MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER

• K Number: K971759
• Device Name: MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
• Manufacturer: GREEN FIELD MEDICAL SOURCING, INC.
• Date Cleared: 1998-03-02 ( 294 days)
• Product Code: BTR
• Regulation Number: 868.5730

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 Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device for administering medication into the lungs via an intubated airway and does not mention any AI or ML capabilities.

Therapeutic

Yes
The device is used to inject medication into the lungs, administer lifesaving drugs, and introduce medication into an intubated airway, all of which are therapeutic interventions.

Diagnostic

No
The device is described as a means to inject medication into the lungs, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The intended use describes a device that establishes a path for medication injection and introduces medication into an intubated airway. This functionality strongly implies a physical device component (e.g., a tube, catheter, or delivery system) is required to perform these actions, not just software. The lack of a device description further supports this, as a software-only device would typically describe the software's functions and inputs/outputs.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Intended Use: The intended use of this device is to administer medication directly into the lungs of a patient through an intubated airway. This is an in vivo procedure (performed within the living body), not an in vitro procedure (performed outside the living body).
• Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or the use of reagents, which are typical characteristics of IVDs.

Therefore, this device falls under the category of a medical device used for therapeutic administration, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

73 BTR

Device Description

MedPort™ Emergency Medication Airway Tube Adapter

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lungs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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.

Not Found

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

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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.

1

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

Page 1 of - 1

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.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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)