(131 days)
The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.
The Hawkeye family consists of two products; the ESTECH Hawkeye Magnetic Introducer System and the ESTECH Hawkeye Scope System.
The Hawkeye Magnetic Introducer System is comprised of three main components:
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- Hawkeye Magnetic Cannula Assembly
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- Magnetic Introducer
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- Malleable Stylet
Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment. These pieces may be packaged, sterilized and sold separately. They are single-use only.
Please provide the acceptance criteria and the study that proves the device meets the acceptance criteria. The requested information is specific to clinical performance, interpretability, or diagnostic accuracy studies.
The provided document describes the Hawkeye™ Introducer Systems, a device intended for minimally invasive surgery to allow access for delivery and placement of surgical instruments and for blunt dissection of tissue.
However, the document does not contain information regarding:
- Any specific acceptance criteria related to the device's clinical performance, interpretability, or diagnostic accuracy (e.g., sensitivity, specificity, accuracy thresholds).
- Details of a study that tested the device against such criteria. The "Summary of Supporting Data" only mentions:
- Biocompatibility analysis (compliance with ISO 10993)
- Bench testing (met proposed product specifications)
- Animal testing
- Cadaver testing
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a clinical or diagnostic accuracy study. The document focuses on establishing substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing clinical performance data.
§ 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.