ESOPHAGEAL INTUBATION DETECTOR by WOLFE TORY MEDICAL, INC.

A device that relies on anatomical differences between the trachea and the esophagus. By applying negative pressure to the endotracheal tube, the rigid trachea remains open allowing free aspiration of air into the EDD, whereas the fibromuscular esophagus collapses around the endotracheal tube and thus prevents aspiration of air.

AI/ML Overview

The provided text describes a 510(k) Summary for an Esophageal Intubation Device (EID). This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against specific, pre-defined acceptance criteria with a rigorous study design. Therefore, the information provided does not fully align with the typical structure of an acceptance criteria and study report for novel device approval.

However, based on the information provided, we can infer and construct the closest possible response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the new device. Instead, it relies on demonstrating that the EID performs comparably to the predicate device in its ability to detect the placement of a double lumen airway tube.

Acceptance Criteria (Inferred from Study Conclusion)	Reported Device Performance (from Wafai et al. study)
Ability to correctly identify the location of the distal lumen (tracheal vs. esophageal) of an esophageal/tracheal double lumen airway tube.	Correctly identified the location of the distal lumen 100% of the time.

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

The "test set" in this context refers to the Wafai et al. study's patient population where the EID was evaluated.

Sample Size: 58 patients (20 tracheas, 38 esophagi).
Data Provenance: The study by Wafai et al. took place in patients undergoing elective surgery. The country of origin is not specified, but the journal name "Anesthesiology" suggests an international or US-based context. The study is described retrospectively.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. The study design implies direct observation or verification of tube placement (e.g., surgical observation of where the tube was placed) rather than expert consensus on imaging. The phrase "The Combitube... was placed into 20 tracheas and 38 esophagi of patients" suggests the placement itself was the ground truth.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct determination of tube placement and the EID's output. There's no mention of an adjudication process for the EID's readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes a study where the device (EID) was used by clinicians to make a determination, but it does not compare human readers with and without AI assistance to measure an effect size. The study is a direct performance evaluation of the EID.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the sense that the EID itself is a standalone physical device that provides an output (air return or no air return). The "algorithm" here is the physical principle of the device detecting negative pressure in the trachea vs. esophageal collapse. The study evaluates this standalone device's performance.

7. The Type of Ground Truth Used

The ground truth was established by direct observation/placement of the esophageal/tracheal double lumen airway tube in either the trachea or esophagus during elective surgery. This can be considered a form of clinical observation/procedure-based ground truth, as the actual anatomical placement was known.

8. The Sample Size for the Training Set

Not applicable. This device is a physical diagnostic tool based on anatomical principles, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Wolfe Tory Medical, Inc. The logo consists of the letters "WT" in a bold, stylized font, with the words "WOLFE TORY" above the words "MEDICAL, INC." To the left of the logo is a handwritten date, 3/26/99.

79 West 4500 Salt Lake City, Utah 84107 Phone: 801-281-3000 Fax: 801-281-0708 E-Mail: wolfetory@aol.com

510(K) Summary Summary of Safety and Effectiveness

Company and Submission Information
Applicant	Wolfe Tory Medical, Inc.79 West 4500 South, Suite 21Salt Lake City, UT 84107(801) 281-3000
Contact	Dr. Tim Wolfe
Date Prepared	2/17/99
Classification Name	Tube, tracheal - accessory (73 BTR II 868.5730)
Common/Usual Name	Esophageal Detector Device (EDD)
Proprietary Name andLegally Marketed Device	Esophageal Intubation Device (EID®)Bulb Model - K942628Syringe Model - K930741
Device Description	A device that relies on anatomical differences between the tracheaand the esophagus. By applying negative pressure to theendotracheal tube, the rigid trachea remains open allowing freeaspiration of air into the EDD, whereas the fibromuscularesophagus collapses around the endotracheal tube and thusprevents aspiration of air.
New Intended Use	To assist verification of placement of the endotracheal tube oresophageal/tracheal double lumen airway tube.

