LIGHTSOURCE OR ILLUMINATOR MODEL I-100

K983277 · Cuda Products Co. · HBI · Dec 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983277
• Device Name: LIGHTSOURCE OR ILLUMINATOR MODEL I-100
• Applicant: Cuda Products Co.
• Product Code: HBI · General, Plastic Surgery
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

Device Story

The I-100 is a lightsource/illuminator designed for clinical use in surgical environments. It functions by generating light, which is transmitted through fiberoptic cables to external surgical instrumentation, including headlights, microscopes, and video cameras. The device is operated by medical professionals to provide necessary illumination for surgical procedures. By supplying consistent light to the surgical field, it enables improved visualization for the clinician, facilitating surgical tasks and diagnostic observation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a lightsource/illuminator utilizing fiberoptic transmission. It is designed for connection to surgical headlights, microscopes, and video cameras. It operates as a standalone electrical device for surgical field illumination.

Indications for Use

Indicated for providing illumination to surgical fields via fiberoptic cables connected to headlights, microscopes, or video cameras for use by clinicians in surgical settings.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEC 1 6 1998

Ms. Kim Reed Cuda Products Corp. 6000 Powers Avenue Jacksonville, FL 32217-2279 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983277

Lightsource Model or Illuminator I-100 Dated: June 25, 1998 Received: September 17, 1998 Regulatory Class: II 21 CFR 878.4580/Procode: 79 HBI 21 CFR 884.1720/Procode: 85 HIE 21 CFR 876.1500/Procode: 78 FCR 78 FCW 78 FFS

Dear Ms. Reed:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 requlations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

.

rant Daniel C. Schultz, M.D.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{1}------------------------------------------------

510(k) Number:

Device Name:

Lightsource or illuminator I-100

Indications for use:

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

## (PLESASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------|----------------------------------------------------------------------------------------------|--------------------------|
| Prescription USE | <div style="text-align:center;"> or </div> | Over-The-Counter USE |
| | <div> (Division Sign-Off) <div>Division of Reproductive, Abdominal, ENT</div> </div> | (Optional format 1-2-96) |

Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.