(90 days)
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.
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.
The provided text is a 510(k) summary for a medical device (K990809, CADIscope Electronic Stethoscope). It focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided document. The submission relies on demonstrating that the CADIscope's performance is similar to already cleared devices through qualitative comparison.
However, I can extract information related to the device's characteristics and its comparison to predicate devices, which implicitly serve as performance benchmarks for substantial equivalence.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
The document does not state explicit quantitative acceptance criteria for the CADIscope. Instead, the "acceptance criteria" are implied by its substantial equivalence to the predicate devices. The device's performance is reported through a comparative table highlighting its features versus the predicate devices.
| Feature/Characteristic | Implied Acceptance Criteria (via Predicate Device Performance) | Reported CADIscope Performance |
|---|---|---|
| Intended Use | Diagnostic aid, part of physical assessment; amplification of body sounds (E-Scope) Diagnostic aid, part of physical assessment; Display of ECG (Miniscope MS-3) | Diagnostic aid, part of physical assessment; amplification of body sounds AND display of ECG |
| Sound Amplification | Electronic, analog amplifier, 0-27 dB at 200 Hz, continuous (E-Scope) | Electronic: analog amplifier, 0-35 dB, 16 levels 5 dB each. (This is arguably better than the E-Scope, suggesting it meets or exceeds the predicate's performance.) |
| Sound Frequency Response | 2 filters: heart: 100-240 Hz; breast: 125-350 Hz (E-Scope) | 3 filters: heart: 15-600 Hz; lungs: 300-1500 Hz; Entero: 15-1500 Hz. (@ -20 dB). (Broader range and more specific filters, suggesting it meets or exceeds the predicate's performance.) |
| Display | None for E-Scope. LCD 64 x 192 pixels, graphics and status display for Miniscope MS-3. | LCD 64 x 96 pixels, graphics and status display. (Comparable to Miniscope MS-3, providing a visual display of heart sounds (phonocardiogram) and ECG.) |
| Cardiac Biopotential | Built-in three-point electrode or 3 or 5 lead patient cable, display 1 lead, with freeze and playback (Miniscope MS-3) | Swiveling electrodes, forming Einthoven triangle, display time parallel to hearing, with freeze function. (Comparable to Miniscope MS-3 for ECG display, but without memory for playback or ability to connect external leads, which are noted as differences.) |
| Power Consumption | Est 100 mW peak / 10 mW normal (E-Scope) Est 250 mW (Miniscope MS-3) | 30 mW peak / 5 uW sleep mode. (Significantly lower than both predicates, implying better battery life/efficiency.) |
| Batteries | 1 x 9V, Alkaline, 150 hours operation (E-Scope) 2 x 1.5V, Alkaline, 12 hours operation (Miniscope MS-3) | 3 x 1.5V, Alkaline, 160 hours operation. (Comparable or better battery life than E-Scope, significantly better than Miniscope MS-3.) |
Study Information (as inferable from the document)
Since this is a 510(k) substantial equivalence submission, the "study" is primarily a comparison to predicate devices rather than a standalone clinical trial with performance endpoints.
- Sample size used for the test set and the data provenance: Not applicable in the context of a 510(k) substantial equivalence comparison. No specific test set or patient data is mentioned for performance evaluation. The comparison is based on device specifications and functionalities.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in the experimental sense is not established as part of this submission. The "ground truth" for the device design and intended use is derived from regulatory guidelines and the established capabilities of the predicate devices.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No formal adjudication process for a test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The CADIscope is an electronic stethoscope with an ECG display, not an AI-based diagnostic tool. No MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated diagnostic aid. Performance is implicitly human-in-the-loop by its nature (healthcare professionals using a stethoscope and interpreting displays).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) substantial equivalence submission. The "ground truth" for regulatory clearance is that the device's features and safety are comparable to legally marketed predicate devices.
- The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
- How the ground truth for the training set was established: Not applicable, as there is no training set.
In summary, the K990809 submission for the CADIscope Electronic Stethoscope relies on demonstrating substantial equivalence to existing predicate devices (Cardionics E-Scope Electronic Stethoscope and Schiller Miniscope MS-3 Electrocardiograph) rather than providing data from a dedicated performance study against explicit, quantitative acceptance criteria. The "acceptance criteria" are effectively met by showing that its intended use, technological characteristics, and performance are similar to or, in some cases, improved upon those of the predicate devices.
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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 : sales@caditec.com Contact Person: Fridolin Voegeli Contact Title: President
- SUBMISSION CORRESPONDENT 2. Medline Industries, Inc. One Medline Place Mundelein. IL 60060 Registration #: 1417592 (847) 949-5500 x1131 Phone: (847) 949-2643 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 |
-
- 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.
