(202 days)
Not Found
No
The summary describes a standard balloon catheter and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to dilate lesions in large vessels, which is a therapeutic action.
No
The device, a balloon catheter, is described as intended to "dilate lesions," which is a treatment or interventional procedure, not a diagnostic one.
No
The device description clearly states it is a physical balloon catheter, which 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 is to "dilate lesions in large vessels." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "balloon catheter," which is a medical device used for interventional procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the body) for treatment.
N/A
Intended Use / Indications for Use
The Maxi PTA catheter is intended to dilate lesions in large vessels.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device is an overthe-wire balloon catheter, with a distal balloon and a proximal hub. The balloon is indicated by two radiopaque marker bands.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of in vitro tests were performed to assure that the introduction of the Maxi PTA catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
07-00032.
K963000
Section 513(j) of the Federal Food, Drug and Cosmetic Act Summary of Safety and Effectiveness
July 26, 1996
FEB 20 1997
General Provisions I.
| Common or Usual name: | PTA Balloon Catheter |
|---|---|
| Proprietary name: | Cordis Maxi PTA Balloon Catheter |
| Name and Address of Applicant: | Cordis Corporation |
| Miami Lakes Operation Center | |
| 14201 NW 60 Avenue | |
| Miami Lakes, FL 33014 |
Name of Predicate Devices II.
Cordis Opta 5 PTA Balloon Catheter Cordis Powerflex 5F PTA Balloon Catheter Cook Omega N.V. Balloon Dilatation Catheter
Classification III.
PTA catheters are class II devices according to 21 CFR 870.1340.
Performance Standards IV.
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description V.
The Maxi PTA catheter is intended to dilate lesions in large vessels. The device is an overthe-wire balloon catheter, with a distal balloon and a proximal hub. The balloon is indicated by two radiopaque marker bands.
VI. Biocompatibility
All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Maxi PTA Catheter.
In vitro Testing VII.
1
A series of in vitro tests were performed to assure that the introduction of the Maxi PTA catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.
VIII. Summary of Substantial Equivalence
้
The Maxi PTA catheter is designed for dilatation of stenotic lesions in large vessels. The Maxi PTA catheters have the same intended use, and several of the same materials, design characteristics and dimensions as the predicate devices.