(71 days)
The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.
Esophageal Stethoscope
The provided text is a 510(k) clearance letter from the FDA for an "Esophageal Stethoscope." This document confirms the device's substantial equivalence to a legally marketed predicate device, allowing it to be marketed.
However, the letter does not contain the specific information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The document primarily focuses on the regulatory aspects of the device, such as its classification, general controls, and the process for marketing it. It states the "Indications for Use" which define what the device is intended for, but not how its performance was measured or validated.
Therefore, I cannot provide the requested information from this document. It does not describe a study that proves the device meets acceptance criteria.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1698 SFP
Mr. Mark Richardson Shore Medical, Inc. 2037 Oak Glen Drive Vista, CA 92083
K982193 Re: Esophaqeal Stethoscope Requlatory Class: II (two) Product Code: 73 BZT Dated: Undated Received: August 24, 1998
Dear Mr. Richardson:
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 Drug 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 regulations.
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Page 2 - Mr. Mark Richardson
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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510(k) Number (if known): not assigned
Device Name: Esophageal Stethoscope
Indications for Use:
The intended use of the esophageal stethoscope is to listen to heart and breath sounds while a patient is under anesthesia. Additionally, patient temperature can be monitored using the stethoscopes with 400 or 700 series thermistors. The stethoscopes are provided "packaged clean" and are for "single use" only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marla Krame
(Division Sign-C Division of Cardiovas and Neurological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).