EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

K040018 · Boston Scientific Corp · EOQ · Jan 20, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K040018
• Device Name: EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
• Applicant: Boston Scientific Corp
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jan 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The eXcelon™ Transbronchial Aspiration Needle is intended for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Device Story

The eXcelon™ Transbronchial Aspiration Needle is a needle catheter designed for tissue aspiration. It is used by clinicians during bronchoscopy procedures to access carinal, paratracheal, and hilar lesions within the bronchial tree that are inaccessible to standard biopsy forceps. The device functions by providing a means to obtain submucosal samples for diagnostic purposes. It is a manual instrument operated by a physician.

Clinical Evidence

Bench testing only. Performance characteristics, biocompatibility, and functional testing support substantial equivalence to the predicate device.

Technological Characteristics

Needle catheter for tissue aspiration. Mechanical device; no energy source or software. Biocompatible materials.

Indications for Use

Indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Boston Scientific Stifcor™ Transbronchial Aspiration Needle (K963252)

Submission Summary (Full Text)

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K040018

Special 510(k) Premarket Notification Transbronchial Aspiration Needle (TBAN) Boston Scientific Corporation January 5, 2004

| JAN 2 0 2004 | 510 (k) SUMMARY |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
| CONTACT PERSON: | James D. McMahon<br>Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:<br>Common Name:<br>Classification: | eXcelon™ Transbronchial Aspiration Needle<br>Transbronchial Aspiration Needle<br>Class II, per 21 CFR Part 874.4680 |
| PREDICATE DEVICE: | Boston Scientific Stifcor™ Transbronchial Aspiration Needle<br>(K963252) |
| DESCRIPTION: | The eXcelon™ Transbronchial Aspiration Needle is a needle<br>catheter used for aspiration of tissue. |
| INTENDED USE: | The eXcelon™ Transbronchial Aspiration Needle is intended for<br>use in aspiration in carinal, paratracheal and hilar lesions of the<br>bronchial tree where biopsy forceps cannot obtain a submucosal<br>sample. |
| COMPARISON OF<br>CHARACTERISTICS: | The modified device is substantially equivalent to the predicate<br>device, as they have the same operating principal and intended<br>use. In addition, the results of design control activities do not<br>raise any new issues of safety or effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",<br>and the results of physical comparison and functional testing<br>support a determination of substantial equivalence for the<br>modified device when compared to the predicate device. The<br>modified device is substantially equivalent to the currently<br>marketed Boston Scientific Stifcor™ Transbronchial Aspiration<br>Needle in terms of performance characteristics, biocompatibility,<br>and intended use. |

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JAN 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corp. c/o James D. McMahon Senior Regulatory Affairs Specialist One Boston Scientific Place Mail Stop A1, Endo Regulatory Natick, MA 01760-1537

Re: K040018

Trade/Device Name: eXcelon™ Transbronchial Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: January 5, 2004 Reccived: January 6, 2004

Dear Mr. McMahon:

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 such 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 agencics. 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); 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 - James D. McMahon

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html

Sincerely yours,

Aeryl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k)<br>Number | To be determined |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | eXcelon™ Transbronchial Aspiration Needle |
| Indications For Use | Indicated for use in aspiration in carinal, paratracheal and hilar lesions of<br>the bronchial tree where biopsy forceps cannot obtain a submucosal<br>sample. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Keuy A. Bohn

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devise

510(k) Number.

Proprietary and Confidential Information of Boston Scientific Corporation