HI-CARE CLOSED SUCTION SYSTEM

K972258 · Mallinckrodt Medical · BSY · Dec 29, 1997 · Anesthesiology

Device Facts

• Record ID: K972258
• Device Name: HI-CARE CLOSED SUCTION SYSTEM
• Applicant: Mallinckrodt Medical
• Product Code: BSY · Anesthesiology
• Decision Date: Dec 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

Device Story

Hi-Care Closed Suction System is a medical device designed to suction tracheobronchial secretions from patients intubated with endotracheal or tracheostomy tubes. The system allows for suctioning without disconnecting the patient from the ventilator circuit, thereby maintaining a closed system. It is intended for single-patient use and requires replacement every 24 hours. The device is operated by healthcare professionals in clinical settings. By facilitating airway clearance while minimizing exposure to secretions and maintaining ventilation, the device helps manage respiratory secretions and potentially reduces the risk of ventilator-associated complications.

Indications for Use

Indicated for patients with endotracheal or tracheostomy tubes requiring suctioning of tracheobronchial secretions. For single patient use only.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Submission Summary (Full Text)

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Rockville MD 20857

DEC 2 9 1997

Mr. Michael B. Schoeck Mallinckrodt Medical, Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, MO 63134

Re: K972258 Hi-Care Closed Suction System Regulatory Class: I (one) Product Code: 73 BSY October 6, 1997 Dated: Received: October 7, 1997

Dear Mr. Schoeck:

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 against misbranding 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 regulation may result in requlatory 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 - Mr. Michael B. Schoeck

This letter will allow you to begin 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 requlation (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 [phone]. Also, please note the regulation entitled, "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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

-

Rockville MD 20857

DEC 2 9 1997

Mr. Michael B. Schoeck Mallinckrodt Medical, Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, MO 63134

Re: K972258 Hi-Care Closed Suction System Regulatory Class: I (one) Product Code: 73 BSY October 6, 1997 Dated: Received: October 7, 1997

Dear Mr. Schoeck:

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 against misbranding 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 regulation may result in requlatory 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.

{3}------------------------------------------------

### Page 2 - Mr. Michael B. Schoeck

This letter will allow you to begin 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 requlation (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 [phone]. Also, please note the regulation entitled, "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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# 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

## Device Name: Hi-Care Closed Suction System

### Indications for Use:

This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions.

This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

chalildo Zwys

Unision Sinn-Off Division of Cardiovasc and Neurological Devices

ption Use

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)