(86 days)
The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site.
The KSEA Puncture Cannula reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA "Irrigation and Suction System" and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel.
I am sorry, but based on the text you provided, there is no information about acceptance criteria or a study proving device performance for the KSEA Puncture Cannula. The document is a 510(k) summary and primarily focuses on device identification, indications for use, device description, and substantial equivalence to predicate devices. It does not contain the detailed study information you are requesting.
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K964779 964379 5100(k) SUMMARY OF SAFETY AND EFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc600 Corporate Pointe DriveCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Kevin KennanRegulatory Affairs Specialist |
| Device Identification: | Common Name:Cannula |
Trade Name: (optional) KSEA Puncture Cannula
Indication: The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site.
Device Description: The KSEA Puncture Cannula reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA "Irrigation and Suction System" and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Puncture Cannula for the puncture and evacuation of cysts are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Puncture Cannula and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
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Signed:
Kevin Kennan
Regulatory Affairs Specialist
§ 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.