(147 days)
Not Found
No
The description focuses on signal amplification, visual display of waveforms, memory storage, and basic software tools for viewing and saving data. There is no mention of algorithms that learn from data or perform automated analysis or interpretation.
No
The device is described as a "diagnostic aid" and an "auscultation tool" to assist in physical assessment and triage. It amplifies body sounds and displays them as waveforms for analysis, but it does not treat or cure any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is intended for use as a diagnostic aid as part of a physical assessment of a patient."
No
The device description clearly states it is an "electronic stethoscope" with an "integrated graphics display" and mentions "switchable modes" for hearing sounds. It also describes two models, one of which can download data to a PC. This indicates the device includes hardware components for sound acquisition, processing, and display, in addition to any software functionality.
Based on the provided information, the ViScope Electronic Stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ViScope is used for direct auscultation of body sounds (heart, lung, etc.) from the patient's body. It does not analyze samples like blood, urine, or tissue.
- The intended use and device description clearly state its function is to amplify and display body sounds for diagnostic aid during a physical assessment. This is a non-invasive, external examination method.
Therefore, the ViScope falls under the category of a medical device used for physical examination and diagnostic aid, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ViScope Electronic Stethoscope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
Product codes (comma separated list FDA assigned to the subject device)
DQD, DQC
Device Description
The ViScope Electronic Stethoscope (ViScope) is an audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Gram (VPCG) with visual display on which the heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dia/wide) for hearing heart, lung, blood vessel, enteral and other body sounds with different frequency ranges. In addition, the ViScope has an incorporated 'memory' feature that provides the user with the ability to review the saved 4 waveforms. The user also has the option to delete each waveform individually.
The ViScope comes in two models. the ViScope 100S and the ViScope 100P. The models are the same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that the ViScope 100P has the ability to download data to a PC or printer, the ViScope 100S does not offer this download feature. The ViScope 100P is supported by software that can be installed in a PC. The user can see the real-time waveforms on the PC monitor (as live data) and record in 10 second intervals. The software allows the user with an option of selecting the entire 10 second signal or select any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lung, blood vessel, enteral and other body sounds.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.
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)
Not Found
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
KIDOS31
HD Medical Services ViScope Electronic Stethoscope Original Premarket 510(k) Notification Summary of Safety and Effectiveness
Image /page/0/Picture/3 description: The image shows a three-dimensional abstract design. The design is composed of geometric shapes, including rectangular blocks and a curved element resembling a letter 'C'. The shapes are arranged in an overlapping manner, creating a sense of depth and complexity. The image is in black and white, with varying shades of gray to define the different planes and surfaces of the design.
HD Medical Services (India) Private Ltd
48, Industrial Estate IT Highway, Perungudi Chennai, 600096, India Tel: +91 44 4215 4771 Fax: +91 44 4215 4772 www.hdmedicalgroup.com
FDA CDRH DMC
1/4
ນັ້ນ 2 2 201910 Received
Summary of Safety and Effectiveness ViScope Electronic Stethoscope
SUBMITTER INFORMATION
Company Name:
HD Medical Services (India) Pvt. LTD.
Company Address:
No. 48, Perungudi Industrial Estate IT Highway Perungudi, Chennai ZIP - 600096
Company Phone:
+91 44 4215 4771
Company Fax:
+91 44 4215 4772
Contact Persons:
S. Subramaniam Manager- Quality Management
January 26, 2010 Date Summary Prepared:
1
જેવા
Original Premarket 510(k) Notification Summary of Safety and Effectiveness
DEVICE IDENTIFICATION
| Common or Usual Name: | Electronic Stethoscope, Cardiogram |
|---|---|
| Trade/Proprietary Name: | ViScope |
| Classification: | Class II, 21 CFR 870.1875, 870.2390 |
| Product Code: | DQD, DQC |
| Performance Standard : | None |
PREDICATE DEVICES:
- CADI Tech AG CADIscope electronic ECG Stethoscope, K990809 Dated 09/21/199 .
