(66 days)
No
The summary describes a physical medical device (a balloon catheter) and its intended use for mechanical dilatation. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on bench testing and pre-clinical studies of the physical device.
Yes
The device is used for balloon dilatation of a stenotic coronary artery or bypass graft, which directly improves myocardial perfusion, indicating a therapeutic purpose.
No
The device description and intended use clearly state that the Gallant PTCA Dilatation Catheter is used for therapeutic purposes (balloon dilatation and stent expansion) rather than for diagnosing conditions.
No
The device description clearly states it is a physical catheter with an expandable balloon, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (in vivo) to treat a physical condition (stenosis in a coronary artery or bypass graft). IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter with an expandable balloon designed for insertion into blood vessels. This is consistent with an in-vivo medical device, not an in-vitro diagnostic.
- Anatomical Site: The specified anatomical site is within the body (coronary artery or bypass graft).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in-vitro diagnostics.
Therefore, the Gallant PTCA Dilatation Catheter is an in-vivo medical device used for therapeutic purposes, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gallant PTCA Dilatation 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.
Product codes
LOX
Device Description
The Gallant is a sterile, single-use, intravascular medical device. The Gallant is a combination of single lumen and dual lumen catheter comprising an expandable semi-compliant (SC) coronary balloon on a rapid exchange (RX) catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Gallant PTCA Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing, pre-clinical studies, biocompatibility testing and chemical characterization testing were performed to support a determination of substantial equivalence. 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 Gallant may be considered substantially equivalent to the predicate device.
The following biocompatibility tests were completed on the Gallant PTCA Dilatation Catheter:
Cytotoxicity, Sensitization, Intracutaneous Toxicity, Material Mediated Pyrogenicity, In Vitro Hemolysis, SC5b-9 Complement Activation Assay.
Chemical Characterization.
The following in-vitro performance tests were completed on the Gallant PTCA Catheter:
Visual and Handling Performance, Dimensional Verification, Crossing Profile, Simulated Use, Kissing Balloon Technique (KBT), Balloon Rated Burst Pressure, Balloon Fatigue (Repeat Balloon Inflations), Balloon Diameter vs. Balloon Pressure (Compliance), Balloon Diameter at NIP, Balloon Diameter at RBP, Balloon Working Length, Balloon Non-uniformity Markers Positioning, Catheter Bond Strength, Tip Pull Test, Flexibility and Kink Resistance, Torque Strength, Catheter Radiopacity, Particulate Evaluation, Coating Integrity, Balloon Rated Burst Pressure (in Stent), Balloon Fatigue (Repeat Balloon Inflations; in Stent), Catheter corrosion resistance, Packaging Integrity, Environmental & Shipping & Accelerated Shelf-Life.
The following in-vitro performance tests were completed on the Gallant PTCA Catheter:
GLP Acute Performance Study of Novel Gallant PTCA Balloons in a Porcine Model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NC Gallant PTCA Dilatation Catheter (K162434)
Reference Device(s)
Trek & Mini-Trek, Abbott (K103110)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 25, 2018
Medinol, Ltd. % H. Semih Oktay President CardioMed Device Consultants 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228
Re: K173581
Trade/Device Name: Gallant PTCA Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: November 16, 2017 Received: November 20, 2017
Dear H. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173581
Device Name Gallant PTCA Dilatation Catheter
Indications for Use (Describe)
The Gallant PTCA Dilatation 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 shows the Medinol logo. On the left is a blue and green abstract shape. To the right of the shape is the word "Medinol" in green, with the words "Ingenuity for life" in a smaller font below it.
510(k) SUMMARY -- K173581 Medinol LTD's Gallant PTCA Catheter
| Submitter's
Name and
Address | Medinol Ltd.
