(209 days)
No
The device description and performance studies focus on the physical characteristics and standard testing of a tracheostomy tube, with no mention of AI or ML capabilities.
No.
The device is a tracheostomy tube for airway management, not for treating a disease or condition. While it aids in patient care, it does not provide therapy itself.
No
Explanation:
The device description and intended use clearly state that the device is a tracheostomy tube designed for airway management and subglottic secretion management. It is a tool for treatment and management, not for diagnosing a medical condition.
No
The device description clearly states it is a "single patient use tracheostomy tube" with physical components like an outer cannula, integrated evac suction line, and available in different configurations (single cannula, DIC, RIC). The performance studies also include physical testing like biocompatibility, sterilization, and bench testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide tracheal access for airway management and subglottic secretion management. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a tracheostomy tube, which is a medical device used to establish an airway. It does not perform any in vitro testing on biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Anatomical Site: The device interacts directly with the trachea, an anatomical site within the body, rather than being used to test samples outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This tracheostomy tube does not fit that description.
N/A
Intended Use / Indications for Use
Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
Product codes (comma separated list FDA assigned to the subject device)
JOH, BTO
Device Description
The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheal
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospitals, long-term care facilities
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)
Biocompatibility testing: The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," recognized by FDA. Testing included cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The subject device met all biocompatibility requirements for its intended use.
Sterilization and Packaging Validation: The subject device is provided sterile via ethylene oxide sterilization and was validated to ensure sterility in accordance with ISO 11135-1 and ISO 10993-7. A packaging validation was conducted accordance with ISO 11607-1. The reusable inner cannula cleaning validation was performed in accordance with the AAMI TIR30:2011.
Bench Testing: Bench testing on the subject device was conducted in accordance with ISO 5366, ISO 5361, ISO 5356-1 and ISO 18190. In addition, internal bench testing was conducted to assess cuff performance, suction performance and evac lumen patency.
MRI Testing: MRI safety and compatibility testing and MR compatibility labeling for the subject devices comply with FDA quidance "Establishing Safety and Compatibility of Passive Implants in the MR Environment", and ASTM F2503-13.
Human Factors Testing: Human Factors testing was conducted in a simulated environment with 15 participants in accordance with FDA Guidance 1757 Applying Human Factors and Usability Engineering to Medical Devices.
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.
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services 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.
Covidien Stacy Barton Senior Regulatory Affairs Specialist 6135 Gunbarrel Ave Boulder, Colorado 80301
Re: K193077
Trade/Device Name: Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube And Tube Cuff Regulatory Class: Class II Product Code: JOH, BTO Dated: April 24, 2020 Received: April 27, 2020
Dear Stacy Barton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Shiley™ Adult Flexible Evac Tracheostomy Tube with TaperGuard™ Cuff
Indications for Use (Describe)
Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
| 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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Image /page/3/Picture/2 description: The image shows the Covidien logo. The logo consists of a blue square made up of smaller squares of varying shades of blue. To the right of the square is the word "COVIDIEN" in a bold, sans-serif font, also in blue.
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the Shiley™ Adult Flexible Evac Tracheostomy Tube with TaperGuard™ Cuff.
| I Submitter | |
|---|---|
| Submitted By: | Covidien |
| 6135 Gunbarrel Avenue | |
| Boulder, CO 80301 | |
| Date: | May 22, 2020 |
| Contact Person: | Stacy Barton |
| Sr. Regulatory Affairs Specialist | |
| (720) 376-0061 | |
| II Device | |
| Proprietary Name: | Shiley™ Adult Flexible Evac Tracheostomy Tube |
| with TaperGuard™ Cuff | |
| Common Name: | Tracheostomy Tube & Tube Cuff |
| Device Classification Regulation: | 21 CFR 868.5800 - Class II |
| Device Product Code & Panel: | JOH, BTO |
| III Predicate Devices | Smiths Medical Portex® BLUselect® Suctionaid® |
| Tracheostomy Tube (K173384) | |
| Shiley™ Adult Flexible Tracheostomy Tube Cuffless | |
| or with TaperGuard™ Cuff, Reusable Inner Cannula | |
| (RIC) (K150844) | |
| Reference Devices | Portex Blue Line Ultra Suctionaid Tracheostomy |
| Tube (K030570) | |
| Shiley™ Adult Flexible Tracheostomy Tube Cuffless | |
| or with TaperGuard™ Cuff, Disposable Inner | |
| Cannula (DIC) (K142296) |
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Image /page/4/Picture/2 description: The image contains the logo for Covidien. The logo consists of a blue square made up of smaller squares of varying shades of blue on the left. To the right of the square is the word "COVIDIEN" in a bold, sans-serif font, also in blue.
Reference Devices (continued):
Shiley™ (formally Mallinckrodt) Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye (K151381)
IV Device Description
The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).
