CLAVEGUARD FREEDOM SURGICAL LIGHT

K142076 · Dickson & Dickson Healthcare (Us), Inc. · FSY · Sep 30, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142076
• Device Name: CLAVEGUARD FREEDOM SURGICAL LIGHT
• Applicant: Dickson & Dickson Healthcare (Us), Inc.
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Sep 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Indications for Use

The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres

Device Story

ClaveGuard Freedom Surgical Light provides illumination for surgical sites in operating rooms. System utilizes Light Emitting Diodes (LEDs) with adaptive focus and shadow-free illumination capabilities. Operates at distances of 70-140cm from surgical site. Configuration includes 1 to 3 light heads mounted on a ceiling-pivoting suspension system; optional components include monitor extension arms, monitor mounts, and in-light video camera. Operated by surgical staff to provide clear visualization of the operative field, facilitating surgical decision-making and procedural accuracy.

Clinical Evidence

Bench testing only. Device conforms to IEC 60601-2-41:2001, IEC 60601-1:2005, IEC 60601-2-41:2009, IEC 60601-1-2:2007, and IEC 60601-1-4:2000. No clinical data utilized.

Technological Characteristics

LED-based surgical luminaire; ceiling-mounted pivoting suspension system; adaptive focus; shadow-free illumination. Operates at 70-140cm distance. Conforms to IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, and IEC 60601-1-4 standards.

Indications for Use

Indicated for illumination of surgical sites in operating theatres for patients undergoing surgical procedures.

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

• Berchtold Chromophare E668 (K090378)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

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

September 30, 2014

Dickson & Dickson Healthcare (US) Incorporated % Ragunath Muniandy Black Diamond Video Incorporated 503 Canal, Boulevard Richmond, California 94804

Re: K142076

Trade/Device Name: ClaveGuard Freedom Surgical Light Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: May 30, 2014 Received: August 4, 2014

Dear Muniandy:

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.

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

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

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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Binita S. Ashar -S 2014.09.30 17:27:22 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K142076

Device Name

ClaveGuard Freedom Surgical Light

#### Indications for Use (Describe)

The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the logo for ClaveGuard. The logo features a stylized blue letter 'G' with an arrow incorporated into its design. Below the 'G' is the word "CLAVEGUARD" in a larger, bolder font, also in blue. Underneath "CLAVEGUARD" is the tagline "SAFE | STERILE | SUSTAINABLE" in a smaller font.

Image /page/3/Picture/1 description: The image shows three different logos. The first logo is a red and white logo with the text "AS/NZS ISO 9001:2008 Quality Management System Certified Registration Number 159". The second logo is a blue and white logo with the text "JAS-ANZ". The third logo is a green and yellow logo with a kangaroo and the text "AUSTRALIAN OWNED".

ClaveGuard Pty Ltd www.claveguard.com Unit 3, 40 Brodie St. Rydalmere NSW 2116 Australia Phone [phone] Fax [phone]

# 510(K) Summary

Date Prepared: 05/30/2014

| 510K Owner: | ClaveGuard Pty, Ltd<br>Unit 3, 40 Brodie St, Rydalmere,<br>NSW 2116, Australia. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ragunath Muniandy<br>Regulatory Affairs Specialist<br>503 Canal Blvd.,<br>Richmond, CA 94804 |
| Trade Name: | ClaveGuard Freedom surgical light |
| Common Name: | Surgical Light |
| Classification Name: | Light, Surgical Accessories |
| Classification Panel: | General and Plastic Surgery |
| CFR section: | 21 CFR 878.4580 |
| Class: | 2 |
| Product Code: | FSY |
| Predicate Device: | Berchtold Chromophare E668 (K090378) |
| Device Description: | The ClaveGuard Freedom surgical lights are suitable for all<br>types of surgical procedures in operating rooms. The light is<br>based on Light Emitting Diodes (LEDs) in combination with<br>adaptive focus and shadow free illumination. It operates at a<br>distance of 70-140cm from the surgical site.<br>A light system may consist of 1 to 3 light heads supported by<br>pivoting suspension system that is mounted to Healthcare<br>facility's ceiling. The system may include optional monitor<br>extension arms, monitor mounts, and in-light video camera. |

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

Image /page/4/Picture/0 description: The image shows the logo for ClaveGuard. The logo features a stylized letter "G" in blue, with an arrow incorporated into its design. Below the "G" is the word "CLAVEGUARD" in a larger, bolder blue font. Underneath "CLAVEGUARD" is the tagline "SAFE | STERILE | SUSTAINABLE" in a smaller font.

