CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
Device Facts
| Record ID | K093386 |
|---|---|
| Device Name | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST |
| Applicant | Bfw, Inc. |
| Product Code | FST · General, Plastic Surgery |
| Decision Date | Jan 28, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
Intended Use
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products. The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
Device Story
Device consists of ChromaLUME Turbo Light Source and XtremeBeam Fiber Optic Headlight; used in surgical settings. Light source generates high-intensity light transmitted via fiber optic cable to passive headlight. Headlight features durable plastic housing, lenses, spot size adjustment, and positioning bar; directs light to surgical field. Compatible with Wolf, Storz, Olympus, and ACMI/BFW fiber optic cables. Operated by surgical staff to provide supplemental illumination, improving visibility during procedures.
Clinical Evidence
Bench testing only; device meets IEC 60601-1 General requirements for safety.
Technological Characteristics
Surgical fiberoptic lamp; durable plastic housing, lenses, mirror, and iris. Compatible with Wolf, Storz, Olympus, and ACMI/BFW fiber optic cables. Meets IEC 60601-1 safety standards.
Indications for Use
Indicated for providing supplemental illumination of a surgical field during surgical procedures via fiber optic headlight systems.
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.
Predicate Devices
- Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator (K071218)
Related Devices
- K994362 — HEADLAMP HL2000. · Angiolaz, Inc. · May 11, 2000
- K013880 — DAYLITE XENON LIGHT SOURCES · Designs For Vision, Inc. · Dec 7, 2001
- K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT · Designs For Vision, Inc. · Aug 20, 2003
- K053227 — LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES · Medical Illumination International, Inc. · Jan 13, 2006
- K991572 — ISOLUX SURGICAL HEADLIGHT · Isolux America · Jul 8, 1999
Submission Summary (Full Text)
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## 510(k) SUMMARY BFW, Inc. ChromaLUME Turbo Light Source With XtremeBeam Fiber Optic Headlight
人093386
### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
BFW. Inc. 2307 River Road, Suite 103 Louisville, Kentucky, 40206
Contact Person:
Lynn Cooper President/CEO BFW Inc.
Date Prepared: October 15, 2009
#### Name of Device and Name/Address of Sponsor
BFW, Inc. ChromaLUME Turbo Light Source With XtremeBeam Fiber Optic Headlight
BFW. Inc. 2307 River Road, Suite 103 Louisville, Kentucky, 40206
#### Common or Usual Name
Surgical Lamp
#### Classification Name
Lamp, Surgical Fiberoptic
#### Predicate Device
Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator (K071218).
#### Intended Use
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic
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cable for illumination of a surgical field. It will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
#### Technological Characteristics and Substantial Equivalence
#### A. Device Description
i
- -
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.
# B. Substantial Equivalence
The ChromaLUME Turbo Light Source with XtremeBeam Fiber Optic Headlight is substantially equivalent to the Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator (K071218).
#### Performance Data
The ChromaLUME with XtremeBeam has been tested to and meets IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety.
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JAN 2 8 2010
BFW. Inc. % Ms. Lynn Cooper President/CEO 2307 River Road Suite 103 Louisville, Kentucky 40206
Re: K093386
Trade/Device Name: ChromaLUME Turbo Light Source™ with XtremeBeam™ Fiber Optic Headlamp
Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: October 15, 2009 Received: October 30, 2009
Dear Ms. Cooper:
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. Insting 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 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
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Page 2 - Ms. Lynn Cooper
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/CDRHQffices/ucm11.5809.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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark A. Milkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
# 510(k) Number (if known): TBD
# Device Name: ChromaLUME Turbo Light Source™ with XtremeBeam™ Fiber Optic Headlamp
Indications for Use:
The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.
The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mink A. Milken
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number _
