(186 days)
The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.
GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.
The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.
The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.
However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.
Acceptance Criteria and Device Performance (based on provided text)
The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.
| Acceptance Criteria Category | Specific Criteria / Test Description | Reported Device Performance |
|---|---|---|
| Product Specifications | Verification of Product Specifications after exposure to ambient, high temperature, and low temperature environmental conditions. | Pass |
| Distribution / Packaging Integrity | Confirmation of Product Specifications following exposure to simulated distribution stress and conditions (per ASTM D4169-16). | Pass |
| Shelf Life (Accelerated) | Confirmation of Product Specifications following exposure to accelerated conditions simulating a shelf-life of two years. | Pass |
| Shelf Life (Real-Time) | Confirmation of Product Specifications following exposure to real-time ambient conditions for two years. | Test is on-going |
| Reliability | Confirmation of Product Specifications following worst-case simulated use. | Pass |
| Bench Safety | Assessed safety of worst-case interactions between biological tissue and GripTract Fingers. | Pass |
| Usability (Set-Up) | Assessment of whether the intended user population can successfully set up GripTract without serious use errors, failure to perform critical tasks, or encountering problems that affect the intended use and expected use environment. | Pass |
| Usability (Use) | Assessment of whether the intended user population can successfully use GripTract without serious use errors, failure to perform critical tasks, or encountering problems that affect the intended use and expected use environment. | Pass |
| Biocompatibility | Testing of final, finished devices for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity (per ISO 10993-12, -5, -10, -23, -11). | Pass |
| In Vivo Safety & Effectiveness (Porcine) | In vivo porcine testing of GripTract against standard of care in worst-case procedure. Acute and chronic time points examined for differences in visual and histological mucosal damage as well as presence of device-attributable adverse events. Equivalent visual and histological mucosal damage compared to endoscope-only (control). | Pass |
| Endoscope Viewing Area (Bench Safety) | Comparison of the endoscope viewing area between GripTract and the Reference Device. | Does not block visualization relative to a standard distal end cap. |
Study Details (based on provided text)
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Sample sizes used for the test set and the data provenance:
- Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
- Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
- Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
- Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/mentioned for this type of non-clinical device testing.
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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 mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Bench tests evaluate the device's standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Performance: Engineering specifications and ASTM/ISO standards.
- Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
- Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
- Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.