The 3M™ Littmann® Electronic Stethoscope, Model 4100, is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds of the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

Device Description

The 3M™ Littmann® Electronic Stethoscope, Model 4100 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 4100 provides three filter frequency modes for auscultation: Bell (20-200 Hz), Diaphragm (100-500 Hz) and "Extended Range" (20-1000 Hz), This stethoscope provides amplification and includes features that permit it to record and store sounds on each of its six soundtracks. The recordings of the heart, lung, and other body sounds can be up to eight seconds in length on each soundtrack. The Model 4100 can play back the recordings at normal or half speed.

The Model 4100 has an infrared data transmission port that permits the recorded sounds to be transferred to another Model 4100 or to a Littmann Electronic Stethoscope Model 4000. The sounds may also be transferred to an IBMcompatible personal computer (PC) equipped with an infrared port and Windows 98/2000/XP, or to a hand-held device (i.e. a Pocket PC with Operating System 2002/2003 or Palm Pilot with Operating System 4/5).

The Model 4100 includes a liquid crystal display (LCD) on the chestpiece that displays the following information:

Heart Rate
Volume Level
Track Number
Record and Playback
Speed of Playback (Half Speed or Normal)
Transmit and Receive Mode
Filter Frequency Mode
Low-battery Indicator

The Model 4100 incorporates embedded software. The embedded software controls all of the various features found in the Model 4100 stethoscope, such as volume control, frequency mode selection, LCD display, record and playback, and the infrared data transfer. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope; DSP produces the bell, diaphragm, and "extended range" frequency response modes that are used to listen to heart, lung, and other body sounds.

The Model 4100 does not incorporate any off-the-shelf (OTS) software.

The Model 4100 operates on two (2) AAA alkaline batteries.

Device modifications that are the subject of this submission include a substitution of the microphone and minor changes to software and circuits to accommodate the change. The design and materials used for the chestpiece diaphragm were also modified to accommodate this change.

AI/ML Overview

The provided text is a 510(k) premarket notification for the 3M™ Littmann® Electronic Stethoscope, Model 4100. This is a submission for a medical device that demonstrates substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria with performance metrics.

Therefore, many of the requested categories (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of document. The document focuses on demonstrating that the new device (Model 4100) is substantially equivalent to an existing legally marketed device (Model 4000) based on features, intended use, and materials.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit "acceptance criteria" with quantitative performance metrics in the way one might expect for an AI/CADe device. Instead, the "acceptance criteria" here is essentially demonstrating "substantial equivalence" to the predicate device (Model 4000) for regulatory approval. The reported "performance" is a comparison of features.

Feature / Criterion (as implied by substantial equivalence)	Model 4100 (Reported Performance)	Model 4000 (Predicate Device)
Ambient Noise Reduction	Yes	No
Intended Use	Electronic Stethoscope	Electronic Stethoscope
Indications for Use	Intended for medical diagnostic purposes only. May be used for detection and amplification of sounds of the heart, lungs, arteries, veins, and other internal organs with selective frequency. Can be used on any person undergoing a physical assessment.	Intended for medical diagnostic purposes only. May be used for detection and amplification of sounds of the heart, lungs, arteries, veins, and other internal organs with selective frequency. Can be used on any person undergoing a physical assessment.
Materials/Biocompatibility	Same or substantially equivalent materials as Model 4000. Reviewed for biocompatibility (ISO10993-Part 1) for limited skin contact. Concluded no adverse health concern.	Established as safe and effective.
Functional Features	Amplification, filtering, three filter frequency modes (Bell, Diaphragm, Extended Range), record/store sounds (up to 8s, 6 soundtracks), playback (normal/half speed), infrared data transmission, LCD display (Heart Rate, Volume, Track #, Record/Playback, Speed, Transmit/Receive, Filter Mode, Low-battery), embedded software for control and DSP.	(Not explicitly detailed in the comparison table, but implied to be similar for core stethoscope functions, aside from specific enhancements in Model 4100)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. This document is a regulatory submission demonstrating substantial equivalence, not a clinical trial with a test set of patient data.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth from experts is not a component of this type of regulatory submission. The assessment relies on a comparison to a previously cleared predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/CADe device comparison study. The device is an electronic stethoscope, not an AI enhancement for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm for standalone performance assessment. It is a diagnostic tool used by a human.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The basis for approval is "substantial equivalence" to a predicate device, not correlation with a "ground truth" established through clinical data. The "truth" is that the predicate device is already legally marketed and considered safe and effective for its indicated use.

