(91 days)
Not Found
No
The document describes an "Interpretation program Hanover ECG System (HES)" which provides automated analysis and suggestions. While this involves complex algorithms, the description does not use terms like AI, ML, or deep learning, nor does it mention training or test sets, which are typical indicators of ML development. The interpretation is presented as a rule-based or algorithmic system rather than a learning model.
No
The device is intended for measurement and data collection of lung function parameters and surface electrocardiograms. It provides diagnostic information and interpretation support to physicians but does not provide therapy or administer drugs.
Yes
The device measures and collects data for lung function parameters and electrocardiograms (ECGs). It also provides automatic analysis and interpretation suggestions for the 12-channel ECG, which supports physicians in evaluating the ECG in terms of morphology and rhythm. These functions are consistent with a diagnostic device that aids in identifying or characterizing a medical condition.
No
The device description explicitly lists hardware components such as an "Ultrasonic handle," "Pneumotach handle/shutter," and "ECG Amplifier," in addition to the software.
Based on the provided text, the MasterScope / MasterScope ECG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) to examine specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- MasterScope / MasterScope ECG Function: The MasterScope / MasterScope ECG measures lung function parameters and records surface electrocardiograms (ECGs). These are in vivo measurements, meaning they are taken directly from the patient's body, not from specimens outside the body.
Therefore, the MasterScope / MasterScope ECG falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is Intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatic patients with an age below 16 years and for pacemaker patients.
MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Product codes
BTY, DPS
Device Description
MasterScope / MasterScope ECG is an active device providing following characteristics:
Mains operation Personal Computer System Graphic user interface Windows XP Professional LAB Software Powerful database for storing patient- and test data
Ultrasonic handle Pneumotach handle/shutter ECG Amplifier
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, heart (cardiovascular)
Indicated Patient Age Range
4 years and older
Intended User / Care Setting
trained physicians in the office or hospital
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 following practices were followed and monitored for development of the MasterScope with the new option ECG:
The new option for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 -Design Control).
The risk analysis method used to assess the impact of the MasterScope with the new option ECG was a Failure Modes and Effects Analysis (FMEA).
Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
The software was developed according to the IEC 601-1-4 Standard.
The EMC testing was performed according EN 60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
510(k) Summary
GENERAL INFORMATION
DEC 0 2 2008
1082539
2.1087
5.1 Type of Submission
Traditional 510(k) Submission
Submission date: 08/26/2008
5.2 Submitter
Name:
Cardinal Health Germany 234 GmbH (formerly Viasys Healthcare GmbH)
Address:
Leibnizstrasse 7 D-97204 Hoechberg Germany
Contact person in Germany: (Official Correspondent) Address:
Thomas Rust Cardinal Health Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 383 +49 931 49 72 - 62383 Thomas. Rust@cardinalhealth.com
Phone: FAX: E-mail
Contact person in the U.S .: (US Agent) Address
Yvette Lloyd Cardinal Health 22745 Savi Ranch Parkway Yorba Linda, CA 92887 (714) - 919 - 3247 Yvette.Lloyd@cardinalhealth.com
Phone/Fax: E-mail
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Establishment Registration Number 5.3
9615102
5.4 Common Name or Classification Name
Predictive pulmonary-function value calculator (CFR 868.1890 Product Code BTY)
Electrocardiograph (CFR 870.2340, Product Code DPS)
5.5 Trade Name
MasterScope MasterScope ECG MasterScope CT
this is the clinical trial version
5.6 Classification
This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868 74 Circular System Devices, ECG Part 870
5.8 Reason for Premarket Notification
New option to an existing Cardinal Health device. (ECG option for MasterSope K071753)
5.9 Legally predicate marketed devices
MasterScope / MasterScreen Pneumo K071753 / Code BTY
FlowScreen / FlowScreen ECG / FlowScreen CT K080734 / Code BTY, DPS,
5.10 Predicate Device Company Cardinal Health Germany 234 GmbH (Owned by Cardinal Health Inc. - owner no. 9028292)
5.11 Device Description
MasterScope / MasterScope ECG is an active device providing following characteristics:
Mains operation Personal Computer System Graphic user interface Windows XP Professional LAB Software Powerful database for storing patient- and test data
Cardinal Health
MasterScope / MasterScope ECG 16
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Ultrasonic handle Pneumotach handle/shutter ECG Amplifier
pulmonary functions a)
- Measurement with ultrasonic handle or pneumotach handle .
- Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) .
- Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, PIF, ... ) .
- Flow-Volume and Volume- Time Loop, pre/post tests �
- MV measurement ◆
- ◆ R Occlusion (only with pneumotach handle)
- Trending capabilities .
- Patient Incentive animations �
- Interpretation modules .
b) ECG functions
- Simultaneous acquisition of the 12 standard leads .
- Storage of 10 seconds of acquired ECG signal �
- Digital filters for base-line drift and mains interference suppression .
- . Interpretation program Hanover ECG System (HES) providing the following additional information:
- Representatives templates of each lead including markers on fiducially points .
- Summary of mean measurements #
- Rhythm Analysis statements .
- Signal noise detection and information �
- Specific findings on QRS complex .
