(86 days)
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No
The summary describes a simple mechanical surgical instrument for puncturing and draining, with no mention of any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as a surgical tool for puncture and drainage, which is an interventional procedure, not necessarily a therapeutic one in itself. It facilitates a medical procedure rather than directly providing therapy.
No
The device is a surgical tool used for puncturing and draining, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a reusable surgical device made of surgical grade stainless steel, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "puncture and drain a cyst or other structure within the surgical site." This is a direct surgical intervention on the patient's body.
- Device Description: The device is a "reusable surgical device" used with a "Irrigation and Suction System Handpiece." This describes a surgical instrument used during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
Therefore, the KSEA Puncture Cannula is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site.
Product codes
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Device Description
The KSEA Puncture Cannula reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA "Irrigation and Suction System" and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel.
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
qualified surgeons or physicians
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 a logo for Karl Storz Endoscopy. The logo is white and features the word "STORZ" in a stylized font. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is black.
K964779 964379 5100(k) SUMMARY OF SAFETY AND EFECTIVENESS
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 |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Cannula |
Trade Name: (optional) KSEA Puncture Cannula
Indication: The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site.
Device Description: The KSEA Puncture Cannula reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA "Irrigation and Suction System" and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Puncture Cannula for the puncture and evacuation of cysts are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Puncture Cannula and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
000065
Signed:
Kevin Kennan
Regulatory Affairs Specialist