(410 days)
Not Found
No
The document describes digital signal processing (DSP) and filtering technologies, but does not mention AI or ML.
No
The device is intended for medical diagnostic purposes only, specifically for detection and amplification of sounds and cardiac electrical activities for analysis, interpretation, and diagnosis, not for treatment.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "The EKOSCOPE device is intended for medical diagnostic purposes only." It also describes functions (stethoscope and ECG) that aid in "analyzing, interpreting and diagnosing heart rate and rhythm."
No
The device description clearly outlines hardware components such as an electronic microphone, electrodes, a removable headset with a speaker, an SD card, a rechargeable battery, a micro USB port, a penlight accessory, and a TFT color screen. While it contains embedded software and digital signal processing, it is not solely software.
Based on the provided text, the EKOSCOPE device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The EKOSCOPE device directly interacts with the body to collect data. It uses a stethoscope to listen to internal sounds and electrodes to detect electrical activity. It does not analyze samples taken from the patient.
- The intended use and device description clearly outline its function as a diagnostic tool that gathers information in vivo (within the living body).
Therefore, the EKOSCOPE is a medical diagnostic device, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (ECG) function with three modes of operation. The Bell mode processes sounds having a frequency range of 20 Hz -500 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The ECG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The ECG are detectable by a series of electrodes marked as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is intended for use in hospitals or health care facilities by doctors and trained health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
DQD, DPS
Device Description
The Ekoscope iS100 Device is an electronic stethoscope with 6 leads EKG capability. The electronic microphone can detect sounds between 1.0 Hz to 2KHz from the heart, vessels, lungs and abdomen. The detected sounds are then processed and filtered to reduce ambient noises and transmitted to a removable headset that contains a built in speaker. The sound may also be amplified or attenuated upon demand. The visceral sounds are processed via three stethoscope modes. The first is the Bell Mode. The Bell mode processes sounds having a frequency range of 20 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The acquired visceral sounds, along with EKG data, are stored in 30 seconds increments into the device's 2 Gigabyte SD card for playback, delete or upload via USB to a PC using Microsoft Window® version Operating System. The Ekoscope iS100 is powered by a rechargeable Lithium battery. The battery is rechargeable via a micro USB. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The Ekoscope iS 100 also features 6 electrodes. The electrodes are positioned on the head of the device and body of the device. The strategically placed electrodes are used for the detection of 6 channel electrocardiograph (ECG) signals. The ECG signals are from the chest, hands and left leg, via three designated modes: A, B and C. The acquired data is first stored on the Ekoscope iS 100, and can be uploaded to a compatible PC for printing or sending to another location via the internet.
The sample frequency of ECG signal is 200Hz and the bit resolution is 16bit: Adopts 50/60Hz interference suppression. The sample frequency of heart sounds signal is 48kHz and bit resolution is 16bit. Different digital filters will be used in the Bell Mode, Diaphragm Mode and Diaphragm Plus Mode. The device embedded software, proprietary filter and Digital Signal Processing (DSP) technologies, attenuate ambient noises of sounds within a frequency range of 1.0 Hz to 2.0KHz. The sounds are attenuated while preserving native auscultated sounds of interest.
The display speed of the ECG wave and heart sound wave is different on the device's TFT color screen. The ECG wave has two display speed 12.5mm/s and 25mm/s. The display speed of heart sound is 153mm/s. The display range of the ECG wave is selectable and they are 'x0.5', 'x1' and 'x2'. The display range of heart sound wave is not alterable. ECG display is marked with 'ECG' while the Sound Wave display is marked with 'Sound'.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, vessels, lungs, abdomen, chest, hands, left leg (for ECG signals)
Indicated Patient Age Range
Adults and pediatrics. Not intended for use on infants and in utero.
Intended User / Care Setting
Doctors and trained health care professionals.
Hospitals or health care facilities.
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)
The Ekoscope™ iS100 which is the subject of this premarket notification submission and bench test as presented in the attachments for this submission, did not require clinical studies to support substantial equivalence.
