PROVOX MICRON HME

K072582 · Atos Medical AB · JOH · May 30, 2008 · Anesthesiology

Device Facts

• Record ID: K072582
• Device Name: PROVOX MICRON HME
• Applicant: Atos Medical AB
• Product Code: JOH · Anesthesiology
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2

Intended Use

The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. It is intended to be used with the Provox® HME System. Environments of use include - hospitals, sub-acute care institutions and home.

Device Story

Provox® Micron HME™ is a stoma cover for laryngectomized patients; functions as heat and moisture exchanger (HME) and air filter. Device captures heat/moisture from exhaled air to humidify inhaled air; filter media removes bacteria, viruses, and particulate matter. User can manually close device to divert exhaled air through esophagus for speech. Used in hospitals, sub-acute care, and home settings. Device restores breathing resistance; provides filtration; facilitates voicing. Benefits include airway protection, reduced airway drying, and speech support. Operates as passive mechanical accessory to Provox® HME System.

Clinical Evidence

Bench testing only. Performance validated per ISO 9360 (moisture loss: 22 mg H2O/L) and ASTM F2101 (BFE >99.8%, VFE >99.8%). Pressure drop measured at 0.7 cm H2O @ 30 Lpm and 1.9 cm H2O @ 60 Lpm. No clinical data presented.

Technological Characteristics

Stoma cover/HME cassette. Materials: standard HME/filter materials. Sensing/Actuation: passive mechanical. Energy source: none. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for laryngectomized patients requiring heat and moisture exchange and air filtration. May facilitate voicing in patients with a voice prosthesis or surgical speech fistula. No contraindications.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Provox® HME system (K014102)
• Provox® Freelands HME (K022125)
• In Health Blom Singer HME systems (K915786)
• Draeger - Uni-Filter (K043120)

Submission Summary (Full Text)

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K072582

MAY 3 0 2008

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 3 12-May-08

| Atos Medical AB | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Box 183 | Tel - 011-46-415 198 00 |
| SE-242 22 Horby Sweden | Fax -- 011-46-415 198 98 |
| Official Contact: | Ferenc Dahnér - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Provox® Micron HME™ |
| Common/Usual Name: | HME and filter |
| Classification Name/Code: | JOH - Tracheostomy tube and cuff (accessory) |
| Device: | Provox® Micron HME™ |
| Predicate Devices: | Atos - Provox® HME system - K014102<br>Atos - Provox® Freelands HME - K022125<br>In Health Blom Singer HME systems - K915786<br>Draeger - Uni-Filter - K043120 |

#### Device Description:

The Provox® Micron HME™ is a device which covers the stoma of a laryngectomy pationt. It is dcsigned to heat and humidify inhaled air to reduce the drying out of the airway as well as it incorporates filter media to filter the inhaled air of bacteria, virus and particulate matter.

It also incorporates a feature whereby the user may close the device, diverting exhaled air through the esophagus to facilitate voicing. This feature is identical to the predicate, Provox® HME cassette (K014102) and Provox® FreeHands HME (K022125), the only difference between the proposed device and the predicates in the addition of filter media.

### Indications for Use:

The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy.

For paticuts with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

It is intended to be used with the Provox® HME System.

Environments of use include - hospitals, sub-acute care institutions and home.

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 12-May-08

Patient Population: For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

Environment of Use: Hospital, acute care settings, and home

# Contraindications: None

# Summary of substantial equivalence

| Specification | Predicates<br>Provox® HME Cassette (K014102)<br>Provox® FreeHands HME (K022125)<br>Blom Singer HME systems (K915786)<br>Uni-filter (K043120) | Proposed Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Is a heat and moisture exchanger (HME)<br>that heats and humidifies inhaled air by<br>retaining heat and moist(ure) from<br>exhaled air in the device.<br>(K014102 and K022125)<br>Partially restores lost breathing<br>resistance. (added)<br>(K014102 and K022125)<br>For patients with a voice prosthesis or<br>surgical speech fistula in may also<br>facilitate voicing.<br>(K014102 and K022125)<br>Provide filtered air whether the patient is<br>in dry or humid surroundings, indoor or<br>outside (K915786)<br>Provide Filtration for reducing possible<br>cross contamination including bacteria,<br>viruses and dust<br>(K043120) | The Provox® Micron Filter™ and<br>HME is a specialized stoma cover<br>that acts as a heat and moisture<br>exchanger (HME) and air filtration<br>device for laryngectomized patients.<br>Provox® Micron HME™ partially<br>restores lost breathing resistance due<br>to laryngectomy.<br>For patients with a voice prosthesis<br>or surgical speech fistula in may also<br>facilitate voicing. |
| Environment of Use | Hospital, sub-acute care settings, and<br>home<br>(K014102, K022125, K915786) | Identical |

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## Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 12-May-()8

| Specification | Predicates<br>Provox® HME Cassette (K014102)<br>Provox® FreeHands HME (K022125)<br>Blom Singer HME systems (K915786)<br>Uni-filter (K043120) | Proposed Device |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Patient Population | For patients with a voice prosthesis or<br>surgical speech fistula in may also<br>facilitate voicing.<br>(K014102) | Identical |
| Contraindications | None | Identical |
| HME function<br>(Moisture loss)<br>Per ISO 9360 | Yes<br>23.7 mg H₂O / 1<br>(K014102) | Yes<br>22 mg H₂O / 1 |
| Filtration<br>BFE/VFE<br>Per ASTM F2101 | Yes<br>No claims of BFE or VFE made<br>indicated in literature<br>(K915786)<br>Filtration efficiency claims<br>BFE - 99.98%<br>Viral - 99.9%<br>(K043120) | Yes<br>BFE ->99.8%<br>VFE ->99.8% |
| Pressure drop (cm<br>H₂O) | 0.9 cm H₂O @ 30 Lpm<br>2.11 cm H₂O @ 60 Lpm<br>(K014102) | 0.7 cm H₂O @ 30 Lpm<br>1.9 cm H₂O @ 60 Lpm |
| Used with Provox®<br>HME system | Yes<br>(K014102) | Yes |
| Materials | Standard materials for HME and filters<br>(K014102, K022125) | Yes |
| Storage conditions | 15 to 25 °C<br>(K014102) | Same |

# Differences Between Other Legally Marketed Predicate Devices

There are no significant differences that affect the safety or effectivencss of the intended device as compared to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. On the left side of the image, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

Atos Medical AB C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K072582

Trade/Device Name: Provox® Micron HMETM Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 12, 2008 Received: May 13, 2008

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.

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## Page 2 – Mr. Dryden

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.

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/industry/support/index.html.

Sincerely yours,

Clive
Chris Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Page I of 1

#### 510(k) Number: K072582

Device Name: Provox® Micron HMETM

## Indications for Use:

The Provox® Micron HME™ is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy.

For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

It is intended to be used with the Provox® HME System.

Environments of use include - hospitals, sub-acute care institutions and home.

| Prescription Use XX<br>( | |
|-----------------------------|--|
| (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)

M. Vhal

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072582