3D SCOPE

K961182 · Oktas · GCJ · Jul 19, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961182
• Device Name: 3D SCOPE
• Applicant: Oktas
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparoscopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

Device Story

3D SCOPE™ is a three-dimensional medical video system used for visualization during endoscopic, laparoscopic, and thoracic surgeries. Device provides 3D visual feedback to surgeons to assist in surgical navigation and examination of internal structures, including evacuated cardiac chambers. System operates as an endoscopic camera; provides real-time video output to a display for physician viewing. Used in OR settings by surgeons to enhance depth perception during minimally invasive procedures. No hardware or software modifications made to the previously cleared device; submission solely adds clinical indication for cardiac chamber examination.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the identical technological characteristics and intended use as the predicate device.

Technological Characteristics

Endoscopic television camera system; 3D visualization capability. No modifications to materials, energy source, or connectivity from predicate device (K923160).

Indications for Use

Indicated for visualization during general endoscopic, laparoscopic, and thoracic procedures, and for visualization and examination of evacuated cardiac chambers in patients undergoing such surgeries.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3D Scope Three Dimensional Medical Video System (K923160)

Submission Summary (Full Text)

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K961182

JUL 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 [phone]
Fax: [phone]

DEVICE TRADE NAME
3D SCOPE™

COMMON NAME
Laparoscopic Video System

PREDICATE DEVICE

1. Device Name: 3D Scope Three Dimensional Medical Video System
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 laparoscopic procedures. This includes general thoracic procedures.

This submission is to add to the indications for use: examination of the evacuated cardiac chambers.

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# INTENDED USE

The 3D SCOPE™ is designed to aid in visualization for general endoscopic and laparoscopic procedures including general thoracic, and as an aid in visualization and examination of the evacuated cardiac chambers.

# DEVICE COMPARISON

1. Device Name: 3D SCOPE™ Three Dimensional Medical Video System
Classification: Camera, Television, Endoscopic, without audio
Manufacturer: American Surgical Technologies
300 Billerica Rd
Chelmsford, MA 01824
510(k) #: K923160

The device is not modified in any way except for the added indication for use.