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.

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

AI/ML Overview

The provided text describes the Provox® Vega™ voice prosthesis but does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. This document is a 510(k) summary for a medical device, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance criteria and the results of a specific clinical study against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions that there are "no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices," which is the basis for its substantial equivalence determination, but it does not report on specific performance metrics or trials against predefined acceptance criteria for the Provox® Vega™ itself.

Summary

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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 ABBox 183SE-242 22Horby 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 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 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	PredicateProvox2 Voice Prosthesis - (K971244)	Proposed Device
Indications for use	The Provox2 Voice Rehabilitation Systemis intended for use in surgical, prostheticvoice restoration after total laryngectomy.The prosthesis may be inserted by thephysician at the time of the totallaryngectomy (primary puncture), or at alater date (secondary puncture), or may beused to replace the present prosthesis.	The Provox® Vega Voice Prosthesis is asterile single use indwelling voiceprosthesis intended for voicerehabilitation after surgical removal ofthe larynx (laryngectomy). Cleaning ofthe voice prosthesis is handled by thePatient while it remains in situ.The Provox SmartInserter is a sterilesingle use device intended foranterograde replacement of the ProvoxVega Voice Prosthesis, and must be usedby a trained and experienced clinician.The Provox SmartInserter is not intendedto be used for insertion of a voiceprosthesis in a freshly made puncture.
Environment ofUse	Hospitals, sub-acute care institutions andhome	Identical
Patient Population	For patients who have got their larynxsurgically removed (laryngectomy)	Identical
Contra-indications	There are no known contraindications foruse or replacement of the prosthesisamong patients already using prostheticvoice rehabilitation.	Identical
Diameters;ShaftTracheal FlangeEsophageal flange	22,5Fr (7,5mm)13,6mm14,3mm	Identical13,1mm / 16,9mm (oval)14,5mm
Shaft lengths (mm)	4.5, 6, 8, 10, 12.5, 15mm	4, 6, 8, 10, 12.5, 15mm
Materials;Voice Prosthesis	Components: Silicone and fluoroplastic.Adhesive: Silicone Adhesive	Components: IdenticalAdhesive: Silicone Adhesive
Materials;Loading tube	Loading tube: Polypropylene	Loading tube: PolyethyleneFolding device: PolypropyleneGuide: 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%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 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

Regulation Number and Section

§ 874.3730 Laryngeal prosthesis (Taub design).

(a)
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.(b)
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.