(27 days)
The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The proposed EndoVive™ Initial Placement Direct PEJ Kit is used during initial placement for direct feeding.
This is a 510(k) summary for the EndoVive™ Initial Placement Direct PEJ Kit, a device for enteral nutritional support. The document indicates that the device is substantially equivalent to a previously marketed device (K020120) with the exception of a modified kit component. This essentially means it is an update or slight modification to an existing device, rather than a completely new one.
Given this context, the submission focuses on demonstrating substantial equivalence rather than fulfilling novel acceptance criteria with a new, extensive study. The performance data section explicitly states: "The proposed device is substantially equivalent to currently marketed device in terms of performance characteristics tested and biocompatibility." This implies that the 'acceptance criteria' are met by showing it performs as well as the predicate device.
Therefore, for this specific device and submission type, the questions about acceptance criteria and study details are addressed by referring to the substantial equivalence claim, rather than a de novo clinical trial with specific performance metrics.
Here's how to interpret the provided information in the context of your questions:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The proposed device must be substantially equivalent to currently marketed predicate devices. | The proposed device is substantially equivalent to currently marketed devices, as they are identical with the exception of a modified kit component. The proposed device is substantially equivalent to currently marketed device in terms of performance characteristics tested and biocompatibility. |
| The device must meet performance characteristics (e.g., integrity, functionality, safety). | Performance characteristics were tested and found to be equivalent to the predicate device. Biocompatibility was also confirmed to be equivalent. |
Study Details (as infered from a Substantial Equivalence submission)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate clinical study with a "test set" and human subjects was likely not conducted for this specific 510(k). The substantial equivalence claim is based on the previously cleared predicate device and engineering/performance testing on the modified component.
- Data Provenance: The 'data' primarily comes from performance characteristics testing of the modified component and biocompatibility assessments, and comparison to the predicate device's established performance. This would typically be internal laboratory testing by the manufacturer. Specific country of origin is not detailed, but the manufacturer (Boston Scientific Corporation) is US-based. These would be retrospective in the sense that they rely on the established performance of the predicate and new internal validation on the modified component, rather than a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of a substantial equivalence submission for a device like this. There isn't a "ground truth" to be established by panels of experts in the way there would be for an AI diagnostic device evaluating images, for example. The evaluation is primarily focused on engineering performance, material properties, and comparison to a predicate device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical trials involving subjective interpretations (e.g., radiology reads) to establish a consensus ground truth. This submission is about the physical and functional equivalence of a medical device component.
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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:
- Not applicable. This device is a physical medical instrument (a Jejunostomy Tube Kit), not an AI diagnostic tool or software. MRMC studies are used for evaluating diagnostic imaging systems or AI assistance tools.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" here relies on established engineering standards, biocompatibility testing results (e.g., ISO standards), and the proven safety and effectiveness profile of the predicate device (EndoVive™ Initial Placement Direct PEJ Kit, K020120). This is essentially a regulatory compliance and engineering performance ground truth.
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The sample size for the training set:
- Not applicable. There is no AI model being trained for this device.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Summary of Approach:
The K022648 submission for the EndoVive™ Initial Placement Direct PEJ Kit is a substantial equivalence filing. This means the primary "study" is a comparison to a legally marketed predicate device (K020120). The manufacturer is demonstrating that the new device is "identical with the exception of a modified kit component" and that its "performance characteristics tested and biocompatibility" are equivalent to the predicate. Therefore, specific clinical trials, expert panels for ground truth, or AI-specific studies are not part of this type of submission. The 'acceptance criteria' are primarily related to proving this substantial equivalence through engineering, material, and performance 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.