(163 days)
Not Found
No
The device description and intended use focus on a mechanical process of atomizing medication and delivering it through an intubated airway. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis.
Yes
The device is used to administer medication into the lungs to treat a medical condition, which is a therapeutic purpose.
No
Explanation: The device is used to inject medication into the lungs, not to diagnose a condition or disease. It is a drug delivery device for therapeutic purposes.
No
The device description clearly states it is a "disposable, sterile device" that converts a solution into a spray, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver medication directly into the lungs of a patient through an intubated airway. This is a therapeutic intervention performed on the patient's body.
- Device Description: The device is described as converting a topical solution into a spray for application into the trachea. This is a drug delivery mechanism, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
-
- To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway.
- To establish a means in which to introduce medication into an intubated airway 2. without interrupting the flow of life-supporting ventilation to the patient.
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The Endotracheal Mucosal Atomization Device (MADett) is a disposable, sterile device that converts a topical solution into a fine particle spray for application into the trachea bevond the ETT. The clinician connects the device in line between the endotracheal tube and the ventilation device. The clinician then attaches a syringe of topical medication to the luer lock fitting of the atomizer and delivers medications into the trachea while simultaneously ventilating the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs, trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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.
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
§ 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).
0
SEP 1 1 2002
510(K) Summary: K021044 Summary of Safety and Effectiveness
Company and Submission Information
| Applicant | Tim Wolfe, MD - Medical Director | ||
|---|---|---|---|
| Wolfe Tory Medical, Inc. | |||
| 79 West 4500 South, Suite 16 | |||
| Salt Lake City, UT 84107 | |||
| (801) 281-3000 | |||
| Contact | Tim Wolfe, MD | ||
| Date Prepared | March 26, 2002, Revised - June 25, 2002 | ||
| Establishment Registration | |||
| Number | 1722554 | ||
| Classification Name and | |||
| Product Code | Accessory, Endotracheal tube | ||
| 73 BTR | |||
| Classification | Class II | ||
| Panel | Anesthesiology | ||
| Common/Usual Name | Atomizer | ||
| Trade Name | MADett | ||
| Predicate Devices | Stat-Med® | ||
| Manufactured by Sheridan (Patented by Sheridan Catheter | |||
| Corporation in 1971; Also called LITA) | |||
| Preamendment: No 510K due to use prior to May 1976. | |||
| EMT® Emergency Medicine Tube | |||
| Manufactured by Mallinckrodt Medical | |||
| 510(k)# K802505 approved March 13, 1981 | |||
| MedPort™ Emergency Medication Airway Tube Adapter | |||
| Manufactured by Greenfield Medical Products | |||
| 510(k)# K971759 approved March 2, 1998 | |||
| Performance Standards | None established |
1
Device description:
The Endotracheal Mucosal Atomization Device (MADett) is a disposable, sterile device that converts a topical solution into a fine particle spray for application into the trachea bevond the ETT. The clinician connects the device in line between the endotracheal tube and the ventilation device. The clinician then attaches a syringe of topical medication to the luer lock fitting of the atomizer and delivers medications into the trachea while simultaneously ventilating the patient.
Indications For Use:
-
- To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway.
- To establish a means in which to introduce medication into an intubated airway 2. without interrupting the flow of life-supporting ventilation to the patient.
Predicate devices:
-
- Stat-Med manufactured by Sheridan (Patented by Sheridan Catheter Corporation in 1971; Also called LITA) - Preamendment device: No 510K due to use prior to May 1976.
-
- EMT® Emergency Medicine Tube manufactured by Mallinckrodt Medical; 510(k)# K802505 approved March 13, 1981.
