(98 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and clinical performance of a standard tracheal tube, with no mention of AI or ML.
No.
A therapeutic device is one that treats or heals a condition. This device is used for airway management, acting as a conduit to maintain an open airway, rather than directly treating a disease or condition. While preventing trauma, its primary function is not therapeutic.
No
The device is described as a tracheal tube for airway management, used for intubation. Its function is to facilitate breathing and minimize trauma during intubation, not to diagnose a medical condition.
No
The device description clearly describes a physical, sterile, single-use tracheal tube made of polyvinyl chloride with a barium sulfate stripe, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states this is a tracheal tube designed for airway management through intubation. It is a physical device used to facilitate breathing, not to analyze biological samples.
- Intended Use: The intended use is for airway management, which is a direct intervention on the patient's respiratory system, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics of the tube (material, shape, features) and its use in a clinical setting (anesthesia, emergent and respiratory care).
- Lack of IVD Indicators: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on biological markers.
This device is a medical device used for a therapeutic or supportive purpose (airway management), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Tracheal tube designed for oral and nasal intubation and indicated for airway management.
Product codes
BTR
Device Description
Sterile, single-use device for use in anesthesia and emergent and respiratory care. Center-beveled, flexible, curved, slightly rounded, tapered distal tip. Curved and preformed (shaped) tube configurations. Two facing Murphy eyes flanking the bevel. Polyvinyl chloride material with a barium sulfate filled stripe along the length of the device.
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
Not Found
Intended User / Care Setting
Not Found
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
Independent clinical testing of the Parker Flex-Tip Tracheal Tube demonstrates that it significantly minimizes and prevents the nasal trauma and bleeding which commonly occur in nasal intubations performed with comparable, commercially available tracheal tubes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Independent clinical testing of the Parker Flex-Tip Tracheal Tube demonstrates that it significantly minimizes and prevents the nasal trauma and bleeding which commonly occur in nasal intubations performed with comparable, commercially available tracheal tubes.
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).
0
510(k) Summary
Responsive
JUN 님 3 2010
| Submitted by: | Parker Medical, Inc. |
|---|---|
| 9457 S. University Blvd., #331 | |
| Highlands Ranch, CO 80126 | |
| Contact Person | Lewis Ward |
| L.W. Ward and Associates, Inc. | |
| 4655 Kirkwood Court | |
| Boulder, CO 80301 | |
| Date Prepared: | February 8, 2010 |
| Product: | Parker Flex-Tip Tracheal Tube |
| Trade Name: | |
| Common Name: | Tracheal Tube (also, Endotracheal Tube) |
| Classification Name: | Tube, Tracheal (w/wo connector) |
| Intended Use: | Tracheal tube designed for oral and nasal intubation and indicated for airway management |
| Technological Characteristics: | Sterile, single-use device for use in anesthesia and emergent and respiratory care. Center-beveled, flexible, curved, slightly rounded, tapered distal tip. Curved and preformed (shaped) tube configurations. Two facing Murphy eyes flanking the bevel. Polyvinyl chloride material with a barium sulfate filled stripe along the length of the device. |
| Substantial Equivalence: | The Parker Flex-Tip Nasal Tracheal Tube is an expanded Indication for Use to the Parker Flex-Tip Tracheal Tube cleared under K984528 for oral intubations. |
| Test Data: | Independent clinical testing of the Parker Flex-Tip Tracheal Tube demonstrates that it significantly minimizes and prevents the nasal trauma and bleeding which commonly occur in nasal intubations performed with comparable, commercially available tracheal tubes. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three overlapping lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 1 2012
Parker Medical, Incorporated C/O Mr. Lewis Ward Consultant to Parker Medical, Incorporated L.W. Ward and Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
Re: K100546
Trade/Device Name: Parker Medical Nasal/Oral Flex-Tip Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: May 13, 2010 Received: May 17, 2010
Dear Mr. Ward:
This letter corrects our substantially equivalent letter of June 3, 2010.
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 (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 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.
2
Page 2 - Mr. Ward
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 (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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and · Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Parker Medical Nasal/Oral Flex-Tip Tracheal Tube
Indications for Use:
Tracheal tube designed for oral and nasal intubation and indicated for airway management.
Prescription Use >