PROVOX 2 VOICE PROSTHESIS SYSTEM

K971244 · Atos Medical AB · EWL · Jun 6, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K971244
• Device Name: PROVOX 2 VOICE PROSTHESIS SYSTEM
• Applicant: Atos Medical AB
• Product Code: EWL · Ear, Nose, Throat
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.

Device Story

Voice prosthesis system for post-laryngectomy rehabilitation; enables speech production by shunting air from trachea to esophagus. Device inserted via primary or secondary TE-puncture; features anterograde replacement method via tracheostoma to improve patient comfort compared to traditional retrograde guide-wire methods. System includes prosthesis, insertion tool, guide wire, trocar, cannula, and pharynx protector. Used by clinicians in clinical settings; facilitates patient communication by restoring voice function.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and technological similarity to the predicate device.

Technological Characteristics

Silicone-based voice prosthesis; includes insertion tool, trocar, cannula, and pharynx protector. Anterograde insertion mechanism. Non-powered, mechanical device.

Indications for Use

Indicated for prosthetic voice restoration in patients post-total laryngectomy. Suitable for primary or secondary tracheoesophageal (TE) puncture procedures.

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

• Original PROVOX Voice Prosthesis

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 6 1997

Eddy Åberg
Technical Manager
Atos Medical
P.O. Box 183
Kraftgaten 8
S242-22 Hörby
Sweden

Re: K971244
Provox 2 Voice Prosthesis System
Dated: March 18, 1997
Received: April 3, 1997
Regulatory class: II
21 CFR 874.3730/Procode: 77 EWL

Dear Mr. Åberg:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".

Sincerely yours,

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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ATOS
MEDICAL

June 4, 1997

## 20.2 INDICATIONS FOR USE, PROVOX® PROSTHESIS SYSTEM

**Premarket Notification 510 (k) Number: K 971244**

The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
OR
Over-The-Counter Use ☐

(Per 21 CFR 801.109)

David A. Seyman
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971244

P.O. Box 383
Kraftgatan 8
S-242 22 Hörby
Sweden
Phone [phone]
Fax [phone]
E-mail [e-mail]
Web Site http://www.atosmedical.com
556268-7607
VAT no.
SF556268760701
Quality System
K971244