(90 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML capabilities.
No
The device is intended to dilate stenoses in various arteries and treat obstructive lesions, rather than providing or supporting therapy.
No
The device is described as a 'Percutaneous Transluminal Angioplasty (PTA) catheter' intended to 'dilate stenoses'. This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly outlines physical components like a catheter, shaft, balloon, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "dilate stenoses 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." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Pacific™ Plus PTA catheter is intended to dilate stenoses 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.
Product codes
LIT, DOY
Device Description
The Pacific Plus is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, a coaxial dual lumen shaft, and a distal dilatation balloon. 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 guide wire with a maximum outer diameter of 0.018 inches (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. Two radiopaque marker bands are placed under the balloon segment of the catherser shaft to provide visual reference points for balloon positioning within the vessel.
The Pacific Plus catheter is compatible with guidewires with a maximum diameter of 0.018" (0.46 mm) and with 4F or 5F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90, 130 and 180 cm.
Balloon sizes range from 2.0mm to 7.0mm in diameter, with balloon lengths from 20mm to l 50mm. All balloons reach nominal diameter at 8atm (Nominal Pressure) and have rated burst pressure (RBP) of 22atm, 16atm, 14atm and 12atm depending on the balloon diameter and balloon length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-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)
Summary of Bench Testing: The Pacific Plus was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed with the consideration of the recommendations outlined in the applicable FDA guidance documents, ISO and ASTM standards. Testing performed on the Pacific Plus device included the following:
- Dimensional verification
- Balloon preparation, deployment and retraction
- Balloon rated burst pressure (RBP)
- Balloon fatigue (repeated balloon inflations)
- Balloon Compliance
- Balloon Inflation/Deflation Time
- Catheter Bond Strength
- Flexibility and Kink test
- Torque Strength
- Radiopacity
- Coating Integrity
- Particulate evaluation
- Guide wire compatibility
- Introducer sheath compatibility
- Coating lubricity
All of the pre-determined acceptance criteria were met and results passed.
Summary of Biocompatibility Testing: The Pacific Plus is an externally communicating device, which contacts circulating blood for the limited contact duration (
§ 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
JAN 2 9 2013
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/Submitter:
Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403
Tel: 707-525-0111 Fax: 707-566-1245
Contact person: Diana Johnson, Regulatory Affairs Director
Official Contact Person: Maddalena Pinsi, Regulatory Affairs Specialist INVATEC INNOVATIVE TECHNOLOGIES, S.p.A. 7, Via Martiri della Libertà Roncadelle, ITALY 25030.
Tel: 707-591-2656 Fax: 707-566-1245
Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403
Tel: 707-591-2656 Fax: 707-566-1245
Email: maddalena.pinsi@medtronic.com
Diana Johnson, Regulatory Affairs Director
Email: diana.j.johnson@medtronic.com
Alternate Contact:
Date Prepared:
October 26, 2012
Device Information:
Trade Name: Common Name: Regulation Name: Classification: Classification Panel: Regulation Number: Product Code:
Medtronic Vascular Pacific™ Plus K123358, Traditional 510(k)
Pacific™ Plus Percutaneous Transluminal Angioplasty Catheter Percutaneous Catheter Class II Peripheral 21 CFR 870.1250 LIT, DOY
1
Predicate Devices
- Pacific™ Xtreme PTA Balloon Dilatation Catheter (K103464 SE-12/22/2010) .
- Amphirion™ DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-11/04/2005 and . K083919 SE-03/13/2009)
- REEF HP™ 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-10/29/2009) .
Reference Device
- · Amphirion™ Plus PTA Catheter (K121265 SE-05/22/2012)
Device Description
The Pacific Plus is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, a coaxial dual lumen shaft, and a distal dilatation balloon. 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 guide wire with a maximum outer diameter of 0.018 inches (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. Two radiopaque marker bands are placed under the balloon segment of the catherser shaft to provide visual reference points for balloon positioning within the vessel.
The Pacific Plus catheter is compatible with guidewires with a maximum diameter of 0.018" (0.46 mm) and with 4F or 5F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90, 130 and 180 cm.
Balloon sizes range from 2.0mm to 7.0mm in diameter, with balloon lengths from 20mm to l 50mm. All balloons reach nominal diameter at 8atm (Nominal Pressure) and have rated burst pressure (RBP) of 22atm, 16atm, 14atm and 12atm depending on the balloon diameter and balloon length.
Indications for Use
The Pacific Plus PTA Catheter is intended to dilate stenoses 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 indications for use for the Pacific Plus are equivalent and covered by the currently cleared predicate devices, Pacific Xtreme PTA Balloon Dilatation Catheter (hereinafter referred to as "Pacific Xtreme"), Amphirion DEEP PTA Balloon catheter (hereinafter referred to as "Amphirion DEEP") and REEF HP PTA Balloon Catheter (hereinafter referred to as "REFF HP").
