(61 days)
The Claveguard Freedom Surgical Light is designed to illuminate the surgical site in Operating theatres
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.
This document describes the ClaveGuard Freedom Surgical Light, a surgical lamp designed to illuminate surgical sites. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for establishing acceptance criteria for a new AI/ML device.
However, based on the provided text, we can infer the "acceptance criteria" relate to performance specifications defined by recognized international standards, and the "study" is the nonclinical testing conducted in accordance with those standards.
Here's an attempt to structure the information as requested, understanding that the context is a medical device for illumination, not an AI/ML diagnostic tool:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from IEC 60601-2-41:2001 & product design specifications) | Reported Device Performance |
|---|---|
| Conforms to IEC 60601-2-41:2001 specifications for performance of surgical lamps. | The ClaveGuard Freedom surgical light meets all requirements of the performance standard and achieved specified desired values per the product design specifications. |
| Basic safety and essential performance (per IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012) | Conforms to IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012. |
| Basic safety and essential performance of surgical luminaires for diagnosis (per IEC 60601-2-41:2009) | Conforms to IEC 60601-2-41:2009. |
| Electromagnetic compatibility (per IEC 60601-1-2:2007) | Conforms to IEC 60601-1-2:2007. |
| Programmable Electrical Medical System standards (per IEC 60601-1-4:2000) | Conforms to IEC 60601-1-4:2000. |
| Intended use: illuminate the surgical site in Operating theatres. | Designed to illuminate the surgical site in Operating theatres. |
| Operating distance | Operates at a distance of 70-140cm from the surgical site. |
| Technology basis | Based on Light Emitting Diodes (LEDs) in combination with adaptive focus and shadow free illumination. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The "test set" refers to the ClaveGuard Freedom Surgical Light device itself, which was subjected to a series of nonclinical tests to assess its compliance with international standards. It's implied that a representative sample of the device, or the device itself, underwent these tests.
- Data Provenance: The testing was conducted in accordance with international standards (IEC standards). The location of testing is not specified, but the manufacturer is ClaveGuard Pty Ltd, based in Australia. The document does not specify "retrospective or prospective" as this type of testing is typically prospective, involving specific performance measurements on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of this document. The "ground truth" for a surgical light's performance is established by objective measurements against engineering and safety standards (e.g., light intensity, color rendering, shadow reduction, electrical safety, EMC). These are typically performed by accredited test laboratories and engineers, not by medical experts in the way ground truth is established for AI/ML diagnostic studies.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers (e.g., radiologists) in AI/ML performance studies. Here, compliance is determined by objective measurements against predefined standard requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The ClaveGuard Freedom Surgical Light is an illumination device, not a diagnostic tool requiring interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/ML algorithms. The ClaveGuard Freedom Surgical Light is a physical medical device, and its performance is evaluated through direct physical and electrical testing.
7. The Type of Ground Truth Used
The "ground truth" for the ClaveGuard Freedom Surgical Light's performance is based on objective measurements and validation against recognized international performance, safety, and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, IEC 60601-1-4) and the product's own design specifications.
8. The Sample Size for the Training Set
This section is not applicable. The device is an electro-mechanical surgical light, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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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
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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
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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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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, LtdUnit 3, 40 Brodie St, Rydalmere,NSW 2116, Australia. |
|---|---|
| Contact: | Ragunath MuniandyRegulatory Affairs Specialist503 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 alltypes of surgical procedures in operating rooms. The light isbased on Light Emitting Diodes (LEDs) in combination withadaptive focus and shadow free illumination. It operates at adistance of 70-140cm from the surgical site.A light system may consist of 1 to 3 light heads supported bypivoting suspension system that is mounted to Healthcarefacility's ceiling. The system may include optional monitorextension arms, monitor mounts, and in-light video camera. |
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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 specificationsfor performance of surgical lamps. Testing was conducted inaccordance with this standard to support substantialequivalence. The ClaveGuard Freedom surgical light meets allrequirements of the performance standard and achievedspecified desired values per the product design specifications.Clinical testing was not required or utilized to supportsubstantial equivalence |
|---|---|
| Summary of Safetyand Effectiveness: | Testing and evaluation indicate that the system meets the needsof the users of the device and does not raise any new safety andefficacy of the predicate device.The ClaveGuard Freedom surgical light conforms to theIEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +AM1:2012 “Medical Electrical Equipment- Part 1 Generalrequirement for basic safety and essential performance. IEC 60601-2-41:2009 Medical Electrical Equipment- Part2-41: Particular requirement for basic safety and essentialperformance of surgical luminaires for diagnosis. IEC 60601-1-2:2007 “Medical Electrical Equipment- Part1-2 General requirement for basic safety and essentialperformance- Collateral Standard: Electromagneticcompatibility- 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
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- IEC 60601-1-4:2000 "Medical Electrical Equipment- Part 1-4 General requirement for safety- Collateral Standard: Programmable Electrical Medical System.
§ 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.