(83 days)
No
The summary describes a standard 3D video endoscope system for visualization and does not mention any AI or ML capabilities, image processing beyond basic video display, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an observation tool for internal body structures, not as an instrument used to treat a condition or disease.
No
The device is described as an observation tool used for visualization during endoscopic procedures, not for identifying the presence or absence of a disease or condition.
No
The device description explicitly states it is an "integrated endoscope and video camera" and includes a "3D Video Endoscope and Camera Control Unit," indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for visualization within the body during endoscopic procedures. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is an endoscope and video camera system designed to observe body cavities, organs, or canals. This aligns with surgical or procedural visualization, not laboratory testing of samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information based on laboratory results
The device is clearly intended for direct visualization within the patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.
Product codes
Not Found
Device Description
The 3D Video Endoscope 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, including general thoracic and as an aid in visualization of the evacuated cardiac chamber. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system.
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)
| IEC 601-1 | "General Safety Requirements for Medical Electrical Equipment" |
|---|---|
| IEC 601-1-2 | "Electrical Magnetic Compatibility" |
| IEC 601-2-18 | "Safety of Endoscopic Equipment" |
| ISO 10993 | "Biological Evaluation of Medical Devices" |
| UL 544 | "Standard for Safety Medical and Dental Equipment" |
| Optical Test Data |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
:
510(k) Notification 3Dimensional Video Endoscope January 1997
新闻
APR 1 4 1997 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 Telephone (508) 366-3668 (508) 366-1543 Fax:
DEVICE TRADE NAME
3D Video Endoscope
COMMON NAME
Video Endoscope System
PREDICATE DEVICE
| 1. | Device Name: | 3D Scope Three Dimensional Medical
VideoSystem |
|----|-----------------|---------------------------------------------------|
| | Classification: | Camera, Television, Endoscopic, without audio |
| | Manufacturer: | American Surgical Technologies |
| | | 300 Billerica Rd |
| | | Chelmsford, MA 01824 |
| | 510(k) #: | K923160 and K961182 |
| 2. | Device Name: | Oktas Video Endoscope System with Zoom |
| | Classification: | Endoscopes and Accessories -
21 CFR 876.1500 |
| | Manufacturer: | Oktas |
| | | 134 Flanders Rd |
| | | Westborough, MA 01581 |
| | 510(k) #: | K946171 |
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1
Vista Medical Technologies Westborough, MA
510(k) Notification 3Dimensional Video Endoscope January 1997
| 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 3D Video Endoscope 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, including general thoracic and as an aid in visualization of the evacuated cardiac chamber. The product is an integrated endoscope and video camera. The system will be supplied as a 3D Video Endoscope and Camera Control Unit. The device is designed to work with commercially available light sources, and video monitors or head mounted displays (HMD). Additionally the device can be mounted in a rack and used as one module of a rack mounted system.
INTENDED USE
The device is intended for use in all types of endoscopic and endoscopic assisted procedures, including general thoracic and as an aid in visualization of the evacuated cardiac chamber.
PERFORMANCE DATA
| IEC 601-1 | "General Safety Requirements for Medical Electrical Equipment" |
|---|---|
| IEC 601-1-2 | "Electrical Magnetic Compatibility" |
| IEC 601-2-18 | "Safety of Endoscopic Equipment" |
| ISO 10993 | "Biological Evaluation of Medical Devices" |
| UL 544 | "Standard for Safety Medical and Dental Equipment" |
| Optical Test Data |
Page 2 of 2