(80 days)
N/A
N/A
No
The description focuses on the display technology and video input capabilities, with no mention of AI or ML.
No
The device is a video display for surgical procedures and is not intended to provide therapy.
No
The device is a video display for surgical procedures. It presents images, but it does not analyze or interpret them to provide a diagnosis.
No
The device description clearly states it is a "high-definition, widescreen LCD surgical display" and mentions hardware components like video inputs, an optional optical module, and an optional wireless transmitter. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for video display during surgical procedures. This involves displaying images from surgical cameras, which are used in vivo (within the living body) during surgery.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used in vitro (outside the living body).
- Device Description: The description focuses on the technical specifications of a display monitor and its video input capabilities. There is no mention of analyzing biological samples or performing diagnostic tests on them.
Therefore, the Stryker Vision Elect WHDTV is a surgical display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Vision Elect WHDTV (VE WHDTV) is intended for video display during surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The VE WHDTV is a non-sterile reusable device not intended for use in the sterile field. The VE WHDTV is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Product codes
FWF, GCJ
Device Description
The Vision Elect WHDTV (VE WHDTV) is a high-definition, widescreen LCD surgical display with a maximum resolution of WUXGA (1920 × 1200 at 60 Hz). The VE WHDTV supports various video inputs, including digital RGB, analog RGB, serial digital interface (SDI), component video (YPbPr/RGB), S-video, and C-video.
The VE WHDTV features an optional optical module accessory, which allows it to receive a high-definition video signal over fiber optic cables. It also features an optional wireless transmitter, which allows it to receive a high-definition video signal over a radio-frequency link.
The VE WHDTV and its accessories will meet the necessary electrical safety (IEC 60601-1), EMC (IEC 60601-1-2) and radio frequency device (47 CFR part 15) requirements.
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
qualified physicians having complete knowledge of these surgical procedures / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
N/A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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Ko 81995
Page 1 of 2
stryker
Endoscopy
510(k) SUMMARY
Device Sponsor:
OCT - 2 2008
| Sponsor and
Manufacturer: | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138
FDA Registration # 2936485 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondence
Regarding this 510(k): | Monica Barrett
Sr. Regulatory Affairs Representative
Stryker Endoscopy
5900 Optical Court
San Jose, CA
t: 408-754-2078
f: 408-754-2521
monica.barrett@stryker.com |
Device Name:
| Proprietary Name: | Stryker Vision Elect WHDTV |
|---|---|
| Common and Usual Name: | television, monitor, screen, display, flat panel, flat screen |
| Classification Name: | General & Plastic Surgery Devices Panel |
| Surgical camera and accessories | |
| Class I, 21 CFR 878.4160 | |
| Product Code FWF |
Predicate Device:
The VE WHDTV is substantially equivalent in terms of safety and efficacy to currently available viewing systems on the market including the Stryker Vision Elect HDTV.
Device Description:
The Vision Elect WHDTV (VE WHDTV) is a high-definition, widescreen LCD surgical display with a maximum resolution of WUXGA (1920 × 1200 at 60 Hz). The VE WHDTV supports various video inputs, including digital RGB, analog RGB, serial digital interface (SDI), component video (YPbPr/RGB), S-video, and C-video.
The VE WHDTV features an optional optical module accessory, which allows it to receive a high-definition video signal over fiber optic cables. It also features an optional wireless transmitter, which allows it to receive a high-definition video signal over a radio-frequency link.
1
to81995
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Endoscopy
The VE WHDTV and its accessories will meet the necessary electrical safety (IEC 60601-1), EMC (IEC 60601-1-2) and radio frequency device (47 CFR part 15) requirements.
Intended Use:
The Stryker Vision Elect WHDTV (VE WHDTV) is intended for video display during surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The VE WHDTV is a non-sterile reusable device not intended for use in the sterile field. The VE WHDTV is intended for use by qualified physicians having complete knowledge of these surgical procedures.
Predicate Device:
The Stryker Vision Elect WHDTV is substantially equivalent in terms of safety and efficacy to the currently marketed devices including the Stryker Vision Elect HDTV.
Name: Stryker Vision Elect HDTV Manufacturer: Stryker Endoscopy 510(k) #: N/A, Class I, 21 CFR 878.4160 Surgical camera and accessories
Substantial Equivalence:
When compared to the predicated device listed above, the Stryker VE WHDTV has the same intended use and the technological differences do not raise new questions of safety and efficacy. Therefore, the Stryker VE WHDTV is substantially equivalent to the predicate marketed device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem resembling an abstract bird or symbol, composed of three curved lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Endoscopy % Ms. Monica Barrett Senior Regulatory Affairs Representative 5900 Optical Court San Jose, California 95138
OCT - 2 2008
Re: K081995
Trade/Device Name: Stryker Vision Elect Wireless High Definition Television (Stryker VE WHDTV)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories. Regulatory Class: II Product Code: GCJ Dated: Scptember 11, 2008 Received: September 11, 2008
Dear Ms. Barrett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Monica Barrett
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely vours.
Mark N. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko8/995
INDICATIONS FOR USE STATEMENT
Device Name: Stryker Vision Elect Wireless High Definition Television (Stryker VE WHDTV).