(124 days)
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and laparoscopic surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mmHg.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies related to a medical device. The document is a 510(k) summary for the Karl Storz Unimat Plus, detailing its intended use and substantial equivalence to predicate devices, but lacks the specific data requested in your prompt.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy".
Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
P 30 1905
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 are accurate and complete to the best of KSEA's knowledge.
Applicant: Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500 Contact: Betty M. Johnson Manager, Regulatory Affairs Device Identification: Common Name Suction/irrigation Pump
Trade Name Karl Storz Unimat Plus
Indication: The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and laparoscopic surgical procedures.
Device Description: The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mmHg.
Substantial Equivalence: The Karl Storz Unimat Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Beck M. Johnson
Betty M. Johnson
ager, Regulatory Affairs
000050
§ 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.