PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

K014102 · Atos Medical AB · JOH · Feb 21, 2002 · Anesthesiology

Device Facts

• Record ID: K014102
• Device Name: PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251
• Applicant: Atos Medical AB
• Product Code: JOH · Anesthesiology
• Decision Date: Feb 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Provox HME system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moisture from exhaled air in the device. It may also facilitate voicing.

Device Story

Provox HME system functions as heat and moisture exchanger; captures heat and moisture from exhaled air to humidify inhaled air; may facilitate voicing. Used by patients with tracheostomies; device operates passively via respiratory airflow. No electronic components, software, or algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive heat and moisture exchanger; non-electronic; no software; materials and design consistent with standard HME devices for tracheostomy applications.

Indications for Use

Indicated for patients requiring heat and moisture exchange for inhaled air, potentially facilitating voicing.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2002

Mr. Eddy Aberg Atos Medical AB P.O. Box 183 SE-242 22 Hörby Sweden

## Re: K014102

Provox HME System Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II (two) Product Code: 73 JOH Dated: January 23, 2002 Received: January 23, 2002

Dear Mr. Aberg:

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.

{1}------------------------------------------------

Page 2 - Mr. Eddy Aberg

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr o resument that your device complies with other requirements of the Act that I DA has made a aowners and regulations administered by other Federal agencies. You must of any I cacial stututes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (DF CFR Part 820); and if applicable, the electronic forth in the quality bystems (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) I mis letter will and w you'll beginn tial equivalence of your device of your device to a legally prematicated predicatedevice 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 11 you desire specific advices for in vitro diagnostic devices), please contact the Office of additionally 21 OF IC Far at 646. Additionally, for questions on the promotion and advertising of Compliance at [phone]. Iffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation children, "Miloranang of esponsibilities under the Act may be obtained from the Outler general information on your respational 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,

Dook Tiller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Atos Medical AB, Sweden Applicant:

K014102 510(k) Number:

Provox HME System Device Name:

## Indications for Use:

The Provox HME system is a heat and moisture exchanger (HME) that heats and The Frovox HiviE system is a nout and moist from exhaled air in the device. For numidines innated an by realiming near all all may also facilitate voicing.

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

Concurrence of CDRH, Office of Device Evaluation (O

510(k) Numbe

\/ PRESCRIPTION USES

(Per 21 CFR 801.109) (Optional Format 1-2-96)9