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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Endotracheal Mucosal Atomization Device (MADett). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a formal study with quantitative performance metrics.

Therefore, many of the requested sections about acceptance criteria, study details, and performance measures are not directly addressed in the provided document. The 510(k) process relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of indications, technological characteristics, and materials, rather than presenting novel clinical study performance data against predefined acceptance criteria for the new device.

Here's an analysis based on the provided text, outlining what can and cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific quantitative performance metrics for the MADett device. Its substantial equivalence argument is based on a qualitative comparison of features and intended use with predicate devices.

Acceptance Criteria (Not explicitly stated for MADett)	Reported Device Performance (Not explicitly stated for MADett)
No specific, quantifiable acceptance criteria or performance metrics are provided in the document for the MADett device. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.	No specific, quantifiable performance data is reported for the MADett device against acceptance criteria in this document.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. No test set or clinical study demonstrating performance against acceptance criteria is described. The submission is a comparison to predicate devices, not a performance study.
Data Provenance: Not applicable. No study data is presented. The "data" consists of a comparison of device characteristics to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth establishment for a test set is mentioned as part of this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable. No test set adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done or described in this document. The submission type (510(k) for substantial equivalence) typically does not require this type of study for devices like an atomizer, especially when demonstrating equivalence to already marketed devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a medical device (an atomizer), not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

Not applicable. No ground truth was established for a performance study. The "truth" in this submission relates to the functional and material characteristics of the MADett being sufficiently similar to the predicate devices. The closest concept might be the "truth" that the predicate devices are legally marketed and safe/effective.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the document):

The document describes a substantial equivalence determination process, not a "study that proves the device meets acceptance criteria" in the typical sense of a clinical trial or performance study with quantitative outcomes.

The "study" presented is a comparative analysis of the MADett device against three predicate devices already on the market:

Stat-Med® (Sheridan)
EMT® Emergency Medicine Tube (Mallinckrodt Medical)
MedPort™ Emergency Medication Airway Tube Adapter (Greenfield Medical Products)

The "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the MADett is "substantially equivalent" to these predicates in terms of:

Intended Use: All four devices share 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" and "To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient."
Technological Characteristics:
- Similarities: User-controlled medication/dosage, target population (intubated patients), power source (piston syringe), similar skill level required, luer lock compatible injection port, disposable.
- Differences (Acknowledged but deemed "minimal" and not raising new safety/effectiveness questions):
  - MADett has a "fine particle spray mist" delivery form, while predicates have "droplet particle spray mist."
  - MADett has a 20-inch semi-rigid cannula that inserts into the ETT, whereas Stat-Med's is part of the ETT, EMT's varies with ETT length, and MedPort™ has no cannula.
  - MADett fits 7.0-9.0 ETT, while predicates have slightly different fitting ranges or are integral to the ETT.
Materials: Polycarbonate and polyvinyl chloride for MADett are described as "similar materials" to those used in predicate devices (e.g., polypropylene and polyvinyl chloride). The submission states that performance testing data and biocompatibility data for these materials were provided elsewhere in the 510(k) and addendums (though not detailed in this summary).

Conclusion of the "Study" (Rationale for Substantial Equivalence):

Wolfe Tory Medical, Inc. concluded that the MADett fulfills the requirements for substantial equivalency because:

All four devices (MADett and the three predicates) have the same intended use.
Although there are minimal technological differences (primarily the MADett being a separate device with its lumen positioned within the ETT, unlike predicates where the lumen is often embedded in the ETT wall), these differences do not raise new questions regarding safety and effectiveness.
The MADett is made of similar materials to the predicate devices, and these materials have supporting performance and biocompatibility data.

The FDA's decision to clear the device K021044 for marketing confirms their agreement with this assessment of substantial equivalence.

Summary

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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 RegistrationNumber	1722554
Classification Name andProduct 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

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Device description:

Indications For Use:

1. 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:

1. 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.
1. EMT® Emergency Medicine Tube manufactured by Mallinckrodt Medical; 510(k)# K802505 approved March 13, 1981.
1. MedPort™ Emergency Medication Airway Tube Adapter manufactured by Greenfield Medical Products; 510(k)# K971759 approved March 2, 1998

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	EndotrachealMucosalAtomizationDevice: WolfeTory	Stat-Med® -KendallEMT -Mallinckrodt	MedPort™ -Greenfield Medical
Indications for use	To applymedications throughan endotracheal tubein an effectivemanner whilereducing risk ofsplash back onto theclinician. ET Tubenot included as partof the device.	To apply medicationsthrough anendotracheal tube inan effective mannerwhile reducing risk ofsplash back onto theclinician. The ETtube is part of theoverall device.	To apply medicationsthrough anendotracheal tube inan effective mannerwhile reducing risk ofsplash back onto theclinician. ET Tubenot included as partof the device.
Medication andDosage amount	User controlled	User controlled	User controlled
Target population	Intubated patientsrequiring pulmonaryfluid or medicationadministration asdetermined by thetreating physician.	Intubated patientsrequiring pulmonaryfluid or medicationadministration asdetermined by thetreating physician.	Intubated patientsrequiring pulmonaryfluid or medicationadministration asdetermined by thetreating physician.
Delivery form	Fine particle spraymist	Droplet particlespray mist	Droplet particlespray mist
Cannula length	20 inches – lengthof insertion intoETT varies based onsize of ETT.	Length of ETT –varies depending ontube size.	No cannula –connects to proximaltube.
Cannula shape	Semi-rigid	Semi-rigid	No cannula
Power source -Spray generated by	Piston syringe	Piston syringe	Piston syringe
Materials	Polycarbonate andpolyvinyl chloride	Polypropylene andpolyvinyl chloride	"Medical plastic"
Skill level required	Similar	Similar	Similar
Injection port	Luer lockcompatible	Luer lock compatible	Luer lock compatible
Sizes	Fits 7.0 to 9.0 ETT	Comes with 6.0 to8.5 ETT	Fits "full range ofairway tube sizes"
Disposable	Yes	Yes	Yes

Table Comparing the MADett to Predicate Devices

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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.

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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.

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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

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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.
1. 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 ._

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).