(501 days)
Not Found
No
The description focuses on sound amplification and filtering, with no mention of AI/ML terms or capabilities. The performance testing described is based on frequency response analysis, not AI/ML model evaluation.
No
The device is described as a "diagnostic aid" used for "amplification of faint heart, lung and other body sounds" and "normal auscultation," indicating its use in diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is a diagnostic aid".
No
The device description explicitly states it is an "Electronic Stethoscope," which is a hardware device used for auscultation. The performance studies also describe testing involving a transducer, microphone, and eartip, all of which are hardware components.
Based on the provided information, the 3M Littmann™ Electronic Stethoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Stethoscope Function: The description clearly states the stethoscope is used for the "amplification of faint heart, lung and other body sounds" as part of a "physical assessment of a patient." This involves listening to sounds directly from the patient's body, not analyzing samples taken from the body.
- No Mention of Sample Analysis: The description does not mention any analysis of biological samples.
- Focus on Physical Assessment: The intended use is explicitly for physical assessment, which is a direct examination of the patient.
Therefore, the 3M Littmann™ Electronic Stethoscope falls under the category of a diagnostic aid used for physical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended rage mode amplifies sound over a broad range of frequencies, including the range where some lung and prosthetic heart valve sounds occur.
Product codes
74 DQD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professional
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
Not Found
Summary of Performance Studies
Non Clinical Testing Brief Description: Testing to determine that the frequency response and gain are substantially equivalent to the predicate electronic stethoscope was performed with a computerized audio analysis system that sweeps a frequency oscillator from 10 to 5000 Hz. This frequency sweep is presented to a transducer on which the stethoscope is placed. The computer measures the response from the stethoscope with a small calibrated microphone placed in the eartip. The signal from the microphone is fed back to the computer where it is recorded, stored and later can be printed out. This test was done in each of the three frequency responses modes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
رن 10007
510(k) Summary
3M Littmann™ Electronic Stethoscope
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Name and address of Device Manufacturer submitting 510(k) Notification: 1.
3M 3M Health Care 3M Center St. Paul, MN 55144-1000 -
Regulatory Correspondent of Device Manufacturer: 2. Linda Johnsen, Senior Requlatory Affairs Associate 612 737- 4376
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Date Summary was prepared: May 10, 1996 3.
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Name of Device: 3M Littmann™ Electronic Stethoscope 4.
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Predicate Device to which 3M is claiming Substantial Equivalence: 5. 3M Littmann Brand Electronic Stethoscope 510(k) K771653.
6. Intended Use:
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended range mode amplifies sounds in a broad frequency range, including a range higher than the traditional diaphragm mode, where some lung and heart sounds may occur, as well as providing low frequency response at a slightly reduced level compared to the bell mode.
Non Clinical Testing Brief Description: 8.
Testing to determine that the frequency response and gain are substantially equivalent to the predicate electronic stethoscope was performed with a computerized audio analysis system that sweeps a frequency oscillator from 10 to 5000 Hz. This frequency sweep is presented to a transducer on which the stethoscope is placed. The computer measures the response from the stethoscope with a small calibrated microphone placed in the eartip. The signal from the microphone is fed back to the computer where it is recorded, stored and later can be printed out. This test was done in each of the three frequency responses modes.
റ്റ. Conclusive Statement:
While there are some differences in the three modes, these differences are intentional and designed to beneficially provide improved frequency response in the bell mode, reduce noise pick-up in the diaphragm mode, and reduce masking of the higher frequency sounds in the extended range mode. In this way, we have determined that the present Littmann Electronic Stethoscope performs as well as, and in many cases substantially better than the predicate electronic stethoscope.
1
Image /page/1/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 26 1997
Ms. Linda Johnsen 3M Health Care 3M Center, Building 275-3E-08 St. Paul, Minnesota 55144-1000
Re: K961848 3M Littmann Electronic Stethoscope Requlatory Class: II (two) Product Code: 74 DQD Dated: July 2, 1997 Received: July 3, 1997
Dear Ms. Johnsen:
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, 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.
2
Page 2 - Ms. Linda Johnsen
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
3
510(k) 3M Littmann™ Electronic Stethoscope
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Intended Use:
The 3M Littmann™ Electronic Stethoscope is a diagnostic aid and used as part of a physical assessment of a patient by a Health Care Professional. It can be used for the amplification of faint heart, lung and other body sounds as well as normal auscultation and selective frequency filtering. The extended rage mode amplifies sound over a broad range of frequencies, including the range where some lung and prosthetic heart valve sounds occur.
Copy of labeling which includes instructions for use and maintenance is included in attachment 2 to the 510(k) submission.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
chat i'do La AAC
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K961848
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)