Summary of Technological Characteristics of the Endotracheal Tube and the Esophageal/Tracheal Double Lumen Airway Tube

Endotracheal Tube	Esophageal/Tracheal Double Lumen Airway Tube
Non-collapsible single lumen hollow tube	Non-collapsible double lumen hollow tube
Outside diameter of distal lumen = 13mm	Outside diameter of distal lumen =14mm
(For inner diameter of 9.0 mm)	(For 41 French size tube)
Distal end lumen opens out the tip with	Distal end lumen opens out the tip with
inflatable/deflatable balloon proximal to tip.	inflatable/deflatable balloon proximal to tip.
15mm standard adapter at proximal end for	15mm standard adapter at proximal end for
ventilation	ventilation
	Second lumen opens on side of tube through
	fenestrated openings.
	A second balloon exists above fenestrated
	openings.
Requires clinical judgement to assure proper	Requires clinical judgement to assure proper
placement.	placement.
Requires distal end placement in the trachea for	Distal end placement may be located in the
ventilation of the lungs.	trachea or the esophagus, but knowing location
	is required for ventilation of the proper lumen.

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Image /page/1/Picture/0 description: The image shows the logo for Wolfe Tory Medical, Inc. The logo consists of the letters "WT" in a bold, blocky font, with the "W" and "T" overlapping. To the right of the letters is the text "WOLFE TORY MEDICAL, INC." in a serif font. The text is arranged in two lines, with "WOLFE TORY" on the top line and "MEDICAL, INC." on the bottom line.

Summary of Research Findings

Sayre MR, Salkes J, Mistler A, et al: "Teaching basic EMTs endotracheal intubation: Can basic EMTs discriminate between endotracheal and esophageal intubation?" Prehosp Disast Med 1994; 9: 234-237.
Hunt RC. Sheets CA. Whitley TW: "Pharyngeal Tracheal Lumen airway training: Failure to discriminate between esophageal and endotracheal modes and failure to confirm ventilation." Ann Emerg Med 1989; 18: 947-952.

Using a mannequin model and an endotracheal tube, basic EMTs were unable to identify an esophageal intubation 27% of the time. Using the same model and an esophageal/tracheal double lumen airway tube (Pharyngeal Tracheal Lumen), 21% of basic EMTs were unable to determine which lumen to ventilate.

Wafai Y, Czinn E, Salem MR, et al: "Proper placement of the esophageal tracheal Combitube." Anesthesiology 1995; 82: 1304-1305 (letter).
The Combitube (esophageal/tracheal double lumen airway tube) was placed into 20 tracheas and 38 esophagi of patients undergoing elective surgery. The EDD was then used to determine which tube to ventilate. The EDD was always attached to the distal lumen and if no air returned into the EDD, the proximal lumen was ventilated. If air immediately returned, then the distal lumen was ventilated. Using this technique, the location of the distal lumen was correctly identified 100% of the time.

Conclusions

Based on the evidence supplied and studies conducted, the Esophageal Intubation Detector safely and effectively assesses the location of the distal lumen of the esophageal/tracheal double lumen airway tube. Use of this device to determine location of the distal end of the esophageal/tracheal double lumen airway tube is substantially equivalent to using this device to determine the location of an endotracheal tube.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 26 1999

Tim Wolfe, M.D. Wolfe Tory Medical, Inc. 79 West 4500 South, Suite 21 Salt Lake City, UT 84107

Re: K990556 Esophageal Intubation Device (EID) Regulatory Class: II (two) Product Code: 73 BTR February 17, 1999 Dated: February 22, 1999 Received:

Dear Dr. Wolfe:

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 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). 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 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 - Tim Wolfe, M.D.

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 (301) 594-4648. 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"(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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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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NUMBER (IF KNOWN) : SIO (K) Intubation Detecter DEVICE NAME: INDICATIONS FOR USE:

o assist veri. endotracheal twoe or especial/trached doible

tube airway

Arle A. Carlows Li

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAC IF NEEDED.)

Office of Device Evaluation CDRH, Concurrence of

Prescription Use (Per 21 CFR 801.109)

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Over - The - Counter - U: (Optional Format

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).