(255 days)
Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.
The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Functional Performance | |
| Appearance | Met requirements |
| Dimensions | Met requirements |
| Jaws open wide | Tested (4.5mm, 8.5mm, 7mm, 8.2mm, similar to predicate devices with 6.3mm, 8.1mm, 10mm) - "results are all meet the requirements." |
| Grasping jaws opened and closed performance and compatibility with endoscope channel | Met requirements |
| Handle to core wire tensile strength | Met requirements |
| Clamping strength | Met requirements |
| Jaws misalignment test | Met requirements |
| Sterilization & Packaging | |
| EO residual | Met criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7 Second Edition 2008-10-15. |
| Shelf-life | Validated for three years in accelerated testing according to ASTM F1980-16 (2016). Essential performance achieved before and after shelf life test. Requirements on packaging for terminally sterilized medical device per ISO 11607-1 First Edition 2006-04-15 and ISO 11607-2 First Edition 2006-04-15 also met. |
| Biocompatibility | |
| Cytotoxicity | Performed and demonstrated biocompatibility in accordance with FDA Guidance, "Use of International Standard ISO 10993-1..." |
| Sensitization | Performed and demonstrated biocompatibility. |
| Intracutaneous irritation test | Performed and demonstrated biocompatibility. |
| Complies with Standards | |
| Packaging, Seal Strength, Seal Leaks, Integrity of Seals, Internal Pressurization, Microbiological methods, Sterility Tests, Bacterial endotoxins test, Ethylene oxide sterilization, Biological evaluation of medical devices (cytotoxicity, residuals, irritation, skin sensitization) | Complied with: EN868-5:2018, ASTM F88/F88M-15, ASTM F1929-15, ASTM F1140/F1140M-13, ISO 11737-1, ASTM F1886/F1886M-16, ASTM F1980-16, ISO 10993-5, ISO 10993-7, ISO 10993-10, USP 37 NF 32:2014 , USP 37-NF 32:2014 , ISO 11135. |
2. Sample size used for the test set and the data provenance:
The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable, as the study is not based on expert adjudication of clinical findings.
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:
This information is not applicable. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.
8. The sample size for the training set:
This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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.