(651 days)
Not Found
No
The device description details a physical catheter with a balloon and coating, and there is no mention of software, algorithms, or any terms related to AI or ML.
Yes.
The device is a "polymeric balloon mounted on a double lumen shaft," explicitly referred to throughout the document as a "Balloon Dilatation Catheter," which is a type of therapeutic device used to dilate vessels.
No
The device is described as a "polymeric balloon mounted on a double lumen shaft" used for "balloon inflation" and "passage of a guide wire," which are functions of an interventional or therapeutic device, not a diagnostic one. The predicate devices are also "Balloon Dilatation Catheters."
No
The device description clearly describes a physical catheter with a balloon and shaft, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a physical device (a balloon catheter) used for a procedure within the body. There is no mention of testing samples (like blood, urine, or tissue) outside of the body, which is the defining characteristic of an IVD.
- Device description aligns with a medical device: The description of a balloon catheter with a guide wire lumen and inflation lumen is consistent with a device used for medical procedures, not laboratory diagnostics.
- Indications for Use are not described as diagnostic: While the specific indications are not detailed, the context of a balloon catheter suggests a therapeutic or interventional use, not a diagnostic one.
- Predicate devices are balloon catheters: The predicate devices listed (MS CLASSIQUE™ Balloon Dilatation Catheter) are also types of balloon catheters, further supporting the conclusion that this is a medical device used for procedures.
Therefore, based on the information provided, this device is a medical device, likely for a procedure involving dilation, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indications for use have not changed, and are equivalent to those of the predicate devices cited above.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly referred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and the other for balloon inflation. The product is coated with Meadox's exclusive hydrophilic coating on the balloon, the tip and distal shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
MS CLASSIQUE™ Balloon Dilatation Catheter
HYDROPASS™ Hydrophilic Coating Catheter
HYDROPASS™ Hydrophilic Coating Cardiovascular 08/03/95
.
MAY 1 6 1997
| 510(k) Summary of Safety & Effectiveness | |||
|---|---|---|---|
| GENERAL INFORMATION: | Sponsor: | Meadox Medicals, Inc. | |
| 112 Bauer Drive | |||
| Oakland, NJ 07436 | |||
| Contact Person: | Stephen B Anderson | ||
| Submission Date: | August 03. 1995 | ||
| DEVICE INFORMATION: | Generic Name: | Balloon Dilatation Catheter | |
| MS CLASSIQUE™ Balloon Dilatation Catheter | |||
| Trade Name: | |||
| w/HYDROPASS™ Hydrophilic Coating | |||
| Classification Name: | Cardiovascular - Percutaneous Catheter | ||
| PREDICATE DEVICE INFO: | The following devices, to which substantial equivalence is claimed, serve as predicate | ||
| devices for this premarket notification submission: | |||
| DEVICE DESCRIPTION: | Proprietary Name | ||
| K942293 | MS CLASSIQUE™ Balloon Dilatation Catheter | 10/18/94 | |
| K943298 | MS CLASSIOUE™ Balloon Dilatation Catheter | 09/08/94 | |
| Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly | |||
| referred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y- | |||
| connector system with two female luer fittings, one for passage of a guide wire, and the | |||
| other for balloon inflation. The product is coated with Meadox's exclusive hydrophilic | |||
| coating on the balloon, the tip and distal shaft. | |||
| BIOCOMPATIBILITY: | Biocompatibility testing, conducted in accordance with the ISO-10993 standard, indicates | ||
| that the MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASSTM | |||
| Hydrophilic Coating is safe for it's labeled indications | |||
| INDICATIONS: | Indications for use have not changed, and are equivalent to those of the predicate devices | ||
| cited above. | |||
| DESIGN MATERIALS: | Design materials have not changed, and are equivalent to those of the predicate devices | ||
| cited above. | |||
| MANUFACTURING: | The manufacturing process now has an additional production step during which | ||
| HYDROPASS™ Hydrophilic Coating is applied to the catheter. | |||
| SPECIFICATIONS: | The package labeling of the MS CLASSIQUE™ Balloon Dilatation Catheter will now | ||
| specify Mean or Average Burst Pressure. All MS CLASSIQUE™ Balloon Dilatation | |||
| Catheters with HYDROPASS™ Hydrophilic Coating meet currently established | |||
| performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters. | |||
| CONCLUSION: | The addition of HYDROPASS™ Hydrophilic Coating to MS CLASSIOUE™ Balloon | ||
| Dilatation Catheters does not alter the level of safety and effectiveness associated with the | |||
| currently marketed products. |
MS CLASSIQUE™ is a trademark of Meadox Surgimed A/S.
HYDROPASS™ is a trademark of Meadox Medicals, Inc.