(88 days)
Not Found
No
The description focuses on electronic amplification, filtering, and digital signal processing (DSP) for frequency modes, which are traditional signal processing techniques, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition beyond basic filtering.
No
The device is described as being for "medical diagnostic purposes only" and is used for "detection and amplification," indicating it's used to identify conditions, not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for medical diagnostic purposes only."
No
The device description explicitly states it is a healthcare device that picks up sounds, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes. While it incorporates embedded software, it is fundamentally a hardware device with software controlling its functions.
Based on the provided information, the 3M™ Littmann ® Electronic Stethoscope Model 3000 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids outside of the body.
- The description of the Littmann Stethoscope clearly states its intended use is for "detection and amplification of heart, lungs, arteries, veins, and other internal organs" by listening to sounds within the body. It is a diagnostic tool used for physical assessment directly on a person.
The device description focuses on the electronic amplification and filtering of sounds from within the body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of 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 3000 is a healthcare device that picks sounds of the heart, arteries, veins, lung and other internal organs, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes. The Model 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphragm (100-500 Hz).
The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope; DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds.
The Model 3000 does not incorporate any off-the-shelf (OTS) software.
The Model 3000 operates on one (1) AAA alkaline 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
Not Found
Intended User / Care Setting
Not Found
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
OCT 15 2004
K04-1934
510(k) Submission Littmann® Electronic Stethoscope, Model 3000
Premarket Notification (510(k)) Summary
Sponsor Information: 1.
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Ginger Cantor |
|---|---|
| Senior Regulatory Affairs Associate | |
| Phone Number: | (651) 736-2101 |
| FAX Number: | (651) 737-5320 |
July 16, 2004 Date of Summary:
2. Device Name and Classification:
Common or Usual Name: Electronic Stethoscope
| Proprietary Name: | 3M™ Littmann® Electronic Stethoscope,
Model 3000 |
|----------------------|-----------------------------------------------------|
| Classification Name: | Electronic Stethoscope |
Classification Name: Electronic Stethoscope (21 CFR § 870.1875(b))
Performance Standards: None
3. Predicate Device:
3M™ Littmann® Electronic Stethoscope, Model 4000 3M™ Littmann® Electronic Stethoscope, Model 2000
1
510(k) Submission Littmann® Electronic Stethoscope, Model 3000
Description of Device: 4.
The 3M™ Littmann® Electronic Stethoscope, Model 3000 is a healthcare device that picks sounds of the heart, arteries, veins, lung and other internal organs, electronically amplifies, filters, and transfers them to the user's ears via an active speaker and passive sound tubes. The Model 3000 provides two filter frequency modes for auscultation: Bell (20-200 Hz) and Diaphragm (100-500 Hz).
The Model 3000 incorporates embedded software. The embedded software controls all of the various features found in the Model 3000 stethoscope, such as volume control and frequency mode selection. In addition, the embedded software provides digital signal processing (DSP) over the entire acoustic range of the stethoscope; DSP produces the bell and diaphragm frequency response modes that are used to listen to heart, lung, and other body sounds.
The Model 3000 does not incorporate any off-the-shelf (OTS) software.
The Model 3000 operates on one (1) AAA alkaline battery.
5. Indications for Use:
The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of 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.
2
Littmann® Electronic Stethoscope, Model 3000
Comparative Data for Determining Substantial Equivalence of New 6. Device to Predicate Device:
The table below illustrates the similarities and differences of the new device (Model 3000) to the predicate devices (Model 4000 and Model 2000). The Model 3000 proposed under this new pre-market notification submission is composed of similar materials, and has similar performance features, intended use and indications for use as the Model 4000 cleared under K003723, and the Model 2000, cleared under K961848.
