(89 days)
The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years -
The Peristeen™ Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI system does not contain natural rubber latex components.
The provided text is a 510(k) summary for the Peristeen™ Anal Irrigation System, which is a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical performance study with statistical metrics.
The document states that the Peristeen™ Anal Irrigation System is substantially equivalent to a previously cleared device (K083770). The equivalence is supported by a comparison of design, materials, intended use, and acceptable results from functional performance and biocompatibility testing. This indicates that the "acceptance criteria" here are likely related to engineering specifications, safety standards, and material compatibility, rather than clinical performance metrics like sensitivity, specificity, or reader agreement.
Since the document focuses on substantial equivalence for a physical medical device, not an AI/algorithm-based diagnostic tool, most of the requested information (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or not provided in this specific type of regulatory filing.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Performance | Acceptable results (implied by substantial equivalence claim) |
| Biocompatibility | Acceptable results (implied by substantial equivalence claim) |
| Design Comparison | Substantially equivalent to predicate device |
| Materials Comparison | Substantially equivalent to predicate device |
| Intended Use Comparison | Expanded indications, but substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. The submission relies on functional performance and biocompatibility testing and substantial equivalence to a predicate device, not clinical performance data from a patient test set in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. This information is relevant for diagnostic accuracy studies, which are not detailed in this 510(k) summary for a physical irrigation system.
4. Adjudication method for the test set:
- Not Applicable/Not Provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional performance and biocompatibility testing, the ground truth would typically be established by established engineering standards, material science testing protocols, and biological safety evaluations.
- For substantial equivalence, the ground truth is the performance, design, and indications for use of the predicate device.
8. The sample size for the training set:
- Not Applicable/Not Provided. This information is relevant for AI models, not for a physical medical device like the Peristeen™ Anal Irrigation System.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided.
Summary of the "study" that proves the device meets acceptance criteria:
The "study" referenced in the document is a comparison to a legally marketed predicate device (K083770) combined with functional performance and biocompatibility testing.
- Comparison to Predicate: The report states: "Substantial equivalence of the Peristeen™ Anal Irrigation System is supported by a comparison of the design, materials, and intended use compared to the predicate..." This comparison essentially serves as the primary "study" for establishing regulatory acceptance based on the 510(k) pathway. If the new device is sufficiently similar to an already cleared device in terms of safety and effectiveness, it can be cleared.
- Functional Performance and Biocompatibility Testing: The document mentions "acceptable results from functional performance and biocompatibility testing." While the details of these tests are not provided in this summary, they would involve engineering tests to ensure the device operates as intended (e.g., proper water flow, balloon inflation/deflation, pressure control) and material tests to ensure the components are safe for human contact (e.g., ISO 10993 series of standards). The "acceptance criteria" for these would be specific engineering and biocompatibility thresholds defined prior to testing.
§ 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.