- 3M Healthcare Littman Electronic Stethoscope, Model 3200 with Zargis Sethassist . Software, K083903 Dated 07/15/09 and K090493 Dated 08/07/2009
DEVICE DESCRIPTION
The ViScope Electronic Stethoscope (ViScope) is an audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Gram (VPCG) with visual display on which the heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dia/wide) for hearing heart, lung, blood vessel, enteral and other body sounds with different frequency ranges. In addition, the ViScope has an incorporated 'memory' feature that provides the user with the ability to review the saved 4 waveforms. The user also has the option to delete each waveform individually.
The ViScope comes in two models. the ViScope 100S and the ViScope 100P. The models are the same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that the ViScope 100P has the ability to download data to a PC or printer, the ViScope 100S does not offer this download feature. The ViScope 100P is supported by software that can be installed in a PC. The user can see the real-time waveforms on the PC monitor (as live data) and record in 10 second intervals. The software allows the user with an option of selecting the entire 10 second signal or select
2
any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.
INDICATIONS FOR USE
The ViScope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
SUBSTANTIAL EQUIVALENCE
The ViScope is substantially equivalent to the following predicate devices:
| Predicate | Manufacturer | 510(k) No. | Date
Cleared | SE Component |
|------------------------------------------------------------------------------------------------|-----------------|--------------------|----------------------|------------------------------------------------------------------------|
| Device | | | | |
| CADIscope
Electronic ECG
Stethoscope | CADI Tech
AG | K990809 | 9/21/1999 | -Indications for Use
-Visual Display
-General Operation |
| 3M Littman *
Model 3200
Electronic
Stethoscope with
Zargis Sethassist
Software* | 3M Healthcare | K083903
K090493 | 07/15/09
08/07/09 | -Indication for Use
-Download
capabilities
-General Operation |
- The two devices are sold as a package.
3
KL00531
પ્રીપ્
HD Medical Services ViScope Electronic Stethoscope Original Premarket 510(k) Notification Summary of Safety and Effectiveness
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ViScope and the predicate devices has been performed. The results of this comparison demonstrate that the ViScope is substantially equivalent to the marketed predicate devices in technological characteristics and performance requirements.
PERFORMANCE DATA and CONCLUSION: The performance data indicate that the Viscope meets specified requirements, and is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
HD Medical Services PVT., LTD. c/o Mr. William H. Murphy Murphy & Associates 11143 Twinleaf Way San Diego, CA 92131
JUL 2 1 2010
Re: K100531
Trade/Device Name: ViScope Electronic Stethoscope (models 100P and 100S)
Regulation Number: 21 CFR 870 1875 Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD, DQC Dated: July 13, 2010 Received: July 14, 2010
Dear Mr. Murphy:
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 market aredicated a for use and in the enclosure) to legally marketed predicate devices marketed in indical 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.
devices that have been reclassified in accordance with the provisions of the Federa and Cosmetic Act (Act (Act that do not require approval of the Federal Food, Joug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions (PMA),
You may, therefore, market the device, subject to the general controls provisions of general controls provisions of the Act include requirements for annual registration, if the Act.
devices, good manufacturing practice, lebeling, ond mail registration, listin devices, good manufacturing practice, labeling, and prohibitions against misbranding and
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to addition (soc above) filio entrols) or class III (PMA)
may be subject to additional controls. Existing major regulations affective your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements, Thie 21, Parts 800 to 898. In addition
publish further announcements concerning your device in the Federal Register,
5
Page 2 - Mr. William H. Murphy
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Original Premarket 510(k) Notification Indications for use
Image /page/6/Picture/3 description: The image shows a 3D rendering of an abstract shape. The shape is composed of rectangular and curved segments, creating an interlocking design. The color scheme appears to be grayscale, with variations in shading to emphasize the three-dimensional aspect of the structure. The overall impression is that of a modern, geometric sculpture.
HD Medical Services (India) Private Ltd
48, Industrial Estate IT Highway, Perungudi Chennai, 600096, India Tel: +91 44 4215 4771 Fax: +91 44 4215 4772 www.hdmedicalgroup.com
510(k) Number : K100531
Device Name: ViScope Electronic Stethoscope
JUL 21 2010
Indications for Use Statement:
The ViScope Electronic Stethoscope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.
Prescription Use Yes AND (Part 21 CFR 801 Subpart D)
Over-The-Counter
(21 CFR 801
Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K100531 |
|---|---|
| --------------- | --------- |
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