(162 days)
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No
The summary describes a simple, disposable esophageal stethoscope for monitoring basic physiological sounds and temperature. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
No
The device is described as a stethoscope for monitoring heart and breath sounds and core temperature, which are diagnostic/monitoring functions, not therapeutic.
No
The device is used for monitoring heart, breath sounds, and core temperature, which falls under general patient monitoring rather than diagnosing a specific disease or condition.
No
The device description explicitly states "Disposable Esophageal Stethoscope," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "Esophageal Stethoscope" used for "Monitoring heart and breath sounds, and core temperature." This involves directly monitoring physiological signals within the body, not analyzing specimens taken from the body.
Therefore, this device falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Esophageal Stethoscope: Monitoring heart and breath sounds. Esophageal Stethoscope with Electrical Conductors: Monitoring heart and breath sounds, and core temperature.
Product codes (comma separated list FDA assigned to the subject device)
74 BTZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
MAR 1 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
John A. Steen, Ph.D. President and CEO Catheter Research, Inc. 6131 West 80th Street Indianapolis, IN 46278
Re: K973839 Disposable Esohageal Stethoscopes Regulatory Class: II (two) Product Code: 74 BTZ Dated: January 23, 1998 Received: January 26, 1998
Dear Dr. Steen:
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 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, Druq, 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 reqistration, 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 Failure to comply with the GMP regulation may result in assumptions. 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 regulations.
1
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 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/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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Section #3
Indications for Use
| 510(k) Number: | K973839
(to be assigned) |
|----------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | Disposable Esophageal Stethoscope |
| Intended Use: | Esophageal Stethoscope: Monitoring heart and breath
sounds. |
| | Esophageal Stethoscope with Electrical Conductors:
Monitoring heart and breath sounds, and core temperature. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
N. Dougls Tiller
(Division Sk Division of Cars and Neurological D 510(k) Numbe
Prescription Use (Per CFR 801.109) OR
Over-the-counter use