JABES ELECTRONIC STETHOSCOPE

K031446 · Gs Technology Co., Ltd. · DQD · Oct 31, 2003 · Cardiovascular

Device Facts

• Record ID: K031446
• Device Name: JABES ELECTRONIC STETHOSCOPE
• Applicant: Gs Technology Co., Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Oct 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

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.

Device Story

JABES Electronic Stethoscope functions as a diagnostic aid for clinicians to amplify and filter body sounds (heart, lung, bronchial). Device captures acoustic signals via a diaphragm-based chest piece; transforms signals using three selectable frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz), and Wide (20-800Hz). Amplifies sounds up to 18 times. Operated by clinicians in clinical settings; features four buttons on the chest piece for mode selection, volume control (12 steps), and power. Powered by two AAA batteries; includes low battery indicator and power-saving functions. Output is delivered to the clinician via ear tips; aids in physical assessment and patient diagnosis.

Clinical Evidence

Bench testing only. Evidence includes electrical safety, EMC, and user testing comparing the device to predicates. No clinical trials or human subject data provided.

Technological Characteristics

Electronic stethoscope; form factor similar to traditional acoustic stethoscopes (diaphragm, binaural pipes, ear tips). Energy source: two 1.5V AAA batteries. Features 12-step volume control, low battery indicator, and automatic shut-off. Three frequency modes: Bell (20-200Hz), Diaphragm (200-500Hz), Wide (20-800Hz). Amplification up to 18x. Connectivity: supports digital signal transfer to/from PC.

Indications for Use

Indicated for medical diagnostic purposes, specifically the amplification of heart, lung, and other body sounds in any patient undergoing a physical assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• 3M Littmann Electronic Stethoscope (K003723)
• Meditron stethoscope system (K991347)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

April 22, 2003 Contact: J. S. Kim Managing Director

- 1. Identification of the Device: Proprietary-Trade Name: Jabes Electronic Stethoscope Classification Name: Electronic Stethoscope, Product code DQD Common/Usual Name: Electronic Stethoscope
- 2. Equivalent legally marketed devices 3M™ Littmann™ Electronic Stethoscope (K003723), Meditron stethoscope system (K991347)
- 3. 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.
- 4. 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.
- 5. 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 Electronic<br>stethoscope,<br>Model 4000(k003723) | Meditron stethoscope<br>system(K9913647) | JABES electronic<br>stethoscope |
| Classification<br>Name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope |
| Applicant | 3M | MEDITRON AS | GS Technology Co., Ltd |
| Frequency<br>Response Mode | Bell(20-200Hz),<br>Diaphragm(100-500Hz)<br>Extended range (20-<br>1,000Hz) | Bell(20-600Hz),<br>Diaphragm(200-<br>20000Hz) Extended<br>range(20-20000Hz) | Bell(20-200Hz),<br>Diaphragm(200-500Hz)<br>Extended range<br>(20-800 Hz) |
| Amplification | Up to 18 times<br>amplification | Up to 30 times<br>amplification | Up to 18 times<br>amplification |
| Display heart rate | Yes | No | Yes |
| Permits data<br>transfer of stored<br>digital signal to<br>and from IBM-<br>Compatible PC | None | Yes | Yes |
| Maximum sound<br>level | 140dB SPL Max | 100dB SPL Max | Within 120dB SPL Max |
| Volume control | 8 Steps Volume control | Continuous variable | 12 Steps Volume<br>control |
| Energy source | Two(2) AAA alkaline<br>batteries | One(1) 1/2 AA Lithium<br>battery | Two(2) AAA alkaline<br>batteries |
| Manual<br>On/Off button<br>Automatic shut-off<br>By electronics | Yes | Yes | Yes |
| Low Battery<br>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.

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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 [phone]. 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 [phone] or [phone] 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