CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE

K983878 · E. Benson Hood Laboratories, Inc. · EOQ · Jan 29, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K983878
• Device Name: CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE
• Applicant: E. Benson Hood Laboratories, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A Rigid Stent Introducer/Endoscope is a device used by a physician to insert Tracheal Stents.

Device Story

Rigid Stent Introducer/Endoscope is a manual surgical instrument used by physicians in clinical settings to assist in the placement of tracheal stents. The device functions as a mechanical delivery system, allowing the clinician to guide and position the stent within the trachea. It does not involve electronic processing, software, or automated analysis. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; rigid construction; non-powered; no software or electronic components.

Indications for Use

Indicated for use by physicians to facilitate the insertion of tracheal stents in patients requiring airway management.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 1999

Anthony M. Sacchetti Quality Manager E. Benson Hood Laboratories 575 Washington Street Pembroke, MA 02359

Re:

K983878

Rigid Stent Introducer/Endoscope Dated: October 30, 1998 Received: November 2, 1998 Regulatory class: II 21 CFR 874.4680/Procode: : 77 EOQ

Dear Mr. Sacchetti:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K983878

Device Name: Rigid Stent Introducer / Endose.ope

Indications For Use:

A Rigid Stent Introducer/Endoscope is a device used by a physician to insert Tracheal Stents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elavid A. Segenm

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(Division Sign-Off)

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

Prescription الاقع (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)