← Product Code [FST](/submissions/SU/subpart-e%E2%80%94surgical-devices/FST) · K082992

# AXXION LIGHT GUIDE (K082992)

_Spinal Elements, Inc. · FST · Feb 18, 2009 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K082992

## Device Facts

- **Applicant:** Spinal Elements, Inc.
- **Product Code:** [FST](/submissions/SU/subpart-e%E2%80%94surgical-devices/FST.md)
- **Decision Date:** Feb 18, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4580
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Intended Use

The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

## Device Story

Axxion Light Guide is a bifurcated fiberoptic cable system; single proximal end with universal adapter connects to external high-intensity light sources (150W-300W); cable branches into four distal ends terminating in stainless steel illumination tips. Device used in surgical settings to deliver light to surgical sites. Operates by propagating light from external source through fiberoptic bundles encased in silicone sheathing. Provides illumination to assist surgeons in visualizing surgical fields.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Bifurcated fiberoptic cable; silicone sheathing; stainless steel illumination tips; universal light source adapter; compatible with 150W-300W external light sources. Passive device; no electrical components or software.

## Regulatory 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

- Medical Light Guide by Fiberoptics Technology, Inc. ([K904378](/device/K904378.md))
- MIS Light by Zimmer ([K080367](/device/K080367.md))
- MaZcess Light Guide by NuVasive ([K042034](/device/K042034.md))

## Submission Summary (Full Text)

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Spinal Elements, Inc. Premarket Notification - Axxion™ Light Guide

FEB 1 8 2009

## 510(k) Summary Axxion™ Light Guide

#### K082992 510(k) Number

Page ① of ②

Manufacturer Identification Submitted by:

Contact Information:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121

Kerri DiMartino Regulatory Affairs Specialist Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad、CA 92010 760-607-1816 760-607-0125 (fax) kdimartino@spinalelements.com

Date Prepared:

October 3, 2008

Device Identification Proprietary Name Common Name Classification Name Device Classification Proposed Regulatory Class Device Product Code

Axxion™ Light Guide Light Guide Light, Surgical, Fiberoptic 21 CFR 878.4580 (Surgical Lamp) Class II FST

#### Device Description

The Axxion Light Guide is a bifurcated light guide that stems from a single cable and branches twice to terminate into four cables with illumination tips at each distal end. The end existing as a single cable contains a universal light source adapter that can be attached to a multitude of high intensity external light sources (ranging from 150 Watts to 300 Watts). Light provided from the external source is propagated through fiberoptic bundles contained by a jacket made of silicone sheathe. Fiberoptic bundles terminate at four stainless steel illumination tips that deliver light to the surgical site.

#### Intended Use of the Device

The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

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u82992 Page (2) of (2)

## Substantial Equivalence

The Axxion Light Guide was shown to be substantially equivalent in design, technical requirements, materials, and intended use to the following predicate devices: Medical Light Guide by Fiberoptics Technology, Inc. (K904378), MIS Light by Zimmer (K080367), and MaZcess Light Guide by NuVasive (K042034).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wing segments.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 8 2009

Spinal Elements, Inc. % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K082992

Trade/Device Name: Axxion™ Light Guide Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: February 10, 2009 Received: February 11, 2009

Dear Ms. DiMartino:

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. Fire . . . . . . . . . . . . . .

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.

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## Page 2 - Ms. Kerri DiMartino

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of SurveillancesSystems at (240) 276-3464. 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,

Mark N. Milliman

Mark N. Melkerson 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

ku82992 510(k) Number (if known):

Device Name: Axxion™ Light Guide

Indications for Use:

The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

WARRE Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, Page 1 of 1 and Neurological Devices

**510(k) Number** K072992

Page 1 of 1

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K082992](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K082992)

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