(90 days)
Not Found
Not Found
No
The summary describes a light source for surgical instruments and explicitly states that AI, DNN, or ML are "Not Found".
No
This device is described as a light source for fiberoptic cables and instruments used in surgical fields, such as for headlights, microscopes, or video cameras. It provides illumination rather than directly treating a disease or condition.
No
The device, a lightsource, is intended to provide illumination for surgical fields and instruments (headlights, microscopes, video cameras). It does not gather information about a patient's health or disease state.
No
The device description clearly states "Lightsource or illuminator I-100," which implies a physical hardware component that provides light. The intended use also describes providing light for fiberoptic cables and instruments, further indicating a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide light for surgical fields via fiberoptic cables and instruments. This is a direct interaction with the patient's body or the surgical environment, not the analysis of biological samples in vitro (outside the body).
- Device Description: The device is described as a "Lightsource or illuminator." This aligns with a surgical lighting device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on biological sample analysis.
Therefore, the device described is a surgical light source, which is a medical device but not an IVD.
N/A
Intended Use / 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.
Product codes
79 HBI, 85 HIE, 78 FCR, 78 FCW, 78 FFS
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 (301) 594-4613. 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/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 | or | Over-The-Counter USE |
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT | (Optional format 1-2-96) |
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.