(67 days)
BSC -- Blue Max Balloon Dilatation Catheter, BSC -- Ultra-thin™ Balloon Catheter, BSC -- SymmetryTM Small Vessel Balloon Dilatation Catheter, BSC -- Courier 1 Balloon Dilatation Catheter
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No
The summary describes a physical medical device (balloon catheter) and its performance and biocompatibility testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for "PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae," which are therapeutic interventions.
No
This device is a balloon dilatation catheter used for therapeutic purposes (PTA of arteries, treatment of obstructive lesions). Its function is to dilate vessels, not to diagnose conditions.
No
The device description clearly indicates it is a physical catheter with a balloon, designed to be placed over guidewires and offered with coatings. The performance studies listed are all related to the physical properties and biocompatibility of 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 describes a device used within the body for a therapeutic procedure (angioplasty). IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed to be inserted into blood vessels. This is consistent with an in-vivo (within the living body) device, not an in-vitro device.
- Lack of IVD-specific information: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
- Performance Studies: The performance studies listed are related to the physical and biological properties of the catheter itself (burst strength, biocompatibility, etc.), not the accuracy or reliability of a diagnostic test performed on a sample.
Therefore, the Diamond™ Vessel Balloon Dilatation Catheter is an in-vivo therapeutic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
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Device Description
The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter indicated for percuraneous transluminal angioplasty of the iliac, femoral arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller. The device is offered with and without Glidex™ and Medi-Glide™ coatings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, renal arteries; 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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following in vitro frunctional tests were performed on the Diamond™ Balloon Dilatation Catheter: - Balloon Burst Testing - Multiple Inflation Testing - Inflation/Deflation Time Testing - . Balloon Compliance Testing - . Balloon Proximal Bond Testing - . Sheath Withdrawal Testing - . Wingfolded Balloon Profile Testing - . Coating Slip/Adhesion Testing - . Coating Coefficient of Friction Testing - Particulate Analysis Testing - . Solvent Residual Testing The following biocompatibility tests were performed: - Cytotoxicity - . Hemolysis - . U.S.P. Class IV - . Mutagenicity - . Sensitization - . Thrombogenicity - . Pyrogenicity - . 90-Day Muscle Implantation
Key Metrics
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Predicate Device(s)
BSC -- Blue Max Balloon Dilatation Catheter, BSC -- Ultra-thin™ Balloon Catheter, BSC -- SymmetryTM Small Vessel Balloon Dilatation Catheter, BSC -- Courier 1 Balloon Dilatation 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 Ultra-thin Thi Diamond The Balloon Dilatation Catheter
K96C50
February 1, 1996
ATTACHMENT H
APR - 9 1996
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 either 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 Diamond™ Balloon Dilatation Catheter is as follows:
| Trade Name: | Diamond™ Balloon Dilatation 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 Diamond™ Balloon Dilatation Catheter:
BSC -- Blue Max Balloon Dilatation Catheter BSC -- Ultra-thin™ Balloon Catheter BSC -- SymmetryTM Small Vessel Balloon Dilatation Catheter BSC -- Courier 1 Balloon Dilatation Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The proposed Diamond™ Balloon Dilatation catheter is an over-the-wire catheter indicated for percuraneous transluminal angioplasty of the iliac, femoral arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller. The device is offered with and without Glidex™ and Medi-Glide™ coatings.
1
February 1, 1996
Medi-tech Ultra-thin™ Diamond™ Balloon Dilatation Catheter
Indications for Use:
The Diamond™ Vessel Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Safety and Performance:
The following in vitro frunctional tests were performed on the Diamond™ Balloon Dilatation Catheter:
- Balloon Burst Testing
- Multiple Inflation Testing
- Inflation/Deflation Time Testing
- . Balloon Compliance Testing
- . Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing
- . Wingfolded Balloon Profile Testing
- . Coating Slip/Adhesion Testing
- . Coating Coefficient of Friction Testing
- Particulate Analysis Testing
- . Solvent Residual Testing
The following biocompatibility tests were performed:
- Cytotoxicity
- . Hemolysis
- . U.S.P. Class IV
- . Mutagenicity
- . Sensitization
- . Thrombogenicity
- . Pyrogenicity
- . 90-Day Muscle Implantation
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Diamond™ Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.