3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

K041934 · 3M Company · DQD · Oct 15, 2004 · Cardiovascular

Device Facts

• Record ID: K041934
• Device Name: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
• Applicant: 3M Company
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended 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.

Device Story

Electronic stethoscope for auscultation of heart, lung, and vascular sounds; captures acoustic signals via chestpiece; processes signals using embedded digital signal processing (DSP) to provide Bell (20-200 Hz) and Diaphragm (100-500 Hz) frequency response modes; amplifies sounds up to 25 dB (18x); outputs audio to user via active speaker and passive sound tubes; operated by clinicians or patients during physical assessment; powered by single AAA battery; features 8-step volume control and automatic shut-off; provides enhanced sound clarity for diagnostic decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on comparison of performance features (frequency response, amplification, sound levels) and biocompatibility assessment of materials.

Technological Characteristics

Electronic stethoscope; Bell (20-200 Hz) and Diaphragm (100-500 Hz) frequency modes; up to 25 dB acoustic gain; 140 dB SPL max; powered by 1 AAA alkaline battery; embedded software for DSP and volume control; biocompatible materials per ISO 10993-1 for limited skin contact.

Indications for Use

Indicated for medical diagnostic purposes, specifically the detection and amplification of heart, lung, arterial, venous, and other internal organ sounds in any person undergoing a physical assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• 3M™ Littmann® Electronic Stethoscope, Model 4000 (K003723)
• 3M™ Littmann® Electronic Stethoscope, Model 2000 (K961848)

Submission Summary (Full Text)

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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: | [phone] |
| FAX Number: | [phone] |

July 16, 2004 Date of Summary:

#### 2. Device Name and Classification:

Common or Usual Name: Electronic Stethoscope

| Proprietary Name: | 3M™ Littmann® Electronic Stethoscope,<br>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 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.

#### 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

| Performance<br>Features | Model 3000<br>(New Device) | Model 4000<br>(Predicate Device)<br>K003723 | Model 2000<br>(Predicate Device)<br>K961848 |
|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Frequency<br>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<br>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<br>Indicator | Includes a low battery indicator | Includes a low battery indicator | Includes a low battery indicator |
| Displays Heart<br>Rate | No | Yes | No |
| Record and<br>Playback Sounds | No | Yes | No |
| Permits Data<br>Transfer of Stored<br>Digital Signals to<br>and from IBM-<br>Compatible PC<br>and Pocket PC<br>and Palm Pilot* | No | Yes | No |
| Volume Control | 8 Step Volume<br>Control | 8 Step Volume<br>Control | Continuous Variable |
| ON/OFF Switch<br>Automatic Shut-off<br>by 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 [phone] 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__

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