PROVOX FREEHANDS FLEXIVOICE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three human profiles facing right, layered on top of each other, with flowing lines suggesting movement or connection. The text is in a sans-serif font, and the emblem is in a solid black color. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 26, 2014 Atos Medical AB Mr. Ferenc Dahnér Regulatory Affairs Manager Kraftgatan 8 Hörby, SE SE-24222 Re: K141380 > Trade/Device Name: Provox FreeHands FlexiVoice Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal prosthesis (Taub Design) Regulatory Class: Class II Product Code: EWL Dated: August 23, 2014 Received: August 27, 2014 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {1}------------------------------------------------ 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 devicerelated 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Eric A. Mann -S for 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K141380 Device Name Provox FreeHands FlexiVoice #### Indications for Use (Describe) The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis. The entire device is for single patient use and the HME-part is for single use, i.e, it has to be exchanged at least every 24 hours. Environments of use include: Hospitals, ICU, sub-acute care institutions and home. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Non Confidential Summary 23 August 2014 Page 1 of 3 # Section 5 - 510(k) Summary | Atos Medical AB<br>P.O. Box 183<br>SE-242 22<br>Hörby Sweden | Tel - 011-46-415 198 00<br>Fax - 011-46-415 198 98 | |--------------------------------------------------------------|----------------------------------------------------| | Official Contact: | Ferenc Dahnér – Regulatory Affairs Manager | | Proprietary or Trade Name: | Provox FreeHands FlexiVoice | | Common/Usual Name: | Speaking Valve | | Classification | Class II - 21 CFR 874.3730 | | Classification Name/Code: | EWL - Prosthesis, laryngeal (taub) | | Device: | Provox FreeHands FlexiVoice | | Predicate Devices: | Atos Medical - Provox FreeHands HME (K022125) | ## Device Description: The Provox FreeHands consists of two functional units that work together, a speech valve unit in a reusable housing and a disposable Provox FreeHands HME Cassette, which is connected to the lower part of the valve housing before it is ready to use. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It has three interchangeable membranes (Light, Medium and Strong). The HME unit of the Provox® FreeHands HME® is a full heat-and-moisture-exchanger, which is used for partial restoration of the lost upper airway functions. It also separates the speech valve from direct contact with the airway and, thus, prevents mucous from being coughed into the valve part of the device. It also reduces the risk of inhalation of small particles, e.g., coming from a defective valve. After proper adjustment and attachment of the speech valve unit and HME cassette, the completed Provox FreeHands HME is inserted into either Provox Adhesive base plate or Provox LaryTube with ring. ### Indications for Use: The Provox FreeHands FlexiVoice combines pulmonary rehabilitation using a Heat and Moisture Exchanger with voice rehabilitation using an Automatic Speaking Valve or Manual Occlusion, in laryngectomized patients using a voice prosthesis. The entire device is for single patient use and the HME-part is for single use, i.e., it has to be exchanged at least every 24 hours. ### Patient Population: Laryngectomized patients using a voice prosthesis. ### Environment of Use: Environments of use include; Everyday environment. (Home, hospital etc.) ### Contraindications: The Provox FreeHands FlexiVoice is not intended to be used by patients unable to remove or operate the device. {4}------------------------------------------------ # Non Confidential Summary 23 August 2014 Page 2 of 3 #### Comparison to Predicate Device: | Attributes of predicates | Proposed Provox FreeHands<br>FlexiVoice | |--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------| | Intended population: Laryngectomized patients using a voice<br>prosthesis. | Same | | Environments of use include; Everyday environment. (Home,<br>hospital etc.). | Same | | Eliminates the necessity of finger occlusion for the patient with a<br>voice prosthesis. | Yes | | Provides heat and humidity | Yes | | Intended to connect to the Provox attachment devices | Yes | | Intended for single patient use | Yes | | HME exchanged at least every 24 h. | Same | | Prescription | Yes | | Standard 22 mm connectors | Same | | Air pressure operated speech valve one-way, always open for<br>inhalation | Same | | Allows exhalation to atmosphere freely during normal breathing and<br>in locked mode under all breathing circumstances. | Same | | Method for diverting exhaled air through voice prosthesis: Turn top<br>to activate air pressure operated speaking valve. | Same | | Method to return too exhalation after speaking: breathe normally | Same | | Materials HME: Calcium chloride treated polyurethane foam | Same | | Speaking Valve: Silicone, plastic, titanium and a magnet alloy | Silicone and plastic | #### Summary of Non-Clinical Testing: The following tests were performed to verify that Provox FreeHands FlexiVoice met applicable safety and performance requirements. The main focus areas of testing were: - Verification of the closing flow, opening pressure, cough-out pressure, moisture loss, airflow resistance and leakage test. - Verification of attachment and detachment forces in the different interfaces including the durability of the devices. - . Simulated use of all FreeHands FlexiVoice products and their IFUs. - Verification of FreeHands FlexiVoice products' function after fatigue test, climate testing, aging and transport. In addition, risk management according ISO 14971 and simulated use testing (usability study) has been conducted. A comparative analysis shows that the Provox FreeHands FlexiVoice closes at approximately the same flow rate as the predicate Provox FreeHands HME. Only a small adjustment has been made in the closing flow based on experience from usage of Provox FreeHands HME. Additionally, moisture loss, flow resistance and air leakage of the two devices are very similar. The flow resistance of Provox FreeHands FlexiVoice is a bit lower than Provox FreeHands. This is also based on experience from usage of Provox FreeHands HME. We therefore conclude that key properties of the devices are equivalent in terms of working principle, safety and effectiveness. {5}------------------------------------------------ ## Non Confidential Summary 23 August 2014 Page 3 of 3 ### Substantial Equivalence Conclusion: There are no significant differences between the Provox FreeHands FlexiVoice compared to the predicate device in terms of indications, materials, design and operating principles. Information presented in this submission supports that Provox FreeHands FlexiVoice is as safe and effective, and performs as well or better than the predicate device. Atos Medical AB concludes that the Provox FreeHands FlexiVoice is substantially equivalent to the predicate device.