(26 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device 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," which indicates a therapeutic purpose of treating a medical condition.
No
This device is a Percutaneous Transluminal Angioplasty (PTA) catheter intended to dilate stenosis, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines a physical medical device (catheter with balloon) and the performance studies focus on bench testing and biocompatibility of this physical device. There is no mention of software as a component or the primary function.
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 device used in vivo (within the body) to physically dilate blood vessels and treat lesions. IVDs are used in vitro (outside the body) to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the body. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Amphirion™ Plus PTA Catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The AmphirionTM 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.
Product codes
DQY, LIT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Indicated Patient Age Range
Not Found
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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)
1
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 Amphirion |
| Plus balloon size matrix. The 14mm balloon is made of | |
| identical materials and manufacturing processes as the other | |
| balloon sizes. | |
| Catheter Useable Length | |
| (cm) | The Amphirion Plus catheter useable lengths are within the |
| Amphirion DEEP and REEF HP catheter useable lengths. | |
| Catheter Shaft Diameter | The Amphirion Plus catheter shaft diameters are within the |
| Amphirion DEEP and REEF HP catheter shaft diameters. |
2
| Characteristic | Modified Amphirion Plus PTA Catheter |
|---|---|
| Catheter Shaft Material | The Amphirion Plus catheter shaft material is identical to the |
| material 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 within | |
| the REEF HP RBP range of 18-22 ATM. | |
| Balloon Material | Amphirion Plus Balloon Material is identical to the Submarine |
| Plus 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.
3
Summary of Biocompatibility Testing:
The Amphirion Plus PTA Catheter is an externally communicating device, which contacts circulating blood for the limited contact duration (