(102 days)
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No
The summary describes a fiberoptic illuminator, a device that provides light for surgical procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses solely on the light source and its accessories.
No
The device provides illumination for surgical procedures, which assists the surgeon but does not directly treat or diagnose a medical condition to be considered therapeutic.
No
Explanation: The device is described as providing light to the surgical operating field for improved visualization, which is an assistive function during surgery, not a diagnostic one. It does not analyze patient data or provide information about a patient's medical condition.
No
The device description clearly states it is a "Fiberoptic Illuminator, also known as a lightsource," which is a hardware component that transmits light via a fiberoptic cable. It is not described as software.
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 to the surgical operating field during surgical procedures. This is a direct interaction with the patient's body during a medical procedure, not an in vitro test performed on samples outside the body.
- Device Description: The description confirms it's a light source used in surgery, transmitting light via fiber optics to illuminate the surgical field.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely illumination for surgical visualization.
N/A
Intended Use / Indications for Use
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
Product codes
FSW
Device Description
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
surgical operating field
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people of different ages and backgrounds.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 01 2002
Ms. Kim Marsh President AcuLux, Inc. 273 South Airport Pulling Road Naples, Florida 34104
Re: K013511
K013911
Trade/Device Name: XENALight™ Fiberoptic Illuminator Regulation Number: 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSW Dated: January 8, 2002 Received: January 9, 2002
Dear Ms. Marsh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premium is substantially equivalent (for the indications felerenced above and nave decembers and and and and and one marketed in interstate for use stated in the encrosure) to regars) at tegally and the Medical Device American be on the col. Fored. Fores commerce prior to May 20, 1976, the enaounce with the provisions of the Federal Food, Drug, devices that have been recassinou in accera approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 classinonal controls. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe advisou that I Dri brassan that your device complies with other requirements of the Act that I Drillas made a sond regulations administered by other Federal agencies. You must of any I cacal statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Part 807), accimig (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by sellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kim Marsh
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you'll ought inding of substantial equivalence of your device to a legally prematicate 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 11 you desire specific arra 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -Compliance at (301) 591-1697 ffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation catured, "Misormation of esponsibilities under the Act may be obtained from the Outcr general mionmation the mational and Consumer 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,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for AcuLux. The logo consists of a black triangle on the left, followed by the word "AcuLux" in a serif font. There is a curved line above the "Lux" portion of the word, and a straight line below the entire word. The logo is simple and professional.
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INDICATIONS FOR USE
STATEMENT
DEVICE NAME: XenaLight™ Fiberoptic Illuminator
The XenaLight™ Fiberoptic Illuminator, also known as a lightsource, is attached to a fiberoptic cable transmitting the light to a fiberoptic headlamp, retractor, endoscopic instrument, etc, providing light to the surgical operating field. This light is utilized in many different surgical procedures requiring additional light when overhead lighting is not sufficient.
The fiberoptic cable and/or headlamps are an accessory to the XenaLight™ Fiberoptic Illuminator to transmit the light from the lightsource.
Kim Marsh, President
Oct. 19 2001
October 19, 2001
Miriam C. Provost
Restorative Neurological L .. vices
510(k) Number K013511
*(Premarket Notification 510(k)