(177 days)
The JABES Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
The JABES Electronic Stethoscope is intended for use as a diagnostic aid in patients diagnosis, treatment and monitoring. It provides three filter frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz). Wide (20-800Hz). Bell Mode is similar to the acoustic bell-type stethoscope and optimized for heart and other cardiology related sound. Diaphragm Mode is similar to the acoustic diaphragm-type stethoscope and optimized for higher pitched sound such as lung and bronchial sounds. Wide Mode is a combination of Bell and Diaphragm Modes. Wide Mode provides wider frequency range compare to the typical acoustic stethoscope including the Bell-type and Diaphragm-type. The JABES amplifies sounds up to 18 times bigger than an ordinary acoustic stethoscope in a broad frequency range, including a range higher than the traditional diaphragm mode. It looks similar to the traditional stethoscope including parts like a diaphragm, binaural pipes and ear tips. However, it has four (4) buttons on top of the chest set (opposite to the diaphragm side). Each of the buttons has a function of controlling the modes, volume up/down and power on/off. As an electronic stethoscope, it needs two (2) batteries (AAA type, 1.5V) to operate. The stethoscope has power saving functions for longer battery life and has a low battery indicator to prevent the use in malfunctioning condition due to the low power.
Here's a breakdown of the acceptance criteria and the study information for the JABES Electronic Stethoscope based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a substantial equivalence comparison, so the "acceptance criteria" for the JABES Electronic Stethoscope are its ability to meet or exceed the performance of the predicate electronic stethoscopes in key functional areas. The acceptance criteria are implicit in the comparison points.
| Feature / Acceptance Criteria (based on Predicate Devices) | JABES Electronic Stethoscope Performance |
|---|---|
| Frequency Response Mode: | |
| Bell Mode (e.g., 20-200Hz) | Bell (20-200Hz) |
| Diaphragm Mode (e.g., 100-500Hz) | Diaphragm (200-500Hz) |
| Extended/Wide Range (e.g., 20-1000Hz) | Extended range (20-800 Hz) |
| Amplification: | Up to 18 times amplification |
| Display Heart Rate: | Yes |
| Permits Data Transfer: | Yes |
| Maximum Sound Level: | Within 120dB SPL Max |
| Volume Control: | 12 Steps Volume control |
| Energy Source: | Two (2) AAA alkaline batteries |
| Manual On/Off Button, Automatic Shut-off: | Yes |
| Low Battery Indicator: | Yes |
| Safety and Effectiveness: | As safe and effective as predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the conventional sense of a clinical trial for diagnostic performance. The document describes "bench and user testing data" and "electrical safety, EMC" data. These types of tests typically involve a limited number of devices or a specific test setup, not a patient-based test set with a defined sample size for diagnostic accuracy.
- Data Provenance: The study appears to be an internal validation effort by GS Technology Co., Ltd. The document does not explicitly state the country of origin of the data beyond the manufacturer being from South Korea. It is a report submitted for a 510(k) premarket notification, implying it's a retrospective analysis of tests conducted on the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "user testing," but it does not detail the nature of this testing, how ground truth (if any for diagnostic performance) was established, or the qualifications of the users. For an electronic stethoscope, "user testing" might relate more to usability and perceived sound quality rather than a formal diagnostic accuracy study with expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the submission (510(k) for substantial equivalence based on functional comparison and safety, rather than a diagnostic accuracy study), a formal adjudication method for a test set is unlikely to have been a primary component.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to existing predicate devices based on technical specifications and general safety/effectiveness rather than a study evaluating diagnostic improvement with AI assistance. The device is the stethoscope; there is no AI component described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is an electronic stethoscope that amplifies and filters sounds for human interpretation. It is not an algorithm that performs a diagnostic task independently.
7. The Type of Ground Truth Used
The document does not explicitly describe the type of ground truth used in the context of diagnostic performance. The "testing" mentioned ("bench and user testing") likely focused on:
- Bench Testing: Verifying technical specifications (frequency response, amplification, sound level, battery life, etc.) against design requirements. The "ground truth" here would be the measured physical properties of the device.
- User Testing: Evaluating the subjective experience of using the stethoscope (e.g., sound quality, comfort, ease of use). The "ground truth" here would be user feedback and satisfaction, which is not a clinical ground truth for diagnostic accuracy.
There is no mention of pathology, expert consensus on patient cases, or outcomes data being used to establish ground truth for diagnostic accuracy in this submission.
