(73 days)
Not Found
No
The summary describes a standard video camera system for endoscopic procedures and does not mention any AI/ML capabilities or image processing beyond basic visualization.
No
The device is described as a camera system for visualization during endoscopic procedures, not as a device that delivers a therapeutic effect or treatment.
No
The device is described as a video camera for observation in body cavities, organs, or canals. Its purpose is visualization, not the diagnosis of a medical condition.
No
The device description explicitly states it is a "video camera" and a "Vista Mini Camera System" which includes a "Vista Mini Camera" and a "Vista camera control unit (CCU)". This indicates the device is a hardware system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Vista Mini Camera System is a video camera used for visualization inside the body during endoscopic and video-assisted procedures. It directly observes anatomical structures within the body.
- Intended Use: The intended use clearly describes its function as an aid in visualization during procedures, not for testing specimens.
- Device Description: The description reinforces its role as a video camera for observing body cavities, organs, or canals.
Therefore, the device's function and intended use fall under the category of a surgical or endoscopic visualization device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.
Product codes
Not Found
Device Description
The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista camera control unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, organs, or canals
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
The Vista Mini Camera System was designed and tested in compliance with the requirements of the following standards:
IEC 601-1 General Safety requirements for Medical Electronic Equipment
IEC 601-1-2 Electromagnetic Compatibility Requirements and Tests
IEC 601-2-18 Safety of Endoscopic Equipment
ISO 10993 Biological Evaluation of Medical Devices
UL544 Standard for Safety, Medical and Dental Equipment
Optical Test Data
Key Metrics
Not Found
Predicate Device(s)
K923160, K961182, K946171, K950988
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
Vista Medical Technologies Westborough MA
510K Notification Vista Mini Cameras January 1997
(970369 510(K) SUMMARY
January 1997
COMPANY NAME AND ADDRESS Vista Medical Technologies 134 Flanders Road Westborough, MA. 01581
CONTACT PERSON
Martin Newman Director of Regulatory Affairs and Quality Assurance (508) 366-3668 Telephone (508) 366-1543 Fax:
DEVICE TRADE NAME
Vista Mini Camera(s)
COMMON NAME
Video Endoscope System
PREDICATE DEVICE
- 3D Scope Three Dimensional Medical 1. Device Name: VideoSystem Camera, Television, Endoscopic, without audio Classification: American Surgical Technologies Manufacturer: 300 Billerica Rd Chelmsford, MA 01824 K923160. K961182 510(k) #: Oktas Video Endoscope System with Zoom 2. Device Name: Endoscopes and Accessories -Classification: 21 CFR 876.1500 Oktas Manufacturer: 134 Flanders Rd Westborough, MA 01581 K946171 510(k) #:
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| 3. | Device Name: | Zeiss EndoLive™ Stereo Endoscope |
|---|---|---|
| Classification: | Endoscopes and Accessories - | |
| 21 CFR 876.1500 | ||
| Manufacturer: | Carl Zeiss, Inc. | |
| Thornwood, NY 10594 | ||
| 510(k) #: | K950988 |
DEVICE DESCRIPTION
The Vista Mini Camera System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orificies. It is designed for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber. The product is a video camera. The system will be supplied as a Vista Mini Camera, intended to be used with a Vista camera control unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.
INTENDED USE
The device is intended for use in endoscopic procedures and all types of video assisted procedures, including anterior spinal and general thoracic procedures and as an aid in visualization of the evacuated cardiac chamber.
PERFORMANCE DATA
The Vista Mini Camera System was designed and tested in compliance with the requirements of the following standards:
| IEC 601-1 | General Safety requirements for Medical Electronic Equipment |
|---|---|
| IEC 601-1-2 | Electromagnetic Compatibility Requirements and Tests |
| IEC 601-2-18 | Safety of Endoscopic Equipment |
| ISO 10993 | Biological Evaluation of Medical Devices |
| UL544 | Standard for Safety, Medical and Dental Equipment |
Optical Test Data
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