(139 days)
The MiNS grasping instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate other soft internal tissues as well as items such as hernia mesh.
The MiNS devices are a family of disposable and re-useable devices. Consisting of an integrated, insulated needle/cannula shaft that houses a retractable grasper (NLU) which are inserted into a reusable Handle. The disposable NLU's when inserted into a reusable Handles are used for mobilization and manipulation of soft tissue during general laparoscopic procedures. The system has the ability to directly penetrate soft tissue to access certain areas of the human anatomy without the need for a traditional insertion conduit. The shaft of the instrument can be introduced percutaneously to the surgical site, after which the working portion of the instrument can be deployed to approximate, grasp and manipulate soft tissue.
Here's a summary of the acceptance criteria and the study information for the MiNS Needlescopic Resposable Laparoscopic device system, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document states that "The subject device has been subjected to and passed a variety of bench tests for mechanical and attribute evaluations." However, it does not explicitly list specific quantitative acceptance criteria or corresponding reported performance metrics in a table format for the MiNS device itself. Instead, it relies on substantial equivalence to predicate devices, implying that its performance is acceptable if it is comparable to the predicates without introducing new risks.
The comparison table provided focuses on technological characteristics rather than specific performance metrics for the new device versus a benchmark.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (MiNS Needlescopic Resposable Laparoscopic device system) |
|---|---|---|
| Use | Comparable to predicate devices; ability to penetrate soft tissue, grasp, hold, and manipulate soft internal tissues and hernia mesh. | "The MiNS grasping instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold, and manipulate other soft internal tissues as well as items such as hernia mesh." (Matches predicate K070686) |
| Needle Diameter | 2.4mm ± .1mm (based on predicate K070686) or generally comparable to needlescopic instruments. | 2.4mm ± .1mm |
| Device Length | 300 mm (based on predicate K070686) | 300 mm |
| Material Composition | Medical Grade Stainless Steel (17-7 SS, 300 SS, 475SS, Polyester) (comparable to predicates) | Medical Grade Stainless Steel 17-7 SS, 300 SS, 475SS, Polyester |
| Sterilization | Autoclavable for reusable handle, sterile disposable for shaft tip combinations. (comparable to predicate K113407) | Autoclavable, non sterile, reusable handles with attachable disposable sterile, single use shaft tip combinations. (Differs from K070686 which is sterile, single use, but aligns with the mixed approach of reusable handle + disposable tip, similar to K113407) |
| Safety & Efficacy | No new risks to the patient compared to predicate devices. | "Mini Lap MiNS Needlescopic Resposable device system does not present any new risks to the patient and therefore, we believe that it is substantially equivalent to other devices and technologies cleared by the FDA." |
Study Information
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states the device "has been subjected to and passed a variety of bench tests for mechanical and attribute evaluations." However, it does not specify the sample size for these bench tests, nor does it mention data provenance (country of origin, retrospective/prospective). -
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 provided in the document, as the evaluations conducted were "bench tests for mechanical and attribute evaluations," rather than clinical studies requiring expert ground truth for interpretation. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided, as the conducted tests are bench tests, not clinical evaluations requiring adjudication of results from independent reviewers. -
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:
No MRMC comparative effectiveness study was done. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this device does not include software or an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the mechanical and attribute bench tests, the "ground truth" would be engineering specifications and established test methods to verify physical properties, material compatibility, and functionality. It is not expert consensus, pathology, or outcomes data. -
The sample size for the training set:
Not applicable. This device does not have a training set, as it is a manual surgical instrument without software or machine learning components. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.