(90 days)
The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.
The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.
Here's a breakdown of the acceptance criteria and study information based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Safety & Performance | Balloon Burst Testing | Implied: Meet specifications for balloon integrity under pressure | Performed (specific results not detailed in summary) |
| Safety & Performance | Pressure vs. Diameter Confirmation | Implied: Achieve specified diameters at recommended inflation pressures | Performed (specific results not detailed in summary) |
| Safety & Performance | Scope Passage Testing | Implied: Proper functionality and compatibility with intended endoscopic equipment | Performed (specific results not detailed in summary) |
| Regulatory Compliance | Design Control Requirements (21 CFR 820.30) | Certification of compliance | Certified as compliant |
| Regulatory Compliance | Risk Analysis Procedure | Description of internal risk analysis procedure (to mitigate identified risks) | Description provided; risks analyzed as per internal procedure |
| Intended Use | Dilatation of GI strictures | Effective in dilatation of gastrointestinal strictures of various etiologies as indicated | Concluded to be safe and effective for intended use |
Study Details
The provided documents describe a Special 510(k): Device Modification submission for the TeleMed Systems PPD™ Balloon Dilatation Catheter. This type of submission generally relies on bench testing (laboratory studies) and comparison to predicate devices, rather than clinical trials with human participants, especially for Class II devices with established mechanisms of action.
Given this context, many of the typical elements of a clinical study (like sample size for test sets, ground truth establishment for AI, MRMC studies) are not applicable here.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" from a patient population, as this was primarily bench testing. The "sample size" would refer to the number of catheters tested in each bench test (e.g., how many balloons were burst, how many were tested for pressure-diameter). This information is not provided in the summary.
- Data Provenance: The data provenance is from bench testing performed by TeleMed Systems, Inc. at their manufacturing site in Hudson, MA, USA. This is retrospective in the sense that the studies were performed on the device after its design, but not on patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies (e.g., a balloon bursts or it doesn't; it inflates to a certain diameter at a given pressure or it doesn't). Expert consensus in a clinical sense is not relevant for this type of testing.
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Adjudication method for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of patient data. For bench testing, results are typically objective measurements.
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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 a medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- The "ground truth" for the performance testing (balloon burst, pressure vs. diameter, scope passage) would be engineering specifications and physical measurements demonstrating the device's ability to meet its design requirements and function safely as intended.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set is involved.
§ 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.