ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)

K120766 · Prosurg, Inc. · FAJ · Sep 11, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120766
• Device Name: ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
• Applicant: Prosurg, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Sep 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ Digital Video System (which includes the Digital Video Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Urinary tract, and can be percutaneously to examine the interior of the kidney and using additional accessories can be used to perform various diagnostic and therapeutic procedures. The Prosurg's Neoscope (Hysteroscope) Digital Video System (which includes the Digital Endoscope and Video Capture Module) is intended for use to examine body cavities, hollow organs and canals in the body, in the Gynecological tract, and can be percutaneously to examine the interior of the uterus and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

Device Story

NeoScope Digital Video Endoscopic System consists of a digital video endoscope and a video capture module. Device captures visual data from internal body cavities, hollow organs, and canals within the urinary and gynecological tracts. System processes optical signals into digital video for display on external monitors. Used by physicians in clinical settings to visualize anatomy and guide diagnostic or therapeutic interventions. Output allows real-time observation of internal structures, facilitating clinical decision-making during minimally invasive procedures. Benefits include enhanced visualization for improved diagnostic accuracy and procedural guidance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital video endoscopic system comprising a digital endoscope and video capture module. System utilizes optical imaging for visualization of internal body cavities. Connectivity via video output for display. Sterilization methods and specific material standards not detailed in provided text.

Indications for Use

Indicated for examination of body cavities, hollow organs, and canals in the urinary tract (including kidney) and gynecological tract (including uterus) for diagnostic and therapeutic procedures. For use by clinicians via prescription.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Inc. 2195 Trade Zone Blvd. SAN JOSE CA 95131

SEP
11
2012

Re: K120766

Trade/Device Name: NeoScope™ Digital Video Endoscopic System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: August 27, 2012 Received: September 4, 2012

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rior relator adverse overies (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you dosite sportion and AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regalations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may octain other gefacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin K-tucker

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):#K12.07 ሬ ८

Device Name: NeoScope TM- Digital Video Endoscopic System

Indications For Use:

The Prosurg's NeoScope (Cystourethroscope /Cystoureteroscope /Cystonephroscope/ The Prosurg's NeoScope (Cystourethroscope TCystourcerosope and Video Capture
Digital Video System (which includes the Digital video Endoscope and Canals in the Digital Video System (which includes the Digital Video progus and canals in the Module) is intended for use to examine body cavine the interior of the kidney
body, in the Urinary tract, and can be perculared in encorporadians and therapeutic body, in the Urinary tract, and can be perculaneously to examme no moster.
and using additional accessories can be used to perform various diagnostic and therapeutic procedures.

The Prosurg's Neoscope (Hysteroscopce) Digital Video System (which includes the The Prosurg's Neoscope (Hysteroscope) Digital Video Of the use to examine body
Digital Endoscope and Video Capture Module) is the Gramine body Digital Endoscope and Video Capture Muddle, is the Gynecological tract, and can be
cavities, hollow organs and canals in of the Synecological tract, and cavities, hollow organs and canals in the body, in the Oylies, and using additional accessories can
percutaneously to examine the interior of the utens and using additional a perculaneously to examine the interest and therapeutic procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| 510(k) Number | K120766 |
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