(59 days)
Not Found
No
The description focuses on the physical and optical properties of the surgical lighting system, with no mention of AI or ML capabilities.
No.
The device is described as providing illumination for surgery or examination, which is a supportive function rather than directly treating or diagnosing a medical condition.
No
The device is a surgical lighting system designed to provide illumination during surgery or examination. While it mentions 'lighting diagnostic procedures' as an option for ambient light, its primary function is illumination for surgical procedures, not diagnosis itself.
No
The device description clearly details a physical lighting system with hardware components like LEDs, optical mechanisms, handles, suspensions, and monitor support. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "provide illumination for surgery or examination at operating room." This describes a device used during a medical procedure on a patient, not a device used to examine specimens outside of the body to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and functionality of a surgical light (LEDs, optical system, brightness, color temperature, maneuverability, etc.). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Keywords: The document does not contain keywords commonly associated with IVD devices, such as "sample," "specimen," "assay," "reagent," "diagnosis," "in vitro," etc.
- Performance Studies: The performance studies mentioned are related to electrical safety and compliance with standards for medical electrical equipment (IEC 60601 series), which are typical for surgical lighting systems, not IVD devices.
In summary, the VIDA LED Surgical Lighting System, V series is a surgical lighting system used to illuminate the surgical field during procedures. This falls under the category of medical devices used in vivo (within the living body), not in vitro (outside the living body for diagnostic purposes).
N/A
Intended Use / Indications for Use
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
Product codes
FSY
Device Description
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
VIDA LED Surgical Lighting System, V series uses high-efficacy light-emitting-diodes (LED) as light source which provides high brightness and no extra heat; the design of the optical mechanism gives a characteristic of less shadow which is significant to the surgeon during the operation. Given of its modular design, VIDA V provided many options for configurations and can be installed in an operating room with or without a laminar air flow system.
The features of VIDA LED Surgical Lighting System, V series are as followed:
- Prism-Based Light Delivery Technology: ConVida's patented optical system, that . combines an advanced refractive prism lens and innovative high-power LED technology, focuses light into an intense 110cm (43") focal cylinder, eliminating the need for refocusing when adjusting surgical table.
- . Consistent Illumination at Different Color Temperature Settings: VIDA V series lighthead's color temperature can be individually adjusted at any of the 5 settings (3500K, 4000K, 4250K, 4500K, 5000K) with a high CRI of 95, R9 94.
- . Optimal Brightness without Glare: Elegant, sophisticated optical system consists up to 2 types of high-power LEDs and multiple refractive prisms produces up to 160,000 lux of intensity without discomfort flare/glare.
- . VIDA V light gives the Surgeon Control: On the VIDA V, both lighthead focus and light intensity can easily be adjusted via turning the lighthead handle. They are also adjustable from the standard lighthead control or optional VIDA V Control Center on the wall.
- Long Lifetime: Under normal use, VIDA V LEDs enjoy an extremely long lifetime of . 50,000+ hours (70% lumen maintenance at 50,000 hours).
- . Two Types of Ambient Lights (Option): 5% central luminance (GUIDE lighting mode) c be configured through standard lighthead control. Guide lighting mode may ambient lighting for manipulating endoscopy instruments or lighting diagnos procedures. Green ambient light sheds low-level green light from the suspension hub
- Camera-Ready Lighthead is Built into the System: All VIDA V lightheads are pre-wired . with HD cabling for taking an optional HD 1080p Camera Handle. The HD 1080p Camera Handle is removable from one VIDA V lighthead to another providing superb flexibility for recording.
- Exceptional Maneuvering Flexibility: The exceptionally durable non-sterile handles allow easy positioning of all our lightheads. Each lighthead rotates a full 360°so that the system can be quickly and easily positioned for any surgical procedure. Individual lightheads can be lower to 810mm above the floor providing excellent low lateral illumination.
- . Sleek Non-Sterile Handle: The lighthead has is molded with a sleek all-around handle that facilitates easy repositioning and adds modern elegance to O.R. setting
- Easy-to-clean Compact Lighthead: Made of tough molded materials, the VIDA V series . lightheads are completely sealed which helps prevent biocontaminants from entering the operative site and lighthead itself, and facilitates cleaning.
- . HD Supported Suspensions: All VIDA V suspensions are prewired with video cables to deliver information users need within and without the surgical field. Images are in crisp and accurate HD format with no signal conversion necessary and no loss of video quality.
