(119 days)
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No
The description focuses on a microprocessor-controlled insufflator with safety features and user-adjustable pressure and flow rate, with no mention of AI or ML capabilities.
No
The device is used to distend the abdomen, which is an enabling step for a diagnostic or surgical procedure, not a therapeutic action in itself.
Yes
Explanation: The device is described as being used during "diagnostic procedures," indicating its involvement in the diagnostic process.
No
The device description explicitly states it is a "microprocessor controlled insufflator system" with a "maximum gas flow rate" and "safety features include acoustic and visual alarms," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Karl Storz Model 264305 20 Electronic Endoflator 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 description clearly states the device is used to distend the abdomen with CO2 gas during laparoscopic surgical and diagnostic procedures. This is a device used in vivo (within the living body) to facilitate a surgical procedure, not to analyze a sample in vitro (outside the living body).
Therefore, the Karl Storz Model 264305 20 Electronic Endoflator falls under the category of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Karl Storz Model 264305 20 Electronic Endoflator is designed to facilitate the use of laparoscopes by distending the abdomen with CO2 gas during laparoscopic surgical and diagnostic procedures.
Product codes
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Device Description
The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is a microprocessor controlled insufflator system with a maximum gas flow rate of 20 liters per minute. The insufflation pressure is user adjustable between 0 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure, negative pressure and low gas supply.
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
abdomen
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 shows a black and white abstract pattern. The pattern consists of a dense collection of small black dots and lines against a white background. The distribution of the black elements is uneven, with some areas appearing more concentrated and darker than others, creating a textured effect.
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
py
NOV 1 8 1990
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
Laparoscopic Insufflator |
Trade Name Karl Storz Model 264305 20 Electronic Endoflator
Indication: The Karl Storz Model 264305 20 Electronic Endoflator is designed to facilitate the use of laparoscopes by distending the abdomen with CO2 gas during laparoscopic surgical and diagnostic procedures.
Device Description: The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is a microprocessor controlled insufflator system with a maximum gas flow rate of 20 liters per minute. The insufflation pressure is user adjustable between 0 and 30 mmHg. The safety features include acoustic and visual alarms for overpressure, negative pressure and low gas supply.
Substantial Equivalence: The Karl Storz Model 264305 20 Electronic Endoflator for laparoscopy is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoflator 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 this device.
Signed: Beth
ty M. Johnson anager, Regulatory Affairs