(62 days)
For use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
The Viking 3DHD Video Camera System consists of camera heads, 3D endoscopes, and a camera controller. The system can be used with commercially available light sources, light cables, 2D endoscopes, couplers, and 2D and 3D video monitors or head mounted displays.
This document is a 510(k) summary for the Viking 3DHD Video Camera System. It states that the device is substantially equivalent to legally marketed predicate devices and does not provide an independent study or specific acceptance criteria for performance metrics of the device itself.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because such information is not present.
The document focuses on demonstrating substantial equivalence to existing devices, which is a regulatory pathway in the U.S. and typically means the new device has the same intended use and technological characteristics as a predicate device, and does not raise new questions of safety and effectiveness. This often relies on comparing the device's characteristics to those of the predicate rather than presenting a performance study against predefined acceptance criteria for the new device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the words "VIKING SYSTEMS" in a stylized font. The word "VIKING" is in a larger font size than the word "SYSTEMS". The letters in "VIKING" are outlined with a double line, while the letters in "SYSTEMS" are in a simple, sans-serif font.
3DHD Camera System Abbreviated 510(k) June 28, 2010
AUG 3 0 2010
6. 510(k) Summary
510(k) Summary for The Viking 3DHD Video Camera System
According to the requirements of 21CFR 807.92, the following information provides sufficient detail to understand the basis for determination of substantial equivalence.
Submitter Name, Address, and Contact Information:
Christine Nichols RAC Regulatory Manager Vision Systems Group A Division of Viking Systems Inc. 134 Flanders Road Westboro, MA 01581 Ph: 508-366-3668 X8273
Device Name and Classification:
| Proprietary Names: | 3DHD Video Camera System |
|---|---|
| Classification name: | Endoscope and/Or Accessories, 21CFR 876.1500 |
| Common/Usual names: | Endoscope and Accessories, KOG |
| Predicate Devices: | K021290 Visualization SystemK081585 3 Chip Endoscopy System |
Device Description:
The Viking 3DHD Video Camera System consists of camera heads, 3D endoscopes, and a camera controller.
The system can be used with commercially available light sources, light cables, 2D endoscopes, couplers, and 2D and 3D video monitors or head mounted displays.
Intended Use:
The 3DHD Video Camera System is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
Indications for Use:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
Substantial Equivalence Information:
The proposed 3DHD Video Camera System is substantially equivalent to the currently legally marketed Visualization System (K021290) and the 3 Chip Endoscopy System (K081585) in terms of intended use, operating principle, and basic design. Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUM." is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Christine E. Nichols, RAC Regulatory Manager Vision Systems Group A Division of Viking Systems, Inc. 134 Flanders Road WESTBORO MA 01581
AUG 3 0 2010
Re: K101810
Trade/Device Name: Viking 3DHD Video Camera System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: June 28, 2010 Received: June 29, 2010
Dear Ms. Nichols:
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 of medical device-related
{2}------------------------------------------------
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duker Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
{3}------------------------------------------------
5. Indications for Use Statement
Indication for Use
510(k) Number (if known): K161810
Device Name: Viking 3DHD Video Camera System
Indications For Use:
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Huker Semu
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.