(270 days)
No
The summary describes a mechanical tracheostomy tube and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is a tracheostomy tube intended for airway management and to facilitate vocalization, not to treat a specific disease or condition.
No
This device is a tracheostomy tube designed to provide tracheal access and facilitate vocalization for tracheostomized patients, not to diagnose a medical condition.
No
The device description clearly states it is a tracheostomy tube, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "providing tracheal access for airway management of tracheostomized patient" and allowing them to "vocalize / phonate." This is a direct intervention and management of a patient's airway, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a tracheostomy tube with features for speaking, which is a medical device used for airway management and communication, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for therapeutic and functional purposes.
N/A
Intended Use / Indications for Use
The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.
Product codes
BTO
Device Description
The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
For adult patients > 30 kg.
Intended User / Care Setting
Home, hospital, and sub-acute care settings
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)
Substantially equivalent to predicate when testing Peak Pressure as measured by the ventilator at various flow rates Peak Pressure - intra-pulmonary at various flow rates Expiratory Flow (average) Expiratory Flow (Peak)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Passy Muir - K962714, Portex – Trach Talk – K972385, Shiley - Trach tubes - K962173
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
510(k) Summary
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 18-Apr-07
Engineered Medical System, Inc. 2055 Executive Dr. Indianapolis, IN 46241
Tel - (317) 246-5500 Fax - (317) 246-5501
| Official Contact: | Jeff Quinn - President |
|---|---|
| Proprietary or Trade Name: | Talking Trach |
| Common/Usual Name: | Tracheostomy tube |
| Classification Name: | Tube, tracheostomy and tube cuff |
| Device: | Traceostomy tube with inner cannula |
| Predicate Devices: | Passy Muir - K962714 |
| Portex - Trach Talk – K972385 | |
| Shiley - Trach tubes - K962173 |
Device Description -- - The proposed EMS Talking Trach is a tracheostomy tube which allows patients who are ventilator dependent or spontaneously breathing to speak or phonate. It can be used with patients on ventilators while the cuff is "up" or inflated. It is offered in sizes from 4.0 to 10.0 mm with disposable standard and speaking inner cannula.
Indications for Use -- The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients.
Patient Population -- For adult patients > 30 kg.
Environment of Use -- Home, hospital, and sub-acute care settings
Contraindications --Do not use this tracheostomy tube with abnormal upper airway anatomy or pathology as this may result in partial or total airway obstruction.
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 18-Apr-07
| Device Attributes: | |
|---|---|
| EMS Talking Trach | |
| Attributes | |
| Intended use | |
| General | To provide tracheal access for airway management of |
| tracheostomized patient. | |
| Intended use | |
| Specific | Can allow a patient to phonate with cuff up while on a |
| ventilator as well be used with a standard inner cannula or as a | |
| standard tracheostomy tube | |
| Environments of use | Home, hospital, sub-acute care settings |
| Patient Population | For adult patients > 30 kg. |
| Contraindications | Not for abnormal airway anatomy |
| Prescription | Prescription |
| Design | |
| Outer tube | Sizes 4 to 10 with or without fenestration |
| Inner cannula | Standard disposable |
| Speech inner cannula | |
| Materials | |
| Components in air pathway | PVC, Silicone |
| Performance | |
| Ventilator performance | Substantially equivalent to predicate when testing |
| Peak Pressure as measured by the ventilator at various flow rates Peak Pressure - intra-pulmonary at various flow rates Expiratory Flow (average) Expiratory Flow (Peak) | |
| Standards | Comply with ISO 5366.1, 5366-3 |
Differences between Other Legally Marketed Predicate Devices
The EMS Talking Trach is viewed as substantially equivalent to the following predicate devices – Passy Muir – K962714, Portex – Trach Talk – K972385, and Shiley – Trach tubes – K962173.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, which is a symbol often associated with healthcare, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the perimeter of the seal. The caduceus is depicted with three lines representing the snakes intertwined around a staff, and the overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Engineered Medical Systems, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court #102 Bonita Springs, Florida 34134-2015
APR 2 0 2007
Re: K062104 Trade/Device Name: EMS Talking Trach Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: March 23, 2007 Received: March 26, 2007
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.
3
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,
Sayete Y. Michael O m.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
4
Indications for Use Statement
Page 1 of 1
510(k) Number: K062104
Device Name:
EMS Talking Trach
Indications for Use:
The EMS Talking Trach tracheostomy tube, cuffed, is intended to provide tracheal access for airway management of tracheostomized patient. The device allows tracheostomy patients with a functional larynx and an unobstructed upper airway to vocalize / phonate. The Inner Speech cannula allows vocalization with the tracheostomy tube's cuff to remain inflated for ventilator dependent patients. For adult patients > 30 kg.
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)
Suette Y. Michie MD.
ion Control, Related Devices
K06 2104