(203 days)
Not Found
No
The summary describes a physical medical device (endotracheal tube) and its performance and biocompatibility testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is used for airway management, which is a supportive function, not a therapeutic one that treats a disease or condition.
No.
The device is described as an endotracheal tube used for airway management, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical endotracheal tube, which is a hardware 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 is "indication of the trachea for airway management." This describes a device used in vivo (within the body) for a therapeutic or supportive purpose (managing the airway).
- Device Description: The description details a physical tube inserted into the trachea. This is consistent with a medical device used for direct patient care, not for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are devices used to perform tests on samples taken from the body to provide information about a person's health. This endotracheal tube is a device used to directly manage a patient's airway.
N/A
Intended Use / Indications for Use
The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indicated for oral or nasal intubation of the trachea for airway management.
Product codes
BTR
Device Description
The subject device is an oral/hasal cuffless pediatric endotracheal tube with Murphy eye. The tube incorporates a Maqill curve, radiopaque line, and ISO 15mm connector. It is manufactured from materials without latex or DEHP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Pediatrics
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 subject device met all acceptance criteria for verification testing per ISO 5361:2012; therefore, it can be considered substantially equivalent to the predicate in terms of performance. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, implantation, chemical characterization, and toxicological risk assessment. The device met all biocompatibility requirements for its intended use. Solvent extraction testing was performed to confirm the content of DEHP is less than 0.1% w/w in the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2015
Covidien Danielle Mueller Regulatory Affairs Manager 6135 Gunbarrel Ave Boulder, CO 80301
Re: K151381
Trade/Device Name: Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: November 9, 2015 Received: November 10, 2015
Dear Danielle Mueller:
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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K151381
Device Name
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
Indications for Use (Describe)
The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indication of the trachea for airway management.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 use of the Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye.
| Submitted By: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|--------------------------------------------------------------------------|
| Date: | December 10, 2015 |
| Contact Person: | Danielle Mueller
Regulatory Affairs Manager
(303) 305-2603 |
| Proprietary Name: | Mallinckrodt™ Oral/Nasal Tracheal Tube Cuffless,
Non-DEHP, Murphy Eye |
| Common Name: | Tracheal Tube |
| Device Classification Regulation: | 21 CFR 868.5730 - Class II |
| Device Product Code & Panel: | BTR |
| Predicate Devices: | BEVER™ Endotracheal Tube (K111401) |
Device Description
The subject device is an oral/hasal cuffless pediatric endotracheal tube with Murphy eye. The tube incorporates a Maqill curve, radiopaque line, and ISO 15mm connector. It is manufactured from materials without latex or DEHP.
Indications for Use/Intended Use
The oral/nasal cuffless non-DEHP pediatric endotracheal tube with Murphy eye is indicated for oral or nasal intubation of the trachea for airway management.
Technological Characteristics Comparison
The subject device is substantially equivalent to the predicate in terms of technological characteristics. Both devices are designed in accordance with ISO 5361 and have the following features in common: cuffless, standard 15mm connector, Magill curve, Murphy eye, similar size range, and similar material composition.
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| SUBJECT | PREDICATE | |
|---|---|---|
| Mallinckrodt™ Oral/Nasal | ||
| Tracheal Tube Cuffless, Non- | ||
| DEHP, Murphy Eye | BEVER™ Oral/Nasal Endotracheal | |
| Tube Cuffless [K111401] | ||
| Intended Use | Oral or nasal intubation of the | |
| trachea for airway management. | Oral or nasal intubation of the | |
| trachea for airway management | ||
| during mechanical ventilation and | ||
| anesthesia. | ||
| Patient | ||
| Population | Pediatrics | Pediatrics, Adults |
| Use | Single patient | Single patient |
| DEVICE DESIGN | ||
| Tube Design | Per ISO 5361:2012 | Per ISO 5361:1999 |
| Magill Curve | Yes | Yes |
| Murphy Eye | Yes | Yes |
| Radiopaque Line | Yes | Yes |
| Size Range | 2.0 - 7.0mm | 2.0 - 9.0mm |
| Sterilization | EtO | EtO |
| Shelf Life | 5 years | 4 years |
| Tube Material | Medical grade PVC with a non- | |
| DEHP plasticizer | Medical grade PVC |
Substantial Equivalence - Non-Clinical Evidence
The subject device met all acceptance criteria for verification testing per ISO 5361:2012; therefore, it can be considered substantially equivalent to the predicate in terms of performance. Additionally, biocompatibility testing was performed per ISO 10993-1:2009 including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, implantation, chemical characterization, and toxicological risk assessment. The device met all biocompatibility requirements for its intended use. Solvent extraction testing was performed to confirm the content of DEHP is less than 0.1% w/w in the device.
Substantial Equivalence - Clinical Evidence
N/A - Clinical evidence was not necessary to show substantial equivalence.
Substantial Equivalence – Conclusions
No new questions of safety and effectiveness have been raised. From the evidence presented in the premarket notification, the subject devices can be considered substantially equivalent.