ESOPHAGEAL INTUBATION DETECTOR

K990556 · Wolfe Tory Medical, Inc. · BTR · Mar 26, 1999 · Anesthesiology

Device Facts

• Record ID: K990556
• Device Name: ESOPHAGEAL INTUBATION DETECTOR
• Applicant: Wolfe Tory Medical, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Indications for Use

To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.

Device Story

The Esophageal Intubation Device (EID) is a manual diagnostic tool used to verify the placement of an endotracheal tube or esophageal/tracheal double lumen airway tube. It operates on the principle of anatomical differences between the trachea and esophagus: the trachea is rigid and remains open, while the esophagus is fibromuscular and collapses. The device is attached to the proximal end of the airway tube; the operator applies negative pressure (via bulb or syringe). If the tube is in the trachea, air is aspirated into the device; if in the esophagus, the esophageal walls collapse around the tube, preventing air aspiration. This provides immediate feedback to clinicians, helping them decide which lumen to ventilate in double-lumen airway tubes. It is used in clinical settings to prevent ventilation errors and improve patient safety during airway management.

Clinical Evidence

Clinical evidence includes a study of 58 patients (20 tracheas, 38 esophagi) undergoing elective surgery. The EID was used to determine which lumen of a Combitube to ventilate. Results showed 100% accuracy in identifying the location of the distal lumen. Additional literature cited failure rates of basic EMTs in identifying tube placement without the device (21-27% error rates in mannequin models), supporting the clinical utility of the EID for verification.

Technological Characteristics

The device consists of a bulb or syringe mechanism designed to create negative pressure. It features a standard 15mm adapter for connection to endotracheal or esophageal/tracheal double lumen airway tubes. It is a non-powered, manual diagnostic accessory. Materials are not specified by ASTM standard in the text. The device is intended for use with non-collapsible hollow tubes.

Indications for Use

Indicated for assisting in the verification of proper placement of an endotracheal tube or an esophageal/tracheal double lumen airway tube in patients requiring airway management.

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.

Predicate Devices

• Esophageal Intubation Device (EID) Bulb Model (K942628)
• Esophageal Intubation Device (EID) Syringe Model (K930741)

Reference Devices

• Pharyngeal Tracheal Lumen airway (Combitube)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-Mail: [e-mail]

## 510(K) Summary Summary of Safety and Effectiveness

| Company and Submission Information | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Wolfe Tory Medical, Inc.<br>79 West 4500 South, Suite 21<br>Salt Lake City, UT 84107<br>[phone] |
| 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 and<br>Legally Marketed Device | Esophageal Intubation Device (EID®)<br>Bulb Model - K942628<br>Syringe Model - K930741 |
| Device Description | A device that relies on anatomical differences between the trachea<br>and the esophagus. By applying negative pressure to the<br>endotracheal tube, the rigid trachea remains open allowing free<br>aspiration of air into the EDD, whereas the fibromuscular<br>esophagus collapses around the endotracheal tube and thus<br>prevents aspiration of air. |
| New Intended Use | To assist verification of placement of the endotracheal tube or<br>esophageal/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 [phone]. Additionally, for questions on the promotion and 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/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