(231 days)
Not Found
No
The 510(k) summary describes a physical medical device (tracheostomy tube) and its intended use, materials, and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a tracheostomy tube intended to provide direct airway access and an artificial airway to the lower respiratory tract, which is a therapeutic function.
No
Explanation: The device is a tracheostomy tube designed to provide airway access. It is not used to diagnose a medical condition, but rather to manage an existing one.
No
The device description clearly states it is a silicone tracheostomy tube with wire reinforcement and includes physical components like an obturator, neck strap, and disconnection wedge. It is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TRACOE silcosoft® Function: The TRACOE silcosoft® tracheostomy tube is a device that is inserted into the body to provide an artificial airway. It is a therapeutic and supportive device, not a diagnostic one that analyzes samples.
The provided information clearly describes a medical device used for direct airway access, which is a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents.
The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician.
For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower respiratory tract
Indicated Patient Age Range
Neonates, infants, children, and adolescents.
Intended User / Care Setting
Applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.
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)
Summary of Non- clinical testing
TRACOE silcosoft® has been fully tested to meet the product requirements and identified control measures from the risk management process. This testing included functional testing, testing of recognized standards, sterility and biocompatibility. Testing has been performed both in house and by accredited 3rd party laboratories. This testing included:
- l Functional/mechanical testing according to ISO 5366 Anaesthetic and respiratory equipment -- tracheostomy tubes -- part 3: pediatric tracheostomy tubes
- . Comprehensive biocompatibility testing was performed based on ISO 10993-1 Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. This test process included a biological risk assessment and chemical analysis, cytotoxicity, genotoxicity, intracutaneous reactivity, sensitization, and acute toxicity
- Sterilization, Reprocessing and Packaging Validation was performed in accordance with ISO 11135-1, ISO 10993-7, ISO 17665-1, ISO 17665-2, and ISO 11138-3.
In addition, a comprehensive comparison testing was performed between the TRACOE silcosoft® and the legally marketed predicate device, Bivona®Tracheostomy Tubes that included design, functionality and performance testing. The successful results of the non-clinical testing demonstrated that TRACOE silcosoft® is substantially equivalent to the predicate device.
Summary of Clinical testing
Clinical testing was not required to demonstrate substantial equivalence.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 27, 2018
TRACOE medical GmbH % Lu Anne Johnson President Capamed Inc. 14 E. Eau Claire St. 447 Rice Lake, Wisconsin 54868
Re: K172720
Trade/Device Name: TRACOE silcosoft Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: March 29, 2018 Received: March 30, 2018
Dear Lu Anne Johnson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name TRACOE silcosoft®
Indications for Use (Describe)
The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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TRACOE medical GmbH Reichelsheimer Str. 1/3 55268 Nieder-Olm Germany Phone: (+49)6136 9169-0 Fax: (+49)6136 9169-200
510(K) SUMMARY as required by section 21 CFR 807.92
| Date: | April 24, 2018 |
|---|---|
| Submitter of 510(k): | |
| Company name: | TRACOE medical GmbH |
| Establishment Registration number: | 8010485 |
| Address: | Reichelsheimer Str. 1/3 |
| 55268 Nieder-Olm | |
| Germany | |
| Phone: | (+49)61369169-0 |
| Fax: | (+49)61369169-200 |
| Correspondent: | Julia Vogler |
| Head of Regulatory Affairs | |
| Device Name: | |
| Trade/Proprietary Name: | TRACOE silcosoft® |
| Common/Usual Name: | Tracheostomy Tubes |
| Classification | Class II |
| Classification Name: | Tracheostomy tube and tube cuff |
| 21 CFR 868.5800 | |
| Product Code: JOH |
Legally Marketed Device
Our device is based on the legally marketed device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Smiths Medical | Bivona® Tracheostomy Tubes | K083641 |
Device Description:
TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents.
The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician.
For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap.
4
The TRACOE silcosoft® is intended for single-patient use up to 29 days and may be reprocessed 7 times within this period. The device is applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.
Intended use:
The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheostomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times.
Patient population: neonates, infants, children, and adolescents.
Summary of the Technical Characteristics
For substantial equivalence, the predicate device K083641 Bivona® Tracheostomy Tube was selected based on its intended use, design and functionality.
| | TRACOE® silcosoft | Bivona® Tracheostomy Tubes
K083641 |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The TRACOE silcosoft®
tracheostomy tube is intended
to provide direct airway access
for a tracheostomized patient
up to 29 days. It may be
reprocessed for single patient
use up to 7 times.
Patient population: neonates,
infants, children and
adolescents. | The Bivona® Tracheostomy Tube
is intended to provide direct
airway access for a
tracheotomized patient for up to
29 days. It may be reprocessed
for single-patient use up to 10
times for adult sizes and up to 5
times for pediatric sizes. |
| Technical Characteristics | | |
| The device is available in
LVHP(H2O) cuffed and uncuffed
models with diameters (ID) of
2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5
mm | Same | Same |
| The device is radiopaque and
can be used in x-ray, CT or MR
imaging (MR Conditional) | Same | Same |
| The device is provided sterile
and intended for single patient
use. | Same | Same |
| The device is inserted into a
tracheastoma for less than 29
days and can be reprocessed. | Same | Same |
| The device is secured with a
fabric tie/strap | Same | Same |
| The tube is made of silicone
with wire reinforcement | Same | Same |
5
| The tube includes an obturator
| to assist with insertion | Same | Same |
|---|---|---|
| The flange, cuff and inflation | ||
| system is made of silicone. | Same | Same |
The TRACOE silcosoft® and the predicate device have the same intended use, design and functionality. The difference between TRACOE silcosoft® and the predicate device are:
- . Patient population: Bivona® offers tracheostomy tubes for adults (larger diameters)
- Reprocessing: Biovona® allows 5 times for pediatrics within 29 days and TRACOE silcosoft® ● allows 7 times within 29 days.
These differences do not raise different questions of safety and effectiveness of the device. The similarities in design and technology are the basis and reason for substantial equivalence of the TRACOE silcosoft® to the legally marketed predicate device.
Summary of Non- clinical testing
TRACOE silcosoft® has been fully tested to meet the product requirements and identified control measures from the risk management process. This testing included functional testing, testing of recognized standards, sterility and biocompatibility. Testing has been performed both in house and by accredited 3rd party laboratories. This testing included:
- l Functional/mechanical testing according to ISO 5366 Anaesthetic and respiratory equipment -- tracheostomy tubes -- part 3: pediatric tracheostomy tubes
- . Comprehensive biocompatibility testing was performed based on ISO 10993-1 Biological evaluation of medical devices - part 1: evaluation and testing within a risk management process. This test process included a biological risk assessment and chemical analysis, cytotoxicity, genotoxicity, intracutaneous reactivity, sensitization, and acute toxicity
- Sterilization, Reprocessing and Packaging Validation was performed in accordance with ISO 11135-1, ISO 10993-7, ISO 17665-1, ISO 17665-2, and ISO 11138-3.
In addition, a comprehensive comparison testing was performed between the TRACOE silcosoft® and the legally marketed predicate device, Bivona®Tracheostomy Tubes that included design, functionality and performance testing. The successful results of the non-clinical testing demonstrated that TRACOE silcosoft® is substantially equivalent to the predicate device.
Summary of Clinical testing
Clinical testing was not required to demonstrate substantial equivalence.
Conclusion
The TRACOE silcosoft® has passed all defined criteria. The device has performed as well or better than the predicate device and is therefore considered substantially equivalent to the cleared predicate device.