FDA 510k for Balloon Catheter
FDA 510k for Balloon Catheter: Balloon catheters are medical devices designed for various therapeutic interventions in the cardiovascular, urological, gastrointestinal, cervical, and other anatomical regions. They generally consist of:
Catheter Shaft: The catheter shaft is a long, flexible tube that serves as the main body of the catheter. It is usually made of materials like nylon, polyethene, or polyurethane, providing flexibility and durability for insertion into the body.
Balloon: At the distal end of the catheter shaft, there is an inflatable balloon. The balloon is made of a thin, flexible material such as latex or silicone. It can be inflated and deflated using a fluid (e.g., saline solution) or gas (e.g., contrast medium) through an inflation port at the proximal end of the catheter.
Inflation Port: The inflation port is located at the proximal end of the catheter and allows for the injection of fluid or gas to inflate the balloon. It typically includes a luer lock or other connection mechanism to secure the syringe or inflation device during balloon inflation.
Guidewire Lumen: Many balloon catheters feature a lumen or channel running through the catheter shaft, allowing for the passage of a guidewire which helps navigate the catheter through the vasculature or other anatomical structures during insertion and positioning.
Balloon catheters come in various sizes and configurations to accommodate different anatomical structures and clinical applications. The balloons may have different shapes, such as cylindrical or tapered, and varying lengths and diameters. Some balloon catheters are coated with medications for drug delivery purposes, while others may include radiopaque markers for fluoroscopic visualization during procedures.
The intended use of balloon catheters varies depending on the specific type and design. Some of the common applications include:
Angioplasty: Dilating narrowed or blocked blood vessels to improve blood flow.
Biliary intervention: Treating obstructions or strictures in the bile ducts.
Urological procedures: Dilating strictures in the urethra or urinary tract.
Oesophagal and gastrointestinal interventions: Treating strictures or bleeding in the oesophagus or gastrointestinal tract.
Obstetrics and gynaecology: Cervical ripening and induction of labour, Cervical dilation for gynecologic interventions
Documents required for Balloon Catheter 510k
In both Traditional and Abbreviated 510(k) submissions, the FDA advises including the listed section headings in the recommended sequence. Although certain sections may not apply to your device, maintaining the specified order of headings is suggested by the FDA to facilitate expedited reviews.
- FDA Medical Device User Fee Cover Sheet
- FDA Premarket Review Submission Cover Sheet
- FDA 510(k) Cover Letter
- FDA 510(k) Indications for Use Statement
- FDA 510(k) Summary or FDA 510(k) Statement
- FDA Truthful and Accuracy Statement
- FDA Class III Summary and Certification
- Financial Certification or Disclosure Statement
- Declarations of FDA Conformity and Summary Reports
- FDA 510 (k) Executive Summary
- Medical Device Description
- FDA 510(k) Substantial Equivalence Discussion
- Proposed Labeling
- Sterilization and Shelf Life
- Biocompatibility
- Software
- Electromagnetic Compatibility and Electrical Safety
- Performance Testing-Bench
- Performance Testing-Animal
- Performance Testing-Clinical
FDA Classification for Balloon Catheter
FDA 510k test requirements for Balloon Catheter
The 510(k) premarket notification warrants conducting a comprehensive array of tests and evaluations such as:
Biocompatibility Testing: Biocompatibility tests per ISO 10993 are conducted based on the extent and duration of contact between the balloon catheter and the patient, as well as the material composition of the product.
The most basic requirements for Biocompatibility tests which all the balloon catheters have to undergo are:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation or Intracutaneous Reactivity (ISO 10993-23)
Depending on the intended use and the duration of contact, additional tests that may be required include:
- Acute Systemic Toxicity (ISO 10993-11)
- Material-Mediated Pyrogenicity (should be conducted to support devices labeled as “non-pyrogenic”) (ISO 10993-11, USP <151>)
- Sub-acute/Sub-chronic Toxicity (ISO 10993-11)
- Genotoxicity (ISO 10993-3)
- Implantation (ISO 10993-6)
- Chemical characterization (If applicable) (ISO 10993-18)
- Haemolysis (ISO 10993-4)
- Hemocompatibility tests (ISO 10993-4)
Performance Testing: To ensure the safety and efficacy of the device by confirming the catheter’s resilience and reliability during clinical use, and to establish substantial equivalence with the predicate device a series of non-clinical performance tests are conducted. Some of the basic tests are:
- Dimensional verification
- Burst pressure assessments
- Balloon inflation and deflation time
- Balloon fatigue
- Catheter bond strength
Additional tests might be required to verify performance characteristics relevant to the intended device function depending on the type of balloon catheter, its components, and its intended use.
Sterilization: Balloon catheters must undergo sterilization to ensure that they are free from harmful microorganisms and safe for patient use. The chosen sterilization method should be validated and effective in achieving sterility without compromising the device’s performance or integrity. Some of the most common sterilization methods for Balloon Catheters include:
- Ethylene Oxide (EtO) Sterilization (ISO 11135)
- Radiation Sterilization (e.g., gamma, electron beam) (Parts 1 through 3 of ISO 11137).
Shelf-Life Testing: The shelf-life testing must confirm that the device maintains integrity and performance throughout its intended shelf life. The FDA requires real-time ageing tests to confirm the accelerated ageing results.
Packaging Validation Tests: Ensures that the packaging maintains the integrity and sterility of the device until the point of use. It includes testing for stability during transportation and storage.
Transportation Tests: These tests are designed to simulate conditions that the product may encounter during shipping and handling to ensure that it remains safe and effective.
Manufacturers must also adhere to labelling requirements that provide clear and concise instructions for use, potential risks, and contraindications. This comprehensive regulatory framework by the FDA is pivotal in safeguarding patient health and optimizing clinical outcomes.