Summary of Performance Features:
Ekoscope iS100 Stethoscope versus Littmann® Electronic Stethoscope Model 4100 and Littmann® Electronic Stethoscope Model 3200:
- Frequency Response: Bell mode: 20 Hz - 550Hz; Diaphragm mode: 20Hz - 700Hz; Diaphragm plus mode: 1KHz - 20KHz (Mechanical heart valves are typically between 1.3KHz to 20KHz)
- Amplification: Up to 30 dB acoustic gain, equivalent to 21.6 times Amplification
- Maximum sound level: 87 dB SPL Max (Note that 100dB is the tolerable maximum human threshold for sound)
- Power source: Lithium-ion Battery
- Displays heart rate: Yes
- Record and playback sounds: Yes
- Permits data transfer of stored digital signals to and from a Personal Computer: Yes
- Volume Control: 8 step volume control
- On/Off Switch: Yes
- Automatic shut-off by Electronics: Not explicitly stated, inferred yes if predicate has it.
Ekoscope iS100 versus Edan SE-3 Electrocardiograph:
- Three channel ECG: Yes
- No of Leads: 6 Leads
- Power source: Rechargeable Lithium-ion AC/DC power supply
- Intended use: Acquire ECG signals from adult and pediatric patients through body surface ECG electrodes
- Display of ECG signal waveforms: TFT LCD
- Results recording/storage: USB printer and internal 2GB storage
- Data transmission: Via PC email system
- Patient data transfer: USB interface
- LCD screen: TFT LCD with touch key interface
- ECG Recording Modes: 3 ECG Recording Modes: Mode A: 6 Lead (Chest); Mode B: 6 Leads (Hands + Legs); Mode C: 1 Lead (Hands)
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
1
K123148 P 1/7
K123148 510k Summary Statement (In accordance with 21 CFR 807.92) Date Prepared: 15 July 2013
Sponsor Information:
PARACE LLC PO Box 171 Yorktown Heights NY 10598 USA
NOV 1 9 2013
| Contact Person: | VanDette Carter, PA-C
President and Chief Executive Officer |
|---------------------------|----------------------------------------------------------------|
| Mailing Address: | 2310 Eastchester Road
Bronx, NY, 10469 |
| Telephone Number: | 914-356-4848 |
| Facsimile Number: | 1-718-519-7898 |
| E-mail: | ekoscope@parace.com |
| Alternate Contact Person: | Fernand A. De Los Reyes, RN, MA
Chief Operations Officer |
| Telephone Number: | 845-270-9289 |
| Facsimile Number: | 1-718-519-7898 |
| E-mail: | dean.dir@parace.com |
| Alternate Contact Person: | Alma L. Carter, RN
Chief Compliance Officer |
| Telephone Number: | 877-727-2231 |
| Facsimile Number: | 1-718-519-7898 |
| E-mail: | paracecorp@aol.com |
Device Name and Classification:
| Common or Usual Name: | Electronic Stethoscope with Electrocardiograph Function |
|---|---|
| Proprietary Name: | PARACE MD® Ekoscope™ Model iS100 |
| Classification Name: | Electronic Stethoscope Class II (Two), 21 CFR 870.1875 |
| Electrocardiograph Class II (Two), 21 CFR |
870.2340 Performance Standards: None
Predicate Devices:
3MTM Littmann ® Electronic Stethoscope, Model 4100, K051790 3MTM Littmann® Electronic Stethoscope, Model 3200, K083903 Edan SE-3 Series Electrocardiograph, K091513
Device Description:
The Ekoscope iS100 Device is an electronic stethoscope with 6 leads EKG capability. The electronic microphone can detect sounds between 1.0 Hz to 2KHz from the heart, vessels, lungs and abdomen. The detected sounds are then processed and filtered to reduce ambient
1
K123148 P 2/7
noises and transmitted to a removable headset that contains a built in speaker. The sound may also be amplified or attenuated upon demand. The visceral sounds are processed via three stethoscope modes. The first is the Bell Mode. The Bell mode processes sounds having a frequency range of 20 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The acquired visceral sounds, along with EKG data, are stored in 30 seconds increments into the device's 2 Gigabyte SD card for playback, delete or upload via USB to a PC using Microsoft Window® version Operating System. The Ekoscope iS100 is powered by a rechargeable Lithium battery. The battery is rechargeable via a micro USB. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The Ekoscope iS 100 also features 6 electrodes. The electrodes are positioned on the head of the device and body of the device. The strategically placed electrodes are used for the detection of 6 channel electrocardiograph (ECG) signals. The ECG signals are from the chest, hands and left leg, via three designated modes: A, B and C. The acquired data is first stored on the Ekoscope iS 100, and can be uploaded to a compatible PC for printing or sending to another location via the internet.
