(46 days)
Not Found
Not Found
No
The device description and intended use are limited to a basic light source for endoscopy, with no mention of image processing, AI, or ML.
No
The device provides illumination for endoscopy and is not described as directly treating a condition or disease.
No
This device is an endoscopic light source that provides illumination for optical inspection, which is an interventional function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a power source, quartz halogen lamp, and lamp illuminator adjuster, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is an endoscopic light source. Its function is to provide illumination within the body (joint cavities and abdominal space) for visualization during endoscopy. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "to provide illumination for fibre optic endoscopy to joint cavities and abdominal space." This is a direct visualization tool, not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a medical device used for visualization during surgical or diagnostic procedures, but it is not an in vitro diagnostic device.
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
Not Found
Device Description
- Power Source
- Quartz Halogen Lamp
- Lamp illuminator adjuster
- Light intensity 75W
- Lamp life - 50 hours full power 200 hours in lamp save mode
- Color temperature - 3200K
- Power Source: 100 - 240V ± 10% 0 - 440 H₂
- On/Off Button
- Manual Illumination Control
- Automatic Illumination Control
- UV/IR Filters
- 2 Lamps in Unit
- Spare bulb
- Stepless Light Intensity Adjustment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joint cavities and abdominal space
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.)
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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.
Not Found
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.
Not Found
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).
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
SEP 2 0 1996
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Detailed Similarities/Differences Comparison: (g)
| Endospot 510(k) Device | Autobrite (Predicate Device) |
|---|---|
| Power Source | Power Source |
| On/Off Button | On/Off Button |
| Manual Illumination Control | Manual Illumination Control |
| Automatic Illumination Control | Automatic Illumination Control |
| UV/IR Filters | UV/IR Filters |
| 75 Watt | 250 Watt |
| Quartz Halogen Lamp | Quartz Halogen Lamp |
| 2 Lamps in Unit | 1 Lamp in Unit |
| Spare bulb | No spare bulb |
| Stepless Light Intensity Adjustment | Stepless Light Intensity Adjustment |
8. 510(k) Summary:
| Classification Name: | Accessory to Endoscope |
|---|---|
| Device Trade Name: | Endospot |
| 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 |
- Quartz Halogen Lamp
- Lamp illuminator adjuster |
| Lamp/Data | - Light intensity 75W - Lamp life - 50 hours full power
200 hours in lamp save mode - Color temperature - 3200K |
| 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 |
1
Page 14
Comparison to Legally Marketed Endoscopic Light Source:
3180 Auto Brite Illuminator II 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 |