V Indications for Use/Intended Use
The subject device is intended for use in providing tracheal access for airway management and subglottic secretion management in adult patients and is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
VI Technological Characteristics Comparison
The subject device and the predicate devices have similar technological characteristics: outer cannula; single patient use inner cannula; 15mm connector; flange; cuff; inflation line; and evac suction line.
The subject and predicate devices are made with similar material (PVC with DEHT plasticizer). The subject device inner cannula is made with polyethylene; the reusable inner cannula material is identical to the RIC of predicate K150844. A comparison table has been provided on the next page.
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| SUBJECT DEVICE | PREDICATE DEVICES | Comparison | ||
|---|---|---|---|---|
| Shiley™ Adult Flexible Evac | ||||
| Tracheostomy Tube with | ||||
| TaperGuard™ Cuff | ||||
| (Single Cannula, DIC, RIC) | ||||
| K193077 | Portex® BLUSelect® | |||
| Suctionaid® Tracheostomy Tube | ||||
| K173384 | Shiley™ Adult Flexible | |||
| Tracheostomy Tube, Reusable | ||||
| Inner Cannula (RIC) | ||||
| K150844 | ||||
| INDICATIONS FOR USE | ||||
| Intended Use | Providing tracheal access for | |||
| airway management and | ||||
| subglottic secretion | ||||
| management for adult patients. | ||||
| Also intended for use with | ||||
| percutaneous dilatational | ||||
| tracheotomy (PDT) procedures. | Airway maintenance of | |||
| tracheostomised patients. | ||||
| Suctionaid® allows aspiration | ||||
| of contaminated mucous and | ||||
| subglottic secretions that | ||||
| collect and build up between | ||||
| the tracheostomy tube cuff and | ||||
| the glottis. | Providing tracheal access for | |||
| airway management. Also | ||||
| intended for use with | ||||
| Percutaneous Dilatational | ||||
| Tracheotomy (PDT) procedures. | Similar to | |||
| K173384 | ||||
| Similar to | ||||
| K150844 | ||||
| Patient | ||||
| Population | Adults | Adults | Adults | Same |
| Environment | ||||
| of Use | Hospitals, long-term care | |||
| facilities | Critical care settings, acute care | |||
| settings, long term care | ||||
| facilities, and for home use | Hospitals, long-term care | |||
| facilities, home care | Similar to | |||
| K173384 | ||||
| Similar to | ||||
| K150844 | ||||
| Use | Single patient | Single Patient | Single patient | Same |
| TECHNOLOGICAL CHARACTERISTICS | ||||
| MRI | ||||
| compatibility | Conditional | Conditional | N/A | Same1 as |
| K173384 | ||||
| PDT | ||||
| compatibility | Yes | No | Yes | Same as |
| K150844 | ||||
| Radiopaque | Yes | Yes | Yes | Same |
| Inner Cannula | Included | Included | Included | Same2 |
| Sterilization | Ethylene oxide (SAL 10-6) | Ethylene oxide (SAL 10-6) | Ethylene oxide (SAL 10-6) | Same |
| Shelf Life | 5 Years | 5 Years | 5 Years | Same |
| Size Range | 6.5mm – 9.0mm, 10mm | 6.0mm – 10mm | 6.5mm – 9.0mm, 10mm | Similar to |
| K173384 | ||||
| Same as | ||||
| K150844 | ||||
| Connector | Standard 15mm connector | Standard 15mm connector | Standard 15mm connector | Same |
| MATERIALS (patient contact) | ||||
| Outer Cannula | PVC with DEHT plasticizer | DEHT PVC | PVC with DEHT plasticizer | |
| Inner Cannula | Reusable: High density polyethylene Disposable: Low density polyethylene | DEHT PVC | Reusable: High density polyethylene | Similar to |
| K173384 | ||||
| Flange | PVC with DEHT plasticizer | DEHT PVC | PVC with DEHT plasticizer | |
| 15mm | ||||
| Connector | Polymethylpentene | DEHT PVC | Polymethylpentene | Similar to |
| K150844 | ||||
| Cuff | PVC with DEHT plasticizer | DEHT PVC | PVC with DEHT plasticizer | |
| (cuffed configuration only) | ||||
| Evac Suction | ||||
| lumen; Yellow | ||||
| Connector/Cap | PVC with ATBC plasticizer; High | |||
| Density Polyethylene | DEHT PVC | N/A | ||
| PERFORMANCE SPECIFICATIONS | ||||
| Device Design | ISO 5366, ISO 18190 | ISO 5366, ISO 18190 | ISO 5366 | Same as |
| K173384 | ||||
| Similar to | ||||
| K150844 |
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1 Magnetic Resonance Environment use was assessed per ASTM F2052-15 (Standard Test Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment) and MRI Conditional labeling according to ASTM F2503 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment) ensures safe use in Magnetic Resonance Environment
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? The subject device offers single cannula (RIC or DIC) configurations. The inner cannula cleaning instructions allow for re-use with the same patient (RIC configuration) and were validated according to AAM TR 30 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices).
