(30 days)
EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
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 EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.
The proposed EndoVive™ Initial Placement PEG Kit, the proposed EndoVive™ Initial Placement Direct PEJ Kit, and the EndoVive™ Initial Placement PEG Safety Kit are used during initial placement for direct feeding.
This 510(k) premarket notification describes a special 510(k) for new material for domed PEG/PEJ devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, and comparative effectiveness studies is not applicable or not provided in the document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (implied by "performance characteristics" and industry standards for implantable devices) | The proposed devices "were tested for biocompatibility." (Specific acceptance criteria, tests performed, and results are not detailed in this summary document.) |
| Substantial Equivalence (primary acceptance criteria for Special 510(k)) | The proposed devices are "substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material." |
| The proposed devices are also "substantially equivalent to currently marketed devices in terms of performance characteristics." (Specific characteristics and comparative data are not detailed in this summary document.) | |
| Functionality (implied, as the new material should not negatively impact the intended use of the devices) | Intended uses remain the same as the predicate devices: enteral nutrition into the stomach (PEG kits) or jejunum (PEJ kit), and safety components to reduce sharps injury (PEG Safety Kit). The change in material for the domed PEG/PEJ is presented as not altering the fundamental function. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The document states that the devices "were tested for biocompatibility" and that they are "substantially equivalent ... in terms of performance characteristics," but it does not detail the size of the test sets for these evaluations.
- Data Provenance: Not specified. Given the context of a 510(k) submission for new material, testing would typically be conducted by the manufacturer (Boston Scientific Corporation). It is likely prospective laboratory testing and/or material characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a device modification submission for material change, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set in the traditional sense. The "ground truth" here is adherence to material and performance specifications, likely evaluated internally by engineers and material scientists.
4. Adjudication method for the test set
- Not applicable. This type of submission does not involve clinical trial data or expert adjudication for a test set.
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
- Not applicable. This submission is for physical medical devices (PEG/PEJ kits) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for physical medical devices and does not involve an algorithm.
7. The type of ground truth used
- The "ground truth" for this special 510(k) primarily relates to material properties and biocompatibility standards. It would be based on:
- Material specifications: Conformance to established physical, chemical, and mechanical properties for the new domed PEG/PEJ material.
- Biocompatibility testing against recognized standards: Such as ISO 10993 (Biological evaluation of medical devices).
- Comparison to predicate device material: Demonstrating that the new material performs equivalently to, or better than, the material of the predicate devices for the relevant characteristics.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned or implied.
Study Proving Device Meets Acceptance Criteria:
The document states: "The proposed devices are substantially equivalent to currently marketed devices in terms of performance characteristics and were tested for biocompatibility."
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Type of Study: This indicates biocompatibility testing and performance characteristics evaluation. While the specific details of these studies are not provided in this summary, they would typically involve:
- In vitro and/or in vivo biocompatibility tests: Following standards like ISO 10993 to assess cytotoxicity, sensitization, irritation, systemic toxicity, and other biological effects of the new material.
- Physical and Mechanical Property Testing: Evaluating properties such as tensile strength, elongation, tear resistance, durometer hardness, and durability of the new domed material to ensure it meets the functional requirements of PEG/PEJ devices.
- Comparison to Predicate: The core of the "substantial equivalence" claim is that the results from the new material's testing demonstrate performance equivalent to or better than the predicate devices for critical parameters.
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Evidence of Meeting Acceptance Criteria: The statement provided by Boston Scientific Corporation, and subsequently accepted by the FDA (as indicated by the clearance letter), is that these tests confirmed the substantial equivalence regarding performance characteristics and biocompatibility. The FDA's letter (K030855) confirms their agreement with this assessment, leading to marketing clearance.
§ 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.