CADISCOPE ELECTRONIC STETHOSCOPE

K990809 · Caditec AG · DQD · Jun 9, 1999 · Cardiovascular

Device Facts

• Record ID: K990809
• Device Name: CADISCOPE ELECTRONIC STETHOSCOPE
• Applicant: Caditec AG
• Product Code: DQD · Cardiovascular
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle. 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. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.

Device Story

CADIscope is a battery-operated electronic stethoscope with integrated ECG monitoring. It captures body sounds via a subminiature back-electret microphone and cardiac biopotentials via three AgCl-plated electrodes forming an Einthoven triangle. A microprocessor processes these inputs, providing sound amplification (0-35 dB) and filtering (heart, lung, entero modes). Outputs include audio via earphones and visual representations (phonocardiograms and 1-lead ECG) on an integrated 64x96 pixel LCD. Used by clinicians or trained first-aid personnel in any environment for physical assessment. The device provides real-time status (heart rate, signal quality, battery) and includes a freeze function for the display. It aids clinical decision-making by providing visual confirmation of cardiac activity alongside auscultation. It does not store data or transmit to external systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated electronic stethoscope; surface mount devices; mixed signal processor. Features AgCl-plated electrodes for ECG, subminiature back-electret microphone for sound. 64x96 pixel LCD display. Three selectable frequency filters (heart: 15-600 Hz; lungs: 300-1500 Hz; entero: 15-1500 Hz). 16-level volume control (0-35 dB). Powered by 3x1.5V alkaline batteries. Portable form factor (170g).

Indications for Use

Indicated for use as a diagnostic aid during physical assessment of patients by healthcare professionals or individuals trained in emergency first aid. Used for amplification of heart, lung, blood vessel, enteral, and other body sounds, and for verifying cardiac biopotential activity via chest-placed electrodes.

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

• E-Scope Electronic Stethoscope Model 718-7120 (K961301)
• Miniscope MS-3 Electrocardiograph (K954066)

Submission Summary (Full Text)

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K990809

CH-6343 Rotkreuz-Zug, Switzerland Phone xx41-41-79 80 120 Fax xx41-41-79 80 133

#### SUMMARY OF SAFETY AND EFFECTIVENESS 12.

1 February, 1999

- SUBMITTER/APPLICANT COMPANY INFORMATION 1. Registration #: None CADItec AG. EURO 1 Rotkreuz-Zug Switzerland, CH6343 Phone : xx41-41-79 80 120 Fax : xx41-41-79 80 133 Email : [e-mail] Contact Person: Fridolin Voegeli Contact Title: President
- SUBMISSION CORRESPONDENT 2. Medline Industries, Inc. One Medline Place Mundelein. IL 60060 Registration #: 1417592 [phone] x1131 Phone: [phone] Fax: Contact Name: Christine M. Galea, Submission Correspondent

| REGULATORY INFORMATION: | |
|-------------------------|------------------------------------------------------|
| DEVICE NAME: | Stethoscope, Electronic |
| PROPRIETARY NAME: | CADIscope Electronic Stethoscope with Integrated ECG |
| COMMON NAME: | Electronic Stethoscope |
| CLASS: | II |
| PRO CODE: | DQD (870.1875) |
| PERFORMANCE STANDARDS: | None |

- 4. DEVICE DESCRIPTION: The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in a standard Einthoven Triangle.
- 5. INTENDED USE: 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. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.

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Image /page/1/Picture/0 description: The image shows the word "CADltec" in a bold, sans-serif font. The letters "C", "A", "D", and "I" are capitalized, while "tec" is in lowercase. A horizontal line made of small squares runs beneath the word, adding a visual element to the design. The overall impression is a logo or branding element, possibly for a technology-related company.

CH-6343 Rotkreuz-Zug, Switzerland Phone xx41-41-79 80 120 Fax xx41-41-79 80 133

- SUBSTANTIAL EQUIVALENCE: The CADIscope, with it's sound channel, is substantially 6. equivalent to other electronic stethoscopes on the market. CADIscope claims for it's sound channel, substantial equivalence to the E-Scope Electronic Stethoscope Model 718-7120, K961301 manufactured by Cardionics Inc., 1100 Hercules Ave, Suite 210, Houston, 77058 TX.
The CADIscope, with it's ECG display, is substantially equivalent to other small portable electrocardiographs on the market. CADIscope claims for it's ECG display, substantial equivalence to the Miniscope MS-3, Electrocardiograph, K954066, manufactured by Schiller AG, Altgasse 68, CH-6340 Baar, Switzerland.

