(66 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or performance studies typically associated with AI/ML algorithms. The device description focuses on standard endoscopic visualization components.
No.
The device is described as a 'Visualization System' intended for observation during surgical procedures, not for treating any medical condition.
No
The device is described as a "Visualization System" intended for "observation in body cavities, organs, or canals" during endoscopic procedures. Its purpose is to provide visual access, not to detect, identify, or determine a disease or condition. While visualization can aid diagnosis, the device itself is for viewing, not diagnosing.
No
The device description explicitly states the system consists of hardware components: a camera head, endoscope, camera control unit, Head Mounted Display (HMD), and HMD processor.
Based on the provided information, the Vista Visualization System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "endoscopic procedures and all types of video assisted procedures" to allow "observation in body cavities, organs, or canals." This describes a device used during a medical procedure to visualize internal structures, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description details components like a camera head, endoscope, camera control unit, and head-mounted display. These are all components of a system for direct visualization within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Vista Visualization System's function is purely for visual observation during procedures.
N/A
Intended Use / Indications for Use
The Vista Visualization System is intended for the use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.
Product codes
GCJ
Device Description
The Vista Visualization System is used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures including bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
body cavities, organs, or canals through manmade or natural orifices
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Vista StereoScope System (K020301), Head Mounted Display System (K973436), ORPC with Infomatix IntraOp Software (K991303)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUN 2 8 2002
7) 510(k) Summary
510(k) Summary for Vista Visualization System
A. Sponsor
Vista Medical Technologies 134 Flanders Road Westborough, MA 01581
B. Contact Name
Graham A. L. Baillie Manager, Quality Assurance and Service Vista Medical Technologies Phone: (508) 366-3668 ext. 8279 Facsimile: (508) 366-8858
C. Device Name
Vista Visualization System
D. Predicate Device(s)
Vista StereoScope System (K020301); Head Mounted Display System (K973436); ORPC with Infomatix IntraOp Software (K991303).
E. Device Description
The Vista Visualization System is used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures including bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.
F. Intended Use
The Vista Visualization System is intended for the use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.
G. Substantial Equivalence
The proposed Vista Visualization System is substantially equivalent to the currently legally marketed Vista devices in terms of intended use, operating principle, basic design, and shelf life. The addition of a specific indication for bariatric surgery does not affect the intended diagnostic affect or safety and effectiveness.
Vista Medical Technologies
134 Flanders Road Westborough MA 01581
Ph 508 366-3668 508 366-1543
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around it. Inside the circle is a symbol composed of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Mr. Graham Baillie Vista Medical Technologies, Inc. 134 Flanders Road Westborough, Massachusetts 01581
Re: K021290
Trade/Device Name: Vista Visualization System, Model 9000 Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: April 22, 2002 Received: April 23, 2002
Dear Mr. Baillie:
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.
2
Page 2 - Mr. Graham Baillie
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stupt Rhodes
M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
- Indications for Use Statement
Statement of Intended Use
,KO21290 510(k) Number (if Known):
Device Name:
Vista Visualization System
Indications For Use:
The Vista Visualization System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use (Optional Format 1-2-96)
Styt Rhodes
OR
Division Sign-Off Division of General, Restorative and Neurological Devices
KO21290 510(k) Number_
Confidential and Proprietary to Vista Medical Technologies