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 undergoing a physical assessment.

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 Diaphragm (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.

AI/ML Overview

The provided text describes the 3M™ Littmann® Electronic Stethoscope, Model 3000, and its submission for 510(k) clearance. The document focuses on establishing substantial equivalence to predicate devices (Model 4000 and Model 2000) rather than providing detailed acceptance criteria and a study to prove they are met.

Therefore, many of the requested details cannot be extracted directly from the given text.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria." Instead, it provides a "Comparison of Performance Features" with predicate devices to demonstrate substantial equivalence. These performance features act as de-facto criteria for the new device based on the predicate devices' established performance.

Performance Features	Model 3000 (New Device)	Model 4000 (Predicate Device)	Model 2000 (Predicate Device)
Frequency Response	Bell (20-200 Hz) and Diaphragm (100-500 Hz) modes.	Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (20-1000 Hz) modes.	Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (100-1000 Hz) modes.
Amplification	Up to 25 dB acoustic gain, equivalent to 18 times amplification.	Up to 25 dB acoustic gain, equivalent to 18 times amplification.	Up to 20 dB acoustic gain, equivalent to 14 times amplification.
Maximum Sound Level	140 dB SPL Max	140 dB SPL Max	140 dB SPL Max
Power Source	One (1) (AAA) alkaline battery	Two (2) (AAA) alkaline batteries	One (1) (AAA) alkaline battery
Low Battery Indicator	Includes a low battery indicator	Includes a low battery indicator	Includes a low battery indicator
Displays Heart Rate	No	Yes	No
Record and Playback Sounds	No	Yes	No
Permits Data Transfer of Stored Digital Signals to and from IBM-Compatible PC and Pocket PC and Palm Pilot*	No	Yes	No
Volume Control	8 Step Volume Control	8 Step Volume Control	Continuous Variable
ON/OFF Switch Automatic Shut-off by Electronics	Yes	Yes	Yes

Study Proving Device Meets Acceptance Criteria:

The provided document does not describe a formal clinical study or a specific test report detailing how the Model 3000's performance was rigorously measured against predefined acceptance criteria. Instead, it relies on a comparative analysis with predicate devices to establish substantial equivalence based on similar design and performance features. The underlying assumption is that because the predicate devices were cleared, and the new device is "substantially equivalent" in its relevant performance aspects, it also meets the necessary safety and effectiveness requirements.

2. Sample sized used for the test set and the data provenance

Not applicable. No specific test set or clinical study is described. The comparison is based on the device's inherent design and specifications relative to the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Expert-established ground truth for a test set is not mentioned as part of this 510(k) submission, which focuses on substantial equivalence to existing devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or human adjudication method is 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 device is an electronic stethoscope, not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm that performs standalone analysis. It is a tool for human practitioners.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission relies on a comparison of device specifications and intended use against predicate devices, not on a ground truth for diagnostic accuracy. The "truth" in this context is established by the functional parameters matching or being acceptably similar to those of a previously cleared device.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set is mentioned.

Summary

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OCT 15 2004

K04-1934

510(k) Submission Littmann® Electronic Stethoscope, Model 3000

Premarket Notification (510(k)) Summary

Sponsor Information: 1.

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

July 16, 2004 Date of Summary:

2. Device Name and Classification:

Common or Usual Name: Electronic Stethoscope

Proprietary Name:	3M™ Littmann® Electronic Stethoscope,Model 3000
Classification Name:	Electronic Stethoscope

Classification Name: Electronic Stethoscope (21 CFR § 870.1875(b))

Performance Standards: None

3. Predicate Device:

3M™ Littmann® Electronic Stethoscope, Model 4000 3M™ Littmann® Electronic Stethoscope, Model 2000

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510(k) Submission Littmann® Electronic Stethoscope, Model 3000

Description of Device: 4.

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.

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 undergoing a physical assessment.

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Littmann® Electronic Stethoscope, Model 3000

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

The table below illustrates the similarities and differences of the new device (Model 3000) to the predicate devices (Model 4000 and Model 2000). The Model 3000 proposed under this new pre-market notification submission is composed of similar materials, and has similar performance features, intended use and indications for use as the Model 4000 cleared under K003723, and the Model 2000, cleared under K961848.

