(177 days)
Not Found
No
The description focuses on electronic amplification and filtering of sounds, with no mention of AI/ML for analysis or interpretation.
No
The device is used for diagnostic purposes by amplifying body sounds for physical assessment, not for treating or preventing a disease or condition.
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 mentions physical components like a diaphragm, binaural pipes, ear tips, buttons, and requires batteries to operate, indicating it is a hardware device with electronic components, not software-only.
Based on the provided information, the JABES Electronic Stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The JABES Electronic Stethoscope is used to listen to sounds directly from within the patient's body (heart, lungs, etc.). It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state its purpose is for amplifying body sounds for diagnostic purposes during a physical assessment. This is a non-invasive method of diagnosis, not an in vitro one.
- There is no mention of analyzing biological samples or using reagents.
Therefore, the JABES Electronic Stethoscope falls under the category of a medical device used for physical examination and diagnosis, but not an IVD device.
N/A
Intended Use / Indications for 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.
Product codes
DQD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lung and other body sounds
Indicated Patient Age Range
any patient
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)
The results of bench and user testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
-
- 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.
-
- 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.
1
| Predicate Device | New Device | ||
|---|---|---|---|
| Device name | 3M Littmann Electronic | ||
| stethoscope, | |||
| Model 4000(K003723) | Meditron stethoscope | ||
| system(K9913647) | JABES electronic | ||
| stethoscope | |||
| Classification | |||
| Name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope |
| Applicant | 3M | MEDITRON AS | GS Technology Co., Ltd |
| Frequency | |||
| Response Mode | Bell(20-200Hz), | ||
| Diaphragm(100-500Hz) | |||
| Extended range (20- | |||
| 1,000Hz) | Bell(20-600Hz), | ||
| Diaphragm(200- | |||
| 20000Hz) Extended | |||
| range(20-20000Hz) | Bell(20-200Hz), | ||
| Diaphragm(200-500Hz) | |||
| Extended range | |||
| (20-800 Hz) | |||
| Amplification | Up to 18 times | ||
| amplification | Up to 30 times | ||
| amplification | Up to 18 times | ||
| amplification | |||
| Display heart rate | Yes | No | Yes |
| Permits data | |||
| transfer of stored | |||
| digital signal to | |||
| and from IBM- | |||
| Compatible PC | None | Yes | Yes |
| Maximum sound | |||
| level | 140dB SPL Max | 100dB SPL Max | Within 120dB SPL Max |
| Volume control | 8 Steps Volume control | Continuous variable | 12 Steps Volume |
| control | |||
| Energy source | Two(2) AAA alkaline | ||
| batteries | One(1) 1/2 AA Lithium | ||
| battery | Two(2) AAA alkaline | ||
| batteries | |||
| Manual | |||
| On/Off button | |||
| Automatic shut-off | |||
| By electronics | Yes | Yes | Yes |
| Low Battery | |||
| Indicator | 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.
2
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.
3
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
4
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