(198 days)
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No
The summary describes a microprocessor-controlled monitoring device for fluid balance, with no mention of AI, ML, or image processing.
No
The device is a monitoring system for fluid management during gynecological procedures, not a device that directly treats a medical condition or ailment.
No
The device monitors fluid inflow and outflow, which is a physiological measurement, not an assessment of a medical condition or disease.
No
The device description explicitly states it is a "microprocessor controlled monitoring device," indicating it includes hardware components beyond just software.
Based on the provided information, the Karl Storz model 203020 20 Equimat system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Equimat system monitors the flow of irrigation fluid within the uterus during a surgical procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it monitors fluid flow during endoscopic surgical procedures, not for diagnostic testing of biological samples.
Therefore, the device falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
uterus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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.
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Image /page/0/Picture/0 description: The image appears to be a scanned document or photograph with significant degradation. The degradation manifests as heavy noise and speckling across the entire surface. There are some areas with denser concentrations of dark marks, suggesting the presence of text or other content that is now obscured by the damage. The overall effect is a high level of visual distortion, making it difficult to discern any specific details or features.
Image /page/0/Picture/1 description: The image shows the text "Karl Storz" on the first line and "Endoscopy-America, Inc." on the second line. The text is in a simple, sans-serif font and is left-aligned. The text appears to be a company name or logo.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
Image /page/0/Picture/4 description: The image is a black and white picture with a black circle in the upper left corner. The circle has a white center and a small black dot on the lower right side of the white center. The rest of the image is filled with a grainy texture, with some areas appearing darker than others. The word "copy" is faintly visible in the lower center of the image.
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 Pointe
Culver City, CA 90230
(310) 558-1500 |
|-----------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Betty M. Johnson
Manager, Regulatory Affairs |
| Device Identification | |
| | Common Name
Fluid Monitoring System |
| | Trade Name
Karl 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
Image /page/0/Picture/15 description: The image shows a series of numbers, which appear to be "888886". The numbers are printed in a bold, sans-serif font and are black in color. The background of the image is white, which provides a clear contrast for the numbers to stand out. The numbers are evenly spaced and aligned horizontally.