Image /page/4/Picture/1 description: The image shows three different logos. The first logo is a red and white logo with the text "GLOBAL CERTIFICATION PTY LTD" at the top and "AS/NZS ISO 9001:2008 Quality Management System Certified Registration Number 159" at the bottom. The second logo is a blue and white logo with the text "JAS-ANZ" at the top. The third logo is a green and yellow logo with a kangaroo in the center and the text "AUSTRALIAN OWNED" around the edge.

ClaveGuard Pty Ltd www.claveguard.com Unit 3, 40 Brodie St. Rydalmere NSW 2116 Australia Phone [phone] Fax [phone]

Indications for use: The ClaveGuard Freedom surgical light is designed to illuminate the surgical site in Operating theatres.

### Substantial Equivalence

| (SE) Rational: | The ClaveGuard Freedom surgical light is substantially equivalent to predicate devices since intended use, operational principle, basic technology and design are similar. The minor differences between the ClaveGuard Freedom surgical lights and predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended of use of the device. Therefore based on the applicable testing and the equivalence information presented in this submission, Claveguard Pty Ltd. believes that ClaveGuard Freedom surgical light does not raise any new safety or efficacy issues. |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

### Summary of Nonclinical

| Testing: | - This device conforms to IEC 60601-2-41:2001 specifications<br>for performance of surgical lamps. Testing was conducted in<br>accordance with this standard to support substantial<br>equivalence. The ClaveGuard Freedom surgical light meets all<br>requirements of the performance standard and achieved<br>specified desired values per the product design specifications.<br>Clinical testing was not required or utilized to support<br>substantial equivalence |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Safety<br>and Effectiveness: | Testing and evaluation indicate that the system meets the needs<br>of the users of the device and does not raise any new safety and<br>efficacy of the predicate device.<br>The ClaveGuard Freedom surgical light conforms to the<br>IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +<br>AM1:2012 “Medical Electrical Equipment- Part 1 General<br>requirement for basic safety and essential performance. IEC 60601-2-41:2009 Medical Electrical Equipment- Part<br>2-41: Particular requirement for basic safety and essential<br>performance of surgical luminaires for diagnosis. IEC 60601-1-2:2007 “Medical Electrical Equipment- Part<br>1-2 General requirement for basic safety and essential<br>performance- Collateral Standard: Electromagnetic<br>compatibility- requirement and test. |

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

Image /page/5/Picture/0 description: The image shows the logo for ClaveGuard. The logo features a stylized letter 'G' in blue, with an arrow incorporated into its design. Below the 'G', the word 'ClaveGuard' is written in a bold, sans-serif font, also in blue. Underneath 'ClaveGuard', the words 'SAFE STERILE SUSTAINABLE' are written in a smaller, thinner font, separated by vertical lines.

Image /page/5/Picture/1 description: The image shows three different logos. The first logo is a red and white logo with the text "communication pty ltd" at the top and "AS/NZS ISO 9001:2008 Quality Management System Certified Accreditation Number 155" at the bottom. The second logo is a blue and white logo with the text "JAS-ANZ" at the top. The third logo is a green and yellow logo with a kangaroo in the center and the text "AUSTRALIAN OWNED" around the edge.

ClaveGuard Pty Ltd www.claveguard.com Unit 3, 40 Brodie St. Rydalmere NSW 2116 Australia Phone [phone] Fax [phone]

- 4. IEC 60601-1-4:2000 "Medical Electrical Equipment- Part 1-4 General requirement for safety- Collateral Standard: Programmable Electrical Medical System.