(26 days)
The Amphirion™ Plus PTA Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Amphirion Plus PTA Catheter (also referred to as Amphirion Plus) is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, coaxial body catheter shaft, and a distal dilatation balloon. The Amphirion Plus device consists of a coaxial lumen. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The Amphirion Plus PTA Catheter is compatible with guidewires with a maximum diameter of 0.014" and with 4F introducer sheaths. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 100cm and 150cm.
This submission describes the Amphirion™ Plus PTA Catheter, an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter. The device is intended to dilate stenosis in various arteries and treat obstructive lesions in dialysis fistulae. The 510(k) summary indicates that the device is substantially equivalent to predicate devices, with modifications primarily in balloon length, and no new safety or effectiveness issues were observed during testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that a battery of bench and biocompatibility tests were performed, and all pre-determined acceptance criteria were met. However, the specific quantitative acceptance criteria values for each test are not detailed in the provided text. The output primarily indicates "All of the pre-determined acceptance criteria were met and results passed." for each category.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter Useable Length | Pre-determined criteria (not specified) | Met and passed |
| Introducer Sheath Compatibility | Pre-determined criteria (not specified) | Met and passed |
| Trackability-Flexibility-Kink test | Pre-determined criteria (not specified) | Met and passed |
| Torque Strength | Pre-determined criteria (not specified) | Met and passed |
| Catheter Body Burst Pressure | Pre-determined criteria (not specified) | Met and passed |
| Tensile Strength | Pre-determined criteria (not specified) | Met and passed |
| Balloon Inflation/Deflation Time | Pre-determined criteria (not specified) | Met and passed |
| Balloon Preparation | Pre-determined criteria (not specified) | Met and passed |
| Balloon Profile | Pre-determined criteria (not specified) | Met and passed |
| Balloon Working Length | Pre-determined criteria (not specified) | Met and passed |
| Minimum Balloon Burst Strength (RBP) | Pre-determined criteria (not specified) | Met and passed. RBP of 20 ATM for all balloon sizes, within predicate range of 18-22 ATM. |
| Balloon Fatigue | Pre-determined criteria (not specified) | Met and passed |
| Balloon Compliance | Pre-determined criteria (not specified) | Met and passed |
| Biocompatibility Testing: | ||
| ISO MEM Elution Cytotoxicity Test | Pre-determined criteria (not specified) | Met and passed |
| ISO Kligman Maximization Test | Pre-determined criteria (not specified) | Met and passed |
| ISO Intracutaneous Reactivity Study | Pre-determined criteria (not specified) | Met and passed |
| ISO Acute Systemic Toxicity Study | Pre-determined criteria (not specified) | Met and passed |
| ISO Material Mediated Rabbit Pyrogen Study | Pre-determined criteria (not specified) | Met and passed |
| ASTM Indirect contact Hemolysis | Pre-determined criteria (not specified) | Met and passed |
| ISO Thrombogenicity Study | Pre-determined criteria (not specified) | Met and passed |
| ISO Indirect contact Complement activation | Pre-determined criteria (not specified) | Met and passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench or biocompatibility test. It mentions that "The Amphirion Plus PTA Catheter was thoroughly tested on the bench" and "Biocompatibility testing was conducted on the finished Amphirion Plus PTA Catheter." These are general statements without specific numbers.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be laboratory-based (bench and biocompatibility testing) and thus would be considered pre-clinical rather than involving human subjects. Therefore, the retrospective or prospective nature of clinical data is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The tests performed are engineering and biological evaluations, not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests would be the established scientific and engineering standards and methods.
4. Adjudication method for the test set
This information is not applicable. This is not a study involving multiple human readers or interpretations needing adjudication. The tests have objective criteria.
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 is not applicable as the device is a PTA catheter, a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device. Performance is assessed through bench and biocompatibility testing, not an algorithm.
7. The type of ground truth used
The "ground truth" for the tests performed can be considered:
- Bench Testing: Engineering specifications, material properties, and performance standards as defined by relevant FDA guidance documents, ISO, and ASTM standards.
