INTEGRA LED SURGICAL HEADLIGHT SYSTEM

K110528 · Integra LifeSciences Corporation · FSR · May 11, 2011 · Ophthalmic

Device Facts

• Record ID: K110528
• Device Name: INTEGRA LED SURGICAL HEADLIGHT SYSTEM
• Applicant: Integra LifeSciences Corporation
• Product Code: FSR · Ophthalmic
• Decision Date: May 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4335
• Device Class: Class 2

Intended Use

The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

Device Story

Integra LED Surgical Headlight System provides illumination for surgical, diagnostic, or therapeutic procedures. Device consists of LED light source mounted on headband; powered by battery pack for portability or direct AC power supply for continuous use. Features active cooling system with thermostatically-controlled fan drawing air through ducts to cool LED module; exhausted behind surgeon. Includes user controls for light attenuation, fan monitoring, and over-temperature protection. Used in operating suites or clinical settings by surgeons/clinicians to improve visualization of surgical site. Output is focused light beam; adjustable spot size and positioning allow clinician to direct illumination as needed for procedure. Benefits include improved visibility and unrestricted movement via battery operation.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

LED light source; AC/DC power; battery-powered. Features: user-controlled light attenuation, fan monitoring/control, over-temperature monitoring/control, adjustable light positioning, and adjustable spot size. Conforms to IEC 60601-1, UL 60601-1, IEC 60601-1-8, and IEC 60335-2-29 safety standards.

Indications for Use

Indicated for providing illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures for patients undergoing such procedures.

Regulatory Classification

Identification

An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

Special Controls

*Classification.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Welch Allyn's Solid State Procedure Headlight (K031548)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the word "INTEGRA" in all capital letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller capital letters. To the right of the word "INTEGRA" are four squares of varying sizes stacked on top of each other.

589 Davies Drive
York, Pa 17402
Phone [phone]
Toll Free [phone]
Fax [phone]
www. Integralife.com

1 1 2011

# 510(k) Summary

K110528

| Submitted by: | Integra Burlington MA, Inc.<br>22 Terry Avenue, Burlington, MA 01803 USA | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Stephanie Sheesley, Regulatory Affairs Manager<br>Integra York PA, Inc.<br>589 Davies Drive, York, PA 17402 USA<br>Phone: [phone] Fax: [phone] | |
| Date Prepared: | February 16, 2011 | |
| Device Trade Name: | Integra™ LED Headlight System | |
| Device Common Name: | Surgical Headlight | |
| Classification Name: | Light, Headband, Surgical | |
| Device Class: | Class II | |
| Product Code: | FSR | |
| CFR Classification: | 21 CFR 886.4335 | |
| Predicate Device: | 510(k) #K031548<br>Welch Allyn's Solid State Procedure Headlight | |

#### Device Description:

The Integra™ LED Surgical Headlight System is a self-contained headlight system that can be operated using either battery or direct power supply. Using a battery pack gives the surgeon complete portability allowing unrestricted movement in and around the operating suite. The direct power supply option can be used as a primary power source for unlimited operating time, or as a back-up to the battery system.

The Integra™ LED Surgical Headlight System utilizes an LED light source with an active cooling system. A thermostatically-controlled cooling fan draws air at a very low flow rate through ports on the side and back of the headlight module, quietly cooling the LED. The air is drawn through a system of ducts and is gently exhausted behind the surgeon.

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

Image /page/1/Picture/0 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, thinner letters. To the right of the word "INTEGRA" are four squares of varying sizes, arranged in a descending order.

## Indications For Use:

The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

#### Predicate Device:

| 510(k) # | Device | Manufacturer |
|----------|---------------------------------|------------------|
| K031548 | Solid State Procedure Headlight | Welch Allyn Inc. |

### Performance Standards:

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Integra™ LED Surgical Headlight conforms to the following standards:

- CAN/CSA-C22.2 No. 601.1-M90 "Medical Electrical Equipment Part 1: . General Requirements for Safety"
- EN 60601-1: 1990 + A1: 1992 + A2: 1995 "Medical Electrical Equipment Part . 1 : General Requirements for Safety
- IEC 60601-1: 1988 + A1: 1991 + A2: 1995 "Medical Electrical Equipment Part . 1 General Requirements for Safety"
- UL 60601-1, First Edition, 2003 "Medical Electrical Equipment Part 1: General . Requirements for Safety"
- IEC 60601-1-8: 2003 (First Edition) in conjunction with IEC 60601-1 (1988) . including Amendments 1 (1991) and 2 (1995).
- CAN/CSA E60335-1/4E. Fourth Edition, 2003 "Household and Similar . Electrical Appliances Safety Part 1: General Requirements"
- UL 60335-1. Fourth Edition, 2004 "UL Standard for Safety of Household and . Similar Electrical Appliances, Part 1:General Requirements"
- IEC 60335-2-29:2002 (Fourth Edition) + A1:2004 + A2:2009 in conjunction with . IEC 60335-1:2001 (Fourth Edition) incl. Corrigendum 1:2002 + A1:2004 + A2:2006 incl. Corrigendum 1:2006

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

Image /page/2/Picture/0 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, black letters. To the right of the word "INTEGRA" are four squares of varying sizes, arranged in a column.

589 Davies Drive York Pa 17402 hone (717) 940-83 oll Free (800) 221-13 Fax [phone] www. Integralife.com

#### Technological Characteristics:

| Feature | Integra LED<br>Surgical Headlight | Welch Allyn Solid<br>State Headlight |
|--------------------------------------------|-----------------------------------|--------------------------------------|
| LED Light Source | YES | YES |
| AC/DC Powered | YES | YES |
| Battery Powered | YES | YES |
| User Control of Attenuated Light Level | YES | NO |
| Fan Monitoring and Control | YES | NO |
| Over Temperature Monitoring and<br>Control | YES | NO |
| Adjustable Light Positioning | YES | YES |
| Adjustable Illuminated Spot Size | YES | YES |

## Substantial Equivalence:

The Integra™ LED Surgical Headlight is substantially equivalent to the legally marketed predicate device based on performance testing. The Integra™ LED Surgical Headlight System has the same intended use, technological characteristics, and general operation as the predicate device identified. Minor differences between these devices simply improve performance and operating characteristics of the device and do not raise any new questions in regards to the system's safety or effectiveness.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2011

Integra Life Sciences Corporation % Integra York PA, Inc. Ms. Stephanie Sheesley Regulatory Affairs Manager 589 Davies Drive York, Pennsylvania 17402

Re: K110528

Trade/Device Name: Integra™ LED Headlight System Regulation Number: 21 CFR 886.4335 Regulation Name: Operating headlamp Regulatory Class: Class II Product Code: FSR Dated: February 23, 2011 Received: February 24, 2011

Dear Ms. Sheesley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

{4}------------------------------------------------

Page 2 - Ms. Stephanie Sheesley

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); 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/CDRHOffices/ucm115809.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/MedicalDevices/Safety/ReportaProblem/default.htm 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications For Use

KII0528

510(k) Number (if known):

Device Name:

IntegraTM LED Surgical Headlight System

Indications for Use:

The Integra™ LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

Prescription Use______________________________________________________________________________________________________________________________________________________________

AND/OR Use

Over-The-Counter-

(Part 21 CFR 801 Subpart D)

(Part 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)

Nil RP Ogden for mkm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110528

Page 1 of 1

INTEGRA