(15 days)
The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.
The Endoscopic Applicator is a sterile, single-use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm (or larger) trocar. The Endoscopic Applicator is designed with a luer connector, which is used for connection to a syringe containing the hemostatic agent. The Endoscopic Applicator system consists of a cannula and stylet. The non-reflective cannula is a composite sheath constructed of PolyMed" (a high strength fiber with ester vinyl resin) with an Acrylonitrile Butadiene Styrene (ABS) over-molded luer lock. The stylet (obturator) consists of a PolyMed® composite rod, an ABS over-molded tip, and an ABS over-molded handle. The Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use.
This looks like a 510(k) premarket notification for a medical device called an "Endoscopic Applicator." The document focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical trial data or performance metrics. As such, much of the requested information about acceptance criteria for AI performance is not present.
However, I can extract the available information regarding non-clinical performance and a general understanding of the acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that non-clinical testing "showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life." However, the specific quantitative acceptance criteria for each test are not provided in this summary. Instead, it lists the types of tests performed.
| Test | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Volume test | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Flex test (stylet and cannula) | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Luer Lock tests (ISO 594-2) | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Hemostatic usage test | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Device leak test | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Pull / Torque tests (cannula) | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Pull / Bend tests (stylet) | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Cannula tissue compliance | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Shipping validation | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Shelf life evaluations | (Specific values not provided) | Met pre-defined acceptance criteria; demonstrated mechanical integrity and suitability for intended use. |
| Biocompatibility | Adherence to ISO 10993-1 (2009) criteria | Considered safe for its intended biocontact. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for each non-clinical test. It generally refers to "test articles."
- Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by Micromedics, Inc. or a contracted testing facility (Intertek Testing Services is mentioned as a contact for Micromedics for this submission). There is no mention of country of origin for data in the sense of patient data, as this is a non-clinical submission. The testing would be considered "prospective" in the sense that it was performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The tests performed are engineering and material science tests, not clinical evaluations requiring expert medical interpretation to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical engineering tests. The results of these tests (e.g., force required to bend, leak rate) would be objectively measured against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an Endoscopic Applicator, and the submission is focused on physical and mechanical properties, not the performance of an AI algorithm that would typically be evaluated with MRMC studies.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the established engineering specifications, international standards (e.g., ISO 594-2 for Luer Lock, ISO 10993-1 for biocompatibility), and internal product design requirements.
8. The Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
§ 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.