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Image /page/7/Picture/2 description: The image contains the logo for Covidien. The logo consists of a blue square made up of smaller squares in varying shades of blue, with a vertical blue line running through the center. To the right of the square is the word "COVIDIEN" in a bold, dark blue sans-serif font.
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Image /page/8/Picture/2 description: The image shows the logo for Covidien. The logo consists of a blue square made up of smaller squares of varying shades of blue, with the word "COVIDIEN" in blue, sans-serif font to the right of the square. The logo is simple and modern, with a focus on the company name.
VII Performance Data
The following performance testing was performed in support of the substantial equivalence determination:
Biocompatibility testing
The biocompatibility evaluation was conducted in accordance with FDA Guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," recognized by FDA.
Testing included cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, subchronic toxicity implantation, chemical characterization, and risk assessment. The subject device met all biocompatibility requirements for its intended use.
Sterilization and Packaging Validation
The subject device is provided sterile via ethylene oxide sterilization and was validated to ensure sterility in accordance with ISO 11135-1 and ISO 10993-7. A packaging validation was conducted accordance with ISO 11607-1. The reusable inner cannula cleaning validation was performed in accordance with the AAMI TIR30:2011.
Bench Testing
Bench testing on the subject device was conducted in accordance with ISO 5366, ISO 5361, ISO 5356-1 and ISO 18190. In addition, internal bench testing was conducted to assess cuff performance, suction performance and evac lumen patency.
MRI Testing
MRI safety and compatibility testing and MR compatibility labeling for the subject devices comply with FDA quidance "Establishing Safety and Compatibility of Passive Implants in the MR Environment", and ASTM F2503-13.
Human Factors Testing
Human Factors testing was conducted in a simulated environment with 15 participants in accordance with FDA Guidance 1757 Applying Human Factors and Usability Engineering to Medical Devices.
VIII Substantial Equivalence
Intended Use
The subject device and predicate devices share similar intended uses. The subject device provides tracheal access for airway management and subglottic secretion management in adult patients while the predicate K173384 is for airway maintenance of tracheostomised patients and the aspiration of contaminated mucous and subglottic secretions that collect and build up between the tracheostomy tube cuff and the glottis.
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Image /page/9/Picture/2 description: The image contains the word "COVIDIEN" in bold, dark blue letters. To the left of the word is a square logo that is also dark blue. The logo is divided into smaller squares of varying shades of blue.
Additionally, the subject device is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures. PDT is an alternative to the surgical placement of a tracheostomy tube and has been shown to be cost-effective and safe. (Najmuddin et al, 2014) 3. The subject device is designed with a tapered tube tip identical to that of the predicate K150844 and the reference device K142296. PDT procedure compatibility does not impact the safety or effectiveness of the subject device.
Technological Characteristics
All patient contacting components of the subject and predicate devices are made with similar materials and plasticizer (PVC with DEHT). The inner cannulas of the subject device are made of polyethylene, and the material of the reusable inner cannula is identical to the RIC of predicate K150844, whereas the inner cannula of predicate K173384 is made of PVC with DEHT.
Both the subject and predicate devices comply with ISO 10993 for material biocompatibility and bench testing on the subject device was conducted per ISO 5366, ISO 5356-1, ISO 5361 and ISO 18190.
Reference Devices
This summary table presents legally marketed reference devices which:
- support the substantial equivalence determination of the subject device with the . predicate devices
- share design, materials, and technological characteristics with the subject device ●
| Name | FDA 510(k)
Number and
Clearance Date | FDA
Product
Code | Relevance |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------|-----------------------------------------------------------------------------|
| Portex Blue Line Ultra Suctionaid
Tracheostomy Tube | K030570 | BTO | Substantially equivalent to
Predicate Device, K173384 |
| Shiley™ Adult Flexible
Tracheostomy Tube Cuffless or
with TaperGuard™ Cuff,
Disposable Inner Cannula (DIC) | K142296 | JOH | Same design platform and
similar materials as Subject
Device, K193077 |
| Shiley™ (formally Mallinckrodt)
Oral/Nasal Tracheal Tube
Cuffless, Non-DEHP, Murphy Eye | K151381 | BTR | Same material as Subject
Device, K193077 |
3 Ahmad, Ali, Najmuddin, Asif, Hussain, Kashif, ... A., A. (2014, September 15), Timing of Tracheotomy in Mechanically Ventilated Critically III Morbidly Obese Patients. Retrieved from https://www.hindawi.com/journals/ccrp/2014/840638/
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Image /page/10/Picture/2 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square logo. The logo is divided into four smaller squares, with the top left and bottom right squares being a darker shade of blue than the other two.
Clinical Evidence
N/A – Clinical evidence was not necessary to show substantial equivalence.
IX Conclusion
Substantial equivalence of the subject device is shown through performance testing as stated in the submission. The subject and predicate devices have similar indications, size ranges, intended use, environment of use, and patient population. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent to the predicate devices.