(61 days)
Not Found
No
The summary describes a surgical light with adaptive focus and shadow-free illumination, but there is no mention of AI or ML technology being used for these features or any other function. The performance studies focus on compliance with a standard for surgical lamps, not on AI/ML performance metrics.
No
The device is a surgical light designed to illuminate the surgical site, which is a supportive function during a surgical procedure, not a therapeutic intervention itself. It does not treat, cure, mitigate, or prevent disease.
No
The device is a surgical light designed to illuminate the surgical site, not to diagnose medical conditions. Its function is illumination for surgical procedures.
No
The device description clearly outlines hardware components such as LEDs, a pivoting suspension system, and optional monitor arms and cameras, indicating it is a physical medical device, not software-only.
Based on the provided information, the Claveguard Freedom Surgical Light is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "illuminate the surgical site in Operating theatres." This is a function performed on the patient during a surgical procedure, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The description details a surgical light system used for illumination during surgery. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: There is no mention of analyzing samples, diagnostic results, or any other activities typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Claveguard Freedom Surgical Light's function is purely illumination during surgery.
N/A
Intended Use / Indications for Use
The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres.
Product codes
FSY
Device Description
The ClaveGuard Freedom surgical lights are suitable for all types of surgical procedures in operating rooms. The light is based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. It operates at a distance of 70-140cm from the surgical site. A light system may consist of 1 to 3 light heads supported by pivoting suspension system that is mounted to Healthcare facility's ceiling. The system may include optional monitor extension arms, monitor mounts, and in-light video camera.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating theatres
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This device conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. Testing was conducted in accordance with this standard to support substantial equivalence. The ClaveGuard Freedom surgical light meets all requirements of the performance standard and achieved specified desired values per the product design specifications. Clinical testing was not required or utilized to support substantial equivalence.
Testing and evaluation indicate that the system meets the needs of the users of the device and does not raise any new safety and efficacy of the predicate device.
The ClaveGuard Freedom surgical light conforms to the IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 “Medical Electrical Equipment- Part 1 General requirement for basic safety and essential performance. IEC 60601-2-41:2009 Medical Electrical Equipment- Part 2-41: Particular requirement for basic safety and essential performance of surgical luminaires for diagnosis. IEC 60601-1-2:2007 “Medical Electrical Equipment- Part 1-2 General requirement for basic safety and essential performance- Collateral Standard: Electromagnetic compatibility- requirement and test.
IEC 60601-1-4:2000 "Medical Electrical Equipment- Part 1-4 General requirement for safety- Collateral Standard: Programmable Electrical Medical System.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4580 Surgical lamp.
(a)
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.(b)
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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 (+61 2) 8845 3800 Fax (+61 2) 9999 1441
510(K) Summary
Date Prepared: 05/30/2014
| 510K Owner: | ClaveGuard Pty, Ltd
Unit 3, 40 Brodie St, Rydalmere,
NSW 2116, Australia. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ragunath Muniandy
Regulatory Affairs Specialist
503 Canal Blvd.,
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
types of surgical procedures in operating rooms. The light is
based on Light Emitting Diodes (LEDs) in combination with
adaptive focus and shadow free illumination. It operates at a
distance of 70-140cm from the surgical site.
A light system may consist of 1 to 3 light heads supported by
pivoting suspension system that is mounted to Healthcare
facility's ceiling. The system may include optional monitor
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 (+61 2) 8845 3800 Fax (+61 2) 9999 1441
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
for performance of surgical lamps. Testing was conducted in
accordance with this standard to support substantial
equivalence. The ClaveGuard Freedom surgical light meets all
requirements of the performance standard and achieved
specified desired values per the product design specifications.
Clinical testing was not required or utilized to support
substantial equivalence |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Safety
and Effectiveness: | Testing and evaluation indicate that the system meets the needs
of the users of the device and does not raise any new safety and
efficacy of the predicate device.
The ClaveGuard Freedom surgical light conforms to the
IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +
AM1:2012 “Medical Electrical Equipment- Part 1 General
requirement for basic safety and essential performance. IEC 60601-2-41:2009 Medical Electrical Equipment- Part
2-41: Particular requirement for basic safety and essential
performance of surgical luminaires for diagnosis. IEC 60601-1-2:2007 “Medical Electrical Equipment- Part
1-2 General requirement for basic safety and essential
performance- Collateral Standard: Electromagnetic
compatibility- requirement and test. |
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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 (+61 2) 8845 3800 Fax (+61 2) 9999 1441
-
- IEC 60601-1-4:2000 "Medical Electrical Equipment- Part 1-4 General requirement for safety- Collateral Standard: Programmable Electrical Medical System.