(56 days)
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.
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).
The provided text does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) Premarket Notification for the 3M Littmann TeleSteth Online Auscultation System, primarily focusing on establishing substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets the criteria. The document explicitly states: "Information provided in this 510(k) submission shows that the 3M™ 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." This indicates that the approval was based on equivalence, not on independent performance studies with detailed acceptance criteria.
To address the specific points of your request based on the absence of this information in the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not provided in the document.
- Reported Device Performance: Not provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. No specific test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no test set or ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no test set or adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is a system for transferring body sounds, not an AI diagnostic tool that assists human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as the device is a communication system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no studies involving ground truth are described.
8. The sample size for the training set:
- Not applicable as no training set or machine learning components are mentioned for this device.
9. How the ground truth for the training set was established:
- Not applicable as no training set or ground truth establishment process is described.
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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 AuscultationSystem |
| 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)
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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.
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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.
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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
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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
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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
§ 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).