(112 days)
The reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator is an access device indicated for use with a disposable 8.5 – 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.
The FloShield 10mm Endoscopic Cannula and Blunt Obturator are re-usable stainless steel endoscopic instruments delivered non-sterile to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 - 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator is a Hasson style, blunt tip obturator that facilitates the insertion of the cannula through an incision site.
The provided text describes a 510(k) premarket notification for a medical device, the FloShield 10mm Endoscopic Cannula and Blunt Obturator. The information focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics against pre-defined acceptance criteria with a formal study.
Therefore, the following information is not provided in the document:
- A table of acceptance criteria and reported device performance. No specific quantitative performance metrics or acceptance criteria are listed.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with vs. without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Instead, the document states that "Performance Testing" was conducted to verify the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and compare functional characteristics to predicate devices. These functional characteristics included:
- Leak Resistance
- Insufflating Flow Rates
- Insertion and Removal Force
- Snap Retention
The conclusion drawn from these tests and analyses was that the intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are similar or equivalent to those of the predicate devices. This implies that the device met an implicit acceptance criterion of performing comparably to the predicate devices for these functional characteristics, but no specific quantitative thresholds are given.
The document also mentions successful sterilization validation in accordance with ISO 17665:2006 and ANSI/AAMI ST81:2004, indicating that the device met the acceptance criteria for those sterilization standards.
§ 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.