(198 days)
The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.
The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the uterus during endoscopic surgical procedures in gynecology.
This document is a 510(k) Summary of Safety and Effectiveness for the Karl Storz Model 203020 20 Equimat, a fluid monitoring system. It declares substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided document is a regulatory submission, not a study report. Therefore, I cannot extract the requested information.
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600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
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OCT - 3 1996
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 PointeCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Betty M. JohnsonManager, Regulatory Affairs |
| Device Identification | |
| Common NameFluid Monitoring System | |
| Trade NameKarl Storz Model 203020 20 Equimat |
Indication: The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.
Device Description: The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the uterus during endoscopic surgical procedures in gynecology.
Substantial Equivalence: The Karl Storz model 203020 20 Equimat system for gynecology is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences between the Karl Storz Equimat 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:
Bed. W. Johnson
Betty L. Johnson
M. Johnson Manager, Regulatory Affairs
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§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. 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.