8. The Sample Size for the Training Set
N/A. The JABES Electronic Stethoscope is a hardware device, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. As stated above, this device does not involve a training set.
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K031446
p.1/2
OCT 3 1 2003
EXHIBIT 2 510(k) Summary
GS Technology Co., Ltd ... B-207, SBI Center 647-26, Deungchon-dong, Kangseo-Gu, Seoul, Korea Phone: 82-2-2668-0610 Fax: 82-2-2668-0752
April 22, 2003 Contact: J. S. Kim Managing Director
-
- Identification of the Device: Proprietary-Trade Name: Jabes Electronic Stethoscope Classification Name: Electronic Stethoscope, Product code DQD Common/Usual Name: Electronic Stethoscope
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- Indications for Use (intended use) The JABES Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
-
- Description of the Device: The JABES Electronic stethoscope The JABES Electronic Stethoscope is intended for use as a diagnostic aid in patients diagnosis, treatment and monitoring. It provides three filter frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz). Wide (20-800Hz). Bell Mode is similar to the acoustic bell-type stethoscope and optimized for heart and other cardiology related sound. Diaphragm Mode is similar to the acoustic diaphragm-type stethoscope and optimized for higher pitched sound such as lung and bronchial sounds. Wide Mode is a combination of Bell and Diaphragm Modes. Wide Mode provides wider frequency range compare to the typical acoustic stethoscope including the Bell-type and Diaphragm-type. The JABES amplifies sounds up to 18 times bigger than an ordinary acoustic stethoscope in a broad frequency range, including a range higher than the traditional diaphragm mode. It looks similar to the traditional stethoscope including parts like a diaphragm, binaural pipes and ear tips. However, it has four (4) buttons on top of the chest set (opposite to the diaphragm side). Each of the buttons has a function of controlling the modes, volume up/down and power on/off. As an electronic stethoscope, it needs two (2) batteries (AAA type, 1.5V) to operate. The stethoscope has power saving functions for longer battery life and has a low battery indicator to prevent the use in malfunctioning condition due to the low power.
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- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
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| Predicate Device | New Device | ||
|---|---|---|---|
| Device name | 3M Littmann Electronicstethoscope,Model 4000(K003723) | Meditron stethoscopesystem(K9913647) | JABES electronicstethoscope |
| ClassificationName | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope |
| Applicant | 3M | MEDITRON AS | GS Technology Co., Ltd |
| FrequencyResponse Mode | Bell(20-200Hz),Diaphragm(100-500Hz)Extended range (20-1,000Hz) | Bell(20-600Hz),Diaphragm(200-20000Hz) Extendedrange(20-20000Hz) | Bell(20-200Hz),Diaphragm(200-500Hz)Extended range(20-800 Hz) |
| Amplification | Up to 18 timesamplification | Up to 30 timesamplification | Up to 18 timesamplification |
| Display heart rate | Yes | No | Yes |
| Permits datatransfer of storeddigital signal toand from IBM-Compatible PC | None | Yes | Yes |
| Maximum soundlevel | 140dB SPL Max | 100dB SPL Max | Within 120dB SPL Max |
| Volume control | 8 Steps Volume control | Continuous variable | 12 Steps Volumecontrol |
| Energy source | Two(2) AAA alkalinebatteries | One(1) 1/2 AA Lithiumbattery | Two(2) AAA alkalinebatteries |
| ManualOn/Off buttonAutomatic shut-offBy electronics | Yes | Yes | Yes |
| Low BatteryIndicator | Yes | No | Yes |
Substantial Equivalence Chart 6.
7. Conclusion
After analyzing bench, electrical safety, EMC, and user testing data, it is the conclusion of GS Technology Co. Ltd, that the Jabes Electronic is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
GS Technology Co., Ltd. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K031446
Trade Name: JABES Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: August 4, 2003 Received: August 6, 2003
Dear Mr. Kamm:
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. Daniel Kamm, P.E.
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dria Heixher for
Bram D. Zuckerman, M.D.
Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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i) Indications for Use
510(k) Number_K03 144b
Device Name: Electronic stethoscope (Model: JABES) Device Namel Libert one JABES Electronic Stethoscope is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Prescription Use $\checkmark$ OR Over the Counter Use ___
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Dua Resher
(Division Sign Off)
510(k) Num
7
§ 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.