MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000

K050159 · 3M Company · DQD · Feb 22, 2005 · Cardiovascular

Device Facts

• Record ID: K050159
• Device Name: MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
• Applicant: 3M Company
• Product Code: DQD · Cardiovascular
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Special
• 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 sounds from 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. Device captures acoustic signals via chestpiece; electronically amplifies and filters signals; transmits to user via active speaker and passive sound tubes. Features two frequency modes: Bell (20-200 Hz) and Diaphragm (100-500 Hz). Operated by clinicians during physical assessments. Embedded software manages volume control, frequency mode selection, and digital signal processing (DSP). Powered by one AAA alkaline battery. Output allows healthcare providers to perform diagnostic auscultation, potentially improving detection of physiological sounds compared to traditional acoustic stethoscopes.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility of all components reviewed per ISO 10993-1 for limited (<24 hour) skin contact.

Technological Characteristics

Electronic stethoscope; AAA battery-powered. Materials evaluated for biocompatibility per ISO 10993-1. Features active speaker and passive sound tubes. Embedded software performs digital signal processing (DSP) for frequency filtering (Bell: 20-200 Hz; Diaphragm: 100-500 Hz). No off-the-shelf (OTS) software.

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 3000 (K041934)

Submission Summary (Full Text)

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

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)

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#### 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.

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### 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 (< 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 modified Littmann® Electronic Stethoscope Model 3000 is composed of the same or substantially equivalent materials as those in the Model 3000 predicate device.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

FEB 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050159

Trade Name: 3M7M Littmann® Electronic Stethoscope Model 3000 Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD Dated: January 24, 2005 Received: January 25, 2005

Dear Ms. Cantor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energears) is segment 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 application (PMA). and Cosmotic Fee (110) has the device, subject to the general controls provisions of the Act. The r ou may, morelore, mains 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 such 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 I least of advised that I Dri brisantes over device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cacal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in and quart) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of the nevels (seting your device as described in your Section 510(k) I mis letter with anow your o begin mating of substantial equivalence of your device to a legally premaired 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 If you desire specific arrantiance at [phone]. Also, please note the regulation entitled, eonider the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation of your respuner Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Bhummon for

3ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):

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

### 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 sounds from 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.

Over-The-Counter-Use XX OR Prescription Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Hemmer

vision or Ografovascu i Jik) Number