OUTPATIENT III MINOR SURGERY LIGHT

K042395 · Burton Medical Products Corp. · FSY · Dec 1, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K042395
• Device Name: OUTPATIENT III MINOR SURGERY LIGHT
• Applicant: Burton Medical Products Corp.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Outpatient® III Minor Surgery Light is designed to provide the required illumination for examinations of patients. The Outpatient® III light is to be used with various mounting configurations in operating rooms, examination rooms, and other health care facilities where the need for additional illumination exists.

Device Story

Outpatient® III is a minor surgical light providing localized illumination for patient examinations. Device utilizes electrical power to drive light source; provides adjustable illumination for clinical tasks. Used in operating rooms, examination rooms, and healthcare facilities; operated by clinicians or healthcare staff. Output is visible light directed at patient site to facilitate visual inspection and minor surgical procedures. Benefits include improved visibility for healthcare providers during diagnostic or therapeutic interventions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical lamp (21 CFR 878.4580); Class II; Product Code FSY. Device features various mounting configurations for clinical environments. Electrical illumination source.

Indications for Use

Indicated for providing illumination during patient examinations in operating rooms, examination rooms, and other healthcare facilities.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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<br>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

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510(k) Number_4042 395