(91 days)
None
No
The description focuses on the mechanical design and function of a balloon catheter for coronary artery dilation. There is no mention of any computational or analytical components that would suggest the use of AI or ML.
Yes
The device directly treats a medical condition (stenosis of a coronary artery or bypass graft) by dilating it.
No
Explanation: The device is a coronary dilatation catheter intended for the treatment of stenotic coronary arteries or bypass grafts. It is used to dilate the stenosis, not to diagnose it.
No
The device description clearly details a physical catheter with a balloon, shaft, lumens, and markers, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the mechanical dilatation of stenotic portions of coronary arteries or bypass grafts. This is a direct intervention on the patient's body.
- Device Description: The device is a catheter with a balloon designed to be inflated within a blood vessel. This is a physical medical device used for treatment.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
Therefore, the MINI TREK™ RX and OTW 1.20 mm Coronary Dilatation Catheters are therapeutic medical devices, not IVDs.
N/A
Intended Use / Indications for Use
The MINI TREK™ RX 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The MINI TREK™ OTW 1.20 mm Coronary Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
Product codes
LOX
Device Description
The MINI TREK RX 1.20 mm Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. All 1.20 mm balloon diameters have a single balloon marker. The co-axial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. All 1.20 mm balloon diameters have a single balloon marker. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary artery or bypass graft
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)
Clinical Study:
Study Purpose: The objective of this trial was to evaluate the acute safety and efficacy of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter (CDC) for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
Design: The CROSS clinical trial was a prospective, open-label, single-arm, multi-center, observational study. Approximately 60 subjects were to be enrolled at 4 clinical sites in the US; 71 subjects were enrolled to compensate for some subjects who did not have a creatine kinase myocardial-band isoenzyme (CK-MB) draw at or later than 16 hours post-index procedure. Each subject was allowed a maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Subjects with single or dual vessel disease and clinical evidence of myocardial ischemia were included in the trial. Subjects with recent AMI (within 72 hours of index or new onset) were excluded. The target lessons were allowed to be de novo or restenotic lesions in native coronary arteries or bypass grafts with ≥ 70% stenosis, which may include chronic total occlusion (CTO).
The target lesion in this trial was defined as a lesion intended to be initially pre-dilated during the index procedure with a MINI TREK RX 1.20 mm balloon. Any commercially available coronary dilatation catether could have been used for further dilatation as needed. The nontarget lesion in this trial was defined as a lesion intended to be initially treated with any commercially available device.
The primary endpoint was procedure success, which was defined as meeting all of the following after single or multiple attempts with the use of the MINI TREK RX 1.20 mm balloon:
- Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion.
- Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon,
- No vessel perforation, no flow-limiting vessel dissection, no reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon,
- Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the lesion.
The secondary endpoints of device success and lesion success were analyzed on a per lesion basis. Other secondary endpoints included individual procedural parameters, in-hospital major adverse cardiac events (MACE) and in-hospital target lesion failure (TLF) and inhospital stent thrombosis (ST).
Device success was defined as meeting all the following after single or multiple attempts:
- Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion.
- Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by improvement in minimal lumen diameter (MLD) based on core lab analysis, and
- No vessel perforation, no flow-limiting dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon.
Lesion success was defined as meeting all the following after single or multiple attempts:
- Successful dilatation with any device(s) defined as achieving a final residual percent diameter stenosis of
§ 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.
0
K110617
JUN - 2 2011
SECTION 2 - 510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. SUBMITTER'S NAME | Abbott Vascular |
|---|---|
| 2. SUBMITTER'S ADDRESS | 26531 Ynez Road, Temecula, CA 92591 |
| 3. TELEPHONE | (951) 914-3243 |
| 4. FAX | (951) 914-0339 |
| 5. CONTACT PERSON | Suzanne Redman |
| 6. DATE PREPARED | March 2, 2011 |
| 7. DEVICE TRADE NAME | • MINI TREK™ RX 1.20 mm Coronary Dilatation Catheter |
| • MINI TREK™ OTW 1.20 mm Coronary Dilatation Catheter | |
| 8. DEVICE COMMON NAME | • Coronary Dilatation Catheter |
| • Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | |
| 9. DEVICE CLASSIFICATION | |
| NAME | PTCA Catheter, LOX, Class II, |
| 21 CFR 870.5100 | |
| 10. PREDICATE DEVICE NAME | • MINI TREK™ RX Coronary Dilatation Catheter |
| • TREK™ RX Coronary Dilatation Catheter | |
| • MINI TREK™ OTW Coronary Dilatation Catheter | |
| • TREK™ OTW Coronary Dilatation Catheter |
DEVICE DESCRIPTION 11.
MINI TREK RX 1.20 mm Coronary Dilatation Catheter 11.1
The MINI TREK RX 1.20 mm Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Table 2-1 provides a matrix of the balloon diameters
1
and lengths available for the complete TREK RX family of devices, including the addition of the 1.20 mm balloon diameter.
| Balloon
Diameter
| (mm) | Balloon Length | ||||||
|---|---|---|---|---|---|---|---|
| 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm | |
| MINI TREK RX | |||||||
| 1.20 | New | New | New | New | New | ||
| 1.50 | X | X | X | X | X | ||
| 2.00 | X | X | X | X | X | X | X |
| TREK RX | |||||||
| 2.25 | X | X | X | X | X | X | X |
| 2.50 | X | X | X | X | X | X | X |
| 2.75 | X | X | X | X | X | X | X |
| 3.00 | X | X | X | X | X | X | X |
| 3.25 | X | X | X | X | X | X | X |
| 3.50 | X | X | X | X | X | X | X |
| 3.75 | X | X | X | X | X | X | X |
| 4.00 | X | X | X | X | X | X | X |
| 4.50 | X | X | |||||
| 5.00 | X | X |
MINI TREK RX & TREK RX Size Matrix Table 2-1
The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. All 1.20 mm balloon diameters have a single balloon marker. The co-axial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate the advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.
