(35 days)
The Macy Catheter is intended to provide rectal access to administer liquids/mediations.
The Macy Catheter has been designed for comfort and safety by utilizing a flexible silicone body that enables administration of liquids/medications to the rectum. The device has two lumens, one for administering the liquids/medications and the other for inflation of the retention balloon. The catheter is inserted into the rectum and a small, soft retention balloon is inflated with water via the inflation valve. Liquids/medications are delivered via the medication valve, through the catheter, and into the rectum. The retention balloon can be easily deflated for removal of the catheter. The Macy Catheter remains in the recturn until expelled upon defecation (or removed for defecation if the patient prefers).
The provided text describes a 510(k) submission for the Macy Catheter, a rectal catheter designed to administer liquids/medications. The submission focuses on establishing substantial equivalence to a predicate device through a comparison of features and performance data, primarily non-clinical bench testing and biocompatibility assessments.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" against those criteria in a table. However, it implicitly states that the device met "design specifications established under the Design Control Process with successful results" and successfully passed various tests.
- Implicit Acceptance Criterion 1: Meet Design Specifications.
- Reported Performance: "Bench testing was conducted on the device to verify that it met design specification established under the Design Control Process with successful results."
- Implicit Acceptance Criterion 2: Biocompatibility.
- Reported Performance: "Biocompatibility testing was conducted in compliance with applicable parts of ISO 10993 as determined by ISO 10993 Part 1." Specific tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Sub-chronic Toxicity, Genotoxicity, Muscle Implantation) were performed with successful results.
- Implicit Acceptance Criterion 3: Mechanical Verification (e.g., ASTM F 2528-06).
- Reported Performance: Tests included "balloon and shaft size, balloon integrity and reliability via balloon volume maintenance and balloon burst volume tests, device tensile strength, lumen patency and flow rate, balloon and shaft mechanical properties" with successful results.
- Implicit Acceptance Criterion 4: Packaging and Shipping Stress Simulation.
- Reported Performance: Tests were conducted with successful results.
- Implicit Acceptance Criterion 5: Mitigation of Misconnections (ISO 80369-1).
- Reported Performance: "Verification of design features intended to mitigate mistaken connections per ISO 80369-1" was conducted with successful results.
- Overall Implicit Acceptance Criterion: As Safe and Effective as Predicate.
- Reported Performance: "The results of the tests performed demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified in Part A of this summary."
2. Sample Size Used for the Test Set and Data Provenance
The document discusses non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests. Data provenance is implied to be from the manufacturer's internal testing ("Bench testing was conducted on the device," "Biocompatibility testing was conducted"). These are laboratory-based tests, not clinical studies. The data is thus prospective in the sense that the tests were specifically conducted for this submission. The "country of origin of the data" is not explicitly stated but is implicitly within the regulatory framework of the US FDA as the submission is to the FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission describes an electromechanical device with an intended use of administering liquids/medications, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for the performance tests would be the established scientific and engineering standards and methods for assessing device functionality and safety.
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or for establishing ground truth in AI performance studies involving human readers, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This is not applicable. The Macy Catheter is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The Macy Catheter is a physical medical device, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used
For the performance data described:
- Bench Testing: The "ground truth" is defined by established engineering design specifications and recognized test standards (e.g., ASTM F 2528-06, ISO 80369-1). Pass/fail criteria are based on these specifications.
- Biocompatibility Testing: The "ground truth" is determined by compliance with international standards for biocompatibility (ISO 10993 and its relevant parts), where specific biological responses (e.g., cytotoxicity, sensitization) are assessed against predefined acceptable limits.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the evaluations presented.
8. The Sample Size for the Training Set
This is not applicable. The Macy Catheter is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.