(198 days)
Not Found
No
The description focuses on sound amplification, filtering, and digital signal processing, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device's intended use is explicitly stated as "for medical diagnostic purposes only" and it is described as a device that "picks up sounds" from internal organs, which points to a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for medical diagnostic purposes only."
No
The device description clearly states it is a "healthcare device that picks up sounds" and includes physical components like an active speaker, passive sound tubes, a keypad, an LCD display, a digital signal processor, and operates on a battery. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the 3M™ Littmann® Electronic Stethoscope, Model 3200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens obtained from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids outside of the body.
- The Littmann Electronic Stethoscope is used for direct physical assessment of a person. It detects and amplifies sounds from internal organs within the body.
The description clearly states its purpose is for "medical diagnostic purposes only" and involves the "detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs". This is a form of in vivo (within the living body) diagnostic assessment, not in vitro (in glass, or outside the body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lungs, arteries, veins, and other internal organs
Indicated Patient Age Range
Any person
Intended User / Care Setting
Healthcare device
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.
0
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: (651) 733-6655 FAX Number: (651) 737-5320
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
1
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
4
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
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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