3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

K101834 · 3M Company · DRG · Sep 3, 2010 · Cardiovascular

Device Facts

• Record ID: K101834
• Device Name: 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM
• Applicant: 3M Company
• Product Code: DRG · Cardiovascular
• Decision Date: Sep 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The 3M™ Littmann® Scope-to-Scope Software System is intended to provide and control the real time data transfer of body sounds between two 3M™ Littmann® Electronic Stethoscopes, Model 3200 over a data network. It can be used on any person undergoing a physical assessment.

Device Story

System enables real-time remote transmission of body sounds between two 3M Littmann Model 3200 electronic stethoscopes; software installed on PCs at patient and consulting sites; connects via Bluetooth to stethoscopes and TCP/IP network between PCs. Consulting clinician controls patient-site filter settings remotely; utilizes 'talk-through' feature for verbal communication between sites. Used in clinical settings to obtain second opinions; facilitates remote physical assessment; improves access to specialist expertise.

Clinical Evidence

Bench testing only.

Technological Characteristics

Software-based system for data transfer; utilizes Bluetooth wireless link to connect stethoscopes to PCs; TCP/IP network for inter-PC communication; compatible with 3M Littmann Model 3200 electronic stethoscopes.

Indications for Use

Indicated for any person undergoing a physical assessment to facilitate real-time remote transmission of body sounds between two 3M Littmann Model 3200 electronic stethoscopes for clinical consultation.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• CareTone® Telephonic Stethoscope (K973873 American TeleCare's Digital Personal Telemedicine Module)

Reference Devices

• 3M Littmann® Model 3200 Electronic Stethoscope (K083903)

Submission Summary (Full Text)

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510(k) Premarket Notification for 3M™ Littmann® Scope-to-Scope Software System

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

#### Sponsor Information:

SEP 3 2010

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

| Contact Person: | Jizhong Jin |
|-----------------|-------------------------------|
| | Regulatory Affairs Specialist |
| Phone Number: | [phone] |
| FAX Number: | [phone] |

June 30. 2010 Date of Summary:

Device Name and Classification:

Common or Usual Name: Telemedicine Module

3M™ Littmann® Scope-to-Scope Software System Proprietary Name:

Classification Name: Transmitters and receivers, physiological signal, radiofrequency (21 CFR § 870.2910)

Performance Standards: N/A

Predicate Device:

CareTone® Telephonic Stethoscope (K973873 American TeleCare's Digital Personal Telemedicine Module)

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510(k) Premarket Notification for 3M™ Littmann® Scope-to-Scope Software System

#### Description of Device:

The 3M™ Littmann® Scope-to-Scope Software System consists of software on a CD working with two 3M Littmann® Model 3200 Electronic Stethoscopes (cleared under K083903), such that when the software program is installed onto a PC, the software provides and controls real time data transfer of body sounds between two 3M Littmann® Model 3200 Electronic Stethoscopes over a data network. The sound captured by the stethoscope at the Patient site can be heard equivalently at both the Patient and Consulting sites through the Model 3200 headsets. The Scope to Scope Software System can be used on any person underqoing a physical assessment. thereby enabling health care professionals in remote clinics to obtain a second opinion from clinicians in a different location.

Both sites' Model 3200 electronic stethoscopes are connected to Microsoft Windowsbased PC's via a Bluetooth wireless link. The two PC's are then connected to each other over a TCP/IP data network. The software allows for the Consulting site to control the Patient site's filter settings remotely when connected. The software also provides for the ability to facilitate verbal communication usinq the stethoscope's 'talk-through' feature that utilizes an expanded frequency range to better capture voice audio. This allows the Consultant to provide verbal cues and/or directions to the Patient site.

#### Indications for Use:

The 3M ™ Littmann® Scope software System is intended to provide and control the real time data transfer of body sounds between two 3M™ Littmann® Electronic Stethoscopes. Model 3200 over a data network. 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 the 3M™ Littmann® Scope-to-Scope Software System is substantially equivalent to the predicate device Care Tone® Telephonic Stethoscope (American TeleCare's Digital Personal Telemedicine Module) cleared under K973873 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

2010 SEP 3

3M Company 3M Health Care c/o Ms. Jizhong Jin 3M Health Center, Bldg. 275-05-W-06 St. Paul, MN 55144-1000

Re: K101834

Trade/Device Name: 3M Littman Scope to Scope Software System (TS1000P, RS1000C, 3200TMC)

Regulation Number: 21 CFR 870.2910

Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: June 30, 2010 Received: July 1, 2010

Dear Ms. 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 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. 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. Yourse us t comply with all the Act's requirements, including, but not limited to: registration and liating (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of morth); device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ellectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1 Ur ov 1, prease the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

W. West

Bren D. Zuelke, 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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510(k) Premarket Notification for 3M™ Littmann® Scope-to-Scope Software System

#### 4.0 Indications for Use Statement

2010 SEP 3

# Indications for Use

510(k) Number (if known):

3M™ Littmann® Scope-to-Scope Software System Device Name:

Indications For Use:

The 3M™ Littmann® Scope to-Scope Software System is intended to provide and control the real time data transfer of body sounds between two 3M™ Littmann® Electronic Stethoscopes, Model 3200 over a data network. 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 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

WMS

**510(k) Number** K101824

1071