- Biocompatibility Testing: Established biological safety limits and responses as defined by ANSI/AAMI/ISO10993-1, FDA 21 CFR Part 58 (GLP), and FDA guidance for PTCA catheters.
8. The sample size for the training set
This is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
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K121265 page MAY 2 2 2012 3
3.0 510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
Applicant:
| Official Contact Person: | Nainesh Sureja, Regulatory Affairs Specialist |
|---|---|
| Medtronic Inc. | |
| 3576 Unocal Place | |
| Santa Rosa, CA 95403 | |
| Tel: 707-591-2912 | |
| Fax: 707-566-1245 | |
| Email: nainesh.m.sureja@medtronic.com | |
| Alternate Contact: | Diana Johnson, Regulatory Affairs Director |
| Medtronic Inc. | |
| 3576 Unocal Place | |
| Santa Rosa, CA 95403 | |
| Tel: 707-591-2656 | |
| Fax: 707-566-1245 | |
| Email: diana.j.johnson@medtronic.com | |
| Date Prepared: | April 23, 2012 |
| Device Information: | |
| Trade Name: | AmphirionTM Plus PTA Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Regulation Name: | Percutaneous Catheter |
| Classification: | Class II |
Classification Panel: Regulation Number: Product Code:
Class II Peripheral 21 CFR 870.1250 DQY
Medtronic Vascular
Amphirion™ Plus PTA Catheter
KXXXX_, Special 510(k)
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Predicate Devices:
Amphirion™ DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-11/04/2005) REEF HP 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-10/29/2009) Submarine TM Plus PTA Catheter (K042537 SE-11/08/2004)
Device Description:
The Amphirion Plus PTA Catheter (also referred to as Amphirion Plus) is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, coaxial body catheter shaft, and a distal dilatation balloon. The Amphirion Plus device consists of a coaxial lumen. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the balloon. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The Amphirion Plus PTA Catheter is compatible with guidewires with a maximum diameter of 0.014" and with 4F introducer sheaths. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 100cm and 150cm.
Indications for Use:
The Amphirion Plus PTA Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The indications for use for the Amphirion Plus PTA Catheter is identical to the currently cleared predicate devices. Amphirion DEEP PTA Balloon catheter (Amphirion DEEP), REEF HP PTA Balloon Catheter (REEF HP) and the Submarine Plus PTA Catheter (Submarine Plus).
Technological Characteristics:
The Amphirion Plus PTA Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter. The overall design and the fundamental scientific technology of the Amphirion Plus device is equivalent to the currently cleared predicate devices. Amphirion DEEP PTA Balloon catheter, REEF HP PTA Balloon Catheter and the Submarine Plus PTA Catheter. Description of the modified device, Amphirion Plus PTA Catheter, is provided in the table below:
| Characteristic | Modified Amphirion Plus PTA Catheter . |
|---|---|
| Balloon Lengths (mm) | A shorter balloon length of 14mm was added to the AmphirionPlus balloon size matrix. The 14mm balloon is made ofidentical materials and manufacturing processes as the otherballoon sizes. |
| Catheter Useable Length(cm) | The Amphirion Plus catheter useable lengths are within theAmphirion DEEP and REEF HP catheter useable lengths. |
| Catheter Shaft Diameter | The Amphirion Plus catheter shaft diameters are within theAmphirion DEEP and REEF HP catheter shaft diameters. |
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| Characteristic | Modified Amphirion Plus PTA Catheter |
|---|---|
| Catheter Shaft Material | The Amphirion Plus catheter shaft material is identical to thematerial used on the Amphirion DEEP device. |
| Nominal Pressure (ATM) | Identical to REEF HP |
| Rated Burst Pressure(ATM) | Amphirion Plus PTA Catheter has a Rated Burst Pressure(RBP) of 20 ATM for all the balloon sizes. This RBP is withinthe REEF HP RBP range of 18-22 ATM. |
| Balloon Material | Amphirion Plus Balloon Material is identical to the SubmarinePlus PTA Catheter balloon material. |
Medtronic believes that the Amphirion Plus PTA Catheter is substantially equivalent to the above mentioned predicate devices, in terms of indications for use, design, material and fundamental scientific technology. Therefore, in accordance with "The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications (March 1998)", the Amphirion Plus PTA Catheter does not affect the intended use or alter the fundamental scientific technology of the device and meets the criteria for a Special 510(k) Pre-Market Notification.
