MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER

K971759 · Green Field Medical Sourcing, Inc. · BTR · Mar 2, 1998 · Anesthesiology

Device Facts

• Record ID: K971759
• Device Name: MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
• Applicant: Green Field Medical Sourcing, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Mar 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. To establish a path in which to inject medication into the lungs of a patient who has undergone cardiac and/or pulmonary arrest and who is being ventilated through an intubated airway. 2. To establish a means in which to introduced medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient. 3. To provide an alternative means other than intravenous injection for administering lifesaving drugs when a patient is being assisted by an endotracheal ube.

Device Story

MedPort Emergency Medication Airway Tube Adapter; mechanical adapter for endotracheal tubes. Facilitates intrapulmonary medication delivery during cardiac/pulmonary arrest; allows drug administration without interrupting mechanical ventilation. Used in emergency clinical settings; operated by physicians or trained medical personnel. Provides alternative to intravenous access for lifesaving drugs; maintains airway integrity during delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical airway adapter; designed for integration with endotracheal tubes. Non-electronic, passive device.

Indications for Use

Indicated for patients experiencing cardiac and/or pulmonary arrest requiring ventilation via an intubated airway; provides an alternative route for medication administration without interrupting life-supporting ventilation.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 1998

Mr. Donald R. Gorsuch GreenField Medical Products, Inc. 910 Boston Turnpike Shrewsbury, MA 01545

Re: K971759 MedPort™ Emergency Medication Airway Tube Adapter Requlatory Class: II (two) Product Code: 73 BTR Dated: December 5, 1997 Received: December 8, 1997

Dear Mr. Gorsuch:

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 Regulation (QS) for Medical Devices: General regulation (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 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 - Mr. Donald R. Gorsuch

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 Additionally, for questions on the promotion and [phone]. 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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## Indications For Use

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510(k) Number (if known): K971759

Device Name: MedPort Emergency Medication Airway Tube Adapter

Indications For Use:

- 1. To establish a path in which to inject medication into the lungs of a patient who has undergone cardiac and/or pulmonary arrest and who is being ventilated through an intubated airway.
- 2. To establish a means in which to introduced medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
- 3. To provide an alternative means other than intravenous injection for administering lifesaving drugs when a patient is being assisted by an endotracheal ube.

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Concurrence of CDRH, Office of Device Evaluation (ODE) "hust (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1971759 510(k) Number _ Over-The-Counter Use Prescription Use J OR (Per 2.1 CFR 801.109) (Optional Format 1-2-96)