(90 days)
Not Found
Not Found
No
The summary describes a surgical light, and there is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is a light designed for illumination during examinations and procedures, not for treating a disease or condition.
No
The device is described as a "Minor Surgery Light" designed to provide illumination for examinations and surgeries. It is not mentioned to diagnose or detect any condition. Its purpose is to provide light, not information about a patient's health status.
No
The device is described as a "Minor Surgery Light," which is a physical hardware device providing illumination. The description does not mention any software component as the primary or sole function.
Based on the provided information, the Outpatient® III Minor Surgery Light is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide illumination for examinations and minor surgery. This is a physical function related to providing light, not a diagnostic test performed on biological samples.
- Device Description: While the description is "Not Found," the intended use clearly defines its function as a light source.
- No Mention of Biological Samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue). There is no mention of the Outpatient® III interacting with or analyzing any biological samples.
- No Mention of Diagnostic Testing: The device's purpose is illumination, not to diagnose a condition or disease.
In summary, the Outpatient® III Minor Surgery Light 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 Outpatient® III Minor Surgery Light is designed to provide the required illumination I he Outpation "It Miner bat graminations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, asod with various moanting er health care facilities where the need for additional illumination exists.
Product codes
FSY
Device Description
Not Found
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
Operating rooms, examination rooms, and other health care facilities.
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): 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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
Mr. Asle Asmul Director of Product Development Burton Medical Products Corp. 21100 Lassen Street Chatsworth, California 91311
Re: K042395
Trade/Device Name: Outpatient® III, Minor Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FSY Dated: August 27, 2004 Received: September 2, 2004
Dear Mr. Asmul:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreative to regars the Medical Device Amendments, or to conninered pror to may 20, 2017 11:11 accordance with the provisions of the Federal Food, Drug, de rices that have been readire approval of a premarket approval application (PMA). and Cosmeter for (110) in 10 (110) in the general controls provisions of the Act. The r ou may, aterefore, mains of the Act include requirements for annual registration, listing of general voltable profice, 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 may be buyeet to been as a seen as 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.
1
Page 2 - Mr. Asle Asmul
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam 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
2
Indications for Use
510(k) Number (if known)
Outpatient® III, Minor Surgical Light Device Name:
Indications For Use:
The Outpatient® III Minor Surgery Light is designed to provide the required illumination I he Outpation "It Miner bat graminations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, asod with various moanting er health care facilities where the need for additional illumination exists.
| V
| Prescription Use | |
|---|---|
| (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 CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of l
510(k) Number_4042 395