(236 days)
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
This document describes a medical device, the "Family of Balloon Cannula," and compares it to a similar device, the "Hasson Stabilizing Access Cannula (SACun)," to demonstrate substantial equivalency. However, the provided text does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.
The document focuses on:
- Intended Use and Indications: Describing what the device is for and how it functions.
- Substantial Equivalency: Directly comparing its materials, sizes, functions, and sterilization methods to a predicate device.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment. This information is simply not present in the provided text.
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SUMMARY OF SAFETY AND EFFECTIVENESS BALLOON CANNULA
The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
The Family of Balloon Cannula are a single use, disposable sterile trocar and sleeve device intended for use during minimally invasive surgery to provide access for operative and diagnostic instrumentation.
Indications
The ability of the Family of Balloon Cannulas to meet its intended function includes the function and employment of the balloon and the control disc to assure an adequate anchor to allow for instrumentation access and removal during minimally invasive surgery. Furthermore, the balloon's tamponage effect, trap door and seals minimize the loss of CO2 gas during minimally invasive operative procedures.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The Family of Balloon Cannula are similar to the Hasson Stabilizing Access Cannula (SACun).
| Hasson SAC tm | Balloon Cannula | |
|---|---|---|
| Materials | ||
| - Balloon | Silicone | Silicone |
| - Cannula/Body | Thermoplastic | Thermoplastic |
| - Trocar | Stainless Steel | Aluminum |
| Sizes | 10/12 and 5mm | Range: 2-15mm |
| Functions | ||
| - Anchor System | Balloon / Cone | Balloon Disc |
| Sterilization | GammaSAL 10-6 | GammaSAL 10-6 |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Family of Balloon Cannula are comparable to that of the Hasson Stabilizing Access Cannula (SAC"m).
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.