The sample frequency of ECG signal is 200Hz and the bit resolution is 16bit: Adopts 50/60Hz interference suppression. The sample frequency of heart sounds signal is 48kHz and bit resolution is 16bit. Different digital filters will be used in the Bell Mode, Diaphragm Mode and Diaphragm Plus Mode. The device embedded software, proprietary filter and Digital Signal Processing (DSP) technologies, attenuate ambient noises of sounds within a frequency range of 1.0 Hz to 2.0KHz. The sounds are attenuated while preserving native auscultated sounds of interest.
The display speed of the ECG wave and heart sound wave is different on the device's TFT color screen. The ECG wave has two display speed 12.5mm/s and 25mm/s. The display speed of heart sound is 153mm/s. The display range of the ECG wave is selectable and they are 'x0.5', 'x1' and 'x2'. The display range of heart sound wave is not alterable. ECG display is marked with 'ECG' while the Sound Wave display is marked with 'Sound'.
Indications for Use:
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (ECG) function with three modes of operation. The Bell mode processes sounds having a frequency range of 20 Hz -500 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
2
K123148 P 3/7
3
The ECG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The ECG are detectable by a series of electrodes marked as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is intended for use in hospitals or health care facilities by doctors and trained health care professionals.
Caution: Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.
Effectiveness and Safety Considerations
Combined in functionality with an electronic stethoscope, the Ekoscope™ iS100 is a safe, accurate, and a reliable device for recording ECG data. The Ekoscope™ iS100 device has generally the same technological characteristics and intended use as its predicate device 3M Littmann Model 3200 and 4100 and Edan SE-3 electrocardiograph. The Ekoscope TM iS100 as compared to its predicate devices is more efficient and clinically practical in terms of ease of use and reliability. There are no new questions of safety or effectiveness.
Further, the Ekoscope iS100 is compliant and conforms to international accepted standards on safety and effectiveness. The following are the standards which the Ekoscope iS100 conforms and complies to:
- IEC 60601-1 Medical equipment/medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007 Medical electrical equipment-Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility - Requirements and test
- ANSI/AMMI EC 38:2007 Medical electrical equipment Part 2-47: Particular . requirements for the safety, including essential performance of ambulatory electrocardiographic systems
- ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro . cytotoxicity
3
- ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for . irritation and skin sensitization
Comparative Discussion for Determining Substantial Equivalence of New Device to Predicate Device:
Information provided in this 510(k) submission shows that Ekoscope™ Model iS100 is substantially equivalent to the predicate device 3M™ Littmann® Electronic Stethoscope, Model 3200, cleared under K083903 and Littmann® Electronic Stethoscope, Model 4100, cleared under K051790 in terms of intended use, indications for use, composition, physical properties and technological characteristics. In addition, Ekoscope iS100 is substantially equivalent to the predicate device Edan SE-3, cleared under K091513 for its electrocardiograph functions. The device is substantially equivalent to predicate devices in technological characteristics and performance requirements. Comparison of performance features of the Ekoscope iS100 are presented in the two succeeding tables.
4
4
5
| K123148 |
|---|
| K123148 P 5/7 | ||
|---|---|---|
| Comparison of Performance Features Ekoscope iS100 | ||
| Stethoscope versus Littmann® Electronic Stethoscope Model 4100 and Littmann® Electronic Stethoscope Model 3200 | ||
| Performance | ||
| Features | Littmann Model 4100* | |
| (Predicate Device K051790) | Ekoscope iS100 | |
| ( New Device K123148) | ||
| Frequency | ||
| Response | Bell mode (20-200 HZ) | |
| and Diaphragm mode | ||
| (100-500 Hz) | Bell mode: 20 Hz - 550Hz | |
| Diaphragm mode: 20Hz - 700Hz | ||
| Diaphragm plus mode: 1KHz - 20KHz |
- Mechanical heart valves are typically
between 1.3KHz to 20KHz |
| Amplification | Up to 25 dB acoustic gain,
equivalent to 18 times
amplification | Up to 30 dB acoustic gain,
equivalent to 21.6 times
Amplification |
| Maximum sound
level | 140 dB SPL Max | 87 dB SPL Max
(Note that 100dB is the tolerable
maximum human threshold for sound) |
| Power source | Two (2) AAA alkaline
batteries | Lithium-ion Battery |
| Displays heart rate | Yes | Yes |
| Record and playback
sounds | Yes | Yes |
| Permits data transfer
of stored digital
signals to and from
a Personal Computer | Yes | Yes |
| Volume Control | 8 step volume control | 8 step volume control |
| On/Off Switch | Yes | Yes |
| Automatic shut-off
by Electronics | | |
| *Approved and cleared under predicate device Littman Model 3200 under K083903 | | |
.
