(78 days)
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No
The summary describes a mechanical pump with fixed flow rates and pressure, with no mention of AI/ML terms or capabilities.
No
The device is used for irrigation and aspiration during surgery, which are supportive functions for the surgical procedure itself, not directly providing therapeutic treatment to the patient for a specific condition.
No
The device is described as an irrigation/aspiration pump used during surgical procedures, which are therapeutic actions, not diagnostic ones. It does not provide information about a patient's condition.
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) device.
Here's why:
- Intended Use: The intended use is for "irrigation and aspiration of the surgical site during gynecologic laparoscopic 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 (in vitro).
- Device Description: The description details a pump for delivering fluids and suctioning, which aligns with a surgical irrigation/aspiration system, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such 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 gynecologic 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 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
gynecologic laparoscopic surgical procedures
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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§ 884.1720 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
K16 3949
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 1 9 1996
Kevin Kennan Contact: Regulatory Affairs Specialist
Common Name: Device Identification: 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 gynecologic laparoscopic surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type Device Description: irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.
The Karl Storz Unimat Plus system is substantially equivalent to the Substantial Equivalence: 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
000083