(94 days)
The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures.
The MINI-TONG instruments are minimally invasive devices. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.
The provided FDA 510(k) summary for the "MINI-TONG" device primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not present a detailed study with acceptance criteria and reported device performance metrics in the way that would typically be seen for a new, complex diagnostic or therapeutic device requiring extensive performance testing.
The document states: "We believe the addition of this new jaw configuration is a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated." This suggests that the primary "study" or justification for equivalence relied on the established performance of existing predicate devices and basic material/sterilization validation.
Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this submission.
Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Grasping/Clamping Effectiveness | Not explicitly stated as numerical criteria in this document. Implied to be equivalent to predicate devices. | "The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures." This function is implicitly deemed equivalent to predicate devices. The document states: "We believe the MINI-TONG instruments are substantially equivalent to the predicate devices have the same technological characteristics as the predicate devices including identical handle design and safety interlock as well as are composed of biocompatible stainless steel." |
| Biocompatibility | Implicit standard for medical devices. | "The subject device is composed of biocompatible materials." |
| Sterilization Efficacy | Implicit standard for sterile medical devices. | "the sterilization process has been validated." |
| Safety | Implicit standard for medical devices; prevention of inadvertent retraction during use. | "The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use." This is a design feature intended to meet safety requirements. |
Missing Information: Specific quantitative acceptance criteria (e.g., minimum grasping force, maximum tissue damage, durability under specific loads) and detailed performance data (e.g., actual measured grasping force, results of biocompatibility tests, sterilization validation reports) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- No specific "test set" sample size for functional performance is mentioned in the provided text.
- No details on data provenance (e.g., country of origin, retrospective/prospective) related to a performance study are provided. The justification for equivalence relies on the known performance of predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as no specific test set requiring expert-established ground truth is described in this submission. The "ground truth" for substantial equivalence appears to be based on the established safety and effectiveness of the predicate devices and the technological similarity.
4. Adjudication Method for the Test Set
- Not applicable as no specific test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or implied. This type of study is typically for diagnostic devices or devices where human-AI interaction is central to the performance. The MINI-TONG is an instrument, not a diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The MINI-TONG is a manual surgical instrument, not an algorithm, so independent algorithmic performance is not relevant. Its performance is always human-in-the-loop.
7. Type of Ground Truth Used
- For the purpose of substantial equivalence, the "ground truth" implicitly relies on:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (Mini Lap Instruments - K070686, U.S. Surgical Modified Hand Instrument Devices K960748, Solos Endoscopy 10mm Atraumatic Grasping Forcep and 5mm Grasping Forcep K900948 / K900958).
- Design & Material Standards: Compliance with biocompatibility standards and validated sterilization processes.
- Functional Description: The device's described ability to perform its intended function of grasping and clamping.
8. Sample Size for the Training Set
- Not applicable. As a physical instrument, there is no "training set" in the context of an AI/ML algorithm. The design and validation are based on engineering principles and testing appropriate for a mechanical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set." The performance characteristics are derived from engineering design, material selection, manufacturing processes, and comparison to predicate devices, rather than machine learning training.
Summary Caveat: This analysis is strictly based on the provided text, which is an FDA 510(k) summary. Such summaries are often high-level and refer to more detailed internal documentation (e.g., test reports for biocompatibility, sterilization validation, mechanical testing) that would contain the specific acceptance criteria and detailed performance data. This document's primary purpose is to articulate the basis for claiming substantial equivalence, not to fully detail all underlying engineering and performance tests.
§ 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.