VIDA LED SURGICAL LIGHTING SYSTEM

K132307 · Convida Healthcare & Systems Corporation · FSY · Nov 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132307
• Device Name: VIDA LED SURGICAL LIGHTING SYSTEM
• Applicant: Convida Healthcare & Systems Corporation
• Product Code: FSY · General, Plastic Surgery
• Decision Date: Nov 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.

Device Story

VIDA LED Surgical Lighting System-X series provides surgical and diagnostic illumination using high-efficacy LEDs. System features modular design, including mounting module, horizontal arm, and suspension device, allowing 360° horizontal rotation and vertical adjustment. Used in operating rooms by surgical staff. Optional accessories include 1080p camera handle module, medical-grade flat monitor, and fiber optic coder/decoder set. Device provides bright, shadow-reduced light to assist clinicians in visualizing surgical sites, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and adherence to recognized international standards (IEC 60601-1, IEC 60601-2-41, IEC 60601-1-2).

Technological Characteristics

LED-based surgical luminaire. Features manual focusing, 4200K color temperature, 95 CRI, and 160,000 lux central illumination. Modular suspension system with 360° rotation. Power input 100-240V, 50-60Hz. Complies with IEC 60601-1 (safety), IEC 60601-2-41 (surgical luminaires), and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for illumination of surgical or examination fields in operating rooms.

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

• Mach LED SC (K093009)

Submission Summary (Full Text)

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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: | [phone] |
| Fax: | [phone]. |
| 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 Lighting<br>System-X series<br>(CONVIDA HEALTHCARE<br>& SYSTEMS<br>CORPORATION) | Mach LED SC<br>(Dr. Mach GmbH& Co.KG.<br>K093009) | | |
| Classification | Class II | Class II | | |
| Code or Federal Regulations | 878.4580 | 878.4580 | | |
| Intended Use | VIDA LED Surgical Lighting<br>System - X series provide<br>illumination for surgery or<br>examination at operating<br>room. | The Mach LED SC lighting<br>system is designed for<br>illuminating an examination<br>area and surgical field at the<br>hospital and doctor's<br>practice. | | |
| 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,<br>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:<br>20-32cm<br>D50/D10:<br>>50% | D10:<br>18-28cm<br>D50/D10:<br>>50% | 20-32cm | 17~28cm |
| Depth of illumination | L1+L2<br>20%: 140cm<br>L1+L2<br>60%: 71cm | L1+L2<br>20%: 145cm.<br>L1+L2<br>60%: 82cm | | |
| Total irradiance at maximum<br>intensity | <656W/m² | <533W/m² | | |
| Average LED Life time(hours) | 50.000 | 50,000 | >40,000 | >40,000 |
| Light focusing mechanism | Manual<br>focusing | Manual<br>focusing | - | - |
| Ultraviolet light filter mechanism | NA | NA | | |
| Available accessories | Standard accessories:<br>-Sterile Handle Cover x2<br>(X50, X70, XV, S12, S15)<br>-Sterile Handle Cover x4<br>(D24)<br>Optional Accessories:<br>-Sterile Handle Cover (for the<br>X50 and X70 lighthead which<br>doesn't mount the Camera,<br>XV, S12, S15 and D24<br>suspensions.)<br>-Camera Handle module<br>(1080p) (which can be<br>installed on X50 or X70<br>lighthead or XV suspension.)<br>-Medical Grade Flat Monitor<br>-Fiber Optic Coder/Decoder | | -Camera module<br>-Remote control for camera<br>module<br>-Remote control with<br>network interface for camera<br>module<br>-Single monitor yoke for flat<br>panel monitors<br>-Double monitor yoke for flat<br>panel monitors<br>-Instrument trays<br>-Trays for CRT monitors<br>-24V DC battery backup<br>support<br>-Low profile wall control<br>unit<br>-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 [phone] or [phone] 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 [phone] or [phone] 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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