(75 days)
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 Endoscope. The lightsource supplies light for the headlight or Endoscope.
Lightsource or illuminator M-300
The provided text is a 510(k) clearance letter from the FDA for a device called "Cuda Products Corp. Model M300 (M-300) Lightsource". This document is a regulatory approval and does not contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report.
Therefore, I cannot extract the information required in your request from this document. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing. It specifies the product code, regulatory class, and indications for use, but no performance data.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1998
Mr. Joseph Cuda President Cuda Products Corporation 6000 Powers Avenue Jacksonville, Florida 32217
Re: K981962 Trade Name: Cuda Products Corp. Model M300 (M-300) Lightsource Regulatory Class: II Product Code: FSS Dated: May 29, 1998 Received: June 4, 1998
Dear Mr. Cuda:
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 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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.
{1}------------------------------------------------
Page 2 - Mr. Joseph Cuda
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Elurchis
$\mu$
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number:
981962
Device Name:
Lightsource or illuminator M-300
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 Endoscope. The lightsource supplies light for the headlight or Endoscope.
(PLESASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription USE _
or
Over-The-Counter USE _________________________________________________________________________________________________________________________________________________________
(Optional format 1-2-96)
Stanton Rivelu
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.