- Heavy Duty HD Flat Monitor Suspension: Flat Monitor Suspension Arms support single/dual monitors up to a total of 24 kg (53 lbs), making them ideal for surgical displays up to 32". Large display compatibility allows the surgical team to see more of the procedural area. Optional Medical Grade LCD Displays from SONY also offer uncompressed HD video at 1080p which shows true images from SD- and HD-endoscopes, ultrasound, C-arms and other equipment.
- Optimal HD Connectivity: The built-in fiber optic cable allows the suspension to support monitors featuring Full HD 1920 x 1080 video signals.
- . Low Profile Suspension: Low-profile cardinal lighthead suspension is offered for rooms with ceiling lower than 280mm.
- . Failsafe Design: The unit is protected against an electrical power failure, thus ensuring that all surgical procedures can continue without interruption.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating room
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
The bench testing result shows that the proposed device is complied with IEC standards, and as safe as the predicate device.
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.
0
Image /page/0/Picture/1 description: The image contains the logo for ConVida Healthcare & Systems. The logo features a geometric pattern resembling a flower or starburst on the left. To the right of the pattern is the text "ConVida" in a bold, sans-serif font. Below "ConVida" is the text "Healthcare & Systems" in a smaller font size.
ConVida Healthcare & Systems Corp. 510(K) Notification, K number: N/A
JUN 0 9 2014
Integrate Visual Clarity at the Highest Precision
VIDA LED Surgical Lighting System, V series
510(K) Summary
| 1. | Type of Submission: | Traditional |
|---|---|---|
| 2. | Preparation Date: | April 3, 2014 |
| 3. | Revised Date: | N/A |
| 4. | Submitter: | ConVida Healthcare & Systems Corporation |
| Address: | No.33, Dinghu Rd., Guishan Township, Taoyua | |
| County 33378, Taiwan | ||
| Phone: | +886-3-318-3777 #332 | |
| Fax: | +886-3-318-7799 | |
| Contact: | Sharon Lee / Regulatory Engineer | |
| Registration Number: | 3010402711 |
5. Identification of the Device:
| Proprietary/Trade name: | VIDA LED Surgical Lighting System, V series |
|---|---|
| Common Name: | Surgical lamp |
| Classification Name: | Light, Surgical, Ceiling Mounted |
| Device Classification: | 2 |
| Regulation Number: | 878.4580 |
| Panel: | General & Plastic Surgery |
| Product Code: | FSY |
б. Identification of the Predicate Device:
| Predicate Device Name: | VIDA LED Surgical Lighting System-X series |
|---|---|
| Manufacturer: | ConVida Healthcare & Systems Corporation |
| Product Code: | FSY |
| 510(K) Number: | K132307 |
1
Integrate Visual Cinrity at the Highest Precision
Image /page/1/Picture/1 description: The image contains the logo for ConVida Healthcare & Systems. The logo consists of a grid-like pattern on the left and the word "ConVida" in bold, sans-serif font on the right. Below "ConVida" are the words "Healthcare & Systems" in a smaller font size.
ConVida Healthcare & Syst 510(K) Notification, K number: N/A VIDA LED Surgical Lighting System, V series
7. Intended Use and Indications for Use of the Subject Device:
Intended Use:
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
Indications for Use:
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
8. Device Description:
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
VIDA LED Surgical Lighting System, V series uses high-efficacy light-emitting-diodes (LED) as light source which provides high brightness and no extra heat; the design of the optical mechanism gives a characteristic of less shadow which is significant to the surgeon during the operation. Given of its modular design, VIDA V provided many options for configurations and can be installed in an operating room with or without a laminar air flow system.
The features of VIDA LED Surgical Lighting System, V series are as followed:
- Prism-Based Light Delivery Technology: ConVida's patented optical system, that . combines an advanced refractive prism lens and innovative high-power LED technology, focuses light into an intense 110cm (43") focal cylinder, eliminating the need for refocusing when adjusting surgical table.
- . Consistent Illumination at Different Color Temperature Settings: VIDA V series lighthead's color temperature can be individually adjusted at any of the 5 settings (3500K, 4000K, 4250K, 4500K, 5000K) with a high CRI of 95, R9 94.
- . Optimal Brightness without Glare: Elegant, sophisticated optical system consists up to 2 types of high-power LEDs and multiple refractive prisms produces up to 160,000 lux of intensity without discomfort flare/glare.
- . VIDA V light gives the Surgeon Control: On the VIDA V, both lighthead focus and light intensity can easily be adjusted via turning the lighthead handle. They are also adjustable from the standard lighthead control or optional VIDA V Control Center on the wall.
