(15 days)
Not Found
No
The description focuses on the physical characteristics and adjustable parameters of a surgical light, with no mention of AI or ML capabilities.
No
The device is a surgical light intended for illumination of the surgical site, not for treating any medical condition.
No
The device is a surgical light intended to provide illumination at the surgical site, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components like LEDs, optical reflectors, and light heads, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing local illumination at the surgical site on the patient's body. This is a direct interaction with the patient during a medical procedure.
- Device Description: The description details a surgical light fixture designed to illuminate the surgical field. It focuses on light characteristics and adjustability for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body).
This device is a surgical light, which is a medical device used in vivo (within the body or on the body surface) to facilitate surgical procedures.
N/A
Intended Use / Indications for Use
The Aurora LED series surgical light is intended to provide local illumination at the surgical site on the patient's body at Hospitals, Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care Centers and Doctor's offices
The SKYTRON Aurora series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites
The SKYTRON Aurora Series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites.
Product codes
FSY
Device Description
The Aurora LED series surgical light is suitable for all types of surgical procedures. The Aurora series surgical light is intended to provide local surgical site illumination throughout the patient's body providing a high-intensity, shadow-free "cold" pattern of light. The lights consist of several modules containing LEDs (light emitting diodes) and optical color corrective reflectors. Each light head features independent focus capability allowing the user to adjust the illumination parameters. The light intensity is adjustable between 10% - 100% and a color temperature of 4000K - 4500K creating the infinite capability to adapt to different situations. LEDs offer low heat radiation and increased illumination and are energy saving.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site on the patient's body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical personnel for the purpose of illuminating surgical sites, Hospitals, Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care Centers and Doctor's offices
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K07/698
Image /page/0/Picture/1 description: The image shows the word "SKYTRON" in a stylized font. The "S" is a unique design with two stars embedded within it. A registered trademark symbol is present to the right of the word.
:
. i
5085 Corporate Exchange Blvd. SE Grand Rapids, MI 49512 Phone: (616) 656-2900 ● 1-800-SKYTRON Fax: (616) 656-2906
JUL - 6 2007
510 (k) SUMMARY
| SUBMITTER: | SKYTRON
5085 CORPORATE EXCHANGE BLVD.
GRAND RAPIDS, MI 49512 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON(s) | MR. LARRY PEREZ, MS. MARY MURPHY |
| PREPARATION DATE: | MAY 3RD, 2007 |
| COMMON NAME: | AURORA LED SERIES |
| CLASSIFICATION NAME: | LIGHT, SURGICAL, CEILING MOUNTED |
| DEVICE DESCRIPTION: | The Aurora LED series surgical light is suitable for all
types of surgical procedures. The Aurora series
surgical light is intended to provide local surgical
site illumination throughout the patient's body
providing a high-intensity, shadow-free "cold"
pattern of light. The lights consist of several
modules containing LEDs (light emitting diodes)
and optical color corrective reflectors. Each light
head features independent focus capability
allowing the user to adjust the illumination
parameters. The light intensity is adjustable
between 10% - 100% and a color temperature
of 4000K - 4500K creating the infinite capability to
adapt to different situations. LEDs offer low heat
radiation and increased illumination and are energy
saving. |
| INTENDED USE OF THE DEVICE: | The Aurora LED series surgical light is intended to provide local
illumination at the surgical site on the patient's body at Hospitals,
Clinics, VA's, Freestanding Surgical centers, Ambulatory/Care
Centers and Doctor's offices |
| PREDICATE DEVICE | TRADE NAME: STELLAR
510 (k):
K002463
PRODUCT CODE: FSY |
1
INDICATIONS FOR USE
The SKYTRON Aurora series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites
SUBSTANTIAL EQUIVALENCE:
THE AURORA LED SERIES IS SUBSTANTIALLY EQUIVALENT TO THE SURGICAL LIGHT STELLAR SERIES. (K002463) ANY EXISTING DIFFERENCES BETWEEN THE STELLAR SERIES AND THE AURORA LED SERIES HAS NO NEGATIVE EFFECT OF THE EFFECTIVENESS OR SAFETY. THE AURORA LED SERIES ACTUALLY AUGMENTS THE USEFULNESS AND RELIABILITY IN THE CHOSEN APPLICATIONS.
PRIMARY DIFFERENCE;
THE LIGHT SOURCE IS A LIGHT EMITTING DIODE (LED) WHICH HAS AN EXPECTED LIFE TIME THAT IS 4 TIMES GREATER THAN TRADITIONAL INCANDESCEBT BULBS AND IS HIGHLY ENERGY EFFICIENT.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.1111 -6 2007
Skytron, Inc. % Intertek Testing Services NA, Inc. Mr. Daniel W. Lehtonen 2307 Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K071698
Trade/Device Name: Aurora LED Series Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: June 19, 2007 Received: June 21, 2007
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. Mark N. Malkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510 (k) Number (if known): K07 16 98
Device Name: Aurora LED Series Surgical Light
Indications For Use:
The SKYTRON Aurora Series surgical light fixture is intended to be used by medical personnel for the purpose of illuminating surgical sites.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
OVER THE COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
DIVISION SIGN-OFF
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071698
DOC: FDA Aurora 510(k) REV. 0 Date: 5/3/2007