BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070

K090217 · Coloplast A/S · FBK · Apr 23, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090217
• Device Name: BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
• Applicant: Coloplast A/S
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Apr 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

Device Story

Endoscopic injection needle for delivery of materials into urinary bladder wall. Device consists of stainless steel cystoscopic needle, thermoplastic polyamide tubing, polyamide Luer Lock connector, and Tuohy Borst adapter. Supplied with Neoplex protective cap to prevent cystoscope channel degradation. Available in 35 cm and 70 cm lengths for use with rigid or flexible cystoscopes (5 French or larger working channel). Used by clinicians during transurethral endoscopic procedures. Single-use, sterile device.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Materials: stainless steel needle, polyamide tubing, polyamide Luer Lock, Neoplex protective cap. Dimensions: 35 cm or 70 cm length, 22G Chiba tip. Compatibility: 5 French or larger cystoscope working channel. Sterilization: sterile, single-use.

Indications for Use

Indicated for delivery of injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

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

• Cook Injection Needles (K022484)

Submission Summary (Full Text)

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K090217

Page 1 of 2

5

# 510(k) SUMMARY

(as required by section 807.92(c)

## APR 2 3 2009

510(K) Owner's Name:

Address:

Holtedam 1 3050 Humlebaek, Denmark

Coloplast A/S

Office:

Phone/Fax/Email:

[phone] Mobile: Fax: [phone] Email: [e-mail]

[phone]

Name of Contact Person:

Trade Or Proprietary Name:

Common Or Usual Name:

Classification Name:

Suresh Ghai Regulatory Affairs Manager

Date Prepared:

January 29th, 2009

Bonee Needle for Bladder Injections

Endoscopic Injection Needle

Endoscope and accessories (21CFR section 876.1500) (Product Code: FBK) Device Class: 2

### Legally Marketed Device To Which Your Firm Is Claiming Equivalence:

The Bonee Needle for Bladder Injections is substantially equivalent in performance, indication, design and materials to Cook Injection Needles from Cook Urological, Inc., cleared under Premarket notification # K022484.

### Device Description:

The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French or larger.

This product is 35 cm (ref: NBI035) or 70 cm (ref: NBI070) length and is made of thermoplastic tubing polyamide (PA) marked by ink, a stainless steel cystoscopic needle, a polyamide Luer Lock connector and a Tuohy Borst adapter to allow connection with the cystoscope.

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K090217
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The assembly of the different components is being insured by gluing (UV process).

A blue protective cap in Neoplex® is also supplied to prevent cystoscope channel degradation during needle insertion.

Shelf life of the full range of the needle for bladder injections is 2 years. The needle for bladder injections is provided sterile and is intended for single use.

Image /page/1/Figure/4 description: The image shows a long, thin object that is curved in an arc. The object appears to be made of a dark material. The object is positioned horizontally across the frame, with the left end of the object being higher than the right end. The right end of the object is partially obscured by some dark shapes.

Figure 1: Bonee Needle for Bladder Injections

#### Product variants available:

| Reference | Length (cm) | Use | Body diameter (mm) | Needle tip |
|-----------|-------------|--------------------------|--------------------|-----------------|
| NBI035 | 35 | With rigid cystoscope | 1.7 mm (= 5 CH/FR) | Chiba tip (22G) |
| NBI070 | 70 | With flexible cystoscope | | 4 mm in length |

Table 2. Sizes and codes of the needle for bladder injections

#### Intended Use Of The Device:

: _ǐ

The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

#### Technological Characteristics Compared To Predicate Device:

The Bonee Needle for Bladder Injections is substantially equivalent in performance, indication, design and materials to Cook Injection Needles from Cook Urological, Inc., cleared under Premarket notification # K022484.

#### Summary and Conclusions from the Nonclinical Tests Submitted:

Substantial equivalence is supported by bench testing comparing Bonee Injection needle to the predicate devices and biocompatibility testing performed on the Bonne Needle.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2009

Mr. Suresh Ghai Regulatory Affairs Manager Coloplast A/S 1601 West River Road N MINNEAPOLIS MN 55411

Re: K090217

Trade/Device Name: Bonee Needle for Bladder Injections Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: April 2, 2009 Received: April 3, 2009

Dear Mr. Ghai: .

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 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

[phone] [phone] [phone] [phone]

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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

#### Enclosure

Page 2

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#### 4 INDICATIONS FOR USE STATEMENT

# Indications for Use

510(k) Number (if known): K090217

Device Name: Bonee Needle for Bladder Injections

Indications for Use:

The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

luzi Whting

(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number