(79 days)
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No
The summary describes a simple irrigation/aspiration pump with fixed flow rates and pressure, and there is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device is described as an irrigation and aspiration system for surgical sites, making it a surgical tool rather than a therapeutic device.
No
Explanation: The device is described as an irrigation/aspiration pump for use during surgical procedures, which is a therapeutic or assistive function, not a diagnostic one.
No
The device description explicitly states it is a "membrane type irrigation/aspiration pump," which is a hardware component.
Based on the provided information, the Karl Storz Unimat Plus system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation and aspiration during surgical procedures. This is a direct interaction with the patient's body during surgery, not the examination of samples taken from the body (which is the core of IVD).
- Device Description: The description details a pump for fluid management during surgery, not a device for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, urine, or any other biological sample. There is no mention of diagnostic purposes or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Karl Storz Unimat Plus system's function is purely procedural during surgery.
N/A
Intended Use / Indications for Use
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic plastic, reconstructive and aesthetic surgical procedures.
Product codes
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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 mm Hg.
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
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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)
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Reference Device(s)
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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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§ 884.1720 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.
0
Image /page/0/Picture/0 description: The image shows a black and white abstract pattern. The pattern consists of a collection of small black dots and specks scattered across a white background. There is a vertical line on the left side of the image.
K 963960
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 is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 | DEC 20 1996 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist | |
| Device Identification: | Common Name:
Suction/irrigation Pump | |
Trade Name: (optional) Karl Storz Unimat Plus
Indication: The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic plastic, reconstructive and aesthetic 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 mm Hg.
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:
Kevin Kennan Regulatory Affairs Specialist