(90 days)
None
Not Found
No
The device description clearly states it is a set of manual reusable surgical devices with disposable components, and there is no mention of AI or ML in the provided text.
No.
The device is used for the collection of peritoneal fluid, which is a diagnostic procedure, not a therapeutic intervention.
No
The device is described as a set of manual surgical devices intended for the collection of peritoneal fluid, not for the diagnosis of conditions based on an analysis of that fluid or an anatomical site.
No
The device description explicitly states it is a set of manual reusable surgical devices with disposable components, made of materials like stainless steel, PTFE, and polyurethane, 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 the "collection of peritoneal fluid". This is a procedure to obtain a sample from the body.
- Device Description: The device is described as "manual reusable surgical devices" used for the collection of fluid.
- Lack of Diagnostic Function: There is no mention of the device being used to examine the collected fluid or to provide any diagnostic information based on the fluid itself. IVDs are designed to perform tests on samples from the body to diagnose or monitor conditions.
This device is a tool for obtaining a sample, not for performing a diagnostic test on that sample.
N/A
Intended Use / Indications for Use
The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.
Product codes
Not Found
Device Description
The KSEA Culdocentesis Set are manual reusable surgical devices (with two single-use disposable components). The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis. The body contact materials are surgical grade stainless steel, PTFE, and polyurethane. The non-body contact materials of the Culdocentesis Set are silicone, polyolefin, and PVC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons or physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. 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 preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: 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
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 | OCT 22 1996 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kevin Kennan
Regulatory Affairs Specialist | |
| Device Identification: | Common Name:
Culdocentesis Set | |
Trade Name: (optional) KSEA Culdocentesis Set
Indication: The KSEA Culdocentesis Set are intended for use by qualified surgeons or physicians in the collection of peritoneal fluid.
Device Description: The KSEA Culdocentesis Set are manual reusable surgical devices (with two single-use disposable components). The KSEA Culdocentesis Set provides a high success rate in the collection of peritoneal fluid, while minimizing the problems of conventional culdocentesis. The body contact materials are surgical grade stainless steel, PTFE, and polyurethane. The non-body contact materials of the Culdocentesis Set are silicone, polyolefin, and PVC.
Substantial Equivalence: The KSEA Culdocentesis for collection of peritoneal fluid 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 K.SEA Culdocentesis Set 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.
Signed:
Karin Kunnari
Kevin Kennan Regulatory Affairs Specialist
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