LITE WAND II

K080962 · Thompson Surgical Instruments, Inc. · FST · Jun 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080962
• Device Name: LITE WAND II
• Applicant: Thompson Surgical Instruments, Inc.
• Product Code: FST · General, Plastic Surgery
• Decision Date: Jun 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. The Lite Wand II is designed to be used by surgeons and other medical care practitioners in a surgical setting.

Device Story

Lite Wand II is a fiber optic surgical task light; provides visible illumination of surgical field or patient. Device consists of Cam Joint fixture for attachment to retractor system arm, flexible gooseneck-supported lighthead, and fiber optic bundle. Operates via external Halogen light source; compatible with standard ACMI, Storz, Wolf, or Olympus connector cables. Used in surgical settings by surgeons and medical practitioners. Functions as a substitute for traditional headlamps; provides localized illumination to assist visualization during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Fiber optic surgical light; Cam Joint attachment for retractor systems; flexible gooseneck; fiber optic bundle; Halogen light source; compatible with ACMI, Storz, Wolf, and Olympus connector cables.

Indications for Use

Indicated for use by surgeons and medical practitioners as a surgical task light to provide visible illumination of the surgical field or patient during surgical procedures. Intended for use with a retractor system via Cam Joint and compatible with ACMI, Storz, Wolf, or Olympus connector cables. Prescription use only.

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)

{0}------------------------------------------------

Traditional 510(k) Premarket Notification: Lite Wand II

K080962

## 510(k) SUMMARY Thompson Surgical Instruments, Inc. Lite Wand II

| Applicant: | Stephanic A. Zalucha<br>Thompson Surgical Instruments Inc.<br>10170 E. Cherry Bend Road<br>Traverse City, MI 49684<br>Tel: [phone]<br>Fax: [phone] | JUN 25 2008 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Registration #: | 1450428 | |
| Date Summary Prepared: | January 16, 2008 | |
| Trade Name: | Lite Wand II | |
| Classification Name: | Surgical Lamp | |
| Common or Usual Name: | Light, Surgical, Fiber Optic | |
| Device Description: | Thompson Surgical Instruments, Inc. Lite Wand II is a fiber optic surgical light<br>designed to provide visible illumination of the surgical field or the patient. The<br>Lite Wand II consists of a Cam Joint fixture which attaches the device to a<br>retractor system arm, a flexible "gooseneck" supported lighthead for easy<br>positioning, and a fiber optic bundle. The Thompson surgical Lite Wand II is<br>designed as a task light for surgical use. | |
| | The Lite Wand II is designed to be a replacement or substitute for headlamps<br>and it uses the same technology currently used in other headlamps and light<br>sources. These other devices have similar performance characteristics which<br>have been previously cleared by the FDA. | |
| Intended use: | The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light<br>for surgical procedures. It is designed to be used in conjunction with a retractor<br>system which it can attach to through the use of a Cam Joint. The Lite Wand II<br>is designed to provide visible illumination of the surgical field or the patient<br>through a Halogen light source only. The Lite Wand II is designed to be used<br>by surgeons and other medical care practitioners in a surgical setting. | |

Traditional 510(k) Premarket Notification: Lite Wand 11

This document contains information considered to be CONFIDENTIAL to Thumpson Surgical Instruments, Inc.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2008

Thompson Surgical Instruments, Inc. % Ms. Stephanie A. Zalucha Product Manager 10170 East Cherry Bend Road Traverse City, Michigan 49684

Rc: K080962

Trade/Device Name: Lite Wand II Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FST Dated: May 22, 2008 Received: June 12, 2008

Dear Ms. Zalucha:

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.

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.

{2}------------------------------------------------

Page 2 - Ms. Stephanie A. Zalucha

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark M. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): K080962

Device Name: Lite Wand II

Indications For Use:

The Thompson Surgical Instruments, Inc. Lite Wand II intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor system which it can attach to through the use of a Cam Joint. The Lite Wand II is designed to provide visible illumination of the surgical field or the patient through a Halogen light source only. It is intended to be used with ACMI, Storz, Wolf, or Olympus connector cables. The Lite Wand II is intended to be used by surgeons and medical care practitioners in a surgical setting.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
| <div style="text-align: center;">✓</div> | | |

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

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

| 510(k) Number | 1208961 |
|---------------|---------|
|---------------|---------|