N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110

K043383 · Physion, Inc. · FBK · Oct 27, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043383
• Device Name: N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
• Applicant: Physion, Inc.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed therapeutic agents into the urethra, prostate and vesical cavities with visualization via a cystoscope.

Device Story

N-DO Endoinjector Needles are endoscopic accessories used to inject therapeutic agents into the urethra, prostate, and vesical cavities. The device is used in conjunction with a cystoscope to provide visualization during the procedure. It is intended for use by clinicians in a clinical setting. The device facilitates targeted delivery of medications to specific anatomical sites within the urinary tract, potentially improving therapeutic outcomes for patients requiring localized treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic injection needle; manual operation; compatible with standard cystoscopes; sterile, single-use design.

Indications for Use

Indicated for delivery of therapeutic agents into the urethra, prostate, and vesical cavities under cystoscopic visualization.

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

OCT 2 7 2005

Physion®, Inc. c/o Eric J. Nemeth, Esq. Sheffet & Dvorin Attorneys at Law 2509 Park Avenue, Suite 2B SOUTH PLAINFIELD NJ 07080

Re: K043383

K045585
Trade/Device Name: N-DO Endoinjector Needle, Models PH00961109 and -1110; PH00971102 and -1103 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: August 15, 2005 Received: August 22, 2005

Dear Mr. Nemeth:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced wowe 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 do not require 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket it your do ree is stable to such additional controls. Existing major regulations affecting your Apple rary, it they of casylone 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 I Dri nas made a drommissions administered by other Federal agencies. You must comply with all the r carrarss and regulating, but not limited to registration and listing (21 CFR Part 807); labeling All CFR Part 801); good nanufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (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 5 I 0(k) This letter will anow you to begin manceing of substantial equivalence of your device to a legally premarket notification. The FDA Inding of substantial of 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), pleased If you desire specific advice for your device on our languing 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 prematic notification" (21 CFR Also, please note the regulation chitted, "thisorians on your responsibilities under the Act from the 807.97). You may obtain other general information on yours I
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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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## Indications for Use

510(k) Number (if known): __ K043383 _________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The N-DO Endoinjector Needles are intended to deliver a variety of legally The N-DO Endomjector Novethra, prostate and vesical cavities with visualization via a cystoscope.

Prescription Use X (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 OF NEEDED)

Daind Lee Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _