(28 days)
The 3M™ Littmann® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from 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.
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 Diaphraqm (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.
The provided document is a 510(k) Premarket Notification Summary for the 3M™ Littmann® Electronic Stethoscope, Model 3000. It details modifications made to the device's embedded software and asserts its substantial equivalence to a predicate device.
However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way a typical AI/ML medical device submission would. This is because the submission is for a classic medical device (electronic stethoscope) where the focus is on functional equivalence and safety rather than a diagnostic performance study with statistical endpoints.
Specifically, for the questions asked, the submission does not contain the following information:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on standalone (algorithm only) performance.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Analysis of the Provided Text:
The relevant section for performance and equivalence is "6. Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device." It states:
"The Model 3000 as modified in this special pre-market notification submission is composed of the same or substantially equivalent materials, has the same performance features, same intended use, same indications for use, and same labeling as the Model 3000 predicate device cleared under K041934."
This statement indicates that the manufacturer is demonstrating equivalence based on the device having the same performance features as its predicate, rather than presenting new performance data against specific acceptance criteria. The modifications were to embedded software, and the submission explicitly states: "The modifications included in this submission do not affect the device's intended use or indications for use, performance features, labeling or claims."
Therefore, the "study" proving the device meets acceptance criteria, in this context, is the demonstration of substantial equivalence to the predicate device by asserting that the modifications made do not alter its performance features, intended use, indications for use, or labeling. No specific quantitative performance study with a test set, ground truth, or expert review is mentioned because it's not relevant to this type of submission for this particular device modification.
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Premarket Notification (510(k)) Summary
1. Sponsor Information:
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 |
Date of Summary: January 24, 2005
2. Device Name and Classification:
Common or Usual Name: Electronic Stethoscope
3M™ Littmann® Electronic Stethoscope, Proprietary Name: Model 3000
Classification Name: Electronic Stethoscope (21 CFR § 870.1875(b))
Performance Standards: None
3. Predicate Device:
3M™ Littmann® Electronic Stethoscope, Model 3000 (K041934)
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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 Diaphraqm (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.
This submission describes modifications made to the device's embedded software. The modifications included in this submission do not affect the device's intended use or indications for use, performance features, labeling or claims. The modified device is substantially equivalent to the Model 3000 predicate device (K041934).
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 undergoinq a physical assessment.
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6. Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
The Model 3000 as modified in this special pre-market notification submission is composed of the same or substantially equivalent materials, has the same performance features, same intended use, same indications for use, and same labeling as the Model 3000 predicate device cleared under K041934.
7. Non-clinical (Biocompatibility) Summary:
3M has reviewed all components of the Model 3000 stethoscope 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 modified Littmann® Electronic Stethoscope Model 3000 is composed of the same or substantially equivalent materials as those in the Model 3000 predicate device.
3M concludes that all of the components of the modified Model 3000 would have minimal potential for any adverse health concern.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
FEB 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3M Health Care c/o Ms. Ginger Cantor Senior Regulatory Affairs Associate 3M Center, Bldg 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K050159
Trade Name: 3M7M Littmann® Electronic Stethoscope Model 3000 Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD Dated: January 24, 2005 Received: January 25, 2005
Dear Ms. Cantor:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energears) is segment 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). and Cosmotic Fee (110) has the device, subject to the general controls provisions of the Act. The r ou may, morelore, mains 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.
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Page 2 - Ms. Ginger Cantor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Dri brisantes over device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cacal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (21 OFR Part 820); and if applicable, the electronic form in and quart) by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of the nevels (seting your device as described in your Section 510(k) I mis letter with anow your o begin mating of substantial equivalence of your device to a legally premaired 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 If you desire specific arrantiance at (240) 276-0120. Also, please note the regulation entitled, eonider the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation of your respuner Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Bhummon for
3ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: 3M™ Littmann® Electronic Stethoscope Model 3000
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 sounds from 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.
Over-The-Counter-Use XX OR Prescription Use
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hemmer
vision or Ografovascu i Jik) Number
§ 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.