MINI TREK OTW 1.20 mm Coronary Dilatation Catheter 11.2
The MINI TREK OTW 1.20 mm Coronary Dilatation Catheter is an over-the-wire (OTW) co-axial design with a balloon at the distal tip. Table 2-2 provides a matrix of the balloon diameters and lengths available for the complete TREK OTW family of devices, including the addition of the 1.20 mm balloon diameter.
2
| Balloon
Diameter
| (mm) | Balloon Length | ||||||
|---|---|---|---|---|---|---|---|
| 6mm | 8mm | 12mm | 15mm | 20mm | 25mm | 30mm | |
| MINI TREK OTW | |||||||
| 1.20 | New | New | New | New | New | ||
| 1.50 | X | X | X | X | X | ||
| 2.00 | X | X | X | X | X | X | X |
| TREK OTW | |||||||
| 2.25 | X | X | X | X | X | X | X |
| 2.50 | X | X | X | X | X | X | X |
| 2.75 | X | X | X | X | X | X | X |
| 3.00 | X | X | X | X | X | X | X |
| 3.25 | X | X | X | X | X | X | X |
| 3.50 | X | X | X | X | X | X | X |
| 3.75 | X | X | X | X | X | X | X |
| 4.00 | X | X | X | X | X | X | X |
| 4.50 | X | X | |||||
| 5.00 | X | X |
Table 2-2 MINI TREK OTW & TREK OTW Size Matrix
The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. All 1.20 mm balloon diameters have a single balloon marker. The co-axial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.
12. INDICATIONS FOR USE
The MINI TREK™ RX 1.20 mm Coronary Dilatatoin Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
The MINI TREK™ OTW 1.20 mm Coronary Dilatatoin Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).
3
13. TECHNOLOGICAL CHARACTERISTICS
Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices.
14. PERFORMANCE DATA
14.1 Summary of Biocompatibility Testing
Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, and complement activation according to the recommendations of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 and ISO 10993-1:2003, Biological evaluation of medical devices – Part 1: Evaluation and testing.
14.2 Summary of In Vitro Bench Testing
The MINI TREK RX 1.20 mm and MINI TREK OTW 1.20 mm Coronary Dilatation Catheters were subjected to the following in vitro bench tests according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010:
- . Catheter Preparation
- Balloon Crossing Profile .
- Refolded Balloon Profile .
- Balloon Inflation / Balloon Deflation .
- . Balloon Fatigue
- . Balloon Rupture
- Balloon Compliance .
- Catheter Shaft Fatigue .
- Catheter Shaft Rupture .
- . Soft Tip to Inner Member Tensile
- Proximal Balloon Seal Tensile .
- Kink and Flexibility .
- Torque .
Summary of Clinical Data 14.3
14.3.1 Study Purpose
The objective of this trial was to evaluate the acute safety and efficacy of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter (CDC) for enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions.
4
14.3.2 Design
The CROSS clinical trial was a prospective, open-label, single-arm, multi-center, observational study. Approximately 60 subjects were to be enrolled at 4 clinical sites in the US; 71 subjects were enrolled to compensate for some subjects who did not have a creatine kinase myocardial-band isoenzyme (CK-MB) draw at or later than 16 hours post-index procedure. Each subject was allowed a maximum of two lesions, including at least one target lesion, in up to two major epicardial distribution trees. Subjects with single or dual vessel disease and clinical evidence of myocardial ischemia were included in the trial. Subjects with recent AMI (within 72 hours of index or new onset) were excluded. The target lessons were allowed to be de novo or restenotic lesions in native coronary arteries or bypass grafts with ≥ 70% stenosis, which may include chronic total occlusion (CTO).
The target lesion in this trial was defined as a lesion intended to be initially pre-dilated during the index procedure with a MINI TREK RX 1.20 mm balloon. Any commercially available coronary dilatation catether could have been used for further dilatation as needed. The nontarget lesion in this trial was defined as a lesion intended to be initially treated with any commercially available device.
The primary endpoint was procedure success, which was defined as meeting all of the following after single or multiple attempts with the use of the MINI TREK RX 1.20 mm balloon:
- . Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target lesion.
- Successful inflation and deflation with the MINI TREK RX 1.20 mm balloon, .
- . No vessel perforation, no flow-limiting vessel dissection, no reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon,
- Achieve a final TIMI flow grade of 3 at the conclusion of the PCI procedure for the . lesion.
The secondary endpoints of device success and lesion success were analyzed on a per lesion basis. Other secondary endpoints included individual procedural parameters, in-hospital major adverse cardiac events (MACE) and in-hospital target lesion failure (TLF) and inhospital stent thrombosis (ST).
Device success was defined as meeting all the following after single or multiple attempts:
- Successful delivery of the MINI TREK RX 1.20 mm balloon to and across the target . lesion.
- Successful dilatation with the MINI TREK RX 1.20 mm balloon as defined by . improvement in minimal lumen diameter (MLD) based on core lab analysis, and
5
-
. No vessel perforation, no flow-limiting dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias that required medical treatment or device intervention following dilatation with the MINI TREK RX 1.20 mm balloon.
Lesion success was defined as meeting all the following after single or multiple attempts: -
Successful dilatation with any device(s) defined as achieving a final residual percent . diameter stenosis of K110617 |
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