Summary of Bench Testing:
The Amphirion Plus PTA Catheter was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed based on the risk assessment of the device modifications, and the recommendations outlined in the applicable FDA guidance documents, ISO and ASTM standards. Testing performed on the Amphirion Plus device included the following:
- Catheter Useable Length ◆
- Introducer Sheath Compatibility .
- Trackability-Flexibility-Kink test .
- Torque Strength .
- Catheter Body Burst Pressure ●
- ◆ Tensile Strength
- Balloon Inflation/Deflation Time ●
- Balloon Preparation ●
- Balloon Profile ●
- Balloon Working Length .
- Minimum Balloon Burst Strength (RBP) .
- Balloon Fatigue ●
- Balloon Compliance .
All of the pre-determined acceptance criteria were met and results passed.
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Summary of Biocompatibility Testing:
The Amphirion Plus PTA Catheter is an externally communicating device, which contacts circulating blood for the limited contact duration (<24hours),
6
Biocompatibility testing was conducted on the finished Amphirion Plus PTA Catheter in accordance with ANSI/AAMI/ISO10993-1 : Biological Evaluation of Medical Devices part 1 : Evaluation and Testing, FDA 21 CFR Part 58: Good Laboratory Practice for Non Clinical Laboratory Studies and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (Sept 2010). The Biocompatibility testing performed for the Amphirion Plus device included the following:
- ISO MEM Elution Cytotoxicity Test .
- ISO Kligman Maximization Test .
- ISO Intracutaneous Reactivity Study ●
- ISO Acute Systemic Toxicity Study ●
- ISO Material Mediated Rabbit Pyrogen Study .
- ASTM Indirect contact Hemolysis ●
- ISO Thrombogenicity Study ●
- ISO Indirect contact Complement activation .
All of the pre-determined acceptance criteria were met and results passed.
Assessment of non-clinical performance data for equivalence:
Bench and biocompatibility testing of the Amphirion Plus PTA Catheter was performed in accordance with the relevant FDA guidance. ISO and ASTM standards. Results from these nonclinical testing demonstrates that the Amphirion Plus PTA Catheter met the pre-determined acceptance criteria and performs comparably to the predicate devices. No new safety or effectiveness issues were observed during the testing.
Conclusion:
Based on the same indications for use, design, material, fundamental scientific technology and performance characteristics, the Amphirion Plus PTA Catheter is substantially equivalent to the predicate devices, Amphirion DEEP, REEF HP and Submarine Plus PTA Balloon Catheter. Results from the non-clinical performance testing demonstrate that the Amphirion Plus PTA Catheter is safe, effective and performs as well as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, rendered in a stylized, minimalist design. The eagle is facing to the left.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 2 2012
Medtronic Vascular c/o Ms. Nainesh Sureja 3576 Unocal Place Santa Rosa, CA 95403
Re: K121265
Trade/Device Name: Amphirion Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: April 25, 2012 Received: April 25, 2012
Dear Ms. Sureja:
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
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Page 2 - Ms. Nainesh Sureja
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M. G. Hillen
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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2.0 Statement of Indications for Use
Indications for Use
510(k) Number (if known): K12/26
Device Name: Amphinon 7 Plus PTA Catheter
Indications For Use:
Indications For Use:
The Amphirion™ Plus PTA Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number_
Page 1 of
(Division Sign-Off) Division of Cardiovascular Devices
§ 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).