PROVOX FREEHANDS HME, MODEL 7710

K022125 · Atos Medical AB · EWL · Jul 30, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K022125
• Device Name: PROVOX FREEHANDS HME, MODEL 7710
• Applicant: Atos Medical AB
• Product Code: EWL · Ear, Nose, Throat
• Decision Date: Jul 30, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

Device Story

Provox FreeHands HME system consists of two functional units: a reusable speech valve unit with two independent valves and a disposable HME cassette. Device functions as heat and moisture exchanger to humidify inhaled air by retaining heat/moisture from exhaled air. Speech valve unit enables hands-free tracheostoma occlusion for voice prosthesis users; features two positions: speaking and breathing. Used by patients with voice prosthesis or surgical speech fistula. Clinical testing performed by Netherlands Cancer Institute. Device facilitates voicing and provides respiratory conditioning.

Clinical Evidence

Clinical study performed by the Netherlands Cancer Institute. Comparison made between Provox® FreeHands HME™, Provox® HME Cassette, and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap. Results support that device performance satisfies design intent.

Technological Characteristics

System comprises a reusable speech valve unit and a disposable HME cassette. Functions as a heat and moisture exchanger with integrated speech valve for hands-free tracheostoma occlusion. Materials are consistent with legally marketed predicate devices.

Indications for Use

Indicated for patients with a voice prosthesis or surgical speech fistula requiring heat and moisture exchange for inhaled air and facilitation of hands-free voicing.

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

• Provox® HME Cassette (K014102)
• Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap (K821568)
• Bivona™ Tracheostoma Valve II (K852272)

Submission Summary (Full Text)

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188

MEDICAL

JUL 3 0 2002

Premarket Notification 510(k) Provox® FreeHands HME™

Page 1 of 3

| 5.4 510(k) Summary of Safety and Effectiveness |
|------------------------------------------------|
|------------------------------------------------|

| Date | Thursday, June 27, 2002 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K022125 (To be assigned) |
| Submitter's Name | Atos Medical AB<br>P O Box 183<br>Kraftgatan 8<br>SE-242 22 Hörby<br>Sweden |
| | Telephone: Int+46-415-198 00<br>Fax: Int+46-415-198 98<br>E-mail: [e-mail] |
| Contact Person | Eddy Åberg<br>Director of Quality & Regulatory Affairs |
| Trade or Proprietary Name | Provox® FreeHands HMETM |
| Common or Usual Name | Heat and Moisture Exchanger with a Speech Valve |
| Device Classification Name | Tracheostomy Tube and Tube Cuff |
| Product Code | 73 JOH |
| Predicate Devices | Provox® HME Cassette<br>510(k) Number : K014102<br>Atos Medical AB, Sweden<br><br>Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap<br>510(k) Number: K821568<br>Inhealth Technologies, USA<br><br>Bivona™ Tracheostoma Valve II<br>510(k) Number: K852272<br>Bivona Medical Technologies, USA |
| Intended Use | The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and |

Org. nr.
556268-7607
Vat No. SE556268760701

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Image /page/1/Picture/2 description: This document describes the Provox FreeHands system, which consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The document explains that the speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position", and mentions that the clinical test was performed by the Netherlands Cancer Institute.

O Box 183 Kraftoaten 8 SE-242 22 Horbv Sweder

46 415 198 00 46 415 198 98 info@atosmedical co www.atosmedical.com 112878-17

5-14

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Premarket Notification 510(k) Provox® FreeHands HME™

Page 3 of 3

approved the study. A comparison was made between Provox® FreeHands HME™, Provox® HME Cassette and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap.

Test results support the conclusion that the actual device performance satisfies the design intent.

Technological Characteristics

The proposed device is substantially equivalent to the legally marketed predicate devices in design, intended use and materials of manufacturer.

P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden

Phone [phone] [phone] Fax E-mail ı[e-mail] Web www.atosmedicai.com

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JUL 3 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Atos Medical, Inc. c/o Paul Dryden ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055

Re: K022125

Trade/Device Name: Provox FreeHands HME, Model 7710 Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub Design) Regulatory Class: Class II Product Code: EWL Dated: June 27, 2002 Received: July 1, 2002

Dear Mr. Dryden:

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 such 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); 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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. Page 2 – Paul Dryden

: This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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MEDICA

## Indications for Use 5.3

| Applicant: | Atos Medical AB, Sweden |
|----------------|--------------------------|
| 510(k) Number: | K022125 (To be assigned) |
| Device Name: | Provox® FreeHands HMETM |

## Intended Use:

The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

## PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

(Division Sign Off) Division of Ounthalmic Ear, Nos and Throat Devises

510(k) Number

P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden

or

Over-the-counter_

(Per 21 CFR 801.109)

[phone] Phone [phone] Fax E-mail info@atosmedical com www.atosmedical.com Web

Org. nr. 556268-7607 Val No SE556268760701 5-12