8. The Sample Size for the Training Set

Not applicable. This document does not describe a machine learning model or a training set. The device incorporates "embedded software" with "digital signal processing," but the training of a model is not discussed.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a ground truth for a training set in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2005

3M Health Care c/o Ms. Ginger Cantor, RAC (US) Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K051790

Trade Name: 3m™ Littman® Electronic Stethoscope, Model 4100 Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: June 28, 2005 Received: July 1, 2005

Dear Ms. Cantor:

This letter corrects our substantially equivalent letter of July 25, 2005 regarding the model number.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Ginger Cantor

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Bzimmnxa for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K051790

Littmann Electronic Stethoscope. Model 4100 Special 510k Submission

Indications for Use Statement

510(k) Number (if known):___

Device Name: 3M™ Littmann® Electronic Stethoscope, Model 41,00

Indications for Use:

OR Over-The-Counter-Use_ Prescription Use_X____________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Sommer

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Kos 1790

3M Confidential

Page IV

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K051790
Pi/4

JUL 25 2005

Littmann Electronic Stethoscope, Model 4100 Special 510k Submission

Pre-Market 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, RAC-USSenior Regulatory Affairs Associate
Phone Number:	(651) 736-2101
FAX Number:	(651) 737-5320

Date of Summary: June 28, 2005

2. Device Name and Classification:

Common or Usual Name: Electronic Stethoscope

3M™ Littmann® Electronic Stethoscope, Proprietary Name: Model 4100 (Modified Model 4000)

Classification Name:

Electronic Stethoscope (21 CFR § 870.1875(b))

Performance Standards: None

3. Predicate Device:

3M™ Littmann® Electronic Stethoscope, Model 4000 (K003723)

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K051790
p2/4

Description of Device: 4.

The Model 4100 includes a liquid crystal display (LCD) on the chestpiece that displays the following information:

Heart Rate ●
. Volume Level
. Track Number
Record and Playback .
. Speed of Playback (Half Speed or Normal)
. Transmit and Receive Mode
. Filter Frequency Mode
Low-battery Indicator .

The Model 4100 does not incorporate any off-the-shelf (OTS) software.

The Model 4100 operates on two (2) AAA alkaline batteries.

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Littmann Electronic Stethoscope, Model 4100 Special 510k Submission

Device modifications that are the subject of this submission include a substitution of the microphone and minor changes to software and circuits to accommodate the change. The design and materials used for the chestpiece diaphragm were also modified to accommodate this change.

The modifications included in this submission do not affect the device's intended use or indications for use. The modified device is substantially equivalent to the Model 4000 predicate device (K003723),

5. Indications for Use:

The 3M™ Littmann® Electronic Stethoscope Model 4100 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds of the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

6. Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:

Other than the one specific performance feature noted below, the Model 4100 proposed under this Special Pre-market Notification (510(k)) submission has the same performance features, intended use and indications for use as the currently marketed Model 4000 cleared under K003723. Therefore the Model 4100 is substantially equivalent to the Model 4000.

Features, Intended Use andIndications for Use	Model 4100(Modified Model 4000)	Model 4000(Predicate Device)K003723
Ambient Noise Reduction	Yes	No
Intended Use	Electronic Stethoscope	Electronic Stethoscope
Indications for Use	The 3M™ Littmann®Electronic Stethoscope,	The 3M™ Littmann®Electronic Stethoscope,
	Model 4100, is intended for	Model 4000, is intended for
	medical diagnostic purposes	medical diagnostic purposes
	only. It may be used for the	only. It may be used for the
	detection and amplification	detection and amplification of
	of sounds of the heart,lungs, arteries, veins, andother internal organs withthe use of a selectivefrequency. It can be usedon any person undergoing aphysical assessment.	sounds of the heart, lungs,arteries, veins, and otherinternal organs with the use ofa selective frequency. It canbe used on any personundergoing a physicalassessment.

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Littmann Electronic Stethoscope, Model 4100 Special 510k Submission

7. Non-clinical (Biocompatibility) Summary:

All components of the modified device have been reviewed for biocompatibility with respect to ISO10993-Part 1 Biological Evaluation of Medical Devices for limited (≤ 24 hour) skin contact for both patient and/or health care professional exposure. Each component with potential skin contact with either the user or patient was reviewed for possible health concerns.

051790

The Model 4100 is composed of the same or substantially equivalent materials as those used in the Littmann® Electronic Stethoscope Model 4000 cleared under K003723.

3M concludes that none of the components of the Model 4100 would have potential for any adverse health concern.

Regulation Number and Section

§ 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.