(28 days)
No
The description mentions embedded software for control and digital signal processing (DSP) for filtering, but there is no mention of AI, ML, or related concepts like training or test sets.
No
The device is described as being for "medical diagnostic purposes only" and functions by amplifying and filtering sounds for listening, not by providing any form of therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only."
No
The device description explicitly states it is a healthcare device that picks up sounds, electronically amplifies and filters them, and transfers them to the user's ears via an active speaker and passive sound tubes. This involves significant hardware components beyond just software. While it incorporates embedded software, it is not a software-only device.
Based on the provided information, the 3M™ Littmann® Electronic Stethoscope Model 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids outside of the body.
- The Littmann Electronic Stethoscope is used for direct auscultation of sounds within the human body. It amplifies and filters sounds from organs like the heart and lungs, which are then listened to by a medical professional. This is a form of physical examination, not an in vitro diagnostic test.
The intended use and device description clearly indicate that it is a tool for physical assessment and listening to internal body sounds, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoinq a physical assessment.
Product codes
DQD
Device Description
The 3M™ Littmann® Electronic Stethoscope, Model 3000 is a healthcare device that picks sounds of the heart, arteries, veins, lung and other internal organs, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes. The Model 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphraqm (100-500 Hz).
The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope: DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds
The Model 3000 does not incorporate any off-the-shelf (OTS) software.
The Model 3000 operates on one (1) AAA alkaline battery.
This submission describes modifications made to the device's embedded software. The modifications included in this submission do not affect the device's intended use or indications for use, performance features, labeling or claims. The modified device is substantially equivalent to the Model 3000 predicate device (K041934).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lungs, 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)
Not Found
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.
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Premarket Notification (510(k)) Summary
1. Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Ginger Cantor |
|---|---|
| Senior Regulatory Affairs Associate | |
| Phone Number: | (651) 736-2101 |
| FAX Number: | (651) 737-5320 |
Date of Summary: January 24, 2005
2. Device Name and Classification:
Common or Usual Name: Electronic Stethoscope
3M™ Littmann® Electronic Stethoscope, Proprietary Name: Model 3000
Classification Name: Electronic Stethoscope (21 CFR § 870.1875(b))
Performance Standards: None
3. Predicate Device:
3M™ Littmann® Electronic Stethoscope, Model 3000 (K041934)
1
Description of Device: 4.
The 3M™ Littmann® Electronic Stethoscope, Model 3000 is a healthcare device that picks sounds of the heart, arteries, veins, lung and other internal organs, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes. The Model 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphraqm (100-500 Hz).
The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope: DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds
The Model 3000 does not incorporate any off-the-shelf (OTS) software.
The Model 3000 operates on one (1) AAA alkaline battery.
This submission describes modifications made to the device's embedded software. The modifications included in this submission do not affect the device's intended use or indications for use, performance features, labeling or claims. The modified device is substantially equivalent to the Model 3000 predicate device (K041934).
5. Indications for Use:
The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoinq a physical assessment.
2
6. Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
The Model 3000 as modified in this special pre-market notification submission is composed of the same or substantially equivalent materials, has the same performance features, same intended use, same indications for use, and same labeling as the Model 3000 predicate device cleared under K041934.
7. Non-clinical (Biocompatibility) Summary:
3M has reviewed all components of the Model 3000 stethoscope for biocompatibility with respect to ISO10993-Part 1 Biological Evaluation of Medical Devices for limited (