(115 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a 3D visualization system, not AI/ML capabilities.
No
The device is a visualization system designed to aid in endoscopic and laparoscopic procedures, not to provide therapy. Its function is descriptive (visualization) rather than curative or interventional.
No
The device is described as an aid in visualization for general endoscopic and laparascopic procedures, not for diagnosing medical conditions. Its purpose is to provide a visual field for surgical intervention.
No
The device description explicitly refers to a "Three Dimensional Medical Video System," which strongly implies hardware components beyond just software. The submission is for an addition of an indication for use to an already marketed, cleared device, further suggesting a pre-existing hardware system.
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 designed to "aid in visualization for general endoscopic and laparascopic procedures" and "aid in visualization and examination of the evacuated cardiac chambers." This describes a device used during a medical procedure to help the clinician see, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description reinforces its use in "general endoscopic surgery and laproscopic procedures."
- 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 the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for visualization during procedures.
N/A
Intended Use / Indications for Use
The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.
Product codes
Not Found
Device Description
This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures. This submission is to add to the indications for use: examination of the evacuated cardiac chambers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general endoscopic and laparascopic procedures including general thoracic, and ... evacuated cardiac chambers.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
19 1996
510(K) SUMMARY July 1, 1996
COMPANY NAME AND ADDRESS
Vista Medical Technologies 5451 Avenida Encinas, Suite A Carlsbad, CA. 92008
CONTACT PERSON Debbie Iampietro Director of Regulatory Affairs and Quality Assurance
Telephone (508) 366-8882 Fax: (508) 366-8858
DEVICE TRADE NAME
3D SCOPE™
COMMON NAME
Laparoscopic Video System
PREDICATE DEVICE
-
- 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
DEVICE DESCRIPTION
This 510(k) submission is for the addition of an indication for use of the currently marketed, cleared device 3D SCOPE™ Three Dimensional Medical Video System. 510(k) #: K923160. The primary application cleared for the AST 3D SCOPE™ is general endoscopic surgery and laproscopic procedures. This includes general thoracic procedures.
This submission is to add to the indications for use: examination of the evacuated cardiac chambers.
1
INTENDED USE
The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparascopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.
DEVICE COMPARISON
- Device Name: 3D SCOPE™ Three Dimensional Medical Video System 1. Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 K923160 510(k) #:
The device is not modified in any way except for the added indication for use.