(69 days)
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.
HL 200 ELECTRONIC STETHOSCOPE is a non-sterile, reusable 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
Here's a breakdown of the acceptance criteria and study information for the HL 200 ELECTRONIC STETHOSCOPE, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Performance Specification | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| Safety | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| EMC Requirements | Conformance to applicable standards | Conforms to IEC 60601-1 and IEC 60601-1-2 & related requirements. | Bench Testing |
| Technological Characteristics | No new questions of safety or effectiveness compared to predicate. | Differences in technological characteristics do not raise any new questions of safety or effectiveness. | Bench Testing, Comparison to Predicate |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This submission relies on substantial equivalence to a predicate device, supported by bench testing. The data provenance is also not explicitly stated as country of origin or retrospective/prospective. The description suggests testing was likely performed by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a ground truth for a test set in the context of clinical performance or diagnostic accuracy. The evaluation is focused on technical and electrical safety standards.
4. Adjudication Method for the Test Set
Since there is no mention of a test set involving clinical data or expert review for diagnostic accuracy, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical standards and comparisons to a predicate's characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an electronic stethoscope, which is a hardware device for sound amplification. It is not an "algorithm only" device in the sense of AI. Its performance is inherent in its electrical and acoustic properties, which are evaluated by bench testing, not as a standalone algorithm's diagnostic accuracy. So, technically, the "standalone" performance is the bench testing, but not in the AI sense.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is adherence to electrical safety and EMC (electromagnetic compatibility) standards (IEC 60601-1 and IEC 60601-1-2), and the functional characteristics of the device as compared to a predicate electronic stethoscope. This is determined through bench testing against these established technical specifications, rather than clinical ground truth like pathology or expert consensus on diagnoses.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. As this is an electronic stethoscope (a hardware device), there is no training set in that context. The device's design and manufacturing processes are likely informed by engineering principles and possibly prior product development, but not by a formal "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense for this device, the question of how its ground truth was established is not applicable. The "ground truth" in its development would relate to engineering specifications, component performance, and adherence to design requirements, verified through internal testing and quality control processes.
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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 , TaiwanZIP 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.
<c50169
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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 (800) 638-2041 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
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.