- Long Lifetime: Under normal use, VIDA V LEDs enjoy an extremely long lifetime of . 50,000+ hours (70% lumen maintenance at 50,000 hours).
- . Two Types of Ambient Lights (Option): 5% central luminance (GUIDE lighting mode) c be configured through standard lighthead control. Guide lighting mode may ambient lighting for manipulating endoscopy instruments or lighting diagnos procedures. Green ambient light sheds low-level green light from the suspension hub
2
Integrate Visual Clarity at the Highest Precision
ConVida Healthcare & Systems Corp.
510(K) Notification, K number: N/A
VIDA LED Surgical Lighting System, V series
and is controllable on the optional VIDA V Control Center.
- Camera-Ready Lighthead is Built into the System: All VIDA V lightheads are pre-wired . with HD cabling for taking an optional HD 1080p Camera Handle. The HD 1080p Camera Handle is removable from one VIDA V lighthead to another providing superb flexibility for recording.
- Exceptional Maneuvering Flexibility: The exceptionally durable non-sterile handles allow easy positioning of all our lightheads. Each lighthead rotates a full 360°so that the system can be quickly and easily positioned for any surgical procedure. Individual lightheads can be lower to 810mm above the floor providing excellent low lateral illumination.
- . Sleek Non-Sterile Handle: The lighthead has is molded with a sleek all-around handle that facilitates easy repositioning and adds modern elegance to O.R. setting
- Easy-to-clean Compact Lighthead: Made of tough molded materials, the VIDA V series . lightheads are completely sealed which helps prevent biocontaminants from entering the operative site and lighthead itself, and facilitates cleaning.
- . HD Supported Suspensions: All VIDA V suspensions are prewired with video cables to deliver information users need within and without the surgical field. Images are in crisp and accurate HD format with no signal conversion necessary and no loss of video quality.
- Heavy Duty HD Flat Monitor Suspension: Flat Monitor Suspension Arms support single/dual monitors up to a total of 24 kg (53 lbs), making them ideal for surgical displays up to 32". Large display compatibility allows the surgical team to see more of the procedural area. Optional Medical Grade LCD Displays from SONY also offer uncompressed HD video at 1080p which shows true images from SD- and HD-endoscopes, ultrasound, C-arms and other equipment.
- Optimal HD Connectivity: The built-in fiber optic cable allows the suspension to support monitors featuring Full HD 1920 x 1080 video signals.
- . Low Profile Suspension: Low-profile cardinal lighthead suspension is offered for rooms with ceiling lower than 280mm.
- . Failsafe Design: The unit is protected against an electrical power failure, thus ensuring that all surgical procedures can continue without interruption.
Image /page/2/Picture/14 description: The image shows a collection of squares of varying sizes arranged in a pattern. The squares are outlined in black, and some of them have a gray fill. The squares are arranged in a way that creates a visually interesting composition. The text "page 5-4" is visible in the lower right corner of the image.
3
Image /page/3/Picture/1 description: The image contains the ConVida Healthcare & Systems logo. The logo consists of a grid-like pattern on the left and the text "ConVida Healthcare & Systems" on the right. The text is in a bold, sans-serif font, with "ConVida" appearing larger than "Healthcare & Systems".
ConVida Healthcare & Syste 510(K) Notification, K number: N/A
Integrate Visual Clarity at the Highest Precision
VIDA LED Surgical Lighting System, V series
9. Performance Summary:
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 •
- ISO 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 manufacturer for the processing of resterilizable medical devices
10. Safety and Effectiveness
The bench testing result shows that the proposed device is complied with IEC standards, and as safe as the predicate device.
11. Substantial Equivalence Determination:
The VIDA LED Surgical Lighting System, V series is substantially equivalent to VIDA LED Surgical System-X series. There are no negative effect on safety or effectiveness between VIDA LED Surgical Lighting System, V series and the predicate device. The following is the detail of the compared item.
Image /page/3/Picture/18 description: The image shows a pattern of squares with rounded corners. The squares are arranged in a grid-like fashion, with some squares being larger than others. The squares are all outlined in black, and the background is white. The text "page 5-5" is written in the bottom right corner of the image.
