(87 days)
BSC -- Courier Balloon Dilatation Catheter, BSC -- Ultra-thin Diamond Balloon Catheter, BSC -- Katzen Thrombolysis Guidewire, LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter
Not Found
No
The summary describes a physical balloon catheter and its intended uses and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for percutaneous transluminal angioplasty, which is a therapeutic procedure to treat obstructive lesions. It also has a secondary function for the infusion of therapeutic agents.
No
Explanation: The device is a balloon catheter used for percutaneous transluminal angioplasty and infusion of agents, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "Balloon catheter," which is a physical hardware device, not software. The performance studies also describe physical testing of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a balloon catheter used for percutaneous transluminal angioplasty and infusion of agents directly into blood vessels. This is an in vivo procedure, meaning it is performed within the living body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples or providing diagnostic information based on laboratory testing.
The device is a therapeutic and interventional medical device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents nto the peripheral vasculature.
Product codes
Not Found
Device Description
The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents nto the peripheral vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral and renal arteries; native or synthetic arteriovenous dialysis fistulae; peripheral vasculature
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
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Summary of Performance Studies
The following in vitro frunctional tests were performed on the Channel™ Balloon Catheter:
- Balloon Burst Testing 1.
- Multiple Inflation Testing 2.
- · 3. Balloon Compliance Testing
- Inflation / Deflation Time Testing
- Sheath Withdrawal Testing 5.
- Proximal Bond Tensile Testig Q.
- Shaft Tensile Testing 7.
- Flow Rate Testing 8.
- Outer Sleeve Distal and Proximal Bond Testing 9.
-
- Flow Uniformity Testing
In addition, the following Biocompatibility Testing was performed:
-
- Intracutaneousl Reactivity
- Sensitization 2.
-
- Cytotoxicity
-
- Acute Systemic Toxicity
- Haemocompatibility (completed as Hemolysis) 5.
-
- Pyrogenicity
- Mutagenicity 7.
Animal testing was also conducted to establish the Vessel Depth of Penetration for the proposed device.
Key Metrics
Not Found
Predicate Device(s)
BSC -- Courier Balloon Dilatation Catheter, BSC -- Ultra-thin Diamond Balloon Catheter, BSC -- Katzen Thrombolysis Guidewire, LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter
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
Medi-tech Channel 7M Balloon Catheter
January 31, 1997
ATTACHMENT I
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to $513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification cither an " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation choose to submit a summary of information respecting safety and effectiveness. According to $513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concearning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Channel™ Balloon Catheter is as follows:
| Trade Name: | Channel™ Balloon Catheter |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| One Boston Scientific Place | |
| Natick, MA 01760 | |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. |
Predicate Devices:
The following devices are referenced in this premarket notification as predicate devices for the ChannelTM Balloon Dilatation Catheter:
BSC -- Courier Balloon Dilatation Catheter BSC -- Ultra-thin Diamond Balloon Catheter BSC -- Katzen Thrombolysis Guidewire LocalMed Inc. - Kaplan Simpson InfusSleeve Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The proposed Channel™ Balloon catheter is an over-the-wire balloon catheter with four lumens indicated for percutaneous transluminal angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A secondary function is the controlled selective regional infusion of contrast or therapeutic agents nto the peripheral vasculature.
1
January 31, 1997
Medi-tech Channel TM Balloon Catheter
Safety and Performance:
The following in vitro frunctional tests were performed on the Channel™ Balloon Catheter:
- Balloon Burst Testing 1.
- Multiple Inflation Testing 2.
- · 3. Balloon Compliance Testing
- Inflation / Deflation Time Testing বা
- Sheath Withdrawal Testing 5.
- Proximal Bond Tensile Testig Q.
- Shaft Tensile Testing 7.
- Flow Rate Testing 8.
- Outer Sleeve Distal and Proximal Bond Testing 9.
-
- Flow Uniformity Testing
In addition, the following Biocompatibility Testing was performed:
-
- Intracutaneousl Reactivity
- Sensitization 2.
-
- Cytotoxicity
-
- Acute Systemic Toxicity
- Haemocompatibility (completed as Hemolysis) న్.
-
- Pyrogenicity
- Mutagenicity 7.
Animal testing was also conducted to establish the Vessel Depth of Penetration for the proposed device.
Conclusion:
Based on the Indications for Use, technological characteristics and safety and performance testing, the Courier TM Balloon Catheter has been shown to be safe and effective for its intended use.