LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP

K090830 · Laborie Medical Technologies, Ltd. · FBK · Jul 21, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090830
• Device Name: LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
• Applicant: Laborie Medical Technologies, Ltd.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Jul 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The injeTAK" Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

Device Story

The injeTAK™ Adjustable Tip Needle is a sterile, single-use accessory for cystoscopes used to deliver drugs into tissues. It consists of a 25-gauge stainless steel needle cannula housed within a 6Fr outer movable sheath. The device features a manual adjusting mechanism on the handle that allows the clinician to set the needle tip penetration depth between 0 and 5 mm relative to the sheath tip. Numerical indicators (0, 2, 3, 5) on the handle provide visual confirmation of the selected depth. The device is operated by a physician during cystoscopic procedures to facilitate precise drug injection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Stainless steel needle, 6Fr sheath. Dimensions: 35-50cm length, 25-gauge needle. Mechanism: Manual adjusting mechanism for 0-5mm tip penetration depth. Sterilization: Supplied sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for delivery of legally marketed drugs into tissues or structures during cystoscopic procedures. For prescription use only.

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

• N-DO Endoinjector Needle (K043383)
• Cook Injection Needles (K022484)

Submission Summary (Full Text)

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Page 1 of 2

L 21 2009

#### K090830 510 (K) SUMMARY

Submitted By:

Barbara Mornet

Laborie Medical Technologies, Corp

Telephone: [phone]

Fax: [phone]

Email: [e-mail]

Date: Jan 28, 2009

#### Device

Proposed Classification:

Regulation Name: Endoscope and accessories, Gastroenterology-Urology

Regulation Number: 21 CFR 876.1500

Regulatory Class: II

Product Code: FBK

### Predicate Devices:

InjeTAK™ Adjustable Tip Needles are similar to:

The N-DO Endoinjector Needle (K043383)

The Cook Injection Needles (K022484),

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K090830

Page 2 of 2

#### Device Description:

The injeTAK'" Adjustable Tip Needle consists of a metal needle cannula and an outer movable sheath with an attached adjusting mechanism.

The needle sheath diameter is 6Fr with 35-50cm in length, The stainless steel needle is 25gauge

Needle tip length adjusting mechanism is used to adjust & set the relative distance between the distal needle point to the distal end tip of needle sheath in a range of 0-5 millimeter (mm).

Numbers (0, 2, 3, 5) printed on handle of the adjusting mechanism are used to indicate the individual needle tip (penetration) lengths in millimeter (mm) unit.

### Substantial Equivalence:

Technologically speaking, the injeTAK™ Adjustable Tip Needle and predicate devices have similar intended uses and principles of action, there are both rigid and flexible needles intended to be accessories for common cystoscopes for the use of administering injection materials. They are all supplied sterile and are for single use only.

In conclusion the Laborie device, the injeTAK™ Adjustable Tip Needle, is substantially equivalent to the N-DO Endoinjector Needle by Physion and the Cook Injection Needles by Cook Urological in both their Intended Use and in physical respects.

#### Intended Use

The injeTAK" Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

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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 features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a graphic representation of a human figure embracing or supporting another, suggesting care and assistance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara Mornet Regulatory Affairs Deputy Laborie Medical Technologies 400 Avenue D. Suite 10 WILLISTON VERMONT 05495-7828

JUL 2 1 2009

Re: K090830

Trade/Device Name: injeTAK™ Adjustable Tip Needles, Models DIS196 and DIS198 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: July 13, 2009 Received: July 15, 2009

Dear Ms. Mornet:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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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# Page 2 -- Ms. Barbara Mornet

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation titled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

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# Indications for Use

510(k) Number (if known): K090830

Device Name: injeTAKTM Adjustable Tip Needles

Indications For Use: The injeTak™ Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile and single use only.

Prescription Use × (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 IF NEEDED)

Concurrence of GDRH, Office of Device Evaluation (ODE)

Samuth Thong

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