-
- MedPort™ Emergency Medication Airway Tube Adapter manufactured by Greenfield Medical Products; 510(k)# K971759 approved March 2, 1998
2
| | Endotracheal
Mucosal
Atomization
Device: Wolfe
Tory | Stat-Med® -
Kendall
EMT -
Mallinckrodt | MedPort™ -
Greenfield Medical |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | To apply
medications through
an endotracheal tube
in an effective
manner while
reducing risk of
splash back onto the
clinician. ET Tube
not included as part
of the device. | To apply medications
through an
endotracheal tube in
an effective manner
while reducing risk of
splash back onto the
clinician. The ET
tube is part of the
overall device. | To apply medications
through an
endotracheal tube in
an effective manner
while reducing risk of
splash back onto the
clinician. ET Tube
not included as part
of the device. |
| Medication and
Dosage amount | User controlled | User controlled | User controlled |
| Target population | Intubated patients
requiring pulmonary
fluid or medication
administration as
determined by the
treating physician. | Intubated patients
requiring pulmonary
fluid or medication
administration as
determined by the
treating physician. | Intubated patients
requiring pulmonary
fluid or medication
administration as
determined by the
treating physician. |
| Delivery form | Fine particle spray
mist | Droplet particle
spray mist | Droplet particle
spray mist |
| Cannula length | 20 inches – length
of insertion into
ETT varies based on
size of ETT. | Length of ETT –
varies depending on
tube size. | No cannula –
connects to proximal
tube. |
| Cannula shape | Semi-rigid | Semi-rigid | No cannula |
| Power source -
Spray generated by | Piston syringe | Piston syringe | Piston syringe |
| Materials | Polycarbonate and
polyvinyl chloride | Polypropylene and
polyvinyl chloride | "Medical plastic" |
| Skill level required | Similar | Similar | Similar |
| Injection port | Luer lock
compatible | Luer lock compatible | Luer lock compatible |
| Sizes | Fits 7.0 to 9.0 ETT | Comes with 6.0 to
8.5 ETT | Fits "full range of
airway tube sizes" |
| Disposable | Yes | Yes | Yes |
Table Comparing the MADett to Predicate Devices
3
Discussion of Substantial Equivalency to predicate devices:
The Wolfe Tory MADett fulfills the requirements set down by the FDA for substantial equivalency to several currently marked devices for the following reasons:
1. All four devices are designed for the same intended use:
- To establish a path in which to inject medication into the lungs of a patient . who is being ventilated through an intubated airway.
- To establish a means in which to introduce medication into an intubated . airway without interrupting the flow of life-supporting ventilation to the patient.
2. Though minimally technologically different from the predicate devices, the MADett meets criteria set down by the FDA to allow substantial equivalency:
The MADett technical design is very similar to the predicate devices and the principles of operation and indications for use are identical. The major difference is that the predicate devices medication lumen is embedded into the ETT wall and is part of the ETT itself, whereas the MADett is a separate device from the ETT and the MADett lumen is positioned within the ETT rather than embedded in its side wall. This minimal difference does not raise questions regarding safety and effectiveness. Furthermore, the MADett is made up of similar materials as the predicate devices. These parts and their design have performance testing data and biocompatibility data provided in this 510k and its addendum's proving they are safe for their intended use. Their combination into the current design creates a device nearly identical to already approved and marketed predicate devices and offers no new questions regarding safety and effectiveness.
Conclusions
The MADett device described in this 510K is very similar in terms of design, materials and indications for use to three predicate devices already approved and marketed. There are no new safety concerns when compared to the already available predicate devices. For these reasons, we feel the MADett fulfills all criteria to be found substantially equivalent to the predicate devices and should be cleared for marketing.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tim Wolfe, M.D. Medical Director Wolfe Tory Medical, Incorporated 79 West 4500 South, Suite 16 Salt Lake City, Utah 84107
Re: K021044
Trade/Device Name: Endotracheal Mucosal Atomization Device (MADett) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: II Product Code: BTR Dated: July 3, 2002 Received: July 9, 2002
Dear Dr. Wolfe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
5
Page 2 - Dr. Tim Wolfe
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for
Ver/ 3 - 4/24/96
Applicant: Wolfe Tory Medical, Inc.
KO2104 510(k) Number (if known): _
Device Name: Endotracheal Mucosal Atomization Device (MADett)
Indications For Use:
- To establish a path in which to inject medication into the lungs of a patient who is 1. being ventilated through an intubated airway.
-
- To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
f
Over-the-counter use __
(Optional Format 1-2-96)
(Division Sign-Off) VY Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ._