PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

K043138 · Atos Medical AB · EWL · Nov 22, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K043138
• Device Name: PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
• Applicant: Atos Medical AB
• Product Code: EWL · Ear, Nose, Throat
• Decision Date: Nov 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision. The Provox NID is intended for single patient use.

Device Story

Non-indwelling (standard) voice prosthesis; includes safety medallion, insertion tool, and accessories. Placed in surgically created tracheoesophageal fistula; diverts air from trachea to esophagus to enable voicing. Used by patients post-total laryngectomy; requires clinician prescription and patient training. Patient self-manages device insertion and use. Benefits include restoration of speech post-laryngectomy.

Clinical Evidence

Clinical trial conducted at Princess Alexandra Hospital, Brisbane, Australia, with 14 patients previously using Blom-Singer Low Pressure Voice Prosthesis. Results confirmed device performance satisfies design intent.

Technological Characteristics

Non-indwelling voice prosthesis available in 17 and 20 French diameters and 6 lengths (6-18 mm). Includes safety medallion and reusable inserter. Design based on Provox1, Provox2, and ActiValve. Mechanical valve mechanism.

Indications for Use

Indicated for prosthetic voice rehabilitation in patients post-total laryngectomy who are trained, capable of understanding, and able to follow instructions for use without clinician supervision.

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®2 Voice Prosthesis System (K971244)
• Blom-Singer Low Pressure Voice Prosthesis (K821568)

Reference Devices

• Provox1
• ActiValve

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, black letters. Below the word "ATOS" is a black line, and below the line is the word "MEDICAL" in a smaller font.

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## 6.4 510(k) Summary of Safety and Effectiveness

| Date | Monday, November 08, 2004 |
|----------------------------|----------------------------------------------------------------------------------------|
| 510(k) Number | K043138 (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® NID™ Voice Rehabilitation System |
| Common or Usual Name | Voice Prosthesis |
| Device Classification Name | Laryngeal prosthesis (Taub design) |
| Product Code | EWL |

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Image /page/1/Picture/1 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, sans-serif font. Below the word "ATOS" is a horizontal line, and below the line is the word "MEDICAL" in a smaller, sans-serif font.

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| Predicate<br>Devices | Provox®2 Voice Prosthesis System |
|----------------------|-------------------------------------------|
| | 510(k) Number : K971244 |
| | Atos Medical AB, Sweden |
| | Blom-Singer Low Pressure Voice Prosthesis |
| | 510(k) Number: K821568 |
| | Inhealth Technologies, USA |

- The Provox NID voice rehabilitation system is intended for use in prosthetic voice Intended Use rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.

The Provox® NID™ Rehabilitation System is a non-indwelling (Standard) voice Description of prosthesis equipped with a safety medallion, an insertion tool and some the Device accessories.

Image /page/1/Picture/7 description: The image shows two medical instruments. The first instrument is a laryngoscope, which is used to view the larynx. It has a handle and a blade with a light at the end. The second instrument is a tracheostomy tube holder, which is used to secure a tracheostomy tube in place. The holder has a strap that goes around the neck and a clamp that attaches to the tube.

The Provox NID voice prosthesis is available in two outer diameters (17 and 20 French) and six different lengths, (6, 8, 10, 12, 14 and 18 mm). Each prosthesis

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Image /page/2/Picture/0 description: The image shows the logo for Atos Medical. The word "ATOS" is in large, bold, sans-serif font, with a thick line underneath. Below the line, the word "MEDICAL" is printed in a smaller, sans-serif font.

Page 3 of 3 comes individually packed with a re-usable inserter. The design of the device is based on the indwelling voice prostheses Provox1, Provox2 and ActiValve. Performed by Princess Alexandra Hospital, Brisbane, Australia. The Human Clinical Test Research Ethics Committee of the hospital approved the study. All of the patients were using the Blom-Singer Low Pressure Voice Prosthesis prior to this study. In total, 14 patients participated in this clinical trail. Test results support the conclusion that the actual device performance satisfies the design intent. The proposed device is substantially equivalent to the legally marketed predicate Technological Characteristics devices in design, intended use and materials of manufacturer. The Provox® NID™ Rehabilitation System is provided for the same indications for use as its predicate devices, the Provox®2 Voice Prosthesis System and the Blom-Singer Low Pressure Voice Prosthesis. All three devices are designed to provide voicing after total laryngectomy. The devices are placed in a surgically created fistula between the trachea and esophagus in order to divert air through the

prosthesis valve to created voicing.

Functional equivalency test have been performed on the three prostheses, which demonstrate the equivalency of the valve performance with the three designs.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Atos Medical AB Attn: Eddy Åberg P O Box 183 Kraftgatan 8 SE-242 22 Hörby Sweden

Re: K043138

: 11015150
Trade/Device Name: Provox® NID™ Voice Rehabilitation System Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub design) Regulatory Class: II Product Code: EWL Dated: November 8, 2004 Received: November 12, 2004

Dear Ms. Åberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rothered your because in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass baced in 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 mat (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 fray of 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 - Ms. Åberg

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalpi korenthal

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

Enclosure

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## 6.3 Indications for Use

| Applicant: | Atos Medical AB, Sweden | | |
|----------------|------------------------------------------|------------------|--|
| 510(k) Number: | K043138 | (To be assigned) | |
| Device Name: | Provox® NID™ Voice Rehabilitation System | | |

## Intended Use:

The Provox® NID™ Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.

The Provox NID is intended for single patient use.

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

Concurrence of CDRH, Office of Device Evaluation

**Prescription Use** √

or

(Per 21 CFR 801.109)

**Over-the-counter**

(Division Sign-Off) Division of Onhthalmic Ear, Nose and Throat Davises

510(k) Number: K043138

6-13

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

Org. nr. 556268-7607 Vat No. SE556268760701