(104 days)
VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room. The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems. A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.
The provided document describes a 510(k) submission for the "VIDA LED Surgical Lighting System-X series," a surgical lamp. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Mach LED SC," rather than presenting a study where acceptance criteria are directly defined and proven for the device's performance in a clinical setting.
Therefore, the document does not contain information for many of the requested categories because it's a regulatory submission based on substantial equivalence to an existing device, not a de novo clinical trial proving novel performance against predefined acceptance criteria.
Here's an attempt to extract relevant information and explain why other information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a surgical lighting system), "acceptance criteria" are primarily established by conformity to recognized medical device standards and demonstrating performance comparable to a predicate device, rather than patient-centric clinical outcomes. The performance metrics are generally technical specifications.
| Performance Metric (Acceptance Criterion implied by predicate comparison) | VIDA LED Surgical Lighting System-X series Performance (X70 model) | Predicate Device Performance (Mach LED SC) |
|---|---|---|
| Intended Use | Illumination for surgery or examination at operating room | Illumination for examination area and surgical field at hospital and doctor's practice |
| Light Source | LED | LED |
| Color Rendering Index (CRI) | 95 | 95 |
| Central Illumination (at 1m) (lux) | 160,000 lux | 160,000 lux (for 5sc model) |
| Color Temperature (Kelvin) | 4200 K | 4500 K |
| Light Field Diameter (D10) | 20-32 cm | 20-32 cm (for 5sc model) |
| Depth of Illumination (L1+L2 20%) | 140 cm | 145 cm (for 5sc model) |
| Depth of Illumination (L1+L2 60%) | 71 cm | 82 cm (for 5sc model) |
| Total Irradiance at maximum intensity | <656W/m² | <533W/m² |
| Average LED Lifetime | 50,000 hours | 40,000 hours |
| Light Focusing Mechanism | Manual focusing | Manual focusing |
| UV Light Filter Mechanism | NA | NA |
Note: The document compares two models for the subject device (X70 and X50) and two for the predicate (5sc and 3sc). For the table above, the most comparable models have been selected to illustrate the comparison. The differences in specific values between the subject and predicate devices are noted in the original document but are deemed not to raise new issues of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission relies on "bench testing" and compliance with standards rather than human clinical test sets in the traditional sense for evaluating diagnostic or therapeutic accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is not applicable to this type of device submission. There is no "ground truth" to establish through expert consensus for a surgical lamp in the way there would be for a diagnostic AI device.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images with or without AI assistance. A surgical lighting system does not fit this category.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
No, this study type is not applicable. The device is a physical surgical lighting system, not an algorithm.
7. The Type of Ground Truth Used
This information is not provided and is not applicable in the typical sense. For this device, "ground truth" is effectively defined by the performance specifications outlined in recognized standards (e.g., IEC 60601-2-41 for surgical luminaires) and the demonstrated performance of the legally marketed predicate device. The "study" proving the device meets the criteria is the comparison to these standards and the predicate.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable.
Summary of the "Study" Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria, as presented in this 510(k) submission, is fundamentally a non-clinical performance testing and substantial equivalence comparison.
- Acceptance Criteria Basis: The implicit acceptance criteria are derived from:
- Compliance with international standards for medical electrical equipment (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 15223-1, ISO 17664).
- Demonstrating technical performance specifications that are comparable to (or in some cases, exceed) those of the legally marketed predicate device (Mach LED SC).
- The predicate device itself serving as a benchmark for what constitutes a safe and effective surgical lamp.
- Proving Acceptance: The document states:
- "Performance testings were conducted to verify that the VIDA LED Surgical Lighting System-X series meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1, IEC 60601-2-42, and IEC 60601-1-2." (Section 5.12)
- "The result of bench testing indicates that the new device is as safe and effective as the predicate device." (Section 5.10)
- The detailed comparison table (Section 5.11) highlights the similarities and differences, concluding that "Any difference that exists between the Mach LED SC and the predicate device has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application."
