72 HOUR USE TRACH CARE WITH MICROBAN

K974630 · Ballard Medical Products · CAH · Mar 11, 1998 · Anesthesiology

Device Facts

• Record ID: K974630
• Device Name: 72 HOUR USE TRACH CARE WITH MICROBAN
• Applicant: Ballard Medical Products
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Closed suction catheter system; used for removal of airway secretions in intubated patients. Device features protective sleeve to isolate patient flora, reducing cross-contamination risk to healthcare providers and patients. Allows multiple suction episodes with single catheter. Used in clinical settings; operated by healthcare providers. Primary change from predicate is extended use duration from 24 to 72 hours.

Technological Characteristics

Closed suction catheter system; includes airway connectors and protective sleeve. Incorporates MICROBAN® antimicrobial agent. Sizes range from 5 French to 18 French. Mechanical device; no software or electronic components.

Indications for Use

Indicated for intubated patients (oral/nasal endotracheal or tracheostomy tubes) requiring airway patency via removal of fluids, secretions, exudate, and transudate. Applicable to patients spontaneously breathing, on mechanical ventilation, or partially supported. Supports saline lavage and surfactant delivery.

Regulatory Classification

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.

Predicate Devices

• TRACH CARE® Set with MICROBAN® (K9564369)

Submission Summary (Full Text)

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K974630

## 510(k) SUMMARY 72 Hour Use TRACH CARE® with MICROBAN®

| Company: | Ballard Medical Products<br>12050 Lone Peak Parkway<br>Draper, Utah 84020<br>MAR '998 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>FAX: | [phone]<br>[phone] |
| Contact Person: | E. Martin Chamberlain<br>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<br>Endotracheal Suction Catheters with MICROBAN® and various<br>airway connectors. |
| Predicate Device: | TRACH CARE® Set with MICROBAN® - K9564369 |
| Indications for Use: | As with the great majority of other ET suction catheters, the<br>indication for endotracheal suctioning is to provide a patent<br>airway by removing excess fluids, secretions, exudate and<br>transudate through the artificial airway. These include patients<br>with indwelling oral or nasal endotracheal tubes, and<br>tracheostomy tubes. This system applies to intubated patients<br>requiring a full range of respiration and ventilatory support.<br>They may be spontaneously breathing, on mechanical ventilation,<br>or partially supported by mechanical devices. The TRACH<br>CARE® closed suction system, as well as other suction<br>catheters, can also be used for saline lavage and surfactant<br>delivery to the distal airway. The closed system device allows<br>for multiple suction episodes utilizing the same catheter. The<br>protective sleeve of the closed system isolates the flora from the<br>patient's secretions, thus reducing the risk of cross-contamination<br>to health care providers and other patients. |
| Substantial<br>Equivalence: | The device of this submission is identical in design, material,<br>chemical composition, and all other logical characteristics as the<br>predicate device. This submission requests permission to market<br>a device with a label change in contraindications FROM "Do not<br>use for more than 24 hours." TO "Do not use for more than 72<br>hours. Change more frequently if catheter becomes soiled or<br>develops any other factor which reduces device efficiency." |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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 [phone] or [phone] 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 √

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