HL 200 ELECTRONIC STETHOSCOPE

K050169 · Health & Life Co., Ltd. · DQD · Apr 5, 2005 · Cardiovascular

Device Facts

• Record ID: K050169
• Device Name: HL 200 ELECTRONIC STETHOSCOPE
• Applicant: Health & Life Co., Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The HL 200 ELECTRONIC STETHOSCOPE is intended for medical diagnostic purposes only. It can be used for the amplification 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

The HL 200 is a reusable electronic stethoscope used by clinicians to amplify and filter body sounds. It captures acoustic signals via a sensor, which are processed by an internal micro-computer chip to provide three selectable frequency modes: heart, lung, and combination. The device provides up to 18X amplification across eight volume levels, eliminating resonance effects common in traditional acoustic stethoscopes. Output is delivered to the user through an integrated earpiece. The device features an ergonomic design, a four-segment battery status display, and an auto-shutoff function (3 minutes) to conserve power. It is intended for use in clinical settings during physical examinations to assist in the detection and diagnosis of physiological sounds.

Clinical Evidence

Bench testing only; device conforms to IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Electronic stethoscope with micro-computer chip for signal amplification and filtering. Features three frequency modes, eight volume levels (up to 18X gain), and four-segment battery display. Powered by battery with 3-minute auto-shutoff. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

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

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 Model 2000 Electronic Stethoscope (K961848)

Submission Summary (Full Text)

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## 510(K) SUMMARY

K050169
p 1/2

APR - 5 2005

This summary of 510(k) safety and effectiveness information is being submitted in a cordance 1 the requirements of SMDA and 21 CFR §807.92

| 1.0 | Submitter's Name: | Health & Life Co., Ltd. |
|-----|-------------------|-------------------------------------------------------------------------------------|
| | Address: | 9 F, No. 168, Jian Yi Road, Chung Ho City, Taipei County , Taiwan<br>ZIP code : 235 |
| | Phone: | 886-2-82271300 |
| | Fax: | 886-2-82271301 |
| | Contact: | Mr. Paul Yang / President |

- 2.0 Device Name HL 200 ELECTRONIC STETHOSCOPE Trade Name Model No. : HL 200 Common Name: Electronic Stethoscope Classification name: Stethoscope, Electronic
- Classification: Class II 3.0
- · 3M Littmann Model 2000 Electronic Stethoscope (K961848) 4.0 Predicate Device: marketed by 3M Health care.

HL 200 ELECTRONIC STETHOSCOPE is a non-sterile, reusable 5.0 Device Description: Electronic Stethoscope . HL 200 ELECTRONIC STETHOSCOPE, equipped with built-in micro-computer chip, includes state-of-the-art amplification and filtering systems. It is ideal for picking up difficult-to-hear heart and other body sounds. The features of HL 200 ELECTRONIC STETHOSCOPE is as follows

- Providing three-mode choices for adequate requirements: heart sound mode, lung sound mode and combination mode
- · Eight volumes levels provide up to 18X amplification of acoustic stethoscopes
- · Electronic design with fully eliminates sound loss and resonance effects associated with traditional acoustic stethoscopes. With amplified signal, you could even hear the slight sounds much clearer than the traditional one.
- Ergonomically designed with comfortable handholding, subtle with material and touch
- · Four-segments display shows the battery conditions could inform you to know the battery using state
- · Auto shut-off after 3 minutes for extending battery life

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The HL 200 ELECTRONIC STETHOSCOPE is intended for medical + 3/2 6.0 Intended Use: diagnostic purposes only. It can be used for the amplification heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

- In terms of performance specification, Safety & EMC requirements, 7.0 Performance the device conforms to applicable standards included IEC 60601-1 Summary: and IEC 60601-1-2 & related requirements.
## 8. Conclusions:

The HL 200 ELECTRONIC STETHOSCOPE have the same intended use and similar technological characteristics as the 3M Littmann Model 2000 Electronic Stethoscope (K961848) marketed by 3M Health care. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. TThus, the HL 200 ELECTRONIC STETHOSCOPE is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 5 2005

Health & Life Co., Ltd. c/o Ms. Jennifer Reich Harvest Consulting Corp. 3892 South America West Trail Flagstaff, AZ 86001

Re: K050169

Trade Name: HL 200 Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: II (two) Product Code: DQD Dated: March 17, 2005 Received: March 24, 2005

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrobate) to togens and the Medical Device Amendments, or to commerce provide to May 20, 1978, in teasonance with the provisions of the Federal Food, Drug, devices mat have been reculability in quire approval of a premarket approval application (PMA). and Costietic Ac. (Tec) that to not requestly subject to the general controls provisions of the Act. The r ou may, mercerere, market the Act include requirements for annual registration, listing of gencial controls provisions of the tice, 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 If your device is classified (500 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller "Life 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements concerning your device in the Federal Register.

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Page 2 – Ms. Jennifer Reich

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be auvised that FDA s issuates of a buice complies with other requirements of the Act that TDA has made a determination and your stered by other Federal agencies. You must of ally recetal statutes and regulations and annual to registration and listing (21 comply with an the Act stequirements, merceing, and manufacturing practice requirements as set CITY at 807), adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons over device as described in your Section 510(k) I ills letter will anow you to begin manieming of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 advice for Jour as 1) 276-0120. Also, please note the regulation entitled, Comacit in Office of Compilance an (2 + + n = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blummenfor

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

¯10(k) Number (if known):

Device Name: HL 200 ELECTRONIC STETHOSCOPE Health & Life Co., Ltd.

Indications For Use:

The HL 200 ELECTRONIC STETHOSCOPE is intended for medical diagnostic purposes only. It can be used for the amplification 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumman
(Division Sign-Off)

Division of Cardiovascular Devices 510(k) Number 625016

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