(69 days)
Balt Magic Infusion Catheter, Transend Steerable Guidewire
Not Found
No
The summary describes a mechanical device for infusion and lists standard performance and biocompatibility tests, with no mention of AI/ML terms or data-driven performance metrics.
No
The device is indicated for infusion of diagnostic agents, not for treatment or therapy.
No
The device is described as an "Infusion Device" for delivering diagnostic agents, not for performing diagnosis itself. Its purpose is to infuse substances, not to diagnose conditions.
No
The device description and performance studies clearly indicate a physical, single-lumen catheter, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "infusion of diagnostic agents into the general vasculature". This describes a device used within the body for delivering substances, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description details a physical device designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of an in vivo medical device, specifically an infusion catheter.
N/A
Intended Use / Indications for Use
The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.
Product codes
Not Found
Device Description
The Intravascular Infusion Device is a single lumen device constructed with progressively softer characteristics from proximal to distal end to aid in selective placement in the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general vasculature including the peripheral, coronary and neurovasculature.
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
The following Functional Testing was performed on the proposed device:
- Infusion Rate Testing
- Dynamic Infusion Testing
- Static Burst Testing
- Tip Flexibility Testing
- Torque Response Testing
- Torsion Strength Testing
- Tensile Strength Testing
- Coatings Testing
- In vivo Testing
In addition, the following Biocompatibility Testing was performed:
- Cytotoxicity
- Hemolysis
- Acute Systemic Toxicity
- Intracutaneous Toxicity
- Sensitization
- Pyrogenicity
- USP Physiochemical Testing
Key Metrics
Not Found
Predicate Device(s)
Balt Magic Infusion Catheter, Transend Steerable Guidewire
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
K9639888
DEC 1 2 1996
510(k) Premarket Notification Medi-tech Intravascular Infusion Device October 3, 1996
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 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 concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Intravascular Infusion Device is as follows:
| Trade Name: | Intravascular Infusion Device |
|---|---|
| Manufacturer: | BSC/SciMed Life Systems |
| 6655 Wedgewood Road | |
| Maple Grove, MN 55311-3646 | |
| Device Generic Name: | Diagnostic Intravascular Catheter |
| Classification: | According to Section 513 of the Federal Food, Drug and |
| Cosmetic Act, the device classification is Class II, Performance | |
| Standards (CFR 870.1200) | |
| Predicate Device: | Balt Magic Infusion Catheter |
| Manufactured by: | |
| Target Therapeutics, Inc. | |
| 130 Rio Robles | |
| San Jose, CA 95134 | |
| Transend Steerable Guidewire | |
| Manufactured by | |
| BSC/Scimed | |
| 6655 Wedgwood Road | |
| Maple Grove, MN 55369 |
1
510(k) Premarket Notification Medi-tech Intravascular Infusion Device October 3, 1996
Product Description:
The Intravascular Infusion Device is a single lumen device constructed with progressively softer characteristics from proximal to distal end to aid in selective placement in the vasculature.
Indications for Use:
The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.
Safety and Performance:
The following Functional Testing was performed on the proposed device:
- Infusion Rate Testing 1 .
-
- Dynamic Infusion Testing
- Static Burst Testing 3.
- Tip Flexibility Testing 4.
-
- Torque Response Testing
- Torsion Strength Testing 6.
- Tensile Strength Testing 7.
-
- Coatings Testing
-
- In vivo Testing
In addition, the following Biocompatibility Testing was performed:
- Cytotoxicity 1.
- Hemolysis 2.
- Acute Systemic Toxicity 3.
-
- Intracutaneous Toxicity
- Sensitization న్.
- Pyrogenicity 6.
- USP Physiochemical Testing 7.
Conclusion :
Based on the Indications for Use, technological characteristics and safety and performance testing, the Intravascular Infusion Device has been shown to be sate and effective for its intended use.