(198 days)
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.
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.
The provided text describes the 3M™ Littmann® Electronic Stethoscope, Model 3200, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood for AI/ML-driven devices.
The submission is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than establishing novel performance metrics or conducting clinical trials for performance acceptance as might be seen for entirely new technologies or AI models.
Therefore, many of the requested sections below cannot be filled with the provided information.
Description of Device and Comparison
The 3M™ Littmann® Electronic Stethoscope, Model 3200, is a healthcare device designed to pick up, amplify, and filter sounds from internal organs (heart, arteries, veins, lungs, etc.) using selective frequency ranges. It transfers these sounds to the user's ears via an active speaker and passive sound tubes. A key technological characteristic noted is its ability to exchange audio data wirelessly with a personal computing device via Bluetooth. The device uses a 5-button keypad and an LCD display for its user interface and carries out sound processing with a digital signal processor. It does not incorporate off-the-shelf (OTS) software.
The submission demonstrates "substantial equivalence" to two predicate devices: the 3M™ Littmann® Electronic Stethoscope, Model 3000 (cleared under K050159), and the 3M™ Littmann® Electronic Stethoscope, Model 4100 (cleared under K051790). This equivalence is based on "intended use, indications for use, composition, physical properties and technological characteristics." The document explicitly states that "There are no new questions of safety or effectiveness."
Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence to predicate devices, specific, quantifiable performance acceptance criteria and a detailed report of the device's performance against these criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) are not provided in the given text. The substantial equivalence argument implies that the new device performs at least as well as the predicate devices for its intended use.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified in the provided text. However, the submission argues "Substantial Equivalence" to predicate devices. | The device is deemed "substantially equivalent" to predicate devices (3M™ Littmann® Electronic Stethoscope, Model 3000 and Model 4100) in terms of intended use, indications for use, composition, physical properties, and technological characteristics. This implies its performance is comparable and acceptable for its intended diagnostic purpose. |
Study Details (Based on the provided text, many fields cannot be filled)
Given that this is a 510(k) for an electronic stethoscope and not a diagnostic AI/ML device, the typical "study" involves demonstrating functional equivalence and safety rather than diagnostic performance metrics like those for an AI algorithm. Therefore, the following information is largely not applicable or not present in the provided text.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / not provided. The submission does not detail a "test set" in the context of an AI/ML algorithm's diagnostic performance study. The evaluation likely involved engineering verification and validation testing to ensure functional requirements were met and that the device performed similarly to its predicates.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / not provided. Ground truth, in the context of diagnostic accuracy for an AI/ML model, is not relevant here. The device amplifies sounds for human interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / not provided.
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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 / not provided. This device is a tool for human clinicians; it does not intrinsically involve AI assistance for "human readers" in a comparative effectiveness study as would be done for an AI diagnostic model.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / not provided. This is an electronic stethoscope, designed for human-in-the-loop use. It does not operate as a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / not provided. The device's "ground truth" performance would be about its ability to accurately capture and amplify physiological sounds, which is a functional test, not a diagnostic accuracy test against a clinical outcome.
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The sample size for the training set:
- Not applicable / not provided. This device does not use an AI/ML training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable / not provided.
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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
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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.
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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.
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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
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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_
Page 1 of 1
§ 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.