(396 days)
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No
The description mentions a "microprocessor-based system" and "contemporary technology in pressure and flow-sensing," but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device aids in surgical procedures by maintaining distention of the peritoneal cavity, but it does not directly treat a disease or condition. Its function is supportive for diagnostic and surgical purposes.
No
The device is described as delivering gas for insufflation and monitoring CO2 during surgical and diagnostic procedures. While it's used in diagnostic procedures, its function is therapeutic (distention) and monitoring, not the diagnosis itself.
No
The device description explicitly states it is a "microprocessor-based system" and mentions "gas output" and "pressure," indicating it is a hardware device that controls gas flow and pressure, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver CO2 gas for insufflation during laparoscopic surgical and diagnostic procedures. This is a therapeutic/surgical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for controlling gas flow and pressure, which are physical parameters used in a surgical procedure. It doesn't mention analyzing biological samples or performing any kind of in vitro test.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
This device is clearly intended for use during a surgical procedure to facilitate visualization and access, which falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures
Product codes
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Device Description
The KSEA Thermoflator (model 26 4320 20) is a microprocessor-based system, with gas output that is user adjustable from 0-30 liters/minute, and pressure that is user adjustable from 0-30 mmHg. The unit uses contemporary technology in pressure and flow-sensing, and incorporates a wide variety of safety features.
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
peritoneal cavity
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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§ 884.1730 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.
0
Image /page/0/Picture/0 description: The image shows a grainy, black and white photograph of what appears to be a label or a piece of paper. The number 455073 is visible in the center of the image. There is a circular shape on the right side of the image. The image is heavily textured and has a worn appearance.
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
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 CRF 807.92. All data included in this documents 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
DEC - 6 1996
Contact:
Betty M. Johnson Manager, Regulatory Affairs
Device Identification:
Common Name Laparoscopic Insufflator
Trade Name (optional) KSEA Thermoflator (model 26 4320 20)
Indication:
This device is designed to carefully deliver large flow rates for rapid insufflation, and monitor the amounts of CO2 gas needed to establish and maintain proper distention of the peritoneal cavity during Ob/Gyn laparoscopic surgical and diagnostic procedures
Device Description:
The KSEA Thermoflator (model 26 4320 20) is a microprocessor-based system, with gas output that is user adjustable from 0-30 liters/minute, and pressure that is user adjustable from 0-30 mmHg. The unit uses contemporary technology in pressure and flow-sensing, and incorporates a wide variety of safety features.
Substantial Equivalence:
The KSEA Thermoflator (model 26 4320 20) is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermoflator (model 26 4320 20) and the predicate device raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices.
Signed: Beth M.C. Johnson
Betty M. Johnson Manager, Regulatory Affairs