(143 days)
Not Found
No
The description focuses on the hardware components (camera and light source) and their function in providing video and light for endoscopy. There is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies.
No
The device is a video system and light source for endoscopes, designed to capture and visualize images during surgical procedures, but it does not directly provide therapy.
No
The device is described as a video and light source system for endoscopes, designed for surgical procedures to capture and visualize images. It does not perform diagnostic functions, but rather aids in visualization for diagnostic or surgical procedures.
No
The device description explicitly details hardware components like control units, video heads, and fiber optic cables, indicating it is a hardware system, 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 that the system is for "surgical procedures" and is used with endoscopes to "capture and visualize the image from the endoscope on a monitor" and "provide light for a high visual and photographic clarity". This describes a system used for direct visualization and imaging within the body during a procedure.
- Device Description: The description reinforces this by detailing the camera system for capturing images and the light source for illumination during endoscopic procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, urine, etc.) outside the body to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for testing samples in vitro.
Therefore, the IEC MedSIGHT and MedBRIGHT system is a medical device used for visualization during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid (Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes ... ) or flexible (Sinoscope, Bronchoscope) Endoscopes and it is designed for surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KOG, GCT, FET
Device Description
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes.
The IEC MedSIGHT is a endoscopic color camera system and used in a variety of endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, ... ) to capture and visualize the image from the endoscope on a monitor. The system consists of a control unit and a video head. The cable of the video head connects to the control unit. The video head connects to all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope).
The IEC MedBRIGHT is a endoscopic light source system and used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) to provide light for a high visual and photographic clarity for color rendition. The system consists of a control unit and a fiber optic cable. The fiber optic cable connects on one site with the control unit and the other side it connects to the endoscope.
All these components are designed, constructed and intended to be operated exclusivelv as a unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.)
Not Found
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.
K974391, K983279, K023659, K003325, K983566, K994090, K070266, K962595, K983628, K905376
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
Koro809
510(k) SUMMARY OF SAFETY AND EFFECTIVENEE& 1 2008
IEC MedSIGHT and MedBRIGHT
March 18th, 2008
1. Submitter Information:
- a. Correspondent/ Distributor:
Name: | Innovative Endoscopy Components, LLC |
---|---|
Address: | 731-733 Shotgun Road |
Ft. Lauderdale, FL 33326 | |
Telephone: | (954) 217-8780 |
Fax: | (954) 217-8781 |
E-Mail: | info@endoscopy.md |
Registration No: | 1064152 |
Owner/ Operator No: | 9026517 |
Manufacturer: | |
Name: | Rudolf InnoView GmbH |
Address: | Am Laidhoelzle 1 |
D-79224 Umkirch | |
GERMANY | |
Telephone: | (+49) 7665 99094 |
Fax: | (+49) 7665 99095 |
E-Mail: | info@rudolf-innoview.de |
Registration No: | 9615001 |
Owner/ Operator No: | 9026517 |
2. Device Name:
b.
Classification Name: Diagnostic Devices, Endoscope and Accessories Common Name: Endoscopic Camera and Light Source System Proprietary Name: IEC MedSIGHT and MedBRIGHT
3. Classification
Classification Number: Product Code:
CFR 876.1500; Class II KOG, GCT
1
4. Indication for use:
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid (Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes ... ) or flexible (Sinoscope, Bronchoscope) Endoscopes and it is designed for surgical procedures.
5. Description of Device:
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes.
The IEC MedSIGHT is a endoscopic color camera system and used in a variety of endoscopic surgical procedures (orthopedic, laparoscopic, urologic, sinuscopic, plastic, ... ) to capture and visualize the image from the endoscope on a monitor. The system consists of a control unit and a video head. The cable of the video head connects to the control unit. The video head connects to all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope).
The IEC MedBRIGHT is a endoscopic light source system and used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) to provide light for a high visual and photographic clarity for color rendition. The system consists of a control unit and a fiber optic cable. The fiber optic cable connects on one site with the control unit and the other side it connects to the endoscope.
All these components are designed, constructed and intended to be operated exclusivelv as a unit.
6. Substantial Equivalence:
K974391, Karl Storz Imaging Endovision XL Endoscopic Camera
K983279, Richard Wolf 1CCD Endocam
K023659, Richard Wolf 1CCD Endocam
K003325, KSI NCA Video Imaging System
K983566, Stryker 888 Video Camera
K994090, KSI Autoclavable Camera Head
K070266, Smith & Nephew 560 HD Camera System
K962595, Karl Storz Xenon 300 Light Source K983628, Richard Wolf Auto LP 5123 Xenon Light Projector
K905376, Karl Storz S6000 Light Source
2
7. Description of Safety:
The selection of the materials has been determined through demonstrated appropriate levels of biocompatibility. The materials are similar or identical to those used for predicate devices as well as other brands legally sold in the United States.
8. Summary:
Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems available for sale in the USA.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 11 2008
Mr. Michael Rizzi Innovative Endoscopy Components, LLC 731-733 Shotgun Road FT LAUDERDALE FL 33326
Re: K080809
Trade/Device Name: IEC MedSIGHT and MedBRIGHT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: FET, GCT Dated: July 23, 2008 Received: July 28, 2008
Dear Mr. Rizzi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. Below that is the acronym "FDA" in a stylized font. The word "Centennial" is below the acronym. The logo is surrounded by a circular border with text and stars.
Protecting and Promoting Public Health
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally. marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
---|---|---|
21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon . Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K080809
Device Name: IEC MedSIGHT and MedBRIGHT
Indications For Use:
The Innovative Endoscopy Components (IEC) MedSIGHT and MedBRIGHT is a video system for endoscopes. MedSIGHT is a color, television camera system (supplies image) and MedBRIGHT is a xenon/halogen light source system (supplies light). Both can be used with all rigid endoscopes (like Arthroscopes, Cystoscopes, Hysteroscopes, Laparoscopes, Ureterorenoscopes, etc.) and some flexible endoscopes (Sinuscope and Bronchoscope) and it is designed for surgical procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
on of Reproductive, Abdomin and Radiological Devices 510(k) Number
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