(78 days)
Not Found
78 KOG
No
The device description focuses on the physical components and function of a catheter for laser fiber delivery and cleaning, with no mention of AI or ML capabilities.
No
The device is described as a catheter used to protect and clean a laser ablation fiber, and for irrigation, not for direct therapeutic action on the patient. The therapeutic action comes from the laser ablation fiber, not this delivery/cleaning catheter.
No
The device is described as a "Laser Fiber Delivery/Cleaning Catheter" used for protecting and cleaning a laser ablation fiber, and for irrigation of a surgical site. Its function is interventional/procedural, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components made of materials like polyethylene, nylon, acetal, polyvinylchloride, and polycarbonate, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used during surgery to protect and clean a laser fiber and irrigate the surgical site. This is a direct intervention on the patient's body.
- Device Description: The description details the physical components and function of a catheter used for delivering and cleaning a laser fiber within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is clearly used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
Not Found
Product codes
78 KOG
Device Description
The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site. The 5.7Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1250 inch). The 8.0Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1500 microns (0.060 inch). The naterials used in this device are polyethylene, nylon, acetal, polyvinylchloride and polycarbonate. Biocompatibility testing has been performed on the polyethylene and results show the materials to meet the requirements of these tests. The nylon, acetal, polyvinylchloride and polycarbonate do not come into contact with body tissue.
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
Not Found
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.
0
510(k) Premarket Notification Laser Fiber Delivery/Cleaning Catheter Cook Urological, Incorporated
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K960768'. The characters are written in a bold, cursive style, with thick strokes and rounded shapes.
L 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 1 4 1996
Submitted By:
Rick Lykins Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 February 23, 1996
Device:
Trade Name:
Laser Fiber Delivery/Cleaning Catheter
Proposed Classification Name: Endoscope and/or Accessories 78 KOG
Predicate Devices:
The Laser Fiber Delivery/Cleaning Catheter is substantially equivalent to predicate laser fiber delivery and laser fiber delivery/cleaning catheters in terms of indications for use, design, construction and materials equivalence. Predicate devices include:
- Lasercath™ manufactured by HGM Medical Laser Systems, Inc. .
- . Continuous Flow Laser Cystoscope manufactured by CIRCON ACMI.
- . Laser Fiber Insert manufactured by Cabot Medical.
Device Description:
The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site. The 5.7Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1250 inch). The 8.0Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1500 microns (0.060 inch). The naterials used in this device are polyethylene, nylon, acetal, polyvinylchloride and polycarbonate. Biocompatibility testing has been performed on the polyethylene and results show the materials to meet the requirements of these tests. The nylon, acetal, polyvinylchloride and polycarbonate do not come into contact with body tissue.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological, Incorporated. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.