(29 days)
Not Found
No
The summary describes a mechanical device (heat and moisture exchanger with speech valves) and does not mention any computational or learning capabilities.
Yes
The device is intended to heat and humidify inhaled air for patients with a voice prosthesis or surgical speech fistula, and it may also facilitate voicing, which are therapeutic functions.
No
The device is described as a heat and moisture exchanger (HME) and speech valve system for patients with a voice prosthesis or surgical speech fistula, not for diagnosing medical conditions. It facilitates voicing and humidifies inhaled air but does not provide diagnostic information.
No
The device description explicitly states it consists of a reusable speech valve unit and a disposable HMET cassette, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that heats and humidifies inhaled air and facilitates voicing for patients with a voice prosthesis or surgical speech fistula. This is a therapeutic and assistive function related to breathing and speech, not a diagnostic test performed on biological samples outside the body.
- Device Description: The device description details a system with a speech valve unit and an HME cassette. This aligns with a device used for managing airflow and facilitating speech, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Provox® FreeHands system does not fit this description.
N/A
Intended Use / Indications for Use
The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
Product codes
73 JOH, EWL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A comparison was made between Provox® FreeHands HME™, Provox® HME Cassette and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap.
Test results support the conclusion that the actual device performance satisfies the design intent.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3730 Laryngeal prosthesis (Taub design).
(a)
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.(b)
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.
0
Image /page/0/Picture/0 description: The image shows the word "ATOS" in a bold, sans-serif font. The letters are filled with a grainy texture, giving them a slightly rough appearance. The word is horizontally aligned and takes up most of the frame.
188
MEDICAL
JUL 3 0 2002
Premarket Notification 510(k) Provox® FreeHands HME™
Page 1 of 3
| 5.4 510(k) Summary of Safety and Effectiveness |
|---|
| ------------------------------------------------ |
| Date | Thursday, June 27, 2002 |
|---|---|
| 510(k) Number | K022125 (To be assigned) |
| Submitter's Name | Atos Medical AB |
| P O Box 183 | |
| Kraftgatan 8 | |
| SE-242 22 Hörby | |
| Sweden | |
| Telephone: Int+46-415-198 00 | |
| Fax: Int+46-415-198 98 | |
| E-mail: info@atosmedical.com | |
| Contact Person | Eddy Åberg |
| Director of Quality & Regulatory Affairs | |
| Trade or Proprietary Name | Provox® FreeHands HMETM |
| Common or Usual Name | Heat and Moisture Exchanger with a Speech Valve |
| Device Classification Name | Tracheostomy Tube and Tube Cuff |
| Product Code | 73 JOH |
| Predicate Devices | Provox® HME Cassette |
| 510(k) Number : K014102 | |
| Atos Medical AB, Sweden |
Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap
510(k) Number: K821568
Inhealth Technologies, USA
Bivona™ Tracheostoma Valve II
510(k) Number: K852272
Bivona Medical Technologies, USA |
| Intended Use | The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and |
Org. nr.
556268-7607
Vat No. SE556268760701
1
Image /page/1/Picture/2 description: This document describes the Provox FreeHands system, which consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The document explains that the speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position", and mentions that the clinical test was performed by the Netherlands Cancer Institute.
O Box 183 Kraftoaten 8 SE-242 22 Horbv Sweder
46 415 198 00 46 415 198 98 info@atosmedical co www.atosmedical.com 112878-17
5-14
2
Image /page/2/Picture/0 description: The image shows the words "ATOS MEDICAL" stacked on top of each other. The word "ATOS" is on the top line, and the word "MEDICAL" is on the bottom line. There is a horizontal line separating the two words. The text is in a sans-serif font.
Premarket Notification 510(k) Provox® FreeHands HME™
Page 3 of 3
approved the study. A comparison was made between Provox® FreeHands HME™, Provox® HME Cassette and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap.
Test results support the conclusion that the actual device performance satisfies the design intent.
Technological Characteristics
The proposed device is substantially equivalent to the legally marketed predicate devices in design, intended use and materials of manufacturer.
P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden
Phone +46 415 198 00 +45 415 198 98 Fax E-mail ınfo@atosmedical.com Web www.atosmedicai.com
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right.
JUL 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atos Medical, Inc. c/o Paul Dryden ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055
Re: K022125
Trade/Device Name: Provox FreeHands HME, Model 7710 Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub Design) Regulatory Class: Class II Product Code: EWL Dated: June 27, 2002 Received: July 1, 2002
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.
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.
4
. Page 2 – Paul Dryden
: 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
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
5
Image /page/5/Picture/0 description: The image shows the word "ATOS" in a bold, sans-serif font. The letters are filled with a grainy texture, giving them a slightly rough appearance. The letters are evenly spaced and aligned horizontally.
MEDICA
Indications for Use 5.3
| Applicant: | Atos Medical AB, Sweden |
|---|---|
| 510(k) Number: | K022125 (To be assigned) |
| Device Name: | Provox® FreeHands HMETM |
Intended Use:
The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Division Sign Off) Division of Ounthalmic Ear, Nos and Throat Devises
510(k) Number
P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden
or
Over-the-counter_
(Per 21 CFR 801.109)
+46 415 198 00 Phone +46 415 198 98 Fax E-mail info@atosmedical com www.atosmedical.com Web
Org. nr. 556268-7607 Val No SE556268760701 5-12