(89 days)
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No
The device description focuses on mechanical components (rigid telescope, BUMM clip) and optical technology (Hopkins rod-lens). There is no mention of software, image processing, AI, ML, or related concepts. The lack of information on training/test sets and performance metrics further supports the absence of AI/ML.
No
The device is used to view the larynx during intubation, which is a diagnostic and assistive function for a medical procedure, not a therapeutic treatment itself.
No
Explanation: The device is used to view the larynx during intubation, which is an interventional procedure, not a diagnostic one. Its purpose is to facilitate the intubation process rather than to diagnose a condition.
No
The device description explicitly states it is comprised of a Rigid Telescope and a BUMM Clip, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "view the larynx during intubation." This is a direct visualization procedure performed on a patient's body.
- Device Description: The device is a set of physical instruments (rigid telescope and clip) used for direct observation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is a tool for a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
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
larynx
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons and 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is black.
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:
Contact:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500
Kevin Kennan Regulatory Affairs Specialist
SEP 17 1996
Device Identification: Common Name: Telescopes and accessories used in Laryngoscopy
Trade Name: (optional) Karl Storz Set for Endoscopic Assisted Intubation
Indication: The KSEA Set for Endoscopic Assisted Intubation is designed to be used by qualified surgeons and physicians to view the larynx during intubation.
Device Description: The KSEA Set for Endoscopic Assisted Intubation is comprised of a Rigid Telescope and a BUMM Clip. KSEA Rigid Telescopes for Endoscopic Assisted Intubation are rigid, straight-shafted, panoramic telescopes which utilize Hopkins rod-lens technology. The KSEA BUMM Clip is used to secure the KSEA rigid telescope to a laryngoscope. The body contact portions of the KSEA Set for Endoscopic Assisted Intubation are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The KSEA Set for Endoscopic Assisted Intubation is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Set for Endoscopic Assisted Intubation and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed: Kevin Kennan
Regulatory Affairs Specialist
00060