(115 days)
Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope.
The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.
The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.
The provided document is a 510(k) summary for the Micro-Tech Grasping Forceps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it explicitly states:
"8. Clinical Test Conclusion: No clinical study is included in this submission."
Therefore, a detailed description of acceptance criteria for a clinical study and the study proving the device meets those criteria, as requested, cannot be provided because no clinical study was conducted or presented in this document.
The document does include a "Non-Clinical Test Conclusion" which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."
Here's the relevant information about the acceptance criteria and non-clinical testing from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria for performance in a clinical setting. Instead, it relies on non-clinical tests to demonstrate that the device complies with various standards, thereby showing it meets design specifications and is substantially equivalent to a predicate device.
| Test Category | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Material/Packaging Integrity | Compliance with: | Met all design specifications and standards. |
| - ASTM F88/F88M-09 (Seal Strength) | ||
| - ASTM F1929-12 (Seal Leaks by Dye Penetration) | ||
| - ASTM F1140/F1140M-13 (Internal Pressurization Failure Resistance) | ||
| - ASTM F1886/F1886M-09 (Integrity of Seals by Visual Inspection) | ||
| Sterility & Biocompatibility | Compliance with: | Met all design specifications and standards. |
| - ISO 11737-1 (Microorganisms on products) | ||
| - AAMI ANSI ST72 (Bacterial Endotoxins) | ||
| - ISO 10993-5 (In Vitro Cytotoxicity) | ||
| - ISO 10993-7 (Ethylene Oxide Sterilization Residuals) | ||
| - ISO 10993-10 (Irritation And Skin Sensitization) | ||
| - USP 37 NF 32 (Sterility Tests) | ||
| - USP 37-NF 32 (Bacterial Endotoxins Test) | ||
| - ISO 11135 (Ethylene Oxide Sterilization) | ||
| Shelf Life | Compliance with ASTM F1980-07:2011 (Accelerated Aging of Sterile Barrier Systems) | Achieved a shelf life of 5 years. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each non-clinical test. The provenance of the data is implicitly from Micro-Tech (Nanjing) Co., Ltd. in Jiangsu Province, PRC, as they are the submitter of the 510(k). The tests are non-clinical (laboratory/bench tests), not human clinical data, so the retrospective/prospective and country of origin for patients are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The "ground truth" for non-clinical tests is compliance with published international and national standards, not expert consensus interpreting clinical data. Therefore, no experts for establishing ground truth in the context of clinical performance are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to clinical data adjudication, which was not performed.
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. No clinical studies, MRMC studies, or AI components are mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No algorithm or AI component is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., ASTM, ISO, USP). For the claim of Substantial Equivalence, the "ground truth" is that the device's technical characteristics, intended use, and performance (as shown through non-clinical testing) are sufficiently similar to the predicate device, and it raises no new questions of safety and effectiveness.
8. The sample size for the training set
Not applicable. No training set is mentioned as there is no AI or machine learning component.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is mentioned.
§ 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.