(325 days)
No
The device description and performance studies focus on standard lung function measurements and safety testing, with no mention of AI or ML technologies.
No.
This device is described as a lung function measurement system and performs diagnostic measurements, not therapeutic interventions.
Yes
Explanation: The device is described as a "lung function measurement system" and its purpose is to perform various lung function measurements (e.g., Tidal Breathing Analysis, Baby-Body Plethysmography, Spirometry). These measurements are used to assess the state of a patient's lungs, which is a diagnostic purpose. The "Intended Use" explicitly states it's for "paediatric use" and "under the direction of a physician," further indicating its role in medical assessment.
No
The device description explicitly mentions hardware components such as "Mains operation", "Trolley for device and Baby Body box", and "Personal Computer System", indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The MasterScreen Paed - Baby Body is a lung function measurement system. It directly measures physiological parameters related to breathing and lung mechanics in living patients. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes measuring lung function in patients, not analyzing biological samples.
Therefore, the MasterScreen Paed - Baby Body falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
Product codes
CCM, BTY, BZC
Device Description
MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:
- Mains operation .
- Trolley for device and Baby Body box .
- Personal Computer System .
- Graphic user interface Windows XP Professional .
- Powerful database for storing patient- and test data .
- Tidal Breathing Analysis .
- Baby-Body Plethysmography .
- Baby Resistance / Compliance .
- Rapid Thoracic Compression (RTC) .
- Raised Volume Rapid Thoracic Compression (RV-RTC) .
- Spirometry / Flow Volume / MVV for children and adolescents ◆
- Airway Resistance (R Occlusion) for children and adolescents .
- P.01 / PImax / PEmax for children and adolescents .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years.
Intended User / Care Setting
It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's 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)
Not Found
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
§ 868.1750 Pressure plethysmograph.
(a)
Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.(b)
Classification. Class II (performance standards).
0
510(k) Summary
MAY 18 2009
GENERAL INFORMATION
5.1 Type of Submission
Traditional 510(k) Submission
Submission date: 06/03/2008
5.2 Submitter
VIASYS Healthcare GmbH (owned by Cardinal Health) Name:
- Address: Leibnizstrasse 7 D-97204 Hoechberg Germany
| Contact person in Germany: | |
|---|---|
| (Official Correspondent) | Thomas Rust |
| Address: | VIASYS Healthcare GmbH |
| Leibnizstrasse 7, 97204 Hoechberg | |
| Germany | |
| Phone: | +49 931 49 72 - 383 |
| FAX: | +49 931 49 72 - 62383 |
| Thomas.Rust@viasyshc.com | |
| or at: Thomas.Rust@cardinalhealth.com |
| Contact person in the U.S.: | |
|---|---|
| (US Agent) | Yvette Lloyd |
| Address | Cardinal Health |
| 22745 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Phone/Fax: | (714) - 919 - 3247 |
| Yvette.Lloyd@cardinalhealth.com |
1
5.3 Establishment Registration Number
9615102
5.4 Common Name or Classification Name
Plethysmograph, Pressure (CFR 868.1750, Product Code CCM) Predictive pulmonary-function value calculator (CFR 868.1890 Product Code BTY) .
5.5 Trade Name
MasterScreen Paed - Baby Body MasterScreen Baby Body MasterScreen Paed
-
complete device
-
device without adult handle/shutter
-
device without baby body cabin
5.6 Classification
This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868
Reason for Premarket Notification 5.8
New options to an existing VIASYS device. (Squeeze measurement for babies and lung function measurements for children)
5.9 Legally predicate marketed devices
MasterScreen Paed - Baby Body K023796 / Code CCM
MasterScreen PFT Body K072061 / Code JEH
IPL (Infant Pulmonary Laboratory) or Collins Infant Plethysmograph K011344 / Code BZC, BZG, CCM
5.10 Predicate Device Company
VIASYS HEALTHCARE GmbH (since July 01, 2007 owned by Cardinal Health - owner no. 9028292)
Collins Medical, Inc. (owned by nSpire Health Inc. - owner no. 9105240)
2
Device Description 5.11
MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:
- Mains operation .
- Trolley for device and Baby Body box .
- Personal Computer System .
- Graphic user interface Windows XP Professional .
- Powerful database for storing patient- and test data .
- Tidal Breathing Analysis .
- Baby-Body Plethysmography .
- Baby Resistance / Compliance .
- Rapid Thoracic Compression (RTC) .
- Raised Volume Rapid Thoracic Compression (RV-RTC) .
- Spirometry / Flow Volume / MVV for children and adolescents ◆
- Airway Resistance (R Occlusion) for children and adolescents .
- P.01 / PImax / PEmax for children and adolescents .