- Conduction statements .
- QRS T diagnostic statements .
- Arrhythmia monitoring detection .
- . Heart Rate Variability
5.12 Intended Use Statement
Device Name:
MasterScope MasterScope ECG MasterScope CT
Indications for Use:
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).
ﺘﮯ
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5 510(k) Summary
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The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
5.13 Required Components
Notebook Pneumotach handle/shutter or Ultrasonic handle or/and ECG Amplifier Accessories User Manual
5.14 Summary Table of Comparision
| Pulmonary Function Comparison | ||
|---|---|---|
| New Device: | ||
| MasterScope with the new | ||
| features | Predicate Device: | |
| MasterScope K071753 | ||
| Intended Use | Diagnostic Spirometry | |
| (VCin, VCex, etc.) | Identical | |
| Patient | ||
| population | To be used as a screening | |
| device to determine whether or | ||
| not a patient requires further | ||
| diagnosis for pulmonary | ||
| function disorders. | Identical | |
| Performance | ||
| (Measurements) | Tital Spirometry (VT, | |
| VCin, ERV, ...) Forced Spirometry | ||
| Flow-Volume (FVC, | ||
| FEV1, MEF50, ...) Maximum Voluntary | ||
| Ventilation R Occlusion (only possible with | ||
| pneumotach handle) Interpretation and quality | ||
| assessment compliant | Identical |
4
.
.
:
:
:
. ·
・・
.. .
| Software | • Windows XP with LAB
Software | Identical |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Patient user
interface | Digital handle (pressure sensor)
or Digital handle (ultrasonic
sensor) | Identical |
| Material of
patient user
interface | Pressure sensor
Pneumotach: Ultem 1010R
Handle (PT): Romira 1001R
Ultrasonic sensor
Ultrsonic handle: Luran S778TE | Identical |
| Patient
contacting
accessories | Nose Clip
Nose Clip pads
Single use mouthpiece for PT
Single use mouthpiece for USS | Identical |
| Material of
patient
contacting
accessories | Nose Clip: Polyacetal
Nose Clip pads: Ethylene Vinyl
Acetate
Single use mouthpiece (PT):
Polypropylen RG835MO
Single use mouthpiece (USS):
HDPE Eraclene MS 80U | Identical |
| Energy type | 100 - 240V AC 50/60Hz | Identical |
1000 - 100
.
:
:
:
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:
:
: :
r
. Previous and
: 2017-07-17 11:10:10
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:
: "
| ECG Function Comparison | ||
|---|---|---|
| New Device: | ||
| MasterScope with the new | ||
| features | Predicate Device: | |
| FlowScreen K080734 | ||
| Intended Use | 3/6- or 12-channel | |
| Surface ECG recording device | Identical | |
| Application | ECG recording | Identical |
| Bandwidth | 0 - 150 Hz digital | Identical |
| ECG leads | Acc. to Einthoven, Wilson, | |
| Goldberger | Identical | |
| Leads | 12 Standard | Identical |
| A/D | ||
| Resolution | 2,6 µV/bit ECG, 19 bit | Identical |
| Sampling rate | ||
| per channel | 1000 Hz | Identical |
| Sampling rate | ||
| for pacemaker | ||
| detection | 4000 Hz | Identical |
| Connection to | ||
| PC | USB connection | Serial connection |
| Power supply | 5V DC via USB interface | 5V DC via Serial interface |
| Connection to | ||
| electrodes | 4 mm snap connector, gold | |
| plated | Identical | |
| Patient | ||
| contacting | ||
| accessories | • Single use electrode | |
| • Electrode cable | Identical | |
| ECG Amplifier | ||
| enclosure | ||
| material | ABS/PC | |
| (no patient contacting part) | Santoprene TPV 281-87 MED |
Cardinal Health
:
6
5 510(k) Summary
Summary of Device Testing 5.15
The following practices were followed and monitored for development of the MasterScope with the new option ECG:
The new option for the above device was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 -Design Control).
The risk analysis method used to assess the impact of the MasterScope with the new option ECG was a Failure Modes and Effects Analysis (FMEA).
Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
The software was developed according to the IEC 601-1-4 Standard.
The EMC testing was performed according EN 60601-1-2.
5.16 Conclusions
Based on the above, Cardinal Health Germany 234 GmbH concludes that the MasterScope with the ECG option is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.
Cardinal Health
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 2 2008
Mr. Thomas Rust Regulatory Affairs Manager Cardinal Health Germany 234 GmbH Leibnizstrasse 7 Hoechberg, Bavaria GERMANY 97204
Re: K082539
Trade/Device Name: MasterScope, MasterScope ECG, MasterScope CT Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY, DPS Dated: August 26, 2008 Received: September 3, 2008
Dear Mr. Rust:
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, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
8
Page 2 - Mr. Rust
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); 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Suste G. Michaels m-d
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
MasterScope MasterScope ECG MasterScope CT
Indications for Use:
The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients.
In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software.
MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is Intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatic patients with an age below 16 years and for pacemaker patients.
MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel).
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements.
The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
{PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suatt y. McheuDns
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
K082 539 510(k) Number:
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