- "No clinical testing is required for this device classification submission." (Section 5.13)
- The ultimate conclusion is substantial equivalence to the predicate, meaning it is considered as safe and effective as the already marketed device.
In essence, the "study" is a collection of engineering tests and a comparison of specifications to established benchmarks and a predicate device, rather than a clinical trial with patient data.
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VIDA LED Surgical Lighting System-X series
510(k) Summary
| 5.1 Type of Submission: | Traditional |
|---|---|
| 5.2 Preparation Date: | July 19, 2013 |
NOV 0 5 2013
| 5.3 Revised Date: | N/A |
|---|---|
| 5.4 Submitter: | CONVIDA HEALTHCARE & SYSTEMS CORPORATION |
| Address: | 2F and B2., No.33, Dinghu Rd., Guishan Township, Taoyuan County. Taiwan |
| Phone: | +886-3-318-3777 |
| Fax: | +886-3-318-7799. |
| Contact: | Ryan Hung / Regulatory Engineer |
| Establishment Registration Number: | N/A |
5.5 Identification of the Device:
| Proprietary/Trade name: | VIDA LED Surgical Lighting System-X serie |
|---|---|
| Common Name: | Surgical lamp |
| Classification Name: | Light. Surgical, Ceiling Mounted |
| Device Classification: | 2 |
| Regulation Number: | 878.4580 |
| Panel: | General & Plastic Surgery |
| Product Code: | FSY |
Identification of the Predicate Device: 5.6
.
| Predicate Device Name: | Mach LED SC |
|---|---|
| Manufacturer: | Dr. Mach GmbH& Co.KG |
| 510(k) Number or Clearance Information: | K093009 |
5.7 Intended Use and Indications for Use of the subject device.
Intended Use: VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
Indications for Use: VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room.
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VIDA LED Surgical Lighting System-X series
Device Description 5.8
The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room.
The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems.
A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.
Optional accessories for the VIDA LED Surgical Lighting System-X series are as follows:
---- Sterile Handle Cover (for the X50 and X70 lighthead which doesn't mount the Camera, XV, S12. S15 and D24 suspensions.)
---- Camera Handle module (1080p) (which can be installed on X50 or X70 lighthead or XV suspension.)
---- Medical Grade Flat Monitor
---- Fiber Optic Coder Set (including fiber optic transmitter and receptor)
Performance Summary 5.9.
This device conforms to the standards listed as below:
- IEC 60601-1:2005 Medical Electrical Equipment ~ Part 1: General Requirements for . Basic Safety and Essential Performance
- IEC 60601-2-41:2009 Medical Electrical Equipment Part 2-41: Particular requirements for the basic and essential performance of surgical luminaires and luminaires for diagnosis
- IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General requirements for basic Safety and essential performance Collateral Standard: Electromagnetic Compatibility Requirements and tests
- IEC 62304:2006 Medical Device Software: Software Life Cycle Process
- 150 14971:2007 Medical Device: Application of Risk Management to Medical Devices
- ISO 15223-1:2012 Medical Device: Symbols to be used with medical device labels, labeling and information to be supplied, part 1: General requirements
- ISO 17664:2004 Sterilization of medical devices: information to be provided by the
20
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VIDA LED Surgical Lighting System-X series
manufacturer for the processing of resterilizable medical devices
5.10 Safety and Effectiveness
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
5.11 Substantial Equivalence Determination
The VIDA LED Surgical Lighting System-X series is substantially equivalent to Mach LED SC. Any difference that exists between the Mach LED SC and the predicate device has no negative effect on safety or effectiveness and actually enhances the usefulness in the chosen application.
