(191 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with 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 various arteries and for the treatment of obstructive lesions, which are actions aimed at treating a medical condition.
No
The device description and intended use clearly state that the SABER™ PTA Dilatation catheter is used for therapeutic purposes, specifically to dilate stenoses and for post-dilation of stents. It is not designed to diagnose conditions.
No
The device description clearly outlines a physical medical device (catheter with balloon, shaft, marker bands, coating) and the performance studies involve bench and animal testing of this physical device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- SABER™ PTA Dilatation Catheter Function: The description clearly states that the SABER™ PTA Dilatation catheter is used to dilate stenoses (narrowings) in blood vessels within the body. It's a therapeutic device used for a medical procedure performed directly on the patient.
The device description and intended use are consistent with a medical device used for interventional procedures, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The SABER™ PTA catheter is intended to dilate stenoses in 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 device is also indicated for postdilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Product codes
LIT
Device Description
The SABER™ PTA Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub and distal dilatation balloon, connected by a . coaxial, concentric dual lumen shaft. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. A hydrophilic coating covers the distal tip, balloon, and sections of the shaft, to facilitate balloon placement. The SABER® PTA Catheter is compatible with 4F, 5F, and 6F catheter introducer sheaths, and with guidewires having a maximum diameter of 0.018 inches. The SABER" PTA Catheter is available in a variety of sizes, ranging from 2 to 10 mm in diameter and 20 to 300 mm in length, and useable length of either 90 or 150 cm. It is packaged as a single use, sterile device.
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)
Bench, animal and biocompatibility testing were performed to support a determination of substantial equivalence.
The SABER™ PTA Catheter was validated by three physicians in one animal study using a swine model. This testing was performed to establish by objective evidence that the Saber .018 inch PTA Catheter conforms to the user needs such as insertion and withdrawal, trackability, crossability, visibility, marker band visibility, placement, and inflation and deflation time. The Saber PTA Catheter met all predetermined acceptance criteria of design verification and validation. Testing results identified no new questions of safety or effectiveness, and demonstrate that the technological characteristics and device performance of the SABER™ PTA Catheter are comparable to currently marketed devices.
No clinical studies were deemed necessary to support substantial equivalence.
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
JUN 2 7 2014
SECTION 5. 510(k) SUMMARY
(As Required By 21 CFR 807.92(a)) -
| A. Company Information | |
|---|---|
| Company Name: | Cordis Corporation (Manufacturer) |
| Address: | 6500 Paseo Padre Parkway |
| Fremont, CA 94555 | |
| Contact Person: | Kim Fonda |
| Telephone: | (510) 248-2480 |
| Fax: | (510) 248-2533 |
| Date of Submission: | Dec. 16, 2013 |
| Company Name: | Cordis Cashel (Legal Manufacturer) |
| Address: | Cahir Road |
| Cashel Co. | |
| Tipperary, Ireland | |
| Contact Person: | Kim Fonda |
| Telephone: | (510) 248-2480 |
| Fax: | (510) 248-2533 |
| B. Trade/Device Name: | SABER™ Percutaneous Transluminal Angioplasty |
| Dilatation Catheter | |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Regulation Number: | 21 CFR 870.1250 - Percutaneous Catheter |
| Product Code: | LIT |
C. Predicate Device Information:
'
| Predicate Devices | |||
|---|---|---|---|
| 510(k) | |||
| Number | Date | ||
| Cleared | Device Name | Manufacturer | |
| K971010 | 6/18/1997 | SAVVY® PTA Balloon Catheter | Cordis Corp. |
1
| K121442 | 6/14/2012 | Powerflex® Pro Percutaneous
Transluminal Angioplasty
Balloon Catheter | Cordis Corp. |
|---------|------------|-----------------------------------------------------------------------------|---------------|
| K103464 | 12/22/2010 | Invatec Pacific™ Xtreme PTA
Balloon Catheter | Medtronic Inc |
D. Device Description:
The SABER™ PTA Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub and distal dilatation balloon, connected by a . coaxial, concentric dual lumen shaft. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. A hydrophilic coating covers the distal tip, balloon, and sections of the shaft, to facilitate balloon placement. The SABER® PTA Catheter is compatible with 4F, 5F, and 6F catheter introducer sheaths, and with guidewires having a maximum diameter of 0.018 inches. The SABER" PTA Catheter is available in a variety of sizes, ranging from 2 to 10 mm in diameter and 20 to 300 mm in length, and useable length of either 90 or 150 cm. It is packaged as a single use, sterile device.
E. Intended Use:
The SABER™ PTA catheter is intended to dilate stenoses in 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 device is also indicated for postdilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
F. Summary of technological characteristics of the proposed device to the predicate devices:
The SABER™ PTA Catheter has the following similarities to the predicate devices:
- ◆ Same intended use
- . Same operating principle
- · · Method of delivery
- . Components
- . Performance properties
- Device dimensions .
- . Device labeling
- . Manufacturing processes
- . Same sterilization methods and sterility assurance level
2
- Packaging materials and configurations .
The intended use of the SABER™ PTA Catheter is identical to the predicate Powerflex® Pro PTA Catheter. The differences between the SABER "PTA Catheter and predicate devices do not raise any new questions of safety and effectiveness.
Summary of Nonclinical Testing:
Bench, animal and biocompatibility testing were performed to support a determination of substantial equivalence. Results of testing demonstrated that the SABER™ PTA Catheter has been tested to assure conformance to the requirements for its intended use.
The SABER™ PTA Catheter is an externally communicating device, contacting circulating blood for