(124 days)
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No
The description focuses on a mechanical pump with fixed flow rates and pressure, and there is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for irrigation and aspiration during surgery. While it assists a medical procedure, it does not directly treat a disease or condition itself.
No
The device is described as an irrigation/aspiration pump used for surgical procedures, which are therapeutic or supportive actions, not diagnostic.
No
The device description clearly 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 of the surgical site during general, endoscopic and laparoscopic surgical procedures." This describes a device used during a surgical procedure on a patient's body, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a pump for irrigation and aspiration, which are physical actions performed during surgery. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Karl Storz Unimat Plus system is a surgical device, not an In Vitro Diagnostic device.
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, endoscopic and laparoscopic 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 mmHg.
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
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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.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in white text on a black background. The word "STORZ" is in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy".
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
P 30 1905
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 Suction/irrigation Pump
Trade Name Karl Storz Unimat Plus
Indication: The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general, endoscopic and laparoscopic 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 mmHg.
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:
Beck M. Johnson
Betty M. Johnson
ager, Regulatory Affairs
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