Kiryat Atidim, Building 8,
Tel Aviv 6158101,
Israel |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Marina Tikhonov Demishtein
VP Regulatory Affairs
Phone: +972 3 7679000
Fax: +972 3 648 2310
marinat@medinol.com |
| Date Prepared | November 16 2017 |
| Proprietary
Name(s) | Gallant PTCA Dilatation Catheter |
| Common
Name | Catheters, transluminal coronary angioplasty, percutaneous |
| Product Code | LOX |
| Classification | Class II, 21 CFR Part 870.5100 |
| Predicate
Devices | NC Gallant PTCA Dilatation Catheter (K162434) |
| Reference
Devices | Trek & Mini-Trek, Abbott (K103110) |
| Device
Description | The Gallant is a sterile, single-use, intravascular medical device. The
Gallant is a combination of single lumen and dual lumen catheter
comprising an expandable semi-compliant (SC) coronary balloon on
a rapid exchange (RX) catheter. |
| Intended Use
of Device | The Gallant PTCA Dilatation Catheter is intended for the dilatation
of stenosis in coronary arteries or bypass grafts. |
| Indications for
Use | The Gallant PTCA Dilatation 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. |
| Comparison of
Technological
Characteristics | The Gallant PTCA Dilatation Catheter incorporates substantially
equivalent device design, fundamental technology, manufacturing
processes, sterilization and intended use as those featured in the
predicate device: NC Gallant PTCA Dilatation Catheter (K162434).
Minor differences identified between the Gallant and it's predicate
device were evaluated in the frame of performance testing as
described below. |
| Medinol | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel | Main: +972-3-767-9000
Fax: +972-3-648-2310 |
|---------|-----------------------------------------------------------------------|-----------------------------------------------|
| Ltd. | Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-2-541-7777
Fax: +972-2-541-7764 |
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Image /page/4/Picture/0 description: The image shows the logo for Medinol. The logo consists of a blue and green abstract shape on the left, resembling a heart or a Mobius strip. To the right of the shape is the word "Medinol" in green, with the tagline "Ingenuity for life" in a smaller font below it, also in green.
| Performance
Data | The Gallant PTCA Dilatation Catheter was subjected to testing
according to the requirements of Guidance for Industry and FDA Staff
– Class II Special Controls for Certain Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheters, September 8, 2010.
Bench testing, pre-clinical studies, biocompatibility testing and
chemical characterization testing were performed to support a
determination of substantial equivalence. 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 Gallant may be considered substantially
equivalent to the predicate device. | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following biocompatibility tests were completed on the Gallant
PTCA Dilatation Catheter: | |
| | Cytotoxicity | Sensitization |
| | Intracutaneous Toxicity | Material Mediated Pyrogenicity |
| | In Vitro Hemolysis | SC5b-9 Complement Activation |
| | | Assay |
| | Chemical Characterization | |
| | The following in-vitro performance tests were completed on the
Gallant PTCA Catheter: | |
| | Visual and Handling
Performance | Dimensional Verification |
| | Crossing Profile | Simulated Use |
| | Kissing Balloon Technique
(KBT) | Balloon Rated Burst Pressure |
| | Balloon Fatigue (Repeat Balloon
Inflations) | Balloon Diameter vs. Balloon
Pressure (Compliance), Balloon
Diameter at NIP, Balloon
Diameter at RBP, Balloon
Working Length, Balloon Non-
uniformity Markers Positioning, |
| | Catheter Bond Strength | Tip Pull Test |
| | Flexibility and Kink Resistance | Torque Strength |
| | Catheter Radiopacity | Particulate Evaluation |
| | Coating Integrity | Balloon Rated Burst Pressure (in
Stent) |
| | Balloon Fatigue (Repeat Balloon
Inflations; in Stent) | Catheter corrosion resistance |
| | Packaging Integrity | Environmental & Shipping &
Accelerated Shelf-Life |
| Medinol
Ltd. | Kiryat Atidim, Building 8, POB 58165 Tel Aviv 6158101, Israel
Beck Tech Building, 8 Hartom St., POB 45026 Jerusalem 9777508, Israel | Main: +972-3-767-9000
Fax: +972-3-648-2310
Main: +972-2-541-7777
Fax: +972-2-541-7764 |
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
|---|
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Image /page/5/Picture/0 description: The image shows the logo for Medinol. The logo features a stylized heart shape in blue and green on the left. To the right of the heart is the company name "Medinol" in green, with the tagline "Ingenuity for life" in a smaller green font below it.
| | The following in-vitro performance tests were completed on the
Gallant PTCA Catheter: |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GLP Acute Performance Study of Novel Gallant PTCA Balloons in a
Porcine Model |
| Conclusion | Based on the indications for use, technological characteristics, safety
and performance testing, the Gallant PTCA Dilatation Catheter has
been shown to be appropriate for its intended use and is considered to
be substantially equivalent to the predicate device. |