(89 days)
K9564369
Not Found
No
The summary describes a standard closed suction catheter system and does not mention any AI or ML components or functionalities.
No.
The device is used to remove fluids and secretions from the airway to maintain a patent airway, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as a closed suction system, an endotracheal suction catheter used to remove excess fluids and secretions from the airway to maintain a patent airway. Its function is interventional (cleaning/maintaining an open airway), not diagnostic.
No
The device description explicitly states it is a "Closed Suction Endotracheal Suction Catheters," which are physical medical devices, 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 to remove secretions from the airway to maintain a patent airway. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a suction catheter, which is a physical tool used for aspiration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of cross-contamination to health care providers and other patients.
Product codes (comma separated list FDA assigned to the subject device)
73BSY, 73 CAH
Device Description
5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, distal airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care providers
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)
Not Found
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.
K9564369
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
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY 72 Hour Use TRACH CARE® with MICROBAN®
| Company: | Ballard Medical Products
12050 Lone Peak Parkway
Draper, Utah 84020
MAR '998 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
FAX: | (801) 572-6800
(801) 572-6869 |
| Contact Person: | E. Martin Chamberlain
Vice President, Regulatory Affairs |
| Trade Name: | 72 Hour Use TRACH CARE® with MICROBAN® |
| Common Name: | Endotracheal Suction Catheter |
| Classification Name: | 73BSY, Suction Catheter - Tracheobronchial (21 CFR 868.6810) |
| Description: | 5 French through 18 French TRACH CARE® Closed Suction
Endotracheal Suction Catheters with MICROBAN® and various
airway connectors. |
| Predicate Device: | TRACH CARE® Set with MICROBAN® - K9564369 |
| Indications for Use: | As with the great majority of other ET suction catheters, the
indication for endotracheal suctioning is to provide a patent
airway by removing excess fluids, secretions, exudate and
transudate through the artificial airway. These include patients
with indwelling oral or nasal endotracheal tubes, and
tracheostomy tubes. This system applies to intubated patients
requiring a full range of respiration and ventilatory support.
They may be spontaneously breathing, on mechanical ventilation,
or partially supported by mechanical devices. The TRACH
CARE® closed suction system, as well as other suction
catheters, can also be used for saline lavage and surfactant
delivery to the distal airway. The closed system device allows
for multiple suction episodes utilizing the same catheter. The
protective sleeve of the closed system isolates the flora from the
patient's secretions, thus reducing the risk of cross-contamination
to health care providers and other patients. |
| Substantial
Equivalence: | The device of this submission is identical in design, material,
chemical composition, and all other logical characteristics as the
predicate device. This submission requests permission to market
a device with a label change in contraindications FROM "Do not
use for more than 24 hours." TO "Do not use for more than 72
hours. Change more frequently if catheter becomes soiled or
develops any other factor which reduces device efficiency." |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I I 1998
E. Martin Chamberlain, Jr., Ph.D. Ballard Medical Products 12050 Lone Peak Parkway Draper, UT 84020
Re: K974630 TRACH CARE-EX™ Regulatory Class: II (two) Product Code: 73 CAH Dated: December 11, 1997 December 12, 1997 Received:
Dear Dr. Chamberlain:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbrandinq and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) · inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - E. Martin Chamberlain, Jr., Ph.D.
This letter will allow you to beqin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for use: TRACH CARE® Closed Suction Catheters
As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of crosscontamination to health care providers and other patients.
M. Pugl
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K974630 510(k) Number_
Prescriptions use √
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