3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200

K083903 · 3M Company · DQD · Jul 15, 2009 · Cardiovascular

Device Facts

• Record ID: K083903
• Device Name: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
• Applicant: 3M Company
• Product Code: DQD · Cardiovascular
• Decision Date: Jul 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The 3M™ Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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 Story

The 3M Littmann Model 3200 is an electronic stethoscope used by clinicians for physical assessment. It captures acoustic signals from heart, lungs, arteries, and veins; processes these signals via a digital signal processor (DSP) for amplification and frequency-selective filtering; and delivers audio to the user via an active speaker and passive sound tubes. The device features a 5-button keypad and LCD display for user control. It supports wireless data exchange with a PC via Bluetooth. The device is powered by a single AA battery (alkaline, lithium, or NiMH). By enhancing auscultation through digital processing, it assists clinicians in identifying physiological sounds, potentially improving diagnostic accuracy during routine physical examinations.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Electronic stethoscope; digital signal processor (DSP) for sound amplification and filtering; 5-button keypad; LCD display; Bluetooth wireless connectivity for PC data exchange; powered by one AA battery (alkaline, lithium, or NiMH).

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 (K050159)
• 3M™ Littmann® Electronic Stethoscope, Model 4100 (K051790)

Submission Summary (Full Text)

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0f3903

#### 5.0 Premarket Notification (510(k)) Summary

## Sponsor Information:

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

JUL 1 5 2009

Contact Person: Jizhong Jin Senior Regulatory Affairs Associate Phone Number: [phone] FAX Number: [phone]

Date of Summary: December 22, 2008

#### Device Name and Classification:

Common or Usual Name: Electronic Stethoscope

Proprietary Name:

3M™ Littmann® Electronic Stethoscope Model 3200

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

Performance Standards: None

## Predicate Device:

3M™ Littmann® Electronic Stethoscope, Model 3000 3M™ Littmann® Electronic Stethoscope, Model 4100

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## Description of Device:

The 3M™ Littmann® Electronic Stethoscope. Model 3200 is a healthcare device that picks up sounds of the heart, arteries, veins, lungs and other internal organs with the use of selective frequency ranges. After amplification and filtering, the sounds are transferred to the user's ears via an active speaker and passive sound tubes.

The Model 3200 can also exchange audio data with a personal computing device (PC) using wireless Bluetooth link.

The user interface includes a 5-button keypad and an LCD display. Sound processing is carried out with the aid of a digital signal processor. The Model 3200 does not incorporate any off-the-shelf (OTS) software. The Model 3200 operates on one (1) AA alkaline, lithium, or NiMH battery.

#### Indications for Use:

The 3M™ Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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.

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

Information provided in this 510(k) submission shows that 3M™ Littmann® Electronic Stethoscope, Model 3200 is substantially equivalent to the predicate device 3M™ Littmann® Electronic Stethoscope. Model 3000, cleared under K050159 and Littmann® Electronic Stethoscope, Model 4100, cleared under K051790 in terms of intended use, indications for use, composition, physical properties and technological characteristics. There are no new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2009

3M Health Care c/o Mr. Jizhong Jin Regulatory Affairs 3M Infection Prevention Division 3M Center, Bldg 275-05-W-06 St. Paul, MN 55144-1000

K083903 Re:

> Trade/Device Name: 3M™ Littmann® Electronic Stethoscope, Model 3200 Regulatory Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (Two) Product Code: DQD Dated: June 16, 2009 Received: June 17, 2009

Dear Mr. Jin:

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 application (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 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 - Mr. Jizhong Jin

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 begin 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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):

Device Name:

Indications For Use:

K083903

3M™ Littmann® Electronic Stethoscope Model 3200

The 3M™ Littmann® Electronic Stethoscope, Model 3200 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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.

Prescription Use X · AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Øffice of Device Evaluation (ODE)

Hthllt Bei by B Zuckerman
(Division Sign-Off) 7/15/09

Division of Cardiovascular D 510(k) Number_

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