(56 days)
No
The description focuses on real-time data transfer and storage of body sounds, with no mention of analysis, interpretation, or algorithms that would typically involve AI/ML.
No
The device is described as an online auscultation system that allows the transfer and evaluation of body sounds, not for treatment. Its function is to facilitate remote evaluation and sharing of diagnostic information.
No
The device is described as a system that facilitates the real-time transfer of body sounds between stethoscopes or for storing and forwarding data. Its intended use is to enable remote evaluation of patient body sounds, but it does not inherently interpret or analyze these sounds to provide a diagnosis or aid in diagnosis. It acts as a data transfer and communication system for auscultation, not a diagnostic tool itself.
No
The device description explicitly states that the system is used "together with the 3MTM Littmann® Model 3200 Electronic Stethoscope," which is a hardware device. While the TeleSteth system includes software, it is dependent on and interacts with the physical stethoscope to acquire the body sounds.
Based on the provided information, the 3MTM Littmann® TeleSteth Online Auscultation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- TeleSteth Function: The TeleSteth system's intended use and description clearly state that it is for the real-time transfer and evaluation of body sounds (heart, lung, etc.) obtained directly from a person using an electronic stethoscope. It does not involve the analysis of any specimens derived from the body.
The system is a tool for facilitating the remote auscultation of a patient, which is a physical examination technique, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 3M Littmann® TeleSteth Online Auscultation 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. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3M Littmann TeleSteth Online Auscultation System can be used on any person undergoing a physical assessment.
Product codes
DRG
Device Description
The 3MTM Littmann® TeleSteth Online Auscultation System, used together with the 3MTM Littmann® Model 3200 Electronic Stethoscope (K083903), allows healthcare professionals to share heart, lung and other body sounds with colleagues located across the globe using the internet or a private data network. When operational, 3MTM Littmann® TeleSteth Online Auscultation System software is physically located on a data network server and on each clients PC (see Figure 1 below). Functionally, software that is located on a clients PC establishes a wireless (Bluetooth) communications connection with a 3MTM Littmann® Model 3200 electronic stethoscope on one side and the designated network server (internet or private data network) on the other. When connected in such a way the 3MTM Littmann® Model 3200 electronic stethoscope can transmit heart, lung, and other body sounds through the clients PC to the server using secured and encrypted digital communications. Data sent to the server in such a way can then be sent on to a remotely located client PC where it can be listened to in real time (data streaming mode) by a second 3MTM Littmann® Model 3200 Electronic Stethoscope, or the sound data may be stored on the server database where it can be retrieved and listened to at a later point in time (store and forward mode).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body sounds (heart, lung, and other body sounds)
Indicated Patient Age Range
any person
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
K120704 1/3
510(k) Premarket Notification for 3M101 Littmann® TeleSteth Online Auscultation System
5:0 Premarket Notification 510(k) Summary
MAY - 3 2012
Sponsor Information:
3M Heath Care 3M Center, Bldg. 275-5 W-06 St. Paul, MN 55144-1000
| Contact Person: | Jon Platt |
|---|---|
| Regulatory Affairs Manager | |
| Phone Number: | (651) 736-1850 |
| FAX Number: | (651) 733-2009 |
| eMail: | jcplatt1(@mmm.com |
| Date of Summary: | March 7, 2012 |
Device Name and Classification:
| Common or Usual Name: | Telemedicine Module |
|---|---|
| Proprietary Name: | 3MTM Littmann® TeleSteth Online Auscultation |
| System | |
| Classification Name: | Transmitters and receivers, physiological signal, |
| radiofrequency (21 CFR § 870.2910) | |
| Performance Standards: | None |
Predicate Device:
3M TM Littmann® Scope-to-Scope Software System (K101834 3M Health Care)
1
4820704 43
510(k) Premarket Notification for 3M1M Littmann® TeleSteth Online Auscultation System
Description of Device:
The 3MTM Littmann® TeleSteth Online Auscultation System, used together with the 3MTM Littmann® Model 3200 Electronic Stethoscope (K083903), allows healthcare professionals to share heart, lung and other body sounds with colleagues located across the globe using the internet or a private data network. When operational, 3MTM Littmann® TeleSteth Online Auscultation System software is physically located on a data network server and on each clients PC (see Figure 1 below). Functionally, software that is located on a clients PC establishes a wireless (Bluetooth) communications connection with a 3MTM Littmann® Model 3200 electronic stethoscope on one side and the designated network server (internet or private data network) on the other. When connected in such a way the 3MTM Littmann® Model 3200 electronic stethoscope can transmit heart, lung, and other body sounds through the clients PC to the server using secured and encrypted digital communications. Data sent to the server in such a way can then be sent on to a remotely located client PC where it can be listened to in real time (data streaming mode) by a second 3MTM Littmann® Model 3200 Electronic Stethoscope, or the sound data may be stored on the server database where it can be retrieved and listened to at a later point in time (store and forward mode).
Image /page/1/Figure/4 description: The image shows a diagram of the 3M Littmann TeleSteth Online Auscultation System. The diagram includes a server connected to two clients via the internet/network. Each client is connected to a stethoscope via Bluetooth. The stethoscopes are labeled as Stethoscope 1 and Stethoscope 2.
2
5 I 0(k) Premarket Notification for 3M Littmann® TeleSteth Online Auscultation System
Indications for Use:
The 3MM Littmann® TeleSteth Online Auscultation 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. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3MM Littmann® TeleSteth Software System 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 3MTM Littmann® TeleSteth Online Auscultation System is substantially equivalent in terms of intended use, composition, physical properties and technological characteristics compared to the predicate device, the 3M " Littmann® Scope-to-Scope Software System (K101834). There are no new questions of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure, with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 3 2012
3M Healthcare c/o Mr. Jon Platt 3M Health Center, BLDG.275-05-W-06 ST. Paul, Minnesota 55144-1000
Re: K120704
Trade/Device Name: 3M™ Littmann® TeleSteth Online Auscultation System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: March 7, 2012 Received: March 8. 2012
Dear Mr. Platt:
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.
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
4
Page 2 -Ms. Jin
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 electronic 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/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please 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 rou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
R. Ze
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K120704 1/1
510(k) Premarket Notification for 3MTN Littmann® TeleSteth Online Auscultation System
4.0 Indications for Use Statement
Indications for Use
K120704 510(k) Number (if known):
Device Name: 3MTM Littmann® TeleSteth Online Auscultation System
Indications for Use:
The 3MTM Littmann® TeleSteth Online Auscultation 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. Patient body sounds may be remotely evaluated in real-time or in store-and-forward mode. The 3M Littmann TeleSteth Online Auscultation System can be used on any person undergoing a physical assessment.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Shin Org Division of Chickorascular Devices 510 k, Namber