(270 days)
Not Found. This document is a certification and summary for a 510(k) submission, but it does not contain the detailed information requested regarding a medical device for imaging or AI/ML.
Not Found
Analysis of Provided Information to Answer the Request
The input provided is a "PREMARKET APPROVAL NOTIFICATION CERTIFICATION AND SUMMARY" for the BioGlide Vascular Catheter, single lumen. This document does not contain any information about acceptance criteria or a study proving the device meets said criteria.
Instead, it lists potential complications associated with the use of the device and certifies that the submitter is aware of these problems. It is a general statement about potential risks, not a performance study.
Therefore, I cannot provide the requested information based on the input.
To answer your request, I would need a document describing:
- Specific performance metrics and their corresponding acceptance criteria. (e.g., "Tensile strength must be > X Newtons," "Flow rate must be > Y ml/min," "Insertion force must be < Z N").
- A study protocol and results demonstrating how the BioGlide Vascular Catheter was tested against these criteria. This would typically include:
- Description of the test methods.
- Test sample sizes.
- Actual performance values measured.
- A conclusion on whether the device met the acceptance criteria.
Without such information, all fields in your requested table and subsequent questions cannot be answered.
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PREMARKET APPROVAL NOTIFICATION CERTIFICATION AND SUMMARY
(To be submitted when claiming equivalence to a Class III device)
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the BioGlide Vascular Catheter, single lumen. I further certify that I am aware of the types of problems to which the BioGlide Vascular Catheter, single lumen is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the BioGlide Vascular Catheter, single lumen is complete and accurate.
Complications associated with the use of the device may be similar to those experienced in any other surgical procedure carried out under local and/or general anesthetic:
Reactions to drugs or anesthetic agents; Electrolyte imbalance: Excessive Blood loss;
Local and Systemic Infections are not uncommon with this type of procedure. They are most usually due to organisms that inhabit the skin, particularly Staphylococcus epidermidis. However, other pathogens circulating in the blood stream may colonize the device and in the majority of patients require its removal.
Other potential complications are listed:
| Catheter or cuff erosion through skin |
|---|
| Catheter malposition, occlusion, fibrin sheath formation |
| at tip, dislodgment, or rupture |
| Intolerance reaction to implanted device |
| Vascular thrombosis |
| Perforation or laceration of vessels or viscous |
| Pneumothorax, hemothorax, or hydrothorax |
| Postural related catheter occlusion, damage, or breakage |
| due to catheter crimping between the clavicle and first rib |
Endocarditis Cardiac arrhythmia Thrombophlebitis Sepsis or infection Embolus Brachial plexus injury Hematoma Cardiac tamponade Exit site necrosis
A Bibliography or other citation of the materials upon which the above summary is based is found in Attachment 7 of this submission.
Printed name of person required to submit 510(k):
Signature of person required to submit 510(k):
Title of person submitting 510(k):
Name of Company:
Date:
Tom Holdych
Director Regulatory Affairs and Quality Assurance
Medtronic PS Medical Corporation
1/3/96
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”