(33 days)
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No
The summary describes a simple irrigation pump with fixed flow rate and pressure, with no mention of AI/ML terms or capabilities.
No
Explanation: The device is designed for irrigation and aspiration during surgical procedures, which are supportive functions rather than directly treating a disease or condition.
No
The device is described as an irrigation and aspiration system for surgical sites, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description explicitly states it is a "membrane type irrigation pump," which is a hardware component, not software.
Based on the provided information, the Karl Storz Unimat Plus system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "irrigation and aspiration of the surgical site during general and endoscopic ENT surgical procedures." This describes a device used during a surgical procedure on a patient, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a pump for fluid management during surgery, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any features related to analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Karl Storz Unimat Plus system's function is purely mechanical and procedural within the surgical setting.
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 ENT surgical procedures.
Product codes
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Device Description
The Karl Storz Unimat Plus and accessories is a membrane type irrigation 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
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§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
AUG 27 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 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 |
| ------------ | --------------------------------------------------------------------------------------------------------------- |
|---|
Kevin Kennan Contact: Regulatory Affairs Specialist
Device Identification: Common Name: Suction/irrigation Pump
Trade Name: (optional) Karl Storz Unimat Plus
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of Indication: the surgical site during general and endoscopic ENT surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type Device Description: irrigation 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: Surry Stewart
Kevin Kennan Regulatory Affairs Specialist
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