Who is the manufacturer of 3D SCOPE?

Oktas filed the 510(k) submission for 3D SCOPE (K961182).

What is the FDA product code for 3D SCOPE?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for 3D SCOPE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 3D SCOPE?

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

Who can help prepare an FDA 510(k) submission like 3D SCOPE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

K101810 — 3DHJD CAMERA SYSTEM MODEL · Vision Systems Group, A Division of Viking Systems · Aug 30, 2010
K990188 — INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 · Intuitive Surgical, Inc. · Apr 1, 1999
K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM · Vista Medical Technologies, Inc. · Feb 12, 2002
K990635 — VISTA STEREOSCOPE SYSTEM · Vista Medical Technologies, Inc. · May 19, 1999
K150525 — SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link · KARL STORZ Endoscopy-America, Inc. · Nov 20, 2015

Submission Summary (Full Text)

{0} 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 (508) 366-8882 Fax: (508) 366-8858 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. {1} # 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.