- COMPARISON TO PREDICATE DEVICE: The CADIscope is similar to the E-Scope in 7. that they both are electronic stethoscopes that operate on batteries. Both stethoscopes work by amplifying and filtering the heart sounds and allowing the user of the device to adjust the volume in order to better hear the heart sounds.
The CADIscope is different than the E-Scope in that it has a visual representation of the heart sounds (or the ECG) and the E-Scope does not. (And therefor the CADIscope contains a microprocessor and the E-Scope does not.)

The CADIscope is similar to the Miniscope MS-3 in that they both are battery operated portable monitors with 3 built-in electrodes to pick up the ECG in an Einthoven Triangle (or Tripode), in both devices the microprocessor optimizes the signal's amplitude and displays a 1-lead ECG on a LCD using similar resolution and base-line and noise filtering technology.

The CADIscope is different than the Miniscope MS-3 in that it does not have memory to store the (two) ECG signal's data over minutes to be played back on the internal LCD or to be transmitted to and analyzed by special ECG analysis programs on special cardiographs or PC's. The Miniscope MS-3 does also offer the possibility to connect an external patient cable with 3 or 5 leads, the CADIscope does not.

| | Predicate Devices | | New Device | |
|----------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| | Cardionics | Schiller | CADItec | |
| Characteristic | E-Scope<br>Electronic Stethoscope | Miniscope MS-3<br>Electrocardiograph | CADIscope<br>Electronic Stethoscope | |
| 1 Intended use | diagnostic aid, part of physical assessment of patient :<br>amplification of body sounds | diagnostic aid, part of physical<br>assessment of patient :<br>Display of ECG | diagnostic aid, part of physica<br>assessment of patient :<br>amplification of body sounds | |
| 2 Indications | any time an assessment of a<br>patient's physical condition is<br>required | any time an assessment of a<br>patient's physical condition is<br>required | any time an assessment of a<br>patient's physical condition is<br>required | |
| | | Predicate Devices | | New Device |
| | Characteristic | Cardionics<br>E-Scope<br>Electronic Stethoscope | Schiller<br>Miniscope MS-3<br>Electrocardiograph | CADItec<br>CADIscope<br>Electronic Stethoscope |
| 3 | Environment | anywhere | anywhere | anywhere |
| 4 | Personnel<br>requirements | individuals that have had<br>medical or first aid training<br>with a stethoscope, plus<br>teachers, students | physicians, nurses, or allied<br>health professionals and their<br>students | individuals that have had<br>medical or first aid training<br>with a stethoscope |
| 5 | Sound pickup | screw-on selectable :<br>- diaphragm flat shape<br>- bell shape | none | bell shape |
| 6 | Microphone | subminiature back-electret<br>microphone | none | subminiature back-electret<br>microphone |
| 7 | Sound<br>amplification | electronic, analog amplifier, 0<br>- 27 dB at 200 Hz, continuos | none | electronic: analog amplifier,<br>0-35 dB, 16 levels 5 dB each |
| 8 | Sound<br>Operating<br>modes | bell and diaphragm mode,<br>heart and breast sound filter | none | Organ specific :<br>heart, lungs, and entero filter |
| 9 | Sound<br>Frequency<br>response | 2 filters :<br>heart : 100-240 Hz<br>(-900Hz@ -20dB)<br>breast : 125-350 Hz.<br>(-2000Hz@ -20dB) | none | 3 filters :<br>heart: 15-600 Hz.<br>lungs: 300-1500 Hz.<br>Entero: 15-1500 Hz.<br>(@ -20 dB) |
| 10 | Sound speaker | 1 speaker, in control box | none | 2 earphones in the ear,<br>reduced noise induction into<br>binaurals |
| 11 | Binaurals | short metal tubes | none | none |
| 12 | On/Off controls | On switch<br>Off time controlled by<br>electronics | On switch<br>Off time controlled by<br>electronics | manual On<br>Off time controlled by<br>microprocessor |
| 13 | Mode / filter /<br>sound controls | mode switch > filters<br>analog potentiometer for<br>volume | none | mode switch > filters<br>+ / - switch for volume |
| 14 | Technology | discrete electronics,<br>integrated op amps | surface mount devices,<br>digital signal processor | surface mount devices,<br>mixed signal processor |
| 15 | Power<br>consumption | est 100 mW peak<br>est 10 mW normal | est 250 mW | 30 mW peak<br>5 uW sleep mode |
| 16 | Batteries | 1 x 9V, Alkaline, 45 gr<br>in control-box, 150 hours<br>operation = ½ year normal<br>operation | 2 x 1.5V, Alkaline, 20 grams<br>12 hours operation | 3 x 1.5V, Alkaline, 30 grams<br>in chestpiece, 160 hours<br>operation = ½ year normal<br>use |
| 17 | Dimensions | overall length 84 cm<br>total weight 250 grams | 77 x 126 x 20 mm<br>total weight 250 grams | cord length 64 cm<br>total weight 170 grams |
| 18 | Display | none | LCD 64 x 192 pixels,<br>graphics and status display | LCD 64 x 96 pixels,<br>graphics and status display |
| | | Predicate Devices | | New Device |
| | Characteristic | Cardionics<br>E-Scope<br>Electronic Stethoscope | Schiller<br>Miniscope MS-3<br>Electrocardiograph | CADItec<br>CADIscope<br>Electronic Stethoscope |
| 1<br>9 | Phonocardio-<br>gram<br>visualization of<br>sounds | no | no | yes, analog sound envelope<br>on built-in display, 4 time-<br>bases,<br>with freeze function |
| 2<br>0 | Display of<br>cardiac<br>biopotentials | no | Built-in three-point electrode<br>or 3 or 5 lead patient cable,<br>display 1 lead, with freeze and<br>playback | swiveling electrodes, forming<br>Einthoven triangle,<br>display time parallel to<br>hearing, with freeze function |
| 2<br>1 | Role of micro-<br>processor | none | switches modes, amplifi-<br>cation, displays status<br>controls | switches modes, amplifi-<br>cation, displays status<br>controls, displays and selects<br>optimum scales |
| 2<br>2 | Signal storage | no | 30 min 1 lead ECG | no |
| 2<br>3 | Signal trans-<br>mission to other<br>persons or to<br>PC | - option second headset<br>- option cable for<br>telemedicine over phone | Optional adapter with RS232<br>and analog output | Optional analog output to<br>hearing aides, second<br>earphone |
| 2<br>4 | Infection control | | | cleaning and disinfection<br>procedure in Operators'<br>Manual |
| 2<br>5 | Materials in:<br>chest contact | aluminum rings<br>polycarbonate diaphragm | AgCl plated electrodes | AgCl plated electrodes |
| 2<br>6 | Storage | | Polycarbonate cover | Optional cushion bag |
| 2<br>7 | Alarms | none | none | none |
| 2<br>8 | Status display | none | Status-line shows heart rate,<br>scale settings, battery low | status-line in display shows<br>mode, "good" signal, "direct"<br>heart rate, volume setting,<br>battery low |
| 2<br>9 | Use with<br>defibrillator | safety hazard | safety hazard | safety hazard |
| 3<br>0 | Source of user<br>hazards | defibrillator; bio-hazard | defibrillator; bio-hazard | defibrillator; bio-hazard |
| 3<br>1 | Patient hazards | bio-hazard | bio-hazard | bio-hazard |
| 3<br>2 | Environmental<br>hazards | none known | none known | none known |
| | | | | |