4
page 5-6
ﻨﺔ ﺍﻟ
Integrate Visual Clarity at the Highest Precision
Image /page/4/Picture/1 description: The image shows the logo for ConVida Healthcare & Systems. The logo consists of a geometric pattern on the left and the text "ConVida" on the right. Below "ConVida" is the text "Healthcare & Systems" in a smaller font. The geometric pattern is made up of small squares arranged in a grid-like pattern.
ConVida Healthcare & Systems Corp. 510(K) Notification, K number: N/A
VIDA LED Surgical Lighting System, V series
| Item | Proposed Device | Predicate Device | ||
|---|---|---|---|---|
| Manufacturer | ConVida Healthcare & Systems Corp. | ConVida Healthcare & Systems Corp. | ||
| Classification | Class II | Class II | ||
| Regulation Number | 878.4580 | 878.4580 | ||
| Product Code | FSY | FSY | ||
| Intended Use | The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room. | VIDA LED Surgical Lighting System- X series provide illumination for surgery or examination at operating room. | ||
| Lighthead model | V70 | V50 | X70 | X50 |
| Similarity | ||||
| Over-the-counter Medical Device | No | No | ||
| Light Source | LED | LED | LED | LED |
| Color Rendering Index (CRI) | 95 | 95 | 95 | 95 |
| LED Life time (hrs) | 50,000 | 50,000 | 50,000 | 50,000 |
| Difference | ||||
| Diameter of Light Head (cm) | 82 | 72 | 72 | 58 |
| Number of LEDs | 55 | 44 | 90 | 60 |
| Central illumination (at 1m) (lux) | 160,000 | 140,000 | 160,000 | 130,000 |
| Color temperature, Kelvins | 3500-5000K | |||
| (3500K, | ||||
| 4000K, | ||||
| 4250K, | ||||
| 4500K, | ||||
| 5000K) | 3500-5000K | |||
| (3500K, | ||||
| 4000K, | ||||
| 4250K, | ||||
| 4500K, | ||||
| 5000K) | 4200 | 4200 | ||
| Total irradiance (W/m²) | 592 | 518 | 50 | > 50 |
| Light field size, d10 (cm) | 17~30 | 16~27 | 20~32 | 18~28 |
| Depth of illumination | 20%: 110 | 20%: 100 | 20%: 140 | 20%: 145 |
| L1+L2 (cm) | 60%: 45 | 60%: 45 | 60%: 71 | 60%: 82 |
| Power Consumption | 100W@24Vdc | 100@24Vdc | 100W | 80W |
5
Image /page/5/Picture/1 description: The image shows the logo for ConVida Healthcare & Systems. The logo consists of a grid-like pattern on the left and the text "ConVida" in bold font on the right. Below "ConVida" is the text "Healthcare & Systems" in a smaller font.
Integrate Visual Clarity at the Highest Precision
510(K) Notification, K number: N/A
VIDA LED Surgical Lighting System, V series
12. Non-clinical Performance Testing:
Performance testing were conducted to verify that the VIDA LED Surgical Lighting System, V series meets the requirements for Medical Electrical Equipment as defined in IEC 60601-1, IEC60601-2-41, and IEC 60601-1-2
13. Clinical Performance Testing:
No Clinical testing is required for this device classification submission.
14. Conclusion:
The VIDA LED Surgical Lighting System, V series submitted in this 510(K) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared VIDA LED Surgical Lighting System-X series which is the subject of K132307. Differences between the devices cited in this section do not raise any new issue of safety or effectiveness. After analyzing bench test, safety testing data, it can be concluded that VIDA LED Surgical Lighting System, V series is substantially equivalent to the predicate device.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight, arranged in a diagonal line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2014
ConVida Healthcare & Systems Corporation Sharon Lee, Regulatory Engineer No. 33, Dinghu Road . Guishan Township, Taoyuan County 33378, Taiwan
Re: K140930
Trade/Device Name: VIDA LED Surgical Lighting System, V Series Regulation Number: 21 CFR 878.4580 Regulatory Name: Surgical lamp Regulatory Class: Class II Product Code: FSY Dated: April 09, 2014 Received: April 11, 2014
Dear Ms. Lee:
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 that I Dri has made a and regulations administered by other Federal agencies. You must of any I edital bandler and a courtements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
7
Page 2 - Ms. Sharon Lee
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
for
- 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
- cc: DMC 510(k) Staff Division D.O.
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140930
Device Name
VIDA LED Surgical Lighting System, V series
Indications for Use (Describe)
The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
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.
NEW YOU WARE OF FOR FDA USE ONLY MASE ONLY CHANGE ON WARRER OF THE WORLD Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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