-
- 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-ScopeElectronic Stethoscope | Miniscope MS-3Electrocardiograph | CADIscopeElectronic Stethoscope | |
| 1 Intended use | diagnostic aid, part of physical assessment of patient :amplification of body sounds | diagnostic aid, part of physicalassessment of patient :Display of ECG | diagnostic aid, part of physicaassessment of patient :amplification of body sounds | |
| 2 Indications | any time an assessment of apatient's physical condition isrequired | any time an assessment of apatient's physical condition isrequired | any time an assessment of apatient's physical condition isrequired | |
| Predicate Devices | New Device | |||
| Characteristic | CardionicsE-ScopeElectronic Stethoscope | SchillerMiniscope MS-3Electrocardiograph | CADItecCADIscopeElectronic Stethoscope | |
| 3 | Environment | anywhere | anywhere | anywhere |
| 4 | Personnelrequirements | individuals that have hadmedical or first aid trainingwith a stethoscope, plusteachers, students | physicians, nurses, or alliedhealth professionals and theirstudents | individuals that have hadmedical or first aid trainingwith a stethoscope |
| 5 | Sound pickup | screw-on selectable :- diaphragm flat shape- bell shape | none | bell shape |
| 6 | Microphone | subminiature back-electretmicrophone | none | subminiature back-electretmicrophone |
| 7 | Soundamplification | electronic, analog amplifier, 0- 27 dB at 200 Hz, continuos | none | electronic: analog amplifier,0-35 dB, 16 levels 5 dB each |
| 8 | SoundOperatingmodes | bell and diaphragm mode,heart and breast sound filter | none | Organ specific :heart, lungs, and entero filter |
| 9 | SoundFrequencyresponse | 2 filters :heart : 100-240 Hz(-900Hz@ -20dB)breast : 125-350 Hz.(-2000Hz@ -20dB) | none | 3 filters :heart: 15-600 Hz.lungs: 300-1500 Hz.Entero: 15-1500 Hz.(@ -20 dB) |
| 10 | Sound speaker | 1 speaker, in control box | none | 2 earphones in the ear,reduced noise induction intobinaurals |
| 11 | Binaurals | short metal tubes | none | none |
| 12 | On/Off controls | On switchOff time controlled byelectronics | On switchOff time controlled byelectronics | manual OnOff time controlled bymicroprocessor |
| 13 | Mode / filter /sound controls | mode switch > filtersanalog potentiometer forvolume | none | mode switch > filters+ / - switch for volume |
| 14 | Technology | discrete electronics,integrated op amps | surface mount devices,digital signal processor | surface mount devices,mixed signal processor |
| 15 | Powerconsumption | est 100 mW peakest 10 mW normal | est 250 mW | 30 mW peak5 uW sleep mode |
| 16 | Batteries | 1 x 9V, Alkaline, 45 grin control-box, 150 hoursoperation = ½ year normaloperation | 2 x 1.5V, Alkaline, 20 grams12 hours operation | 3 x 1.5V, Alkaline, 30 gramsin chestpiece, 160 hoursoperation = ½ year normaluse |
| 17 | Dimensions | overall length 84 cmtotal weight 250 grams | 77 x 126 x 20 mmtotal weight 250 grams | cord length 64 cmtotal weight 170 grams |
| 18 | Display | none | LCD 64 x 192 pixels,graphics and status display | LCD 64 x 96 pixels,graphics and status display |
| Predicate Devices | New Device | |||
| Characteristic | CardionicsE-ScopeElectronic Stethoscope | SchillerMiniscope MS-3Electrocardiograph | CADItecCADIscopeElectronic Stethoscope | |
| 19 | Phonocardio-gramvisualization ofsounds | no | no | yes, analog sound envelopeon built-in display, 4 time-bases,with freeze function |
| 20 | Display ofcardiacbiopotentials | no | Built-in three-point electrodeor 3 or 5 lead patient cable,display 1 lead, with freeze andplayback | swiveling electrodes, formingEinthoven triangle,display time parallel tohearing, with freeze function |
| 21 | Role of micro-processor | none | switches modes, amplifi-cation, displays statuscontrols | switches modes, amplifi-cation, displays statuscontrols, displays and selectsoptimum scales |
| 22 | Signal storage | no | 30 min 1 lead ECG | no |
| 23 | Signal trans-mission to otherpersons or toPC | - option second headset- option cable fortelemedicine over phone | Optional adapter with RS232and analog output | Optional analog output tohearing aides, secondearphone |
| 24 | Infection control | cleaning and disinfectionprocedure in Operators'Manual | ||
| 25 | Materials in:chest contact | aluminum ringspolycarbonate diaphragm | AgCl plated electrodes | AgCl plated electrodes |
| 26 | Storage | Polycarbonate cover | Optional cushion bag | |
| 27 | Alarms | none | none | none |
| 28 | Status display | none | Status-line shows heart rate,scale settings, battery low | status-line in display showsmode, "good" signal, "direct"heart rate, volume setting,battery low |
| 29 | Use withdefibrillator | safety hazard | safety hazard | safety hazard |
| 30 | Source of userhazards | defibrillator; bio-hazard | defibrillator; bio-hazard | defibrillator; bio-hazard |
| 31 | Patient hazards | bio-hazard | bio-hazard | bio-hazard |
| 32 | Environmentalhazards | 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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 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.