(39 days)
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No
The device description and intended use clearly indicate that this is a kit for replacing physical components (nozzles and set screws) of endoscopes. There is no mention of software, data processing, or any technology that would involve AI or ML.
No
The device is a replacement kit for endoscope nozzles, which are components used in diagnostic or therapeutic procedures but are not therapeutic devices themselves.
No
The device is described as a replacement kit for endoscope nozzles and associated tools, not for diagnosing medical conditions.
No
The device description clearly lists physical components like nozzles, set screws, sealant, and tools, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a physical part (nozzle) on an endoscope. This is a maintenance or repair function for a medical device used for visualization, not for performing tests on samples taken from the human body.
- Device Description: The components are physical tools and replacement parts for the endoscope. There are no reagents, calibrators, controls, or other components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of substances, or diagnosis of conditions based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
"These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes. Each kit includes 6 nozzles, three set screws, sealant, and the necessary tools (#1 screw driver, tweezers, and magnifying glass) to replace the nozzle. Each kit will include only the nozzle size(s) and set screw size(s) appropriate for use with the Olympus of America, Inc. endoscope models currently being used by the purchaser."
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
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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 (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
K 970372
MAR I I 1997
Attachment E
510(k) Summary for Endoscope Nozzle Repair Kits
P. E. A. Products, Inc. Applicant: 10969 McCormick Road Hunt Valley, Maryland 21031 Contact: Mr. Daniel M. Honeywell Phone: (800) 285-5959
Olympus America, Inc. endoscope nozzles and set screws Predicate Device:
These endoscope nozzle replacement kits are intended for use in Device Description: replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes. Each kit includes 6 nozzles, three set screws, sealant, and the necessary tools (#1 screw driver, tweezers, and magnifying glass) to replace the nozzle. Each kit will include only the nozzle size(s) and set screw size(s) appropriate for use with the Olympus of America, Inc. endoscope models currently being used by the purchaser.
Substantial Equivalence:
The nozzles, set screws, and sealant are the only kit components that are incorporated into the endoscope and come in contact with the patient. The premarket notification contains information and documentation that these components are substantially equivalent to those used by the original manufacturer in that they are for the same intended use and have the same technological characteristics. The remaining kit components (i.e., tools) are general purpose articles not regulated by FDA as medical devices. They are provided both as a convenience and as an assurance that the proper tools are used to replace the nozzle.
The applicant has extensive experience in the servicing and repair of endoscopes. This experience has demonstrated that nozzle replacement is easily performed and that proper nozzle alignment can readily be confirmed without the need for additional equipment.