PROVOX VEGA, MODEL 8130-8135
Device Facts
| Record ID | K090455 |
|---|---|
| Device Name | PROVOX VEGA, MODEL 8130-8135 |
| Applicant | Atos Medical AB |
| Product Code | EWL · Ear, Nose, Throat |
| Decision Date | Jun 5, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3730 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ. The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines. The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture. Environments of use for the Provox® Vega Voice Prosthesis include – hospitals, sub-acute care institutions and home. For the Provox SmartInserter environments of use include -- hospitals and sub-acute care institutions.
Device Story
Provox Vega is a one-way valve (voice prosthesis) for TE-puncture; maintains puncture patency for speech; reduces risk of fluid/food aspiration into trachea. Device is non-permanent; requires periodic replacement. Used in hospitals, sub-acute care, and home settings. Operated by clinicians for replacement; patient performs in-situ cleaning. Supplied pre-loaded in single-use SmartInserter. Input: manual insertion by clinician. Transformation: mechanical valve function. Output: restored voice capability. Benefits: enables speech rehabilitation for laryngectomy patients.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: Silicone and fluoroplastic (prosthesis); Polyethylene, Polypropylene, Polyoxymethylene (inserter components). Lubricant: Fluorsilicone oil. Form factor: Indwelling valve with tracheal/esophageal flanges. Connectivity: None. Sterilization: Sterile, single-use. Operation: Mechanical one-way valve.
Indications for Use
Indicated for voice rehabilitation in patients post-laryngectomy. No known contraindications for patients already using prosthetic voice rehabilitation.
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
- Atos – Provox2 Voice Prosthesis – K971244
Submission Summary (Full Text)
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Provox® Vega™
Non-Confidential Summary of Safety and Effectiveness Page 1 of 2
4-Jun-09
# Section 5 - 510(k) Summary
| Atos Medical AB<br>Box 183<br>SE-242 22<br>Horby Sweden | Tel - 011-46-415 198 00 | JUN - 5 2005 |
|---------------------------------------------------------|--------------------------------------------|--------------|
| Official Contact: | Ferenc Dahnér – Regulatory Affairs Manager | |
| Proprietary or Trade Name: | Provox® Vega™ | |
| Common/Usual Name: | Voice Prosthesis | |
| Classification Name/Code: | EWL – Prosthesis, Laryngeal (Taub) | |
| Device: | Provox® Vega™ | |
| Predicate Devices: | Atos – Provox2 Voice Prosthesis – K971244 | |
#### Device Description:
The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture open for speech, while reducing the risk of fluids and food entering the trachea. The Provox Vega voice prosthesis is not a permanent implant, and needs periodic replacement. The prosthesis is available in different diameters and several lengths. The device is made of silicone and fluoroplastic.
The Provox Vega package contains the following items:
- · 1 Provox Vega voice prosthesis pre-loaded in a single-use SmartInserter, sterile
- · 1 Provox Brush of a size corresponding to the voice prosthesis, non-sterile
- · 1 Clinician Manual
- · 1 Patient Manual
- · 1 Provox Brush Instructions for Use
#### Indications for Use:
The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ.
The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines.
The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.
Environments of use for the Provox® Vega Voice Prosthesis include – hospitals, sub-acute care institutions and home.
For the Provox SmartInserter environments of use include -- hospitals and sub-acute care institutions.
For patients who have got their larynx surgically removed. Patient Population:
Hospitals, sub-acute care institutions and home. Environment of Use:
There are no known contraindications for use or replacement of the Contraindications: prosthesis among patients already using prosthetic voice rehabilitation.
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4-Jun-09
### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2
#### Summary of substantial equivalence
| Specification | Predicate<br>Provox2 Voice Prosthesis - (K971244) | Proposed Device |
|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Provox2 Voice Rehabilitation System<br>is intended for use in surgical, prosthetic<br>voice restoration after total laryngectomy.<br><br>The prosthesis may be inserted by the<br>physician at the time of the total<br>laryngectomy (primary puncture), or at a<br>later date (secondary puncture), or may be<br>used to replace the present prosthesis. | The Provox® Vega Voice Prosthesis is a<br>sterile single use indwelling voice<br>prosthesis intended for voice<br>rehabilitation after surgical removal of<br>the larynx (laryngectomy). Cleaning of<br>the voice prosthesis is handled by the<br>Patient while it remains in situ.<br><br>The Provox SmartInserter is a sterile<br>single use device intended for<br>anterograde replacement of the Provox<br>Vega Voice Prosthesis, and must be used<br>by a trained and experienced clinician.<br><br>The Provox SmartInserter is not intended<br>to be used for insertion of a voice<br>prosthesis in a freshly made puncture. |
| Environment of<br>Use | Hospitals, sub-acute care institutions and<br>home | Identical |
| Patient Population | For patients who have got their larynx<br>surgically removed (laryngectomy) | Identical |
| Contra-indications | There are no known contraindications for<br>use or replacement of the prosthesis<br>among patients already using prosthetic<br>voice rehabilitation. | Identical |
| Diameters;<br>Shaft<br>Tracheal Flange<br>Esophageal flange | 22,5Fr (7,5mm)<br>13,6mm<br>14,3mm | Identical<br>13,1mm / 16,9mm (oval)<br>14,5mm |
| Shaft lengths (mm) | 4.5, 6, 8, 10, 12.5, 15mm | 4, 6, 8, 10, 12.5, 15mm |
| Materials;<br>Voice Prosthesis | Components: Silicone and fluoroplastic.<br>Adhesive: Silicone Adhesive | Components: Identical<br>Adhesive: Silicone Adhesive |
| Materials;<br>Loading tube | Loading tube: Polypropylene | Loading tube: Polyethylene<br>Folding device: Polypropylene<br>Guide: Polypropylene |
| | Loading tube lubricant: Silicone oil | Loading tube lubricant: Fluorsilicone oil |
| Materials; Inserter | Polypropylene | Polyoxymethylene, glass reinforced |
| Storage conditions | Standard 22°C ± 20 °C, 45% rH ± 35%<br>rH, not direct sunlight | Identical |
## Differences between Other Legally Marketed Predicate Devices
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atos Medical AB c/o Mr. Ferenc Dahnér Regulatory Affairs Manager P.O. Box 183 SE-242 22 Hörby - Sweden
JUN - 5 2009
Re: K090455 Trade/Device Name: Provox® Vega™ Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal prosthesis (Taub design) Regulatory Class: Class II Product Code: EWL Dated: May 12, 2009 Received: May 14, 2009
Dear Mr. Dahnér:
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 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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/.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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely, John,
Kesia Alexander Jr
Malvina B. Eydelman, 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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K090455
Premarket Notification 510(k) Section 04 - Indications for Use Statement Provox® Vega™
Page 1 of 1
510(k) Number:
#### K090455
Device Name:
Provox® Vega
Indications for Use:
The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ.
The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines.
The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.
Environments of use for the Provox® Vega. Voice Prosthesis include - hospitals, subacute care institutions and home.
For the Provox SmartInserter environments of use include - hospitals and sub-acute care institutions.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C. Clapp
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090455
