UROPLASTY RIGID ENDOSCOPIC NEEDLE

K051905 · Uroplasty, Inc. · FBK · Aug 29, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051905
• Device Name: UROPLASTY RIGID ENDOSCOPIC NEEDLE
• Applicant: Uroplasty, Inc.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Aug 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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 ≥ 5 French; stainless steel cannula (380-500 mm length) with 18-gauge tip; metal luer lock connector; protective polyethylene sheath. Device supplied sterile for single use. Operated by clinician during endoscopic procedures to deliver injectable materials into tissue. Facilitates targeted delivery of therapeutic or diagnostic agents; improves procedural efficiency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel cannula; 5 French diameter; 380-500 mm length; 18-gauge tip; polyethylene sheath; metal luer lock connector. Sterile, single-use accessory. No software or electronic components.

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

• Advanced UroScience Injection Needle (K982890)

Submission Summary (Full Text)

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Page 16 of 17

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

AUG 2 9 2005

K 05/905

### Section 8: 510(k) Summary

| Date Prepared | July 13, 2005 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device Name | Uroplasty Rigid Endoscopic Needle |
| Predicate Device | Advanced UroScience Injection Needle (K982890) |
| Contact | Uroplasty, Inc.<br>2718 Summer Street NE<br>Minneapolis, MN 55413-2820<br>Telephone: [phone], Facsimile: [phone]<br>[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 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 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 Both devices have similar intended uses and principles of action; they are both materials. 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 Advance UroScience (K982890).

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Image /page/1/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The logo is encircled by text, which is oriented vertically along the left side of the circle and horizontally along the top. The text appears to be part of the organization's name or a related phrase.

AUG 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Morrell Director of Regulatory Affairs Uroplasty, Inc. 2718 Summer Street, NE MINNEAPOLIS MN 55413-2820

Re: K051905

K051769
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: July 13, 2005 Received: July 14, 2005

Dear Mr. Morrell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section Dro(is) promotialy equivalent (for the indications for use stated in above and have delemined the devices is a devices marketed in interstate commerce prior to the enclosure) to regary markets predicato accal Device Amendments, or to devices that have been May 28, 1976, the enaculicit aate of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of application (PMA). You may, therefore, market the do not require approval of a prematics approvat approvations of the general controls provisions of the Act
device, subject to the general controls provisions of the Act. The device, subject to the general controls provincies 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 If your device is classified (see above) and controls. Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Pars 800 of 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paristss device can be found in the code of I ousers in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issualic of a substance of the requirements of the Act or ally
FDA has made a determination that your device with other rise. You must complive w FDA has made a determination mat your device complex. You must comply with all the Federal statues and regulations administered of Child College the production the purchip areases (AS Act's requirements, including, but not thance to registerial in the quality systems (QS) (21 CFR Part 801); good manufacturing practice requirement 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 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/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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Uroplasty, Inc. Premarket Notification [510(k)] Submission Uroplasty Rigid Endoscopic Needle

.

## PREMARKET NOTIFICATION [510(k)] SUBMISSION UROPLASTY RIGID ENDOSCOPIC NEEDLE

### Indication for Use Statement

| 510(k) Number: | K051905 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over the Counter Use __________ |
|------------------------------------------|----|---------------------------------|
|------------------------------------------|----|---------------------------------|

Nancy Brogdon

(Division Sign-off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K051905 |
|---------------|---------|
|---------------|---------|