(46 days)
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No
The summary describes a standard endoscopic light source with a Xenon lamp and power source, with no mention of AI, ML, image processing, or any related performance metrics or data sets.
No
The device is an endoscopic light source, providing illumination for diagnostic procedures. It does not exert any direct therapeutic effect on the patient.
No
The device is an endoscopic light source, providing illumination for endoscopy. It does not perform any diagnostic function itself; it is an accessory for a diagnostic procedure.
No
The device description explicitly details hardware components such as a Power Source and Xenon Microdischarge Lamp, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is an endoscopic light source. Its function is to provide illumination inside the body during endoscopic procedures in joint cavities and abdominal space. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states providing illumination for endoscopy, which is an in vivo (inside the body) procedure.
Therefore, based on its function and intended use, this device falls under the category of a surgical or endoscopic accessory, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Endoscopic light source to provide illumination for fibre optic endoscopy to joint cavities and abdominal space.
Product codes
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Device Description
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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
joint cavities and abdominal space.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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- Detailed Similarities/Differences Comparison: (g)
- Endospot 510(k) Device Power Source On/Off Button Manual Illumination Control Automatic Illumination Control UV/IR Filters 35 Watt Xenon Microdischarge Lamp 1 Lamp in Unit 4000 Lamp Hours
SEP 2 0 1996 Autobrite (Predicate Device) Power Source On/Off Button Manual Illumination Control Automatic Illumination Control UV/IR Filters 100 Watt Xenon Lamp Module 1 Lamp in Unit Stepless Light Intensity Adjustment Stepless Light Intensity Adjustment 1000 Lamp Hours
510(k) Summary: 8.
| Classification Name: | Accessory to Endoscope |
|---|---|
| Device Trade Name: | Endobeam |
| Sponsor: | Corin U.S.A. |
| 10500 University Center Drive | |
| Suite 130 | |
| Tampa, FL 33612 | |
| USA | |
| Reason for Submission: | New device |
| Intended Use: | Endoscopic light source to provide |
| illumination for fibre optic endoscopy to | |
| joint cavities and abdominal space. | |
| Major Components: | - Power Source |
- Xenon Microdischarge Lamp |
| Lamp/Data | - Light intensity 35W - Lamp life - 4000 hours
- Color temperature - 3700K |
| Power Source: | 100 - 240V ± 10% 0 - 440 H₂ |
| Safety Testing: | - TUV tested to IEC 601/1 1988 - DIN VDE 0750 TI/11.91
- Electromagnetic compatibility
tested |
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Comparison to Legally Marketed Endoscopic Light Source:
Dyobrite 3000 Xenon Illuminator Smith and Nephew Dyonics 160 Dascomb Road Andover, Massachusetts 01810 USA
Truthful and Accurate Statement: 9.
I hereby confirm that the attached information is, to the best of my knowledge, truthful and accurate.
| PRINT NAME: | Jack Thomas |
|---|---|
| SIGNED: | |
| POSITION: | President |
| DATE: | 1 August 1996 |