddress | Medinol Ltd.Kiryat Atidim, Building 8,Tel Aviv 6158101,Israel |
| Contact NameandInformation | Michal HershkovitzVP Clinical and Regulatory AffairsPhone: +972 3 7679000/ext.Fax: +972 3 648 2310michalh@medinol.com |
| Date Prepared | August 18 2016 |
| ProprietaryName(s) | NC Gallant PTCA Catheter |
| CommonName | Catheters, transluminal coronary angioplasty, percutaneous |
| Product Code | LOX |
| Classification | Class II, 21 CFR Part 870.5100 |
| PredicateDevices | NC Trek, Abbott (K110134)NC Quantum, Boston Scientific (K121667) |
| DeviceDescription | The NC Gallant is a sterile, single-use, intravascular medical device.The NC Gallant is a double lumen catheter comprising an expandablenon-compliant (NC) coronary balloon on a rapid exchange (RX)catheter. |
| Intended Useof Device | The NC Gallant PTCA Catheter is indicated for the dilatation ofstenosis in coronary arteries or bypass grafts. |
| Indications forUse | The NC Gallant PTCA Catheter is indicated for:• Balloon dilatation of the stenotic portion of a coronary artery orbypass graft stenosis for the purpose of improving myocardialperfusion;• Post-deployment stent expansion. |
| Comparison ofTechnologicalCharacteristics | The NC Gallant PTCA Catheter incorporates substantially equivalentdevice design, fundamental technology, manufacturing processes,sterilization and intended use as those featured in the Boston Scientificpredicate devices: NC Quantum, Boston Scientific (K121667) and NCTrek, Abbott (K110134) |
| PerformanceData | The NC Gallant PTCA Catheter was subjected to testing according tothe requirements of Guidance for Industry and FDA Staff – Class IISpecial Controls for Certain Percutaneous Transluminal CoronaryAngioplasty (PTCA) Catheters, September 8, 2010.Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these testsprovide reasonable assurance that the proposed device has beendesigned and tested to assure conformance to the requirements for itsintended use. No new safety or performance issues were raised duringthe testing and, therefore, the NC Gallant may be consideredsubstantially equivalent to the predicate devices. |
| Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel | Main: +972-3-767-9000 | Fax: +972-3-648-2310 Medinol Ltd. | Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-2-541-777 | Fax: +972-2-541-7764
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Image /page/4/Picture/0 description: The image shows the Medinol logo. The logo consists of a blue and green abstract shape on the left, and the word "Medinol" in green on the right. Below "Medinol" is the phrase "Ingenuity for life" in a smaller font, also in green. The logo is clean and modern, with a focus on the company name and tagline.
| Gallant PTCA Catheter: | |
|---|---|
| Cytotoxicity | Sensitization |
| Intracutaneous Toxicity | Material Mediated Pyrogenicity |
| In Vitro Hemolysis | Partial Thromboplastin Time |
| In Vivo Thromboresistance | Bacterial Reverse Mutation |
| Mouse Lymphoma Assay | Mouse Peripheral Blood |
| Micronucleus Study | |
| C3a Complement ActivationAssay | SC5b-9 Complement ActivationAssay |
| The following in-vitro performance tests were completed on theNC Gallant PTCA Catheter: | |
| Visual and Handling Performance | Dimensional Verification |
| Crossing Profile | Simulated Use |
| Kissing Balloon Technique (KBT) | Balloon Rated Burst Pressure |
| Balloon Fatigue (Repeat BalloonInflations) | Balloon Diameter vs. BalloonPressure (Compliance), BalloonDiameter at NIP, BalloonDiameter at RBP, MarkersPositioning, Balloon WorkingLength |
| Catheter Bond Strength | Tip Pull Test |
| Flexibility and Kink Resistance | Torque Strength |
| Catheter Radiopacity | Particulate Evaluation |
| Coating Integrity | Balloon Rated Burst Pressure (inStent) |
| Balloon Fatigue (Repeat BalloonInflations; in Stent) | Catheter corrosion resistance |
| Packaging Integrity | Environmental & Shipping &Accelerated Shelf-Life |
| The following in-vitro performance tests were completed on theGallant PTCA Catheter: | |
| GLP Acute Performance Study of Novel NC PTCA Balloons inPorcine Model |
Based on the indications for use, technological characteristics, safety Conclusion and performance testing, the NC Gallant PTCA Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.
| Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel | Main: +972-3-767-9000 | Fax: +972-3-648-2310 Medinol Ltd. | Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-2-541-777 | Fax: +972-2-541-7764
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.