(28 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its mechanical properties and performance. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to dilate stenoses in arteries, which is a therapeutic intervention aimed at improving blood flow and treating a medical condition.
No
Explanation: The device is a Percutaneous Transluminal Angioplasty (PTA) balloon catheter intended to dilate stenoses, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like a hub, shaft, and balloon, and the performance studies focus on bench testing of these physical attributes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate stenoses in the femoral, popliteal, and infrapopliteal arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "Percutaneous Transluminal Angioplasty (PTA) catheter" with a balloon. This is a medical device used for interventional procedures.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The device is clearly an interventional medical device used for treating blockages in arteries, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
Product codes
LIT, DQY
Device Description
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, dual lumen coaxial shaft, and a distal dilatation balloon. The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.018" and with 4F and 5F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90 and 130cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal, and infrapopliteal arteries
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
In vitro bench testing of the PACIFIC XTREME™ PTA Balloon Dilatation Catheter was conducted in accordance with Medtronic Invatec Risk Analysis and all applicable FDA guidance documents and ISO standards, testing included: Minimum Balloon Burst Strength (RBP), Balloon Compliance (diameter vs pressure), Balloon Inflation and Deflation time, Balloon Fatigue (repeat balloon inflations), Flexibility and Kink Test, Torque Strength, Balloon Preparation, Guidewire Compatibility, Coating Durability, Coating Lubricity, Catheter Diameter-balloon profile usable length, Tensile Strength, Catheter Body Burst Pressure, Introducer Sheath Compatibility.
Biocompatibility testing was conducted on finished PACIFIC XTREME™ PTA Balloon Catheters in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices part 1:Evaluation and testing," as specified in the FDA Blue Book Memorandum #G95-1 and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (May 30 2008). All testing documented below was conducted in accordance with the provisions of the FDA GLP regulations 21 CFR 58. The following Biocompatibility tests were completed and passed: Cytotoxicity Study, Maximisation Sensitization Study, Intracutaneous Study, Systemic Toxicity Study, Material Mediated Pyrogen Study, Hemolysis Study, In Vivo Thromboresistance Study, Lee White Coagulation Test, Complement Activation.
No clinical investigation has been performed for this device.
Key Metrics
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
510(k) Summary
DEC 2 2 2010
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).
Applicant:
Official
| Contact Person: | Heather Morose, Associate Regulatory Specialist
Medtronic Inc.
37A Cherry Hill Drive
Danvers, MA 01923
Tel: 978-739-3187
Fax: 978-739-7380
Email: heather.p.morose@medtronic.com |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alternate Contact: | Fred Boucher, Director, RA |
Medtronic, Inc. 37A Cherry Hill Drive Danvers, MA 01923 Tel: 978-739-3116 Fax: 978-739-7380 Email: fred.boucher@medtronic.com
Date Prepared: November 22, 2010
Device Information:
| Trade Name: | Medtronic Invatec PACIFIC XTREME™ PTA Balloon |
|---|---|
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Regulation Name: | Percutaneous Catheter |
| Classification: | II |
| Classification Panel: | Peripheral |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT, DQY |
1
Image /page/1/Picture/0 description: The image contains the Medtronic logo. The logo consists of a stylized image on the left and the word "Medtronic" on the right. The stylized image appears to be a representation of a brain. The text is in a bold, sans-serif font.
Predicate Devices:
Invatec SUBMARINE PLUS PTA Balloon catheter (K042537) Invatec AMPHIRION DEEP OTW PTA Balloon Dilatation Catheter (K083919) Invatec ADMIRAL XTREME PTA Balloon Catheter (K100921)
Device Description:
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, dual lumen coaxial shaft, and a distal dilatation balloon. The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.018" and with 4F and 5F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90 and 130cm.
Indication for Use:
The PACIFIC XTREME PTA Balloon Dilatation Catheter in 150mm, 200mm, 250mm and 300mm balloon length is intended to dilate stenoses in the femoral, popliteal, and infrapopliteal arteries.
Technological Characteristics:
The PACIFIC XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter. The catheter is compatible with .018" guidewire. The technological characteristics of the PACIFIC XTREME™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the Submarine Plus PTA Balloon catheter (K042537), Amphirion Deep PTA Balloon Catheter (K083919), and the Admiral Xtreme PTA Balloon Catheter (K100921).
Summary of Bench Testing:
In vitro bench testing of the PACIFIC XTREME™ PTA Balloon Dilatation Catheter was conducted in accordance with Medtronic Invatec Risk Analysis and all applicable FDA guidance documents and ISO standards, testing included:
- Minimum Balloon Burst Strength (RBP) .
- Balloon Compliance (diameter vs pressure) .
- Balloon Inflation and Deflation time .
2
Image /page/2/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The circular graphic appears to be a stylized representation of the earth. The word "Medtronic" is written in a bold, sans-serif font.
- . Balloon Fatigue (repeat balloon inflations)
- Flexibility and Kink Test �
- Torque Strength .
- Balloon Preparation ●
- Guidewire Compatibility .
- . Coating Durability
- . Coating Lubricity
- Catheter Diameter-balloon profile usable length .
- Tensile Strength .
- Catheter Body Burst Pressure 0
- Introducer Sheath Compatibility 0
Summary of Biocompatibility Testing:
The PACIFIC XTREMETM PTA Balloon Dilatation Catheter is an externally communicating device, which contacts circulating blood for the limited contact duration (