:
·
·
.
5
K123148 P 6/7
| Comparison of Performance Features Ekoscope iS100 | ||
|---|---|---|
| versus Edan SE-3 Electrocardiograph | ||
| Performance Features | Edan SE-3 | |
| (Predicate Device K091513) | Ekoscope iS100 | |
| (New Device K123148) | ||
| Three channel ECG | Yes | Yes |
| No of Leads | 6 to 12 Leads | 6 Leads |
| Power source | Rechargeable Lithium-ion | |
| AC/DC power supply | Rechargeable Lithium-ion | |
| AC/DC power supply | ||
| Intended use | Acquire ECG signals | |
| from adult and pediatric | ||
| patients through body | ||
| surface ECG electrodes | Acquire ECG signals | |
| from adult and pediatric | ||
| patients through body | ||
| surface ECG electrodes | ||
| Display of ECG signal waveforms | LCD | TFT LCD |
| Results recording/storage | Thermal printer or | |
| USB printer | USB printer and | |
| internal 2GB storage | ||
| Data transmission | Via PC Ethernet port | Via PC email system |
| Patient data transfer | USB interface | USB interface |
| LCD screen | Foldable LCD screen | TFT LCD with |
| touch key interface | ||
| ECG Recording Modes | 1 ECG Recording Mode | 3 ECG Recording Modes: |
| Mode A: 6 Lead (Chest) | ||
| Mode B: 6 Leads (Hands + Legs) | ||
| Mode C: 1 Lead (Hands) |
Determination of Substantial Equivalence
The Ekoscope™ iS100 complies with voluntary standards as detailed in this pre-market submission. The following quality assurance measures and related measures cited in the attached reports were undertaken and applied to the Ekoscope™ iS100:
- . Risk Analysis
- . Reliability Test
- . Safety Test
- Electromagnetic and Biocompatibility Test .
- Performance Test voluntarily against AAMI EC38 Performance .
- . Product Specification Verification
- Software Verification and Validation .
17
6
Summary of Clinical Tests and Conclusion:
The Ekoscope™ iS100 which is the subject of this premarket notification submission and bench test as presented in the attachments for this submission, did not require clinical studies to support substantial equivalence.
PARACE LLC's Medical Division considers the electronic stethoscope Ekoscope™ iS100 with electrocardiograph function (ECG) as a product to be as safe, as effective, more compact and efficient and substantially equivalent in performance to its predicate devices. Above all, there are no significant differences that affect the safety or effectiveness of the Ekoscope iS100™ compared to the predicate devices as earlier mentioned.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, which is a symbol often associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Parace LLC c/o Mr. Vandette Carter President and Chief Executive Officer P.O. Box 171 Yorktown Heights, NY 10598 US
Re: K123148
Trade/Device Name: PARACE MD Ekoscope iS100 Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: II (two) Product Code: DQD, DPS Dated: September 30, 2013 Received: October 8, 2013
Dear Mr. Carter:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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. 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
8
Page 2 - Mr. Vandette Carter
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, M.D. I. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K123148
Device Name: PARACE MD Ekoscope iS100
Indications For Use:
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (ECG) function with three modes of operation. The Belle mode processes sounds having a frequency range of 20Hz to 500Hz. Secondly the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm plus mode. The Diaphragm plus mode processes mechanical heart sounds between 1KHz to 20KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.
The ECG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The ECG are detectable by a series of electrodes marked as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and thythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is intended for use in hospitals or healthcare facilities by doctors and trained health care professionals.
Caution: Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Digitally signed by
Owen P. Faris -5
Date: 2013.11.19
14:38:57 -05'00'
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