(89 days)
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.
5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.
This device, the TRACH CARE® with MICROBAN®, is an Endotracheal Suction Catheter. The 510(k) summary indicates that the submission requests permission to market a device with a label change, extending the recommended use time from "24 hours" to "72 hours."
The submission explicitly states: "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.""
This implies that the acceptance criteria and study proving the device meets them are based on demonstrating that the device remains safe and effective for the extended 72-hour use period, given that its physical characteristics are otherwise identical to the previously cleared 24-hour version. However, the provided text does not contain any specific performance data, acceptance criteria, or details of a study that directly prove the device meets these extended use criteria for the 72-hour period. The clearance is based on the substantial equivalence argument of the label change.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's what can be inferred or stated based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from label change) | Reported Device Performance |
|---|---|
| Maintain safety and effectiveness for 72 hours of continuous use (compared to predicate's 24 hours). | Not reported in the provided text. The submission states the device is "identical in design, material, chemical composition, and all other logical characteristics as the predicate device," implying its fundamental performance characteristics are unchanged. The justification for extending the usage period from 24 to 72 hours, which would typically require performance data, is not present. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe any specific test set or study conducted for the 72-hour extended use claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Since no specific test set or study is described, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical device (endotracheal suction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. The basis for extending the use time to 72 hours is not detailed in terms of specific ground truth data or studies. The substantial equivalence argument relies on the physical identity to the predicate.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
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510(k) SUMMARY 72 Hour Use TRACH CARE® with MICROBAN®
| Company: | Ballard Medical Products12050 Lone Peak ParkwayDraper, Utah 84020MAR '998 |
|---|---|
| Telephone:FAX: | (801) 572-6800(801) 572-6869 |
| Contact Person: | E. Martin ChamberlainVice 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 SuctionEndotracheal Suction Catheters with MICROBAN® and variousairway connectors. |
| Predicate Device: | TRACH CARE® Set with MICROBAN® - K9564369 |
| Indications for Use: | As with the great majority of other ET suction catheters, theindication for endotracheal suctioning is to provide a patentairway by removing excess fluids, secretions, exudate andtransudate through the artificial airway. These include patientswith indwelling oral or nasal endotracheal tubes, andtracheostomy tubes. This system applies to intubated patientsrequiring a full range of respiration and ventilatory support.They may be spontaneously breathing, on mechanical ventilation,or partially supported by mechanical devices. The TRACHCARE® closed suction system, as well as other suctioncatheters, can also be used for saline lavage and surfactantdelivery to the distal airway. The closed system device allowsfor multiple suction episodes utilizing the same catheter. Theprotective sleeve of the closed system isolates the flora from thepatient's secretions, thus reducing the risk of cross-contaminationto health care providers and other patients. |
| SubstantialEquivalence: | The device of this submission is identical in design, material,chemical composition, and all other logical characteristics as thepredicate device. This submission requests permission to marketa device with a label change in contraindications FROM "Do notuse for more than 24 hours." TO "Do not use for more than 72hours. Change more frequently if catheter becomes soiled ordevelops any other factor which reduces device efficiency." |
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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
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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 √
orc
§ 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).