(69 days)
Not Found
No
The description focuses on amplification and filtering of sounds, not analysis or interpretation using AI/ML. The mention of a "built-in micro-computer chip" is common for electronic devices and doesn't necessarily indicate AI/ML.
No
The device is described as an electronic stethoscope intended for diagnostic purposes (amplification of body sounds), not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for medical diagnostic purposes only."
No
The device description explicitly states it is an "Electronic Stethoscope" and lists hardware components and features like a built-in micro-computer chip, amplification and filtering systems, ergonomic design, and a battery display, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, the HL 200 ELECTRONIC STETHOSCOPE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic purposes.
- HL 200 Function: The HL 200 ELECTRONIC STETHOSCOPE is used for the amplification of body sounds (heart, lung, etc.) directly from the patient's body. It does not involve the examination of specimens in vitro (outside the body).
- Intended Use: The intended use clearly states "for medical diagnostic purposes only" and describes its function as amplifying body sounds during a physical assessment. This aligns with the function of a traditional stethoscope, which is not an IVD.
Therefore, the HL 200 ELECTRONIC STETHOSCOPE is a medical device used for physical examination and diagnosis based on auscultation, not an IVD.
N/A
Intended Use / 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.
Product codes
DQD
Device Description
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
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
Not Found
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)
In terms of performance specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 & related requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 | |
| 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
1
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.