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This document is a "Summary of Safety and Effectiveness" for the Medtronic PS Medical AlgoLine Intraspinal Catheter, submitted to the FDA on March 18, 1997. It describes potential adverse effects and provides a summary of product complaints rather than presenting a study designed to evaluate specific acceptance criteria for a device's performance.
Therefore, the requested information (acceptance criteria and a study proving the device meets them) cannot be extracted from the provided text. The document focuses on listing potential complications and a history of complaints, which are aspects of post-market surveillance or risk assessment, not a pre-market performance study with defined acceptance criteria.
To answer your request, here's an explanation of why the information isn't available in this document:
- No Acceptance Criteria or Performance Study: This document does not describe any specific acceptance criteria for device performance (e.g., a certain percentage of successful catheter placements, a defined rate of complication, or a specific functional outcome that the device must achieve). Consequently, there is no study presented that "proves the device meets the acceptance criteria."
- Focus on Adverse Effects and Complaints: The document is primarily concerned with detailing potential adverse effects associated with intraspinal catheters in general and listing reported complaints for this specific device model. This information is typically part of a regulatory submission to demonstrate awareness of risks and track real-world performance, but not a controlled study against pre-defined performance metrics.
If this were a document about a performance study, the sections would typically include:
- Objective: Stating what the study aims to measure (e.g., accuracy, sensitivity, specificity, durability, etc.).
- Methods: Describing the study design, sample size, how data was collected, and how the device's performance was measured.
- Acceptance Criteria: Quantifiable thresholds for the device's performance that must be met for it to be considered safe and effective.
- Results: The measured performance metrics.
- Conclusion: A statement on whether the acceptance criteria were met.
Since none of these elements are present, I cannot fill out the requested table or describe the specific study details.
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MAR 1 8 1997
14 965251 ; Medtromic PS Medical Algoline Intraspinal Cotheter
SUMMARY OF SAFETY AND EFFECTIVENESS PROBLEMS ASSOCIATED WITH INTRASPINAL CATHETERS (ADVERSE EFFECTS)
The adverse effects associated with the use of the AlgoLine Intraspinal Catheter System may include, but may not be limited to, the following.
Catheter Complications
Change in catheter performance, due to kinking, disconnection, leakage, breakage, complete or partial occlusion, dislodgement or migration, or fibrosis or hygroma, which can result in:
- delivery of drug into the subcutaneous tissue, .
- drug withdrawal symptoms, �
- return of underlying symptoms, ●
- free-floating catheter in the cerebrospinal fluid (CSF), .
- . underinfusion of the drug,
- CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS . pressure-related problems,
- damage to the spinal cord, or .
- surgical replacement / revision of the catheter. .
Drug Complications
- Local and systemic drug toxicity and related side effects .
- Complications due to use of untested drugs with the system .
- Complications due to using drugs not in accordance with the drug labeling .
Procedural (Surgical) Complications
- Lumbar puncture-type headache .
- CSF leak leading to spinal headache, CSF subcutaneous collection, or rare CNS � pressure-related problems
- Radiculitis .
- Arachnoiditis .
- Bleeding .
- Damage to the spinal cord .
- Meningitis ●
- Spinal headache .
- Medical complications �
- Complications from anesthesia .
- Damage to the catheter due to improper handling .
Other
- Allergic or immune system response to the implanted materials .
- Body rejection phenomena ●
- Complications due to the interaction of the catheter with unusual physiological . variations in patients
- Surgical replacement of the catheter due to complications ●
- Complications due to other intervening acts ◆
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PRODUCT COMPLAINT HISTORY
Approximately 5,000 AlgoLine intraspinal catheters of various models and designs have been distributed worldwide. As of January 15, 1997, the complaint history consists of a total of nine complaints involving 12 catheters reported. These complaints have included:
- (3 ea) Catheter fracture
- (3 ea) Catheter leakage
- (2 ea) Strain relief missing from package (involving 5 packages)
- (1 ea) Tuohy needle broke during use
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§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).