Comparison of Performance Features Littmann® Electronic Stethoscope Model 3000 versus Littmann® Electronic Stethoscope Model 4000 and Littmann® Electronic Stethoscope Model 2000

PerformanceFeatures	Model 3000(New Device)	Model 4000(Predicate Device)K003723	Model 2000(Predicate Device)K961848
FrequencyResponse	Bell (20-200 Hz) and Diaphragm (100-500 Hz) modes.	Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (20-1000 Hz) modes.	Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (100-1000 Hz) modes.
Amplification	Up to 25 dB acoustic gain, equivalent to 18 times amplification.	Up to 25 dB acoustic gain, equivalent to 18 times amplification.	Up to 20 dB acoustic gain, equivalent to 14 times amplification.
Maximum SoundLevel	140 dB SPL Max	140 dB SPL Max	140 dB SPL Max
Power Source	One (1) (AAA) alkaline battery	Two (2) (AAA) alkaline batteries	One (1) (AAA) alkaline battery
Low BatteryIndicator	Includes a low battery indicator	Includes a low battery indicator	Includes a low battery indicator
Displays HeartRate	No	Yes	No
Record andPlayback Sounds	No	Yes	No
Permits DataTransfer of StoredDigital Signals toand from IBM-Compatible PCand Pocket PCand Palm Pilot*	No	Yes	No
Volume Control	8 Step VolumeControl	8 Step VolumeControl	Continuous Variable
ON/OFF SwitchAutomatic Shut-offby Electronics	Yes	Yes	Yes

With Infrared Port and Windows /98/2000/XP, Pocket PC 2002/2003 and Palm OP Sys 4/5 Microsoft and Windows™ are registered trademarks of Microsoft Corporation.

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Non-clinical (Biocompatibility) Summary: 7.

All components of the Model 3000 stethoscope 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.

The Littmann® Electronic Stethoscope Model 3000 is composed of the same or substantially equivalent materials as those in the Littmann® Electronic Stethoscope Model 4000 cleared under K003723, and the Littmann® Electronic Stethoscope Model 2000, cleared under K961848.

3M concludes that all of the components of the Model 3000 Stethoscope would have minimal potential for any adverse health concern.

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Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that resembles an abstract eagle or bird-like figure with three wing-like lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 15 2004

3M Company c/o Ms. Ginger Cantor Senior Regulatory Affairs Associate 3M Healthcare 3M Center, Bldg 275-5W-06 St Paul, MN 55144-1000

Re: K041934

K041934
Trade Name: 3M Littman Electronic Stethoscope, Model 3000 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: July 16, 2004 Received: July 19, 2004

Dear Ms. Cantor:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I (x) premaited is substantially equivalent (for the indications
referenced above and have determined the devices and sets to interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments. for use stated in the enclosure) to regally manced peoples and Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue, commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance who areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval estarsas provisions of the Act. T and Cosmetic Act (Act) that ao not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, listing You may, therefore, market the uctives, subject of annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Act mender requirements on the many of the superior misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlist - Existing may one of 898 - In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Federal Regarding 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 Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decermination that your acceral agencies. You must or any Federal statutes and regulations continued to registration and listing (21)
comply with all the Act's requirements, including, increation requirements as set comply with all the Act S requirements, morams manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Fall on ); good manatalog production (2000); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 C forth in the quality systems (Q5) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Acction Section S product radiation control provisions (Occions of I svice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will anow you to begin marketing your artist equivaler of your device to a legally premarket notification. The PDA mining of substantial equal 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
ntitled If you desire specific advice for your ac 1100 %. Also, please note the regulation entitled, contact the Office of Computation at (301) 971-77 (21CFR Patt 807.97). You may obtain " Misoranding by reference to premanter to allietas in the Act from the Division of Small other general information on your responsion issues at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the new an arrant Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bf. nimimotor for
B. Zukerman, M.D.

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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Indications for Use

510(k) Number (if known): K041934

Device Name: 3M™ Littmann ® Electronic Stethoscope Model 3000

Indications For Use:

Indications For Ose.
The 3MTM Littmann ® Electronic Stethoscope Model 3000 is intended for medical The SM- Entination & Elections enved for the detection and amplification of draghostic purposes only. It may ob a internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Abstmmerman

on Sign-Off) n of Cardiovascular Deyices KON19 .. , Number__

Page 1 of

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.