(49 days)
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
Not Found
This section provides an analysis of the provided FDA 510(k) document for the Ambu Esophageal Intubation Detector (Bulb version and Syringe version).
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or provide a table of performance metrics. The FDA's 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than setting specific performance thresholds for a new device's efficacy.
The "Indications For Use" sections for both the Bulb and Syringe versions state: "To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement." This indicates the device is intended as an aid, not a definitive diagnostic tool on its own.
Without a detailed clinical study report, it is impossible to extract specific performance data like sensitivity, specificity, accuracy, or any comparative metrics against a ground truth.
2. Sample Size and Data Provenance:
The provided 510(k) summary letter and indications for use do not contain information about any specific study (clinical or otherwise) that would include details on sample size, test set characteristics, or data provenance (e.g., country of origin, retrospective/prospective). The letter refers to the "510(k) premarket notification," which would contain these details, but this specific document is not included in the input.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide any information regarding the number of experts used to establish ground truth, their qualifications, or the context of a "test set."
4. Adjudication Method:
Given the lack of information regarding a specific study or test set, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance, as this device predates widespread AI applications in medical devices and is a physical, non-AI diagnostic aid.
6. Standalone Performance:
The concept of "standalone performance" typically refers to the algorithm-only performance of an AI-based device. Since the Ambu Esophageal Intubation Detector (Bulb and Syringe versions) is a physical, mechanical device and not software or AI-driven, the concept of standalone algorithmic performance is not applicable. Its performance is inherent in its physical and mechanical operation.
7. Type of Ground Truth Used:
Without information about a specific study, the type of ground truth used cannot be determined from this document. For a device like this, common ground truth methods in a clinical study would typically involve:
- Direct Visualization/Bronchoscopy: The gold standard for confirming endotracheal tube placement.
- Capnography: Measurement of exhaled carbon dioxide, highly accurate for tracheal intubation.
- Clinical Assessment: Auscultation, chest rise, and other physical signs.
8. Sample Size for the Training Set:
This document does not contain information about a training set. As a physical, non-AI device, the concept of a "training set" in the context of machine learning is not relevant. Development for such a device would involve engineering design, prototyping, and testing rather than data-driven training.
9. How Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device.
Summary of Information Not Found in the Provided Document:
The provided FDA letter is a 510(k) clearance letter confirming substantial equivalence to a predicate device. It does not include the detailed technical and clinical study reports that would contain the specific information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the full 510(k) submission, which is not part of the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Mr. Sanjay Parikh Ambu Inc. 611 N. Hammonds Ferry Road Linthicum, MD 21090
K981891 Re: Ambu Esophageal Intubation Detector (Bulb version and Syringe version) Requlatory Class: II (two) Product Code: 73 BTR Dated: May 20, 1998 Received: May 29, 1998
Dear Mr. Parikh:
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 requlations.
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Page 2 - Mr. Sanjay Parikh
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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,
sincerely yours,
Thomas J. Callehan
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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Esophageal Intubation Detector
Intended Use
BULB VERSION
ESOPHAGEAL INTUBATION DETECTOR (BULB) INDICATION FOR USE
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
Mark Reiner
(Division Sign-On)
on of Cardiovascular, Respiratory,
eurological Devices
5.K: Number K981891
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Esophageal Intubation Detector
Intended Use
SYRINGE VERSION
ESOPHAGEAL INTUBATION DETECTOR (SYRINGE) INDICATION FOR USE
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
e kame
(Division Sign-Off) Division of Cardiovascula and Neurological Device 510(k) Number
§ 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).