UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518

K091391 · Uroplasty, Inc. · FBK · Jun 30, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091391
• Device Name: UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
• Applicant: Uroplasty, Inc.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Jun 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

Device Story

Rigid endoscopic needle accessory for endoscopes with working channel inner diameter ≥ 4 French. Device consists of stainless steel cannula (300-500 mm length, 18-23 gauge tip) with metal luer lock connector and protective polyethylene sheath. Supplied sterile for single use. Operated by clinicians during endoscopic procedures to deliver injectable materials into tissues. No complex processing or electronic components; purely mechanical delivery tool.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel cannula (300-500 mm length, 18-23 gauge tip); polyethylene protective sheath; metal luer lock connector. Compatible with endoscopes having ≥ 4 French working channel. Sterile, single-use, mechanical device. No software or energy source.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring delivery of injectable materials (e.g., bulking agents, sclerosing agents, anesthetics, saline, contrast media) into tissues.

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

• Uroplasty Rigid Endoscopic Needle (K051905)

Submission Summary (Full Text)

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Uroplasty, Inc. Premarket Notification [510(k)] Submission Uroplasty Rigid Endoscopic Needle

/C09139/

## Section 5: 510(k) Summary

| Date Prepared | May 8, 2009 | JUN 30 2009 |
|------------------|------------------------------------------------------|-------------|
| New Device Name | Uroplasty Rigid Endoscopic Needles | |
| Predicate Device | Uroplasty Rigid Endoscopic Needle (K051905) | |
| Contact | Uroplasty, Inc. | |
| | 5420 Feltl Road | |
| | Minnetonka, MN 55343 | |
| | Telephone: [phone], Facsimile: [phone] | |
| | [e-mail] | |

#### Intended Use

The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure.

#### Device Description

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The stainless steel cannula is 300 to 500 mm long with an 18-23 gauge tip (10 - 15 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

### Indication for Use

The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

### Technological Characteristics

The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only. In the few instances where the devices differ, no concerns about safety or effectiveness are raised.

#### Performance

The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use.

#### Conclusion

The subject device, the Uroplasty Rigid Endoscopic Needle, is substantially equivalent to the previously cleared endoscopic needle by Uroplasty (K051905).

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 30 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Morrell, RAC Director of Regulatory Affairs and Quality Assurance Uroplasty, Inc. 5420 Feltl Road MINNETONKA MN 55343-7982

Re: K091391

Trade/Device Name: Uroplasty Rigid Endoscopic Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: May 8, 2009 Received: May 11, 2009

Dear Mr. Morrell:

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.

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 forth in the quality systems (QS) regulation (21 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 go to http://www.fda.gov/AboutFDA/CentersOffices/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 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/indr/ 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 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 vours.

uch

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Uroplasty, Inc. Premarket Notification [510(k)] Submission Uroplasty Rigid Endoscopic Needle

### Section 4: Indications for Use Statement

| 510(k) Number: | K091391 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device Name: | Uroplasty Rigid Endoscopic Needle |
| Indication for Use: | The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media. |

Prescription Use X (Per 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)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_

CONFIDENTIAL