(70 days)
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any AI/ML components or functionalities.
Yes.
The device is used for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to open blocked arteries.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) catheter, which is used for treatment (dilating vessels), not for diagnosis.
No
The device description clearly states it is a dual lumen catheter with a balloon mounted on its distal end, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) of the Iliac and Femoral vessels. This is a surgical procedure performed directly on the patient's blood vessels.
- Device Description: The device is a catheter with a balloon, designed to be inserted into the body to physically dilate blood vessels.
- Anatomical Site: The device is used within the Iliac and Femoral vessels, which are internal anatomical structures.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device is used within the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.
Product codes
Not Found
Device Description
The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accomodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliac and Femoral vessels
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
Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material test, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The test results indicate that the proposed Opti-Plast XL 5.5 F PTA Catheter is substantially equivalent to the current Opti-Plast® PTA Catheter marketed under 510(k) concurrence K933483. There are no new safety or effectiveness issues.
Key Metrics
Not Found
Predicate Device(s)
Opti-Plast® PTA Catheter (K933483)
Reference Device(s)
Medi-tech® XXL™ Balloon Dilatation Catheter (K952063)
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
MAY -9 1997
510(k) SUMMARY STATEMENT of SAFETY AND EFFECTIVENESS
FOR THE
OPTI-PLAST® XL 5.5F PTA CATHETER
| A. | Submitter Information: | Vas-Cath Incorporated |
|---|---|---|
| Address: | 2380 Tedlo Street | |
| Mississauga, Ontario L5Z 3V3 | ||
| Canada | ||
| Telephone Number: | (905) 281-7745 | |
| Fax Number: | (905) 848-6638 | |
| Contact Person: | Dolores McGirr | |
| Date of Preparation: | January 24, 1997 : | |
| B. | Device Name: | Opti-Plast® XL 5.5 F PTA Catheter |
| XL (Xtra-Large) | ||
| Common/Usual Name: | Peripheral Angioplasty Catheter | |
| Classification Name: | Surgical Vessel Dilator | |
| C. | Predicate Device : | Opti-Plast® PTA Catheter (K933483) |
| Trade Name: | Opti-Plast | |
| Predicate Device for the Indications for Use: Medi-tech® XXL™ Balloon Dilatation |
Catheter (K952063)
D. · Device Description:
The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accomodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.
E. Indicated Use:
The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.
- F. Technological Characteristics Summary: Summarized in Table 6.1.
Opti-Plast® XL PTA Catheter 510(k) Summary Page(o
2380 Tedlo Street Mississauga, Ontario Canada, LSA 3V3
Tel. (905) 848-5800 Fax (905) 848-6638
1
Image /page/1/Picture/0 description: The image shows the word "vascoath." in a stylized font. Below the word is the word "INCORPORATED" in a smaller, sans-serif font. The text is black on a white background. The dot after the word "vascoath" is larger than the letters in the word "INCORPORATED."
| Features | Proposed Vas-Cath
Opti-Plast® XL 5.5 F
PTA Catheter | Vas-Cath Opti-Plast®
PTA Catheter
(K933483) | Medi-tech" XXLTM
Balloon Dilatation
Catheter (K952063) |
|-----------------------------------|-----------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Indicated Use | PTA of Iliac and
Femoral vessels | PTA of vessels of the
peripheral vascular
system | PTA of the Iliac and
Femoral arteries in the
peripheral vasculature |
| Balloon Material | Nylon | Nylon | NA |
| Inflated Balloon
Diameters | 12 mm | 10 mm* | 12, 14 mm |
| Inflated Balloon
Length | 4 cm | 4 cm* | 2, 4, 6 cm |
| Recommended
Operating Pressure | 5 atmospheres | 6 atmospheres* | NA |
| Rated Burst Pressure | 8 atmospheres | 8 atmospheres* | 8 atmospheres |
| Catheter Shaft Material | Nylon | Nylon | NA |
| Radiopaque | Yes | Yes | NA |
| Shaft Diameter | 5.5 French | 5.5 French | 5.8 French |
| Shaft Length | 75, 100, 120 cm | 75, 100, 120 cm | 75, 120cm |
| Shaft configuration | Double lumen | Double lumen | Double lumen |
| Marker Bands | Yes, Tantalum | Yes, Tantalum | Yes |
| Tip Length | 5 mm | 5 mm | 5 mm |
| Tip Inner Diameter | 0.037 inch | 0.037 inch | 0.037 inch |
| Guidewire Capability | 0.035 inch diameter | 0.035 inch diameter | 0.035 inch diameter |
TABLE 6.1 : Technological Characteristics Summary
NA- Not available from promotional literature
- Note that there are many other sizes of balloons in this product line. However, the comparison here is made with the 10 mm x 4 cm balloon since this is the closest size to the proposed catheter.
G. Performance Data
Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material test, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The test results indicate that the proposed Opti-Plast XL 5.5 F PTA Catheter is substantially equivalent to the current Opti-Plast® PTA Catheter marketed under 510(k) concurrence K933483. There are no new safety or effectiveness issues.