Intended Use Statement 5.12
The MasterScreen Paed – Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
5.13 Required Components
Desktop PC Monitor Trolley with power supply Pneumotach handle / Shutter Baby Body box Accessories User Manual
3
5.14 Summary Table of Comparision
| Comparison of MS Paed - Baby Body with the new features to MS Paed -
| Baby Body with 510(k) # K023796 | ||
|---|---|---|
| MasterScreen Paed - Baby | ||
| Body with 510(k) # K023796 | MasterScreen Paed - Baby | |
| Body with new features | ||
| Intended Use | The MS PAED - BABY BODY | |
| is a neonatal lung function | ||
| measurement system that | ||
| utilizes a bodyplethysmograph. | ||
| It is intended to be used under | ||
| the direction of a physician. MS | ||
| PAED - BABY BODY may be | ||
| used in the clinic, doctors office, | ||
| or hospital. Patient populationthis device include only babies | ||
| and premature infants. | ||
| The MS PAED - BABY BODY, | ||
| or any of the accessories | ||
| supplied with it, is not to be | ||
| used, alone or in combination, | ||
| as a life support device, a life | ||
| support system, or as a critical | ||
| component in a life support | ||
| device or life support system. | The MasterScreen Paed - Baby | |
| Body is a lung function | ||
| measurement system for | ||
| paediatric use. It is intended to | ||
| be used under the direction of a | ||
| physician. The MasterScreen | ||
| Paed - Baby Body may be used | ||
| in the clinic, doctor's office, or | ||
| hospital. Patient populations that | ||
| may benefit from the use of this | ||
| device include newborns | ||
| (neonate), infants, children and | ||
| adolescent. | ||
| The lung function measure- | ||
| ments including RTC and RV- | ||
| RTC can be performed in term | ||
| neonates (weight 3kg) up to | ||
| toddlers (weight 13kg). The | ||
| digital adult pneumotach with | ||
| shutter feature is for use with | ||
| children and adolescent from 4 | ||
| up to 21 years. The device is AC | ||
| powered from 115V-240V / 50- | ||
| 60Hz wall outlet. | ||
| Patient | ||
| population | Babies Premature Infants | |
| from 4 to 40 lbs | Newborns (Neonate) Infants | |
| from 4 to 40 lbs Children Adolescent up to 21 year | ||
| Performance | ||
| (Measurements) | Tital Breathing Analysis | |
| Baby Bodyplethysmo- | ||
| graphy | ||
| [Functional Residual (FRC) | ||
| and Airway Resistance (Raw) |
- Conductance (Gaw)] Resistance
Single Occlusion Technique
(SOT) and Double Occlusion
Technique (DOT) Compliance | Identical |
| | | |
| Software | • JLAB Version 4.5 | • JLAB Version 4.6 |
| Device
Specification | PT Paed S Flow range
0 to +/- 1500 ml/s Flow resolution
1 ml/s Flow accuracy
+/- 3% / +/- 4 ml/s Volume range
+/- 3000 ml Volume resolution
0,1 ml Deadspace
1,7 ml Mouth pressure Range
+/- 5 kPa Resolution
0,003 kPa Accuracy
+/- 2% Shutter Balloon material
Latex Balloon pressure
0,9 bar Balloon volume
0,7 ml Baby Body (Cabin) Length - weight - height
127cm - 71cm - 128cm Box volume
98 liters Box sensor
+/- 80 ml at 1000 hPa Resolution
0,04 ml Accuracy
+/- 1% | Identical |
| Accessories | Manual Calibration Syringe 100 ml Paediatric-PT XS Paediatric-PT S Screen small for paediatric Screen large for paediatric Anesthetic mask type "Silikomed" size 0 Anesthetic mask type "Silikomed" size 1 | Identical |
4
・
5
| | MasterScreen PFT Body with
510(k) # K072061 | MasterScreen Paed - Baby
Body with new features |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Performance
(New measure-
ments) | • Spirometry
• MVV
• Flow Volume
• R Occlusion
• Respiratory Muscle
Strength and Respiratory
Drive
(P.01 / Plmax / PEmax) | Identical |
| Device
Specification | PT Adult (MS-Paed only)
• Flow range
0 to +/- 20 l/s
• Flow resolution
0,01 l/s
• Flow accuracy
+/- 2% / 0,2 to 12 l/s
• Volume range
+/- 20 l
• Volume resolution
0,001 l
• Dead space
0,07 l | Identical |
| Comparison of MS Paed - Baby Body with the new features to Infant
| Plethysmograph (IPL) with 510(k) # K011344 | ||
|---|---|---|
| Infant Plethysmograph (IPL) | ||
| with 510(k) # K011344 | MasterScreen Paed - Baby | |
| Body with new features | ||
| Performance | ||
| (New measure- | ||
| ments) | • Rapid Thoracic | |
| Compression (RTC) | ||
| • Raised Volume Rapid | ||
| Thoracic Compression | ||
| (RV-RTC) | • Rapid Thoracic | |
| Compression (RTC) | ||
| • Raised Volume Rapid | ||
| Thoracic Compression | ||
| (RV-RTC) |
6
Summary of Device Testing 5.15
The following practices were followed and monitored for development of the MasterScreen Paed - Baby Body / MasterScreen Baby Body and MasterScreen Paed:
The new options for the above devices were developed in accordance with the VIASYS development standard operating procedures (000490 06 - Design Control).
The risk analysis method used to assess the impact of the MasterScreen Paed – Baby Body with the new options Squeeze and the adult handle for children 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 60601-2.
5.16 Conclusions
Based on the above, VIASYS HEALTHCARE GMBH concludes that the MasterScreen Paed - Baby Body 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.
7
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
MAY 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Rust VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg GERMANY
Re: K081823
Trade/Device Name: MasterScreen Paed - Baby Body MasterScreen Baby Body MasterScreen Paed Regulation Number: 21 CFR 868.1880 Regulation Name: Pulmonary-Function Data Calculator Regulatory Class: II Product Code: BZC, CCM Dated: May 13, 2009 Received: May 15, 2009
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 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Susan Ranner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K081823
Device Name:
MasterScreen Paed - Baby Body MasterScreen Baby Body MasterScreen Paed
Indications for Use:
The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.
The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.
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)
L. Schutten
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081823
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