(115 days)
The balloon 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.
The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for post deployment expansion of balloon expandable stents.
The Euphora™ RX Balloon Dilatation catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
The document provided is a 510(k) premarket notification for the Euphora™ Rapid Exchange Balloon Dilatation Catheter. It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Based on the provided text, the device discussed is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter, which is a physical medical device, not an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study design referencing AI/ML performance (e.g., sample size for test set, data provenance, ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable.
However, I can extract information related to the performance criteria and the non-clinical studies conducted for this conventional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful completion of the "Design Verification in-vitro testing" and "Biocompatibility testing" in accordance with relevant guidance documents and standards. The reported device performance is that it met all these requirements.
| Acceptance Criteria Category | Specific Tests Performed (as per FDA Guidance and ISO) | Reported Device Performance |
|---|---|---|
| Design Verification (In-Vitro) | Effective length | Met requirements |
| Catheter Profile | Met requirements | |
| System Pressure Capability & System Pressure Capability (in Stent) | Met requirements | |
| Balloon Fatigue & Balloon Fatigue (in Stent) | Met requirements | |
| Balloon Compliance | Met requirements | |
| Balloon Inflation and Deflation Time | Met requirements | |
| Catheter Bond Strength | Met requirements | |
| Coating Integrity | Met requirements | |
| Coating Particulate Evaluation | Met requirements | |
| Flexibility and Kink | Met requirements | |
| Torque Strength | Met requirements | |
| Biocompatibility Testing | Cytotoxicity Study (ISO MEM Elution) | Met requirements |
| ISO Maximisation Sensitisation Study | Met requirements | |
| ISO Acute Intracutaneous Reactivity | Met requirements | |
| ISO Acute Systemic Toxicity | Met requirements | |
| USP Material Mediated Pyrogen Study in Rabbits | Met requirements | |
| In Vivo Thromboresistance Study | Met requirements | |
| ASTM In-vitro Haemolysis | Met requirements | |
| ASTM Partial Thromboplastin Time (PTT) Coagulation Testing | Met requirements | |
| C3a Complement Activation Assay Study | Met requirements | |
| Sc5b-9 Complement Activation Assay Study | Met requirements | |
| USP Physicochemical Tests | Met requirements | |
| Sterilization Validation | EtO Sterilization in accordance with ISO11135 and EN556 to achieve SAL of 10⁻⁶ | Validated |
| Pre-Clinical Study | Evaluation of Radiopacity attribute (non-GLP in-vivo) | Met requirements |
The overall conclusion is that "The Euphora™ RX Balloon Dilatation Catheter met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Euphora™ RX Balloon Dilatation Catheter is substantially equivalent in terms of safety and effectiveness to the predicate device."
Regarding the AI/ML specific questions:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device, not an AI/ML system.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (for clinical endpoints, as no clinical study was conducted). For bench testing, the "ground truth" would be the engineering specifications and established standards the device had to meet.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest a sense of community and care. The profiles are depicted in a flowing, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Medtronic, Inc. c/o Elaine Gullane Senior Regulatory Affairs Specialist, Medtronic Ireland Parkmore Business Park West Galway, Ireland
Re: K143480
Trade/Device Name: Euphora Rapid Exchange Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Dated: February 17, 2015 Received: February 19, 2015
Dear Ms. Elaine Gullane:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
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" (21CFR 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.
Sincerelv vours.
M.A. Hilleman
for Bram Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| K143480Page 1 of 1 | |
|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number ( if known ) | K143480 |
| Device Name | Euphora™ Rapid Exchange Balloon Dilatation Catheter |
| Indications for Use ( Describe ) | The balloon 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.The balloon dilatation catheter (balloon models 2.00 mm to 4.00 mm) is also indicated for post deployment expansion of balloon expandable 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) | |
| 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 ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@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." | |
| FORM FDA 3881 (8/14) | Page 1 of 1 |
| PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary per 21 CRF 807.92
December 4th, 2014 Date Prepared: Applicant: Medtronic Ireland Parkmore Business Park West Galway Ireland Official Elaine Gullane Senior Regulatory Affairs Specialist Correspondent: Medtronic Ireland Parkmore Business Park West Galway Ireland Phone: (353) 91 708682 Fax: (353) 91 708672 Email: elaine.gullane@medtronic.com Proprietary Euphora™ Rapid Exchange Balloon Dilatation Catheter Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Common Name: Device Class II (special controls) Classification: Regulation 21 CFR 870.5100 Number: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Classification Name: LOX Product Code:
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The Euphora™ RX Balloon Dilatation catheter is a Percutaneous Device Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The Description: balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
| Diameters(mm) | Lengths (mm) | ||||||
|---|---|---|---|---|---|---|---|
| 6 | 10 | 12 | 15 | 20 | 25 | 30 | |
| 1.50 | EUP1506X | EUP1510X | EUP1512X | EUP1515X | EUP1520X | - | - |
| 2.00 | EUP2006X | EUP2010X | EUP2012X | EUP2015X | EUP2020X | EUP2025X | EUP2030X |
| 2.25 | EUP22506X | EUP22510X | EUP22512X | EUP22515X | EUP22520X | EUP22525X | - |
| 2.50 | EUP2506X | EUP2510X | EUP2512X | EUP2515X | EUP2520X | EUP2525X | EUP2530X |
| 2.75 | EUP27506X | EUP27510X | EUP27512X | EUP27515X | EUP27520X | EUP27525X | - |
| 3.00 | EUP3006X | EUP3010X | EUP3012X | EUP3015X | EUP3020X | EUP3025X | EUP3030X |
| 3.25 | EUP32506X | EUP32510X | EUP32512X | EUP32515X | EUP32520X | EUP32525X | - |
| 3.50 | EUP3506X | EUP3510X | EUP3512X | EUP3515X | EUP3520X | EUP3525X | EUP3530X |
| 3.75 | EUP37506X | EUP37510X | EUP37512X | EUP37515X | EUP37520X | EUP37525X | - |
| 4.00 | EUP4006X | EUP4010X | EUP4012X | EUP4015X | EUP4020X | EUP4025X | EUP4030X |
-
. The Euphora device is available in the following model numbers:
The models differ only in the balloon diameter and the balloon length across the size matrix. -
The Euphora device has a nominal pressure of 8atm and a rated burst pressure of 14atm.
