(64 days)
Not Found
No
The summary describes a basic arthroscope with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
No
Explanation: The device is described as providing access, illumination, observation, or manipulation of body cavities, hollow organs, and canals. These functions are diagnostic or interventional, but not inherently therapeutic. The predicate device is also an arthroscope, which is used for examination and surgical procedures, not specifically therapeutic treatment.
No
Explanation: The device is described as providing "access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals." While observation can contribute to diagnosis, the primary intended use stated is to facilitate direct inspection and manipulation, which is an interventional or procedural function, not solely diagnostic image interpretation or analysis.
No
The device description clearly details physical dimensions and materials, indicating it is a hardware device (an arthroscope) and 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 clearly states the device is for "access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals." This describes a device used directly on or within the body for visualization and manipulation, which is characteristic of a surgical or endoscopic instrument.
- Device Description: The description details physical characteristics like length and diameter, and mentions it's composed of materials identical to an arthroscope. Arthroscopes are surgical instruments used for viewing joints.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue) outside the body to diagnose a condition. IVDs are designed for laboratory or point-of-care testing of biological specimens.
Therefore, this device falls under the category of a surgical or endoscopic instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
Product codes
Not Found
Device Description
This device has an overrall lenght of 354mm. This diameter of the shaft is 2.7mm for direction of the center of field of view of 0/30/70 degrees. Diameter of the shaft of 4mm for direction of the center of field of view of 0/15/30/70 dearees. This device is composed of identical materials to that of the Sight-Plus Arthroscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs, and canals.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Sight-Plus Arthroscope K925226
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
February 28, 1996
MAY - 7 1996
510(k) Summary
Submitter: Pollux Endoscopy, Inc. Address: 4696 NW 103rd Avenue Sunrise, FL 33351
Voice: (954) 748-8002 Contact: Precious Resch
Device: Cystoscope 0/15/30/70 degrees 2.7mm/4mm Classification: Rigid Endoscope Common/Usual Name: Rigid Cystoscope/Resectoscope
Name of device to which substantial eqivalence is claimed: Sight-Plus Arthroscope K925226
Intended Use: This device is intended to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
Description: This device has an overrall lenght of 354mm. This diameter of the shaft is 2.7mm for direction of the center of field of view of 0/30/70 degrees. Diameter of the shaft of 4mm for direction of the center of field of view of 0/15/30/70 dearees. This device is composed of identical materials to that of the Sight-Plus Arthroscope.
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."