Technological Characteristics
The Pacific Plus (hereinafter referred to also as "subject device") is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter. The overall design and the fundamental scientific technology (operating principle or mechanism of action) of the Pacific Plus device are
Medtronic Vascular Pacific™ Plus K123358 Traditional 510(k)
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K123358
p. 3 of 5
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equivalent to the currently cleared predicate devices, Pacific Xtreme, Amphirion DEEP and REEF HP. Description of the modified device, Pacific Plus, is provided in the table below:
| Characteristic | Modified Pacific Plus |
|---|---|
| Balloon Lengths (mm) | The subject device balloon lengths are within the Amphirion DEEP predicate |
| device balloon length range. | |
| Balloon Diameter | |
| (mm) | The subject device balloon diameters are within the Amphirion DEEP and REEF |
| HP predicate devices balloon diameter range. | |
| Balloon Material | The subject device with balloon diameter from 2.0mm to 4.0mm uses a balloon |
| material type that is the same as the one used in the REEF HP predicate device. | |
| In addition the balloon material is supplied as compliant to USP Class VI. | |
| The Pacific Plus balloons with diameter from 5.0mm to 7.0mm use a material | |
| identical to the guidewire tube component of the Pacific Xtreme predicate device. | |
| Biocompatibility evaluation and comparative, design verification and shelf life | |
| testing have been performed on the subject device in order to support with | |
| objective evidence its safety and effectiveness and the results met the required | |
| specifications. | |
| Catheter Useable | |
| Length (cm) | The Pacific Plus 90cm and 130cm usable lengths are within the Pacific Xtreme |
| predicate device's range, while the longer catheter useable length of 180cm was | |
| designed for the subject device increasing the shaft length by 30cm compared to | |
| Amphirion DEEP without changing the fundamental scientific technology. This | |
| longer catheter useable length was added to the subject catheter usable length | |
| size matrix in order to expand the size offerings and it is driven by the need to | |
| provide the physicians with a more comprehensive size mix. There are no | |
| changes to the technical features of the usable length design and the 180cm shaft | |
| length is made of identical materials and manufacturing processes as the other | |
| sizes. | |
| Proper design verification, shelf life and comparative testing has been performed | |
| on the subject device in order to support with objective evidence its safety and | |
| effectiveness and all the results have met the requested specifications. | |
| Catheter Shaft | |
| Diameter | The shaft diameter is within the range of the Pacific Xtreme shaft diameters. |
| Catheter Shaft | |
| Material | The Pacific Plus catheter shaft material is identical to the material used on the |
| Amphirion DEEP predicate device. | |
| Catheter Coating | The coating has the same base and function as the coating of the Amphirion |
| DEEP and Pacific Xtreme predicate devices; three reagents have been changed in | |
| the formula in comparison to the predicate devices with no new risks. | |
| Biological evaluation and comparative, design verification and shelf life testing | |
| have been performed on the subject device in order to support with objective | |
| evidence its safety and effectiveness and the results met the required | |
| specifications. | |
| Guidewire | |
| Compatibility | The subject device guidewire compatibility is within the Amphirion DEEP and |
| Pacific Xtreme predicate devices guidewire compatibility range. | |
| Guidewire Tube | |
| Material | The subject device guidewire tube material is the same as the Pacific Xtreme |
| predicate device guidewire tube material. | |
| Characteristic | Modified Pacific Plus |
| Introducer Sheath | |
| Compatibility | The subject device introducer sheath compatibility is the same as the Pacific Xtreme predicate device introducer sheath compatibility. |
| Nominal Pressure | |
| (atm) | The nominal pressure (8atm) is within the range of the REEF HP and Pacific Xtreme predicate devices nominal pressure. |
| Rated Burst Pressure | |
| (atm) | The subject device has a Rated Burst Pressure (RBP) of 22,16,14 and 12 atm depending on balloon diameters. These RBPs are within the range of the REEF HP and Pacific Xtreme predicate devices RBP. |
Medtronic Vascular .
Pacific™ Plus
K123358 Traditional 510(k)
3
Summary of Bench Testing
The Pacific Plus was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed with the consideration of the recommendations outlined in the applicable FDA guidance documents. ISO and ASTM standards. Testing performed on the Pacific Plus device included the following:
- . Dimensional verification
- . Balloon preparation, deployment and retraction
- . Balloon rated burst pressure (RBP)
- . Balloon fatigue (repeated balloon inflations)
- . Balloon Compliance
- Balloon Inflation/Deflation Time •
- . Catheter Bond Strength
- . Flexibility and Kink test
- . Torque Strength
- . Radiopacity
- . Coating Integrity
- . Particulate evaluation
- . Guide wire compatibility
- . Introducer sheath compatibility
- . Coating lubricity
All of the pre-determined acceptance criteria were met and results passed.
Summary of Biocompatibility Testing
The Pacific Plus is an externally communicating device, which contacts circulating blood for the limited contact duration (