(14 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the optical and video components of the system.
No
The device is described as an observation system for visualization during endoscopic procedures, not for treatment or therapy.
No
The device is described as allowing observation in body cavities, organs, or canals and is used in endoscopic procedures for visualization, not for diagnosing specific conditions. Its function is to provide visual access rather than to interpret or analyze information for diagnostic purposes.
No
The device description explicitly lists hardware components such as a Camera Head, Stereo Endoscope, and a 3D Camera Control Unit (CCU).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for use in endoscopic and video-assisted procedures to visualize body cavities, organs, or canals. This is a direct visualization tool used in vivo (within the living body).
- Device Description: The description reinforces its use for observation in body cavities, organs, or canals.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, urine, etc.) in vitro (outside the living body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical/endoscopic tool for direct visualization during procedures.
N/A
Intended Use / Indications for Use
The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures
Product codes (comma separated list FDA assigned to the subject device)
FET, GCJ
Device Description
The Vista StereoScope System is a device 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. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, organs, or canals, cardiac structures
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)
Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The eagle is composed of three curved lines, and the text is in a bold, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Vista Medical Technologies Mr. Graham A.L. Baillie Manager, Quality Assurance and Service 134 Flanders Road Westborough. MA 01581
JUL 2 7 2015
Re: K020301 Trade/Device Name: Vista Stereoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET. GCJ Dated (Date on orig SE ltr): January 28, 2002 Received (Date on orig SE Itr): January 29, 2002
Dear Mr. Baillie,
This letter corrects our substantially equivalent letter of February 12, 2002.
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
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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 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 toll-free number (800) 638 2041 or (301) 796-7100 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/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/ResourcesforYou/Industry/default.htm.
z/www.fda.gov/MedicalDevices/ResoucesforIndustry/default.htm
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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11) Indications for Use Statement
Statement of Intended Use
510(k) Number (if Known):
Device Name:
Vista Stereoscope System
Indications For Use:
The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (Optional Format 1-2-96)
Muriam C. Provost
Division of OM
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020361
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FEB 1 2 2002
Image /page/3/Picture/2 description: The image shows a logo for Avista Medical Technologies. The logo consists of a stylized letter "A" with a triangle on the left side and the rest of the letters forming the word "AVISTA". Below the word "AVISTA" is the phrase "Medical Technologies". The logo is in black and white.
9) 510(k) Summary
510(k) Summary for Vista Stereoscope 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 Stereoscope System
D. Predicate Device(s)
Vista Stereoscope System (K990635); Vista Single Chip Video Camera (K971373)
E. Device Description
The Vista StereoScope System is a device 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. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.
F. Intended Use
The Vista StereoScope System is intended for the use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures
G. Substantial Equivalence
The proposed modified Vista Stereoscope System is substantially equivalent to the currently legally marketed Vista Stereoscope System (K990635) in terms of intended use, operating principle, basic design, and shelf life. Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness.
Vista Modical Tochnologics
134 Flanders Road Westborough, MA D1581
Ph 508 366-8882 Fx 508 366-8858
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