(50 days)
Not Found
No
The description focuses on electronic amplification and basic controls, with no mention of AI/ML terms or capabilities.
No
The device is described as an electronic stethoscope for projecting sounds from organs, which is a diagnostic tool, not a therapeutic one. Its function is to enhance acoustical sounds for examination, not to treat or alleviate a medical condition.
No
The device is described as an electronic stethoscope intended for projecting and amplifying sounds from internal organs. While it aids in sound detection, its indicated use does not involve diagnosing conditions, but rather enhancing acoustical sounds for a user to interpret. The stated intended use is "For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device," which aligns with an assistive listening device rather than a diagnostic tool.
No
The device description explicitly states it is an "electronic stethoscope" and describes physical components like a diaphragm housing, buttons, and switches, indicating it is a hardware device with electronic amplification.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The intended use and device description clearly state that this device is an electronic stethoscope used for projecting and amplifying sounds from within the body (heart, arteries, veins, etc.). This is a non-invasive method of listening to internal body sounds.
- No Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
Therefore, this device falls under the category of a medical device used for physical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.
Product codes
Not Found
Device Description
This electronic stethoscope electronically amplifies sound with fingertip control; it is turned on by pressing and holding a button on the back of the diaphragm housing. The stethoscope has a volume control and a two position frequency response switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, arteries, veins and other internal organs.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing information demonstrating safety and effectiveness of the Labtron Electromax device in the intended environment of use is supported by testing conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submissions", DCRND outlining electrical, mechanical and environmental performance standards.
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
§ 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
U. - 3 1996
EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: 1961857 -
1. Submitter's Identification:
Ms. Carol Bergh VP Regulatory Affairs Graham-Field, Inc. 400 Rabro Drive East Hauppauge, NY 11788
Date Summary Prepared: May 6, 1996
2. Name of the Device:
Labtron Electromax Electronic Stethoscope
3. Predicate Device Information:
Littmann Brand Electronic Stethoscope 510(k) #K771653, 3M Company, St. Paul, Minnesota
4. Device Description:
This electronic stethoscope electronically amplifies sound with fingertip control; it is turned on by pressing and holding a button on the back of the diaphragm housing. The stethoscope has a volume control and a two position frequency response switch.
5. Intended Use:
For projecting the sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to enhance the acoustical sounds of the device.
1
6. Comparison to Predicate Devices:
Basic design is comparable in both operation and functionality, with the following differences: the Labtron electronically amplifies sound; the Littmann uses 2 silver oxide batteries vs. the Labtron utilizing 4 alkaline manganese batteries, frequency ranges for the Littmann is 20-200 Hz; the Labtron has an electrostatic microphone and only the Littmann has speaker in tubing vs. both having electronics in the chest piece.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Labtron Electromax device in the intended environment of use is supported by testing conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submissions", DCRND outlining electrical, mechanical and environmental performance standards.
8. Discussion of Clinical Tests Performed:
Non-Applicable
9. Conclusions:
Based upon the aforementioned information, the Labtron Electromax Electronic Stethoscope is substantially equivalent to the 3H Littmann Brand Electronic Stethoscope, and, safety and effectiveness have been established.