(263 days)
Not Found
No
The summary describes a mechanical device for humidifying air and facilitating speech in patients with tracheostomy or endotracheal tubes. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as providing heat and humidity for entrained air, incorporating a cough relief and suction port valve, and facilitating speech by directing air through the vocal cords, which are all actions intended to restore or improve physiological function or alleviate medical conditions in patients.
No
The device provides heat, humidity, and airflow control for patients with tracheostomy or endotracheal tubes to facilitate breathing and speech. It does not analyze physiological data to diagnose a medical condition.
No
The device description clearly outlines physical components like HME media, a suction port, and connectors, indicating it is a hardware device.
Based on the provided information, the TrachVox is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The TrachVox connects directly to a patient's airway (tracheostomy or endotracheal tube) and interacts with the air they breathe. It does not analyze or test any biological samples like blood, urine, or tissue.
- The intended use and device description focus on providing heat and humidity to inhaled air, facilitating speech, and providing a suction port. These are all functions related to respiratory support and management, not diagnostic testing.
- There is no mention of analyzing or measuring any biological markers or substances. The key metrics provided are related to the device's performance in terms of dead space, resistance, weight, and moisture output, which are physical characteristics and functional parameters, not diagnostic measurements.
Therefore, the TrachVox falls under the category of a medical device used for respiratory support and management, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech.
For patients breathing spontaneously via an endotracheal tube the TrachVox provides heat and moisture for the inhaled air. For single patient use.
Product codes
JOH
Device Description
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air
- Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen
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
Any patient
Intended User / Care Setting
Home, Hospital, ICU, Sub-acute Institutions
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)
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dead Space (ml): 9.5 ml
Resistance to flow: 0.23 cm H₂O @ 30 Lpm or 0.9 cm H₂O @ 60 Lpm
Weight: 2.9 gm
Moisture output (mg H₂O/l) ISO 9360: 20.1 mg H₂O /l @ 500 ml TV
Moisture output (mg H₂O/I) ISO 9360 with supplemental oxygen: 14.9 mg H₂O /l @ 10 Lpm
Predicate Device(s)
K821568, K944451, K952845, K914336, K811241
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 3 0 2002
K0137∂X
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 April 30, 2002
| Engineered Medical Systems
2055 Executive Dr.
Indianapolis, IN 46241 | Tel (317) 246-5500
Fax (317) 246-5501 |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Bonnie Holly - Quality Manager |
| Proprietary or Trade Name: | TrachVox |
| Common/Usual Name: | Tracheal HME with speech valve and suction port |
| Classification Name: | Laryngeal (Taub) Prosthesis - Accessory |
| Predicate Devices: | In Health - Blom-Singer Tracheostoma with
HumidiFilter Cap - K821568
Passy Muir Speaking Valves - K944451
Gibeck, Inc. - Trach-Vent - K952845
Vital Signs - Breathe Easy - K914336
Intersurgical - Hydro-Trach T - exempt
B&B Technologies - Bodai Suction Safe -- K811241 |
Device Description:
The TrachVox connects to a 15 mm tracheostomy or endotracheal tube connector of a spontaneously breathing patient. It incorporates four (4) key features:
- HME media for humidifying inhaled air �
- 0 Suction port
- Method for closing off exhalation to outside and divert the exhaled breathe around the 0 tracheostomy tube and through the vocal cords for speech
- Connector for delivery of supplemental oxygen 0
| Intended Use: | |
|---|---|
| Indicated Use -- | For patients breathing spontaneously via a tracheostomy tube, the |
| TrachVox provides heat and humidity for entrained air and | |
| incorporates a cough relief and suction port valve. The unit may be | |
| closed by the patient's finger, which directs the air through the vocal | |
| cords to facilitate speech. | |
| For patients breathing spontaneously via an endotracheal tube the | |
| TrachVox provides heat and moisture for the inhaled air. For single | |
| patient use. | |
| Environment of Use -- | Home, Hospital, ICU, Sub-acute Institutions |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 April 30, 2002
Comparison to Predicate Devices:
11
| Attribute | Proposed TrachVox device |
|---|---|
| For spontaneously breathing tracheostomy patients | Yes |
| Incorporated speech valve | Yes |
| Provides heat and humidity | Yes |
| Can provide supplemental oxygen | Yes |
| Intended to connect to tracheostomy tube of | |
| spontaneously breathing patient | Yes |
| Can connect to an ET tube of spontaneously breathing | |
| patient | Yes |
| Intended for single patient up to 24 hours | Yes |
| Prescription | Yes |
| Intended population | Any patient |
| Intended Environment of Use | Home, Hospital, sub-acute, ICU |
| Placement in various locations in circuit | Yes |
| Supplemental oxygen connection | Yes |
| Standard 15/22 mm connectors | Yes |
| Dead Space (ml) | 9.5 ml |
| Resistance to flow | 0.23 cm H₂O @ 30 Lpm or 0.9 cm H₂O @ 60 Lpm |
| Weight | 2.9 gm |
| Normally closed suction slit valve | Yes |
| Speech valve normally open for inhalation | Yes |
| Allows exhalation to atmosphere freely | Yes |
| Method for diverting exhaled air through vocal cord | |
| for facilitating speech (Speech valve) | Cover suction valve with fingers, depress housing, |
| compressing foam and closes off exhalation to | |
| atmosphere vents | |
| Method for revert to normal exhalation after speaking | Remove finger, foam spring-action raises housing, |
| opening exhalation to atmosphere vents | |
| Moisture output (mg H₂O/l) ISO 9360 | 20.1 mg H₂O /l @ 500 ml TV |
| Moisture output (mg H₂O/I) ISO 9360 | |
| with supplemental oxygen | 14.9 mg H₂O /l @ 10 Lpm |
| Housing components - polypropylene | Yes |
| HME media | Foam |
| Valve | Silicone |
| None under Section 514 | Yes |
| ISO 5356-1 Conical 15/22 | Yes |
| ISO 9360 - HME moisture output | Yes |
Differences between Other Legally Marketed Predicate Devices
The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
JUL 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Engineered Medical Systems C/O Mr. Paul Dryden Promedic. Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501
Re: K013728
Trade/Device Name: Trach Vox Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: April 30, 2002 Received: May 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.
3
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,
Ullatorst
Timo ry A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 2.3 Indications for Use | |
|---|---|
| ------------------------- | -- |
| Page 1 of 1 | |
|---|---|
| 510(k) Number: | K013728 (To be assigned) |
| Device Name: | TrachVox |
| Intended Use: | For patients breathing spontaneously via a tracheostomy tube, the TrachVox provides heat and humidity for entrained air and incorporates a cough relief and suction port valve. The unit may be closed by the patient's finger, which directs the air through the vocal cords to facilitate speech. |
For patients breathing spontaneously via an endotracheal tube (ET tube) the TrachVox provides heat and moisture for the inhaled air. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
le Aulutohn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 11/01/3728
Prescription Use
(Per CFR 801.109)
or
Over-the-counter use__________________________________________________________________________________________________________________________________________________________