(260 days)
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.
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.
Here's an analysis of the acceptance criteria and the study information for the Provox® Micron HME™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Provox® Micron HME™) |
|---|---|---|
| HME function (Moisture loss) | 23.7 mg H₂O / L (K014102) | 22 mg H₂O / L |
| Filtration BFE/VFE (Per ASTM F2101) | BFE - 99.98% / Viral - 99.9% (K043120 - Uni-Filter) | BFE ->99.8% / VFE ->99.8% |
| Pressure drop (cm H₂O) @ 30 Lpm | 0.9 cm H₂O @ 30 Lpm (K014102) | 0.7 cm H₂O @ 30 Lpm |
| Pressure drop (cm H₂O) @ 60 Lpm | 2.11 cm H₂O @ 60 Lpm (K014102) | 1.9 cm H₂O @ 60 Lpm |
2. Sample size used for the test set and the data provenance
The provided text does not contain details about specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for the performance evaluations. The performance metrics listed are presented as single values, likely representing the results of a conducted test or series of tests, but the methodology and sample size for these tests are not described in this summary. The document focuses on demonstrating substantial equivalence to predicates through comparison of specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the data provided. The performance metrics (moisture loss, filtration efficiency, pressure drop) are objective measurements typically determined through laboratory testing according to established standards (e.g., ISO 9360, ASTM F2101), not through expert consensus or interpretation of subjective data requiring ground truth establishment by human experts.
4. Adjudication method for the test set
This information is not applicable as the performance metrics are objective measurements, not subjective evaluations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a medical device (HME and filter for laryngectomized patients), not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in the way described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reported performance metrics would be laboratory measurements conforming to established international standards.
- HME function (Moisture loss): Measured according to ISO 9360.
- Filtration BFE/VFE: Measured according to ASTM F2101.
- Pressure drop: Measured under controlled airflow conditions.
These standards define the precise methodology and equipment for obtaining these objective measurements.
8. The sample size for the training set
This information is not applicable. The Provox® Micron HME™ is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
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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 - K014102Atos - Provox® Freelands HME - K022125In Health Blom Singer HME systems - K915786Draeger - 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 | PredicatesProvox® 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 byretaining heat and moist(ure) fromexhaled air in the device.(K014102 and K022125)Partially restores lost breathingresistance. (added)(K014102 and K022125)For patients with a voice prosthesis orsurgical speech fistula in may alsofacilitate voicing.(K014102 and K022125)Provide filtered air whether the patient isin dry or humid surroundings, indoor oroutside (K915786)Provide Filtration for reducing possiblecross contamination including bacteria,viruses and dust(K043120) | The Provox® Micron Filter™ andHME is a specialized stoma coverthat acts as a heat and moistureexchanger (HME) and air filtrationdevice for laryngectomized patients.Provox® Micron HME™ partiallyrestores lost breathing resistance dueto laryngectomy.For patients with a voice prosthesisor surgical speech fistula in may alsofacilitate voicing. |
| Environment of Use | Hospital, sub-acute care settings, andhome(K014102, K022125, K915786) | Identical |
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Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 12-May-()8
| Specification | PredicatesProvox® 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 orsurgical speech fistula in may alsofacilitate voicing.(K014102) | Identical |
| Contraindications | None | Identical |
| HME function(Moisture loss)Per ISO 9360 | Yes23.7 mg H₂O / 1(K014102) | Yes22 mg H₂O / 1 |
| FiltrationBFE/VFEPer ASTM F2101 | YesNo claims of BFE or VFE madeindicated in literature(K915786)Filtration efficiency claimsBFE - 99.98%Viral - 99.9%(K043120) | YesBFE ->99.8%VFE ->99.8% |
| Pressure drop (cmH₂O) | 0.9 cm H₂O @ 30 Lpm2.11 cm H₂O @ 60 Lpm(K014102) | 0.7 cm H₂O @ 30 Lpm1.9 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.
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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 (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
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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( | |
|---|---|
| (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
§ 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.