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Image /page/2/Picture/0 description: The image shows the logo for CADItec. The logo is in black and white and features the word "CADItec" in a stylized font. The letters "CADI" are in a larger, bolder font than the letters "tec". The "A" in "CADI" is stylized to look like a mountain peak. There is a dotted line underneath the word "CADItec".

CH-6343 Rotkrouz-Zug, Switzerland

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Image /page/3/Picture/0 description: The image shows the logo for CADItec. The logo is in black and white, with the letters "CADItec" in a bold, sans-serif font. A jagged line runs underneath the letters. The logo is simple and modern.

CH-6343 Rotkreuz-Zug, Switzenland

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ਰ JUN

CADItec c/o Ms. Betty Lock Submission Correspondent Medline Industries, Inc. One Medline Place Mundelein, IL 60060

Re: K990809 CADIscope Electronic Stethoscope Regulatory Class: II (two) Product Code: DQD Dated: February 8, 1999 Received: March 11, 1999

Dear Ms. Lock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.

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regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, 2Misbranding by reference to premarket notification? (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J.Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE 5.

Page 1 1 1

#### INDICATIONS FOR USE STATEMENT

510(k) Number : K980105

Device Name: CADIscope Electronic Stethoscope

Indications for Use:

The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle.

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. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

V. Ruth Hillin

11 Carringscular No irologica Douges 510(k) Number