(45 days)
No
The description focuses on basic optical and electrical components for illumination, with no mention of AI/ML terms, image processing, or data analysis.
No.
The device is a light source for high intensity illumination required in surgery and medical applications, not for treating a disease or condition.
No
This device is a fiberoptic light source used for illumination during surgery and medical applications, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a lamp, chassis, AC power supply, dimmer, filter, fiberoptic cable, and optics in the headlight. It is a physical light source system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgery and medical applications where high intensity illumination is required." This describes a device used during medical procedures on a patient, not a device used to test samples outside of the body to diagnose or monitor a condition.
- Device Description: The description details a light source, power supply, dimmer, filter, fiberoptic cable, and headlight optics. This is consistent with a surgical illumination system, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other components typically associated with in vitro diagnostics.
In summary, the Designs for Vision Melide Fiberoptic Light is a surgical illumination device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
Product codes
FST
Device Description
The Designs for Vision Melide Fiberoptic Light (Melide Fiberoptic Light) is a modification of other legally marketed Designs for Vision surgical headlight systems. The Melide Fiberoptic Light consists of a lamp mounted in a chassis that also holds the AC power supply, dimmer for light intensity control, and a 530 nm filter. Light is passed through a fiberoptic cable to a set of optics in the headlight. The Melide Fiberoptic Light is compatible with all of the headsets available for use with the Designs for Vision surgical headlight systems described in K032283.
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)
Performance testing was conducted that confirms the safety and effectiveness of the modified Melide Fiberoptic Light for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032283, Cuda Products Corporation M300 Light Source
Reference Device(s)
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
K051786/S'
AUG 1 5 2005 Special 510(k) Summary For
Designs for Vision, Inc. Designs for Vision Melide Fiberoptic Light
1. SPONSOR
Designs for Vision, Inc. 760 Koehler Avenue Ronkonkoma, NY 11779
Contact Person: Ken Bragança (631) 585-3300 Telephone:
June 29, 2005 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Melide Fiberoptic Light |
|---|---|
| Common/Usual Name: | Surgical Lights |
| Classification Name: | Surgical lamp |
PREDICATE DEVICES 3.
- K032283 Designs for Vision Fiberoptic Light .
- Cuda Products Corporation M300 Light Source .
K981962
DEVICE DESCRIPTION 4.
The Designs for Vision Melide Fiberoptic Light (Melide Fiberoptic Light) is a modification of other legally marketed Designs for Vision surgical headlight systems. The Melide Fiberoptic Light consists of a lamp mounted in a chassis that also holds the AC power supply, dimmer for light intensity control, and a 530 nm filter. Light is passed through a fiberoptic cable to a set of optics in the headlight. The Melide Fiberoptic Light is compatible with all of the headsets available for use with the Designs for Vision surgical headlight systems described in K032283.
1
5. INTENDED USE
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The only modification made to the parent Designs for Vision Fiberoptic Light to produce the proposed Melide Fiberoptic Light is the type of lamp used as a light source. The parent Designs for Vision Fiberoptic Light was supplied with a tungsten halogen bulb that gave the light an intensity range of 0 -- 2700 foot candles (±5%). The modified Melide Fiberoptic Light uses a metal halide bulb that provides an intensity range of 0-8000 foot candles (±5%). The Cuda Products M300 Light Source is also supplied with a metal halide bulb.
PERFORMANCE TESTING 7.
Performance testing was conducted that confirms the safety and effectiveness of the modified Melide Fiberoptic Light for the intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a head and torso.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2005
Designs For Vision, Inc. c/o Ms. Cynthia J.M. Nolte, Ph.D. Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760-4153
V/
Re: K051786
Trade/Device Name: Designs for Vision Melide Fiberoptic Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: August 4, 2005 Received: August 8, 2005
Dear Dr. Nolte:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becasin 9 r (x) person is substantially equivalent (for the indications felerenced above und nave aswnloadly marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to they 20, 1977, 11:23
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resuire approval of a premarket approval application (PMA). and Costience Act (11ct) that as noves subject to the general controls provisions of the Act. The 1 ou may, mercroro, maines of the Act include requirements for annual registration, listing of general controls provisions of wastice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is onestired (600 as controls. Existing major regulations affecting your device can may or subject to basil as a substions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of advised that I Drimination that your device complies with other requirements of the Act that 1 Dr Hass statutes and regulations administered by other Federal agencies. You must or any I 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.
3
Page 2- Ms. Cynthia J.M. Nolte, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manteeing your antial equivalence of your device to a legally premaired nothleadon: The PDF mining of easification 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 If you desire specific advice for your as not to the regulation of the regulation entitled, comact the Office of Complanes as (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Designs for Vision Melide Fiberoptic Light
Indications for Use:
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K051786 Audray Buehus for
Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K051786 510(k) Number.