(156 days)
The FMX314 Surgical Platform is composed of FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery:
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The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.
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The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.
The FMX314 Surgical Platform is a single-port laparoscopic surgery platform, featuring single-use, disposable articulating surgical instruments for the purpose of doing minimally invasive abdominal laparoscopic surgery by closely mimicking multi-port laparoscopic surgery. The FMX314 Surgical Platform is composed of the reusable FMX314 Introducer, the single-use FMX314 Hub Cap & Sealing Unit, and the single-use FMX314 Instruments that are used as part of laparoscopic surgery according to the intended use. The FMX314 Surgical Platform does not require a larger diameter incision than standard laparoscopic surgery (compatible with a single, standard 15mm trocar) and will utilize currently marketed conventional 15mm laparoscopic access devices (trocars), rigid 5mm laparoscopes, and instrument compatible handles for instrument manipulation and monopolar cutting and cauterizing.
The FMX314 Introducer is a reusable, single port access device for abdominal laparoscopic surgical procedures to be used in combination with a standard 15 mm trocar, FMX314 Hub Cap & Sealing Unit assembly (accessory), and the FMX314 Introducer is designed for introducer is designed for introducing, holding, supporting and guiding the FMX314 Instruments and a standard, rigid 5 mm laparoscope. The cavity at the top of the FMX314 Introducer (hub) is designed to place the single-use FMX314 Hub Cap & Sealing Unit. The FMX314 Hub Cap & Sealing Unit is designed to maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not one or more FMX314 Instruments are inserted in the instrument lumen(s) of the Introducer. Locking recesses in the hub guide the correct placement of the FMX314 Sealing Unit. The bayonet fitting at the hub is designed to properly position the single-use FMX314 Hub Cap & Sealing Unit on the FMX314 Introducer and to lock the FMX314 Sealing Unit in the hub. By turning the FMX314 Hub Cap clockwise a "click" is heard indicating that the FMX314 Hub Cap & Sealing Unit is locked into position. Prior to its reuse after completion of a procedure the FMX314 Introducer has to be disassembled and sterilized per Instructions For Use.
The FMX314 Surgical Platform comprises six (6) disposable articulating laparoscopic surgical instruments (i.e. FMX314 Grasper, Maryland, Clip Applier, Scissors, Hook-knife, and Suction/Irrigation Instrument). The FMX314 Instruments are locked into position in the instrument clamps of the FMX314 Introducer to activate a triangulated approach within the surgical field and facilitate independent anterior/posterior mobility. Each instrument is capable of 360 degree axial rotation of the end-effector as well as multidirectional lateral and superior/inferior mobility.
The FMX314 Instruments and FMX314 Hub Cap & Sealing Unit are provided sterile and are single-use, disposable. When the surgical procedure is completed, the single-use FMX314 Instruments as well as the FMX314 Hub Cap & Sealing Unit are removed from the Introducer and discarded according to standard hospital protocol.
The provided text describes the 510(k) premarket notification for the FMX314 Surgical Platform. It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and states that the device "PASSED all testing" or "PASSED required testing." Specific quantitative acceptance criteria are generally not provided in this summary, only the qualitative outcome.
| Test Category | Acceptance Criteria (Implicit from "PASSED") | Reported Device Performance |
|---|---|---|
| Biocompatibility | All testing related to cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity per ISO 10993-1 should be passed. | PASSED all testing |
| Electrical Safety (AAMI/ANSI ES60601-1) | Applicable sections of AAMI/ANSI ES60601-1 should be passed. | PASSED required testing |
| Electrical Safety (IEC 60601-2-2) | Applicable sections of IEC 60601-2-2 should be passed. | PASSED required testing |
| Electrical Safety (IEC 60601-2-18) | Applicable sections of IEC 60601-2-18 should be passed. | PASSED required testing |
| Axial Guidance Verification & Durability (FMX314 Introducer) | Complies with requirements for friction and dynamic-static friction through a number of cycles. | PASSED required testing |
| Triangulation & Range of Motion (FMX314 Instruments) | Lateral, superior/inferior, and anterior/posterior mobility is maintained. | PASSED required testing |
| Instrument Stiffness | Maximal axial load forces, minimum torqued, and minimum distal articulation stiffness meet specifications. | PASSED required testing |
| Cleaning & Reprocessing (FMX314 Introducer) | Meets all requirements for reprocessing. | PASSED required testing |
| Sterilization Testing (FMX314 Instruments & Hub Cap & Sealing Unit) | Meets ISO 11137 standard for radiation sterilization with an SAL of 10^-6. | PASSED required testing |
| Shelf Life Testing | Functionality testing for a period of two (2) years for sterilized product. | PASSED all testing |
| Animal Model Study (Performance - Acute & Chronic) | Endpoints of the study relating to cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, and compatibility across energy settings should pass defined criteria. | PASSED defined criteria |
| Human Cadaver Study | Relevant human landmarks in the abdominal cavity were reachable with no incidents; no negative feedback regarding landmark access, instrument manipulation, articulation, and overall surgical procedure. | Supports claims; no negative feedback |
| Usability Study | Positive feedback on the unpacking, installation, surgical procedure, and reprocessing; completion of all task selections. | Feedback obtained and assessed |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical Performance Tests: Sample sizes are not explicitly mentioned for the various bench tests. They are generally reported as "PASSED required testing" or "PASSED all testing."
- Animal Model Studies (in vivo): The document states "The animals were each processed through a surgical procedure..." but does not specify the number of animals used for either the acute or chronic studies. The data provenance is stated as "animal model in vivo study."
- Human Cadaver Study (ex vivo): The document mentions "A human cadaver study was performed..." but does not specify the number of cadavers used. The data provenance is "ex vivo cadaver studies."
- Usability Study: This was conducted during the animal and cadaver studies, implying the sample size would correlate to the users performing those studies, but no specific number is provided for users or cases.
The document does not explicitly state the country of origin for the data from these studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth in any of the studies (bench, animal, cadaver, or usability). It mentions "negative feedback was given by the user" for the cadaver study and "feedback that was obtained from each of the users" for the usability study, implying at least one user/expert per study.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for any of the studies. The results are reported as "PASSED" or "no negative feedback," suggesting a direct verification against predefined criteria rather than a multi-expert consensus adjudication process for discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done comparing human readers with AI assistance versus without AI assistance. The device is a surgical platform, not an AI-powered diagnostic tool, so this type of study would not be applicable.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. The FMX314 Surgical Platform is a physical surgical device designed for human use, not a standalone algorithm.
7. Type of Ground Truth Used
- Non-Clinical Performance Tests: The "ground truth" for these tests would be the established engineering specifications, national/international standards (e.g., ISO 10993-1, AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 11137), and internal requirements for factors like friction, mobility, stiffness, sterilization, and shelf life.
- Animal Model Studies: The ground truth involved "defined criteria" for tissue testing (cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, compatibility) evaluated both grossly and histopathologically. This suggests a combination of quantitative measurements and expert pathological assessment.
- Human Cadaver Study: "Relevant human landmarks" and "dimensional and functional adequacy" were assessed, implying a physical verification against anatomical expectations and user experience.
- Usability Study: The ground truth was based on "feedback" from intended users regarding the unpacking, installation, surgical procedure, and reprocessing steps.
8. Sample Size for the Training Set
Not applicable. The FMX314 Surgical Platform is a physical medical device. It does not utilize machine learning or AI algorithms that require a "training set."
9. 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.