| Item | Proposed Device | Predicate Device | ||
|---|---|---|---|---|
| VIDA LED Surgical LightingSystem-X series(CONVIDA HEALTHCARE& SYSTEMSCORPORATION) | Mach LED SC(Dr. Mach GmbH& Co.KG.K093009) | |||
| Classification | Class II | Class II | ||
| Code or Federal Regulations | 878.4580 | 878.4580 | ||
| Intended Use | VIDA LED Surgical LightingSystem - X series provideillumination for surgery orexamination at operatingroom. | The Mach LED SC lightingsystem is designed forilluminating an examinationarea and surgical field at thehospital and doctor'spractice. | ||
| Similarity | X70 | |||
| X50 | 5sc | 3sc | ||
| Over-the-counter Medical Devices | No | No | ||
| Light Source | LED | LED | LED | LED |
| Color Rendering Index | 95 | 95 | 95 | 95 |
| Central illumination (at 1m) (lux) | 160,000 | 130.000 | 160,000 | 130.000 |
| Input Power | 100-240V, single phase,50-60Hz | - | ||
| Difference | ||||
| Diameter of Light Head | 72cm | 58cm | 72cm | 57cm |
| Number of LEDS | 90 | 60 | 40 | 28 |
| Lighthead Wattage | 150W | 120W | ||
| Power Consumption | 100W | 80W | 65W | 45W |
| Color temperature (Kelvin) | 4200 | 4200 | 4500°K | 4500°K |
| Light field diameter | D10:20-32cmD50/D10:>50% | D10:18-28cmD50/D10:>50% | 20-32cm | 17~28cm |
| Depth of illumination | L1+L220%: 140cmL1+L260%: 71cm | L1+L220%: 145cm.L1+L260%: 82cm | ||
| Total irradiance at maximumintensity | <656W/m² | <533W/m² | ||
| Average LED Life time(hours) | 50.000 | 50,000 | >40,000 | >40,000 |
| Light focusing mechanism | Manualfocusing | Manualfocusing | - | - |
| Ultraviolet light filter mechanism | NA | NA | ||
| Available accessories | Standard accessories:-Sterile Handle Cover x2(X50, X70, XV, S12, S15)-Sterile Handle Cover x4(D24)Optional Accessories:-Sterile Handle Cover (for theX50 and X70 lighthead whichdoesn't mount the Camera,XV, S12, S15 and D24suspensions.)-Camera Handle module(1080p) (which can beinstalled on X50 or X70lighthead or XV suspension.)-Medical Grade Flat Monitor-Fiber Optic Coder/Decoder | -Camera module-Remote control for cameramodule-Remote control withnetwork interface for cameramodule-Single monitor yoke for flatpanel monitors-Double monitor yoke for flatpanel monitors-Instrument trays-Trays for CRT monitors-24V DC battery backupsupport-Low profile wall controlunit-Integrated laser pointer |
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LED Surgical Lighting System-X series
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VIDA LED Surgical Lighting System-X series
| Set (including fiber optic transmitter and receptor) | -Sterilizable handle sleeves | |
|---|---|---|
5.12 Non-clinical Performance Testing
Performance testings were conducted to verify that the VIDA LED Surgical Lighting System-X series meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1, IEC 60601-2-42, and IEC 60601-1-2.
5.13 Clinical Performance Testing
No clinical testing is required for this device classification submission.
5.14 Conclusion
.
The VIDA LED Surgical Lighting System-X series submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Mach LED SC which is the subject of K093009. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness. After analyzing bench tests, safety testing data, it can be concluded that VIDA LED Surgical Lighting System-X series is substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
November 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CONVIDA HEALTHCARE & SYSTEMS COPRORATION Mr. Ryan Hung Regulatory Engineer 2F and B2., No.33, Dinghu Road., Guishan Township Taoyuan County Taiwan 33378
Re: K132307
Trade/Device Name: VIDA LED Surgical Lighting System-X series Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: September 18, 2013 Received: September 19, 2013
Dear Mr. Hung:
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
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Page 2 - Mr. Ryan Hung
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Night Jierson -S
Mark N. Melkerson Acting 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): K132307
Device Name: VIDA LED Surgical Lighting System-X series
Indications for Use:
VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
Prescription Use -X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use-(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)
Lona 01 3.11.05 14.37.31 -05 00
for MXM
(Division Sign-off) Division of Surgical Devices 510(k) Number: K132307
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§ 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.