NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM

K042780 · Prosurg, Inc. · FAJ · Feb 3, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042780
• Device Name: NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
• Applicant: Prosurg, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Neoscope™ - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.

Device Story

NeoScope™ is an endoscopic diagnostic and treatment system used by physicians in clinical settings. It functions as a platform for performing minimally invasive procedures, including cystoscopy, hysteroscopy, and laparoscopy. The system facilitates the use of various endoscopic accessories, microsurgical instruments, laser devices, RF devices, and tissue ablative/augmenting agents. By providing visualization and access to internal organs (prostate, bladder, urethra, uterine cavity, stomach, GI tract, urinary tract, and reproductive organs), the device enables diagnosis and therapeutic intervention. The physician operates the system to visualize the target anatomy and deliver treatments, potentially reducing the need for open surgery and improving patient recovery outcomes.

Technological Characteristics

Endoscopic diagnostic and treatment system; supports integration with laser, RF, and microsurgical instrumentation; intended for use with various biomaterials and tissue agents. Technical specifications and material standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring cystoscopic, hysteroscopic, laparoscopic, or endoscopic diagnostic and treatment procedures for urological, gynecological, and gastroenterological disorders involving the prostate, bladder, urethra, uterine cavity, stomach, GI tract, urinary tract, and reproductive organs.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 3 2005

Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Inc. 2193 Trade Zone Blvd. SAN JOSE CA 95131

Re: K042780

Trade/Device Name: NeoScope™ - Endoscopic Diagnostic & Treatment System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FAJ Dated: December 30, 2004 Received: January 18, 2005

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreatinent date of the enactment date of the Medical Device Amendments, or to commerce provision to may 20, 1978, are enames with the provisions of the Federal Food, Drug, devices martic 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 r ou may, therefore, maines of the Act include requirements for annual registration, listing of general condois provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elassified (500 above) and existing major regulations affecting your device can be it may be subject to additions, 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 I Teast of advised that I Drives and in that your device complies with other requirements of the Act that I Dri has made a asted regulations administered by other Federal agencies. You must of any I ederal statues and regarments, including, but not limited to: registration and listing comply with an the rise Frequent art 801); good manufacturing practice requirements as set (21 CFR Part 007), laborning (21 CFR Part 820); and if applicable, the electronic forth in the quarty by stems (QS) =s (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510k # K042780

NUMBER 510 (k) Neoscope- Endoscopic & Treatment System

(IF KNOWN) :

DEVICE NAME:

INDICATIONS FOR USE:

Neoscope™ - Endoscopic Diagnostic and Treatment System is intended for cystoscopic, hysteroscopic laparoscopic and endoscopic treatment of urological, gynecological, gasteroenterological disorders and diseases of prostate, bladder, urethra, uterine cavity, stomach, GI, urinary tract and reproductive organs using biomaterials, laser & RF devices, tissue ablative and augmenting agents, microsurgical instrument and endoscopic accessories.

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

Device Evaluation (ODE) Concurrence of CDRH, Office of

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use
(Optional Format 1-2

(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number.