(32 days)
No
The device description relies on a simple physical principle (negative pressure and anatomical differences) and does not mention any computational analysis, image processing, or AI/ML terms.
No
The device is used to verify the placement of an endotracheal tube, which is a diagnostic or verification function rather than a therapeutic one. It does not treat or alleviate a medical condition.
Yes
The device is described as assisting "verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube," which implies it is used to identify or determine a medical condition or physiological state (correct tube placement). The "Key Results" stating it "correctly identified 100% of the time" also supports its diagnostic function.
No
The device description explicitly describes a physical device that applies negative pressure, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device works by applying negative pressure to an endotracheal tube and observing the physical response of the trachea or esophagus. It relies on anatomical differences and mechanical principles, not on the analysis of biological specimens.
- Intended Use: The intended use is to "assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube." This is a procedural verification, not a diagnostic test based on analyzing bodily fluids or tissues.
The device is used in vivo (within the body) to assess the location of a tube, not in vitro (outside the body) to analyze a specimen.
N/A
Intended Use / Indications for Use
To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.
Product codes
73 BTR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea, Esophagus
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The location of the distal lumen was correctly identified 100% of the time.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 21 | |
| Salt 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 and | |
| Legally Marketed Device | Esophageal Intubation Device (EID®) |
| Bulb Model - K942628 | |
| Syringe Model - K930741 | |
| Device Description | 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. | |
| New Intended Use | To assist verification of placement of the endotracheal tube or |
| 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. |
1
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.
2
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.
3
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
4
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