-
The Euphora device is single use, sterile, EtO sterilised device. It has a hydrophilic coating and is classified as an external communicating device with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.
-
. The Euphora device environment of use is a healthcare facility.
-
Indications For The Euphora™ RX Balloon Dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft Use: stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.00mm to 4.00mm) is also indicated for post deployment expansion of balloon expandable stents.
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The Euphora™ RX Balloon Dilatation Catheter is similar to the following Substantially Equivalent predicate device with respect to intended use, design and technology: Sprinter Legend® Device: Medtronic Balloon Dilatation Catheter (P790017/S096, approved October 31, 2008) This predicate has not been subject to a design-related recall. Reference devices were used in this submission.
The Euphora™ RX Balloon Dilatation Catheter is offered in more balloon Summary of sizes compared to its predicate and the 2.0mm diameter size is indicated Technological for post deployment expansion of balloon expandable stents. The Differences to the Euphora™ RX Balloon Dilatation Catheter has a consistent nominal Predicate Device: (8atm) and rated burst pressure (14atm) across all balloon diameters, and has a higher nominal and rated burst pressure for the 1.5mm balloon diameter when compared to the predicate Sprinter Legend® RX Balloon Dilatation Catheter. The EuphoraTM RX Balloon Dilatation Catheter incorporates the identical balloon material, identical radiopaque marker band material, identical hydrophilic coating and identical outer shaft material to the predicate device. All other materials utilized are deemed substantially equivalent to the predicate device Sprinter Legend® RX Balloon Dilatation Catheter.
Design Verification in-vitro testing: Summary of Non-
Clinical Data:
1- Design verification in-vitro testing:
The following in-vitro bench tests were completed on the Euphora™ RX Balloon Dilatation Catheter 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 verify that it meets the required performance specifications:
- Effective length ●
- Catheter Profile ●
- System Pressure Capability & System Pressure Capability (in Stent)
- Balloon Fatigue & Balloon Fatigue (in Stent)
- Balloon Compliance ●
- Balloon Inflation and Deflation Time ●
- Catheter Bond Strength
- Coating Integrity ●
- Coating Particulate Evaluation ●
- Flexibility and Kink ●
- Torque Strength ●
Pre-Clinical Study (non-GLP):
Medtronic conducted pre-clinical in-vivo (non-GLP) studies for evaluation of the Radiopacity attribute of the Euphora™ RX Balloon Dilatation
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Catheter.
Biocompatibility Testing:
Biocompatibility testing for the Euphora™ RX Balloon Dilatation Catheter has been completed in accordance with the recommendations 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 International Standard ISO10993-1:2009, Biological Evaluation of Medical devices- Part 1: Evaluation and Testing for an external communicating device with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.
The following Biocompatibility tests were performed to support the Euphora™ RX Balloon Dilatation Catheter:
- Cytotoxicity Study using ISO MEM Elution method ●
- ISO Maximisation Sensitisation Study ●
- ISO Acute Intracutaneous Reactivity ●
- ISO Acute Systemic Toxicity ●
- USP Material Mediated Pyrogen Study in Rabbits ●
- In Vivo Thromboresistance Study ●
- ASTM In-vitro Haemolysis .
- ASTM Partial Thromboplastin Time (PTT) Coagulation Testing ●
- C3a Complement Activation Assay Study ●
- Sc5b-9 Complement Activation Assay Study ●
- USP Physicochemical Tests ●
The Euphora" RX Balloon Dilatation Catheter met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device Euphora™ RX Balloon Dilatation Catheter is substantially equivalent in terms of safety and effectiveness to the predicate device.
Summary of No clinical investigation has been performed for this device.
Clinical Data:
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| Sterilization | The Euphora™ RX Balloon Dilatation Catheter will be sterilized and |
|---|---|
| Validation: | validated for EtO sterilization in accordance with ISO11135 and EN556 toachieve a minimum Sterility Assurance Level (SAL) of 10°. |
| Conclusion: | Through the data and information presented, Medtronic Ireland considersthe Euphora™ RX Balloon Dilatation Catheter to be substantiallyequivalent to the predicate device. |
§ 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.