VOICE MASTER PROSTHESIS

K974132 · E. Benson Hood Lab, Inc. · EWL · Feb 25, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974132
• Device Name: VOICE MASTER PROSTHESIS
• Applicant: E. Benson Hood Lab, Inc.
• Product Code: EWL · Ear, Nose, Throat
• Decision Date: Feb 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.

Device Story

Indwelling voice prosthesis; designed for placement in tracheo-esophageal fistula. Device utilizes one-way ball valve mechanism to control airflow and direction for speech restoration. Used by patients post-laryngectomy. Physician-placed device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Indwelling voice prosthesis; one-way ball valve design; tracheo-esophageal fistula form factor. Materials similar to predicate devices.

Indications for Use

Indicated for patients post-laryngectomy seeking vocal restoration.

Regulatory Classification

Identification

A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.

Special Controls

*Classification.* Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

• Groningen Voice Prosthesis
• Panje Voice Prosthesis
• Provox Voice Prosthesis

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 2 5 1998

510 (K) Summary as required by section 807.92 (C)

## Contact Information:

Anthony M. Sacchetti E. Benson Hood Laboratories 575 Washington St. Pembroke, MA 02359

Phone: [phone] Fax:

Product Names:

VoiceMaster Prosthesis Trade name: VM-008 Catalog Code #: VM-010

## Product Description:

This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.

74132

## Intended Use:

The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.

Predicate Devices: Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis

## Summary of Technological Similarities and Differences with the Predicate Device:

The body design and material used in the submitted device is similar to the Predicate Devices. The submitted device uses a ball valve design rather than slit or flap valves as a means to control airflow and direction.

(Signed)
`Anthony M. Sacchetti`
(Typed Name)
`10/30/97`
(Dated)

(Permanent Notification [510K] number)

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Image /page/1/Picture/17 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three overlapping lines that resemble an abstract human form.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1998

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

Re:

K974132 VoiceMaster Indwelling Voice Prosthesis Dated: February 9, 1998 Received: February 11, 1998 Regulatory class: II 21 CFR 874.3730/Procode: 77 EWL

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 question 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/edrh/dsmamain.html":

Sincerely yours,

h. Tliau Yu.

Lillian Yin, Ph.D. 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 (il known): K914132

Device Name: Voice Name: _ Voice Mass + 23 Pro ; thisis

Indications I-or Use:

The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore
s and their vocal abilities.

Page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

();i

Uver-The-Counter Use_

Optional Format 1-2-96)

David C. Bryson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices

510(k) Number K974113.2

SK=11