(126 days)
Not Found
No
The document describes a surgical lighting system with basic features like dimming and beam size adjustment. There is no mention of AI, ML, image processing, or any data-driven functionalities.
No
This device is a surgical light system primarily intended for illuminating the surgical field during procedures, not for directly treating or diagnosing a medical condition.
No
The device is described as a surgical lighting system intended to provide visible illumination of the surgical field, not to diagnose medical conditions.
No
The device description explicitly states it is an AC powered device consisting of LED lights, which are hardware components.
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 visible illumination of the surgical field and the patient during surgical and non surgical procedures." This describes a device used on the patient or the surgical environment, not a device used to examine specimens from the body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description details a surgical lighting system, focusing on its physical characteristics and function of providing light. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
In summary, the device is a surgical light, which is a medical device used for illumination during procedures, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.
The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery.
It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
D1 = small minor surgical light / satellite
D2 = large minor surgical light
D3 = major surgical light
Product codes (comma separated list FDA assigned to the subject device)
FSY
Device Description
The proposed 21st Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
- D1 = small minor surgical light / satellite
- D2 = large minor surgical light
- D3 = major surgical light
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical field and the patient
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 to verify that the 21st Century Centurion ExcelLED and System Two LED lights meet the requirements for Medical Electrical Equipment as defined in:
CEI / IEC 60601-1 IEC 60601-2-41
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K083066, K070442, K071698, K072072, K061317
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the words "MEDICAL ILLUMINATION" stacked on top of each other in a stylized font. Below that, the word "INTERNATIONAL" is written in a smaller, simpler font. The text appears to be part of a logo or heading, possibly for a company or organization related to medical lighting.
JUN 2 2 2010
510 (k) SUMMARY
1100388
| Submitter: | Medical Illumination International Inc.
547 Library St.
San Fernando, CA 91340 |
|------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Wayne Gerow, QA / RA Manager |
| Trade Name: | 21st Century Centurion ExceLED and System Two LED
Lighting Systems |
| Common Name: | Surgical Light |
| Classification Number: | 21 CFR 878.4580 |
| Product Code: | FSY |
Predicate Devices:
.
- Berchtold Chromophare E558 and E778 . K083066 dated October 30, 2008 510 (k): Product Code: FSY
- Maquet PowerLED 500 Surgical Light . 510(k): K070442 dated March 16, 2007 Product Code: FSY
- . Skytron Aurora LED Series Surgical Light 510 (k): K071698 dated July 6, 2007 Product Code: FSY
- Steris Harmony LED-1 Surgical Lighting System . K072072 dated October 5, 2007 510 (k): Product Code FSY
- Trumpf Kreuzer Medizin iLED Surgical Lighting System . 510 (k): K061317 dated June 22, 2006 Product Code FSY
547 LIBRARY ST. • SAN FERNANDO. CALIFORNIA 91340 • PHONE 818-838-3025 • FAX 818-838-3725
1
Image /page/1/Picture/0 description: The image shows the logo for Medical Illumination International. The words "MEDICAL ILLUMINATION" are stacked on top of each other in a stylized font. Below that, the word "INTERNATIONAL" is written in a smaller, simpler font. The logo has a textured, almost pixelated appearance.
Device Description:
215t Century Centurion ExceLED
The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.
System Two LED
The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
- D1 = small minor surgical light / satellite
- D2 = large minor surgical light
- D3 = major surgical light
Intended Use:
The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.
Description of Safety:
The performance of the 21th Century Centurion ExceLED and System Two LED lights meet the general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment.
Substantial Equivalence:
The 21tt Century Centurion ExceLED and System Two LED lights are similar in function, intended use, components, technology and performance to the following predicate devices:
- a. Berchtold Chromophare E558 and E778 (K083066)
- b. Maquet PowerLED 500 Surgical Light (K070442)
- c. Skytron Aurora LED Series Surgical Light (K071698)
- d. Steris Harmony LED-1 Surgical Lighting System (K072072)
- Trumpf Kreuzer Medizin iLED Surgical Lighting System (K061317) e.
2
Image /page/2/Picture/0 description: The image shows the logo for Medical Illumination International. The logo is in black and white and features a stylized font. The words "Medical Illumination" are stacked on top of each other, with "International" written below.
Substantial Equivalence (con't):
The differences between the proposed and predicate devices are limited to differences in design, material, and operational. These differences do not raise any new issues of safety and efficiency
Performance Testing:
Performance testing was conducted to verify that the 21st Century Centurion ExcelLED and System Two LED lights meet the requirements for Medical Electrical Equipment as defined in:
CEI / IEC 60601-1 IEC 60601-2-41
Wayne Estes
Wayne Gerow QA / RA Manager Medical Illumination International, Inc.
547 LIBRARY ST. • SAN FERNANDO, CALIFORNIA 91340 • PHONE 818-838-3025 • FAX 818-838-3725
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medical Illumination International, Inc. % Mr. Wayne Gerow QA / RA Manager 547 Liberty Street San Fernando, California 91340
JUN 2 2 2010
Re: K100388
Trade/Device Name: System Two LED Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: May 17, 2010 Received: May 18, 2010
Dear Mr. Gerow:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Mr. Wayne Gerow
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Daniel Krone
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the words "MEDICAL ILLUMINATION INTERNATIONAL" in a stylized font. The words "MEDICAL ILLUMINATION" are stacked on top of each other in a large, bold font with a textured, almost distressed appearance. A horizontal line runs beneath these words, leading to the word "INTERNATIONAL" written in a smaller, simpler font. The overall design suggests a logo or branding for a company in the medical lighting or illumination field.
Indications for Use
4100388 510(k) Number:
Device Name: System Two LED
Indications for Use:
The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery.
It can consist of any combination of the 3 lights (D1, D2, D3) listed below.
All 3 models will have 5-level dimming and beam size (8"-12") adjustments.
D1 = small minor surgical light / satellite
- D2 = large minor surgical light
D3 = major surgical light
Prescription Use (Per 21 CFR 801.109 X OR
Over- the- Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atel K. Ogden for mxm
sion Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100388
547 LIBRARY ST. • SAN FERNANDO, CALIFORNIA 91340 • PHONE 818-838-3025 • FAX 818-838-3725