Comparison of Performance Features Littmann® Electronic Stethoscope Model 3000 versus Littmann® Electronic Stethoscope Model 4000 and Littmann® Electronic Stethoscope Model 2000
| Performance
Features | Model 3000
(New Device) | Model 4000
(Predicate Device)
K003723 | Model 2000
(Predicate Device)
K961848 |
|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Frequency
Response | Bell (20-200 Hz) and Diaphragm (100-500 Hz) modes. | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (20-1000 Hz) modes. | Bell (20-200 Hz), Diaphragm (100-500 Hz) and Extended Range (100-1000 Hz) modes. |
| Amplification | Up to 25 dB acoustic gain, equivalent to 18 times amplification. | Up to 25 dB acoustic gain, equivalent to 18 times amplification. | Up to 20 dB acoustic gain, equivalent to 14 times amplification. |
| Maximum Sound
Level | 140 dB SPL Max | 140 dB SPL Max | 140 dB SPL Max |
| Power Source | One (1) (AAA) alkaline battery | Two (2) (AAA) alkaline batteries | One (1) (AAA) alkaline battery |
| Low Battery
Indicator | Includes a low battery indicator | Includes a low battery indicator | Includes a low battery indicator |
| Displays Heart
Rate | No | Yes | No |
| Record and
Playback Sounds | No | Yes | No |
| Permits Data
Transfer of Stored
Digital Signals to
and from IBM-
Compatible PC
and Pocket PC
and Palm Pilot* | No | Yes | No |
| Volume Control | 8 Step Volume
Control | 8 Step Volume
Control | Continuous Variable |
| ON/OFF Switch
Automatic Shut-off
by Electronics | Yes | Yes | Yes |
- With Infrared Port and Windows /98/2000/XP, Pocket PC 2002/2003 and Palm OP Sys 4/5 Microsoft and Windows™ are registered trademarks of Microsoft Corporation.
3
Non-clinical (Biocompatibility) Summary: 7.
All components of the Model 3000 stethoscope have been reviewed for biocompatibility with respect to ISO10993-Part 1 Biological Evaluation of Medical Devices for limited (≤ 24 hour) skin contact for both patient and/or health care professional exposure. Each component with potential skin contact with either the user or patient was reviewed for possible health concerns.
The Littmann® Electronic Stethoscope Model 3000 is composed of the same or substantially equivalent materials as those in the Littmann® Electronic Stethoscope Model 4000 cleared under K003723, and the Littmann® Electronic Stethoscope Model 2000, cleared under K961848.
3M concludes that all of the components of the Model 3000 Stethoscope would have minimal potential for any adverse health concern.
4
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem that resembles an abstract eagle or bird-like figure with three wing-like lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
3M Company c/o Ms. Ginger Cantor Senior Regulatory Affairs Associate 3M Healthcare 3M Center, Bldg 275-5W-06 St Paul, MN 55144-1000
Re: K041934
K041934
Trade Name: 3M Littman Electronic Stethoscope, Model 3000 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: July 16, 2004 Received: July 19, 2004
Dear Ms. Cantor:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I (x) premaited is substantially equivalent (for the indications
referenced above and have determined the devices and sets to interstate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments. for use stated in the enclosure) to regally manced peoples and Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drue, commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance who areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval estarsas provisions of the Act. T and Cosmetic Act (Act) that ao not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, listing You may, therefore, market the uctives, subject of annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Act mender requirements on the many of the superior misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mits existing major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlist - Existing may one of 898 - In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Federal Regarding your device in the Federal Register.
5
Page 2 - Ms. Ginger Cantor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decermination that your acceral agencies. You must or any Federal statutes and regulations continued to registration and listing (21)
comply with all the Act's requirements, including, increation requirements as set comply with all the Act S requirements, morams manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements CFR Part 807); labeling (21 CFR Fall on ); good manatalog production (2000); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path, 11 C forth in the quality systems (Q5) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Acction Section S product radiation control provisions (Occions of I svice as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will anow you to begin marketing your artist equivaler of your device to a legally premarket notification. The PDA mining of substantial equal 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
ntitled If you desire specific advice for your ac 1100 %. Also, please note the regulation entitled, contact the Office of Computation at (301) 971-77 (21CFR Patt 807.97). You may obtain " Misoranding by reference to premanter to allietas in the Act from the Division of Small other general information on your responsion issues at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the new an arrant Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bf. nimimotor for
B. Zukerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K041934
Device Name: 3M™ Littmann ® Electronic Stethoscope Model 3000
Indications For Use:
Indications For Ose.
The 3MTM Littmann ® Electronic Stethoscope Model 3000 is intended for medical The SM- Entination & Elections enved for the detection and amplification of draghostic purposes only. It may ob a internal organs with the use of a selective frequency. 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 X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Abstmmerman
on Sign-Off) n of Cardiovascular Deyices KON19 .. , Number__
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