(260 days)
No
The device description and performance metrics focus on physical properties (heat/moisture exchange, filtration, pressure drop) and mechanical function (closing for voicing). There is no mention of AI, ML, data processing, or algorithms.
Yes.
The device acts as a heat and moisture exchanger and air filtration device for laryngectomized patients, partially restoring lost breathing resistance and facilitating voicing, which are therapeutic functions.
No
The device description clearly states its functions as a heat and moisture exchanger, air filter, and a facilitator for voicing in laryngectomized patients. None of these functions involve diagnosis.
No
The device description clearly indicates it is a physical stoma cover with filter media, designed to heat, humidify, and filter inhaled air. It also has a mechanical feature for voicing. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Provox® Micron HME™ is a physical device that covers a stoma and modifies inhaled air. It does not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use describes the device's function as a heat and moisture exchanger, air filter, and facilitator of voicing. None of these activities involve in vitro diagnostic testing.
- Device Description: The description focuses on the physical components and their function in modifying inhaled air and facilitating voicing. There is no mention of analyzing biological samples.
Therefore, the Provox® Micron HME™ falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JOH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stoma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Environment of Use: Hospital, acute care settings, and home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K014102, K022125, K915786, K043120
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
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.(b)
Classification. Class II.
0
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 |
| Atos - Provox® Freelands HME - K022125 | |
| In Health Blom Singer HME systems - K915786 | |
| 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.
1
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
Provox® HME Cassette (K014102)
Provox® FreeHands HME (K022125)
Blom Singer HME systems (K915786)
Uni-filter (K043120) | Proposed Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Is a heat and moisture exchanger (HME)
that heats and humidifies inhaled air by
retaining heat and moist(ure) from
exhaled air in the device.
(K014102 and K022125)
Partially restores lost breathing
resistance. (added)
(K014102 and K022125)
For patients with a voice prosthesis or
surgical speech fistula in may also
facilitate voicing.
(K014102 and K022125)
Provide filtered air whether the patient is
in dry or humid surroundings, indoor or
outside (K915786)
Provide Filtration for reducing possible
cross contamination including bacteria,
viruses and dust
(K043120) | The Provox® Micron Filter™ and
HME is a specialized stoma cover
that acts as a heat and moisture
exchanger (HME) and air filtration
device for laryngectomized patients.
Provox® Micron HME™ partially
restores lost breathing resistance due
to laryngectomy.
For patients with a voice prosthesis
or surgical speech fistula in may also
facilitate voicing. |
| Environment of Use | Hospital, sub-acute care settings, and
home
(K014102, K022125, K915786) | Identical |
2
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 12-May-()8
| Specification | Predicates
Provox® HME Cassette (K014102)
Provox® FreeHands HME (K022125)
Blom Singer HME systems (K915786)
Uni-filter (K043120) | Proposed Device |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Patient Population | For patients with a voice prosthesis or
surgical speech fistula in may also
facilitate voicing.
(K014102) | Identical |
| Contraindications | None | Identical |
| HME function
(Moisture loss)
Per ISO 9360 | Yes
23.7 mg H₂O / 1
(K014102) | Yes
22 mg H₂O / 1 |
| Filtration
BFE/VFE
Per ASTM F2101 | Yes
No claims of BFE or VFE made
indicated in literature
(K915786)
Filtration efficiency claims
BFE - 99.98%
Viral - 99.9%
(K043120) | Yes
BFE ->99.8%
VFE ->99.8% |
| Pressure drop (cm
H₂O) | 0.9 cm H₂O @ 30 Lpm
2.11 cm H₂O @ 60 Lpm
(K014102) | 0.7 cm H₂O @ 30 Lpm
1.9 cm H₂O @ 60 Lpm |
| Used with Provox®
HME system | Yes
(K014102) | Yes |
| Materials | Standard materials for HME and filters
(K014102, K022125) | Yes |
| Storage conditions | 15 to 25 °C
(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.
3
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.
4
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
5
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
| ( | |
|---|---|
| (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