MASTERSCREEN PAED - BABY BODY

K081823 · Viasys Healthcare GmbH · CCM · May 18, 2009 · Anesthesiology

Device Facts

• Record ID: K081823
• Device Name: MASTERSCREEN PAED - BABY BODY
• Applicant: Viasys Healthcare GmbH
• Product Code: CCM · Anesthesiology
• Decision Date: May 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

MasterScreen Paed - Baby Body is a pediatric lung function measurement system. Inputs include respiratory flow, volume, and pressure data captured via pneumotach and body plethysmography (Baby Body box). The system processes these signals to calculate parameters like tidal breathing, airway resistance, compliance, and lung volumes (FRC). It also performs Rapid Thoracic Compression (RTC) and Raised Volume RTC (RV-RTC) for infants, and spirometry/MVV/occlusion resistance for older children. Operated by clinicians in hospitals or clinics, the system displays results on a PC via a Windows-based GUI. Data is stored in a database for clinical review. The device aids physicians in assessing pediatric pulmonary health and diagnosing respiratory conditions. It is AC-powered and includes a trolley-mounted PC, pneumotach handle, and plethysmograph cabin.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including safety testing per IEC 601-1-4 and EMC testing per EN 60601-2, alongside design control documentation and risk analysis (FMEA).

Technological Characteristics

System includes PC, trolley, pneumotach handle, and plethysmograph cabin. Materials include latex for shutter balloons. Sensing via pneumotach (flow/volume) and pressure sensors. Connectivity via PC interface. Software-based data processing. Power: 115V-240V AC. Standards: IEC 601-1-4 (software), EN 60601-2 (EMC).

Indications for Use

Indicated for lung function measurement in newborns (neonates), infants, children, and adolescents. RTC/RV-RTC measurements for term neonates (min 3kg) to toddlers (max 13kg). Digital pneumotach with shutter for children/adolescents aged 4 to 21 years. Used under physician direction in clinics, offices, or hospitals.

Regulatory Classification

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.

Predicate Devices

• MasterScreen Paed - Baby Body (K023796)
• MasterScreen PFT Body (K072061)
• IPL (Infant Pulmonary Laboratory) or Collins Infant Plethysmograph (K011344)

Submission Summary (Full Text)

{0}------------------------------------------------

K081823

# 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: | [phone] - 383 |
| FAX: | [phone] - 62383 |
| E-mail | [e-mail] |
| | or at: [e-mail] |

| 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 |
| E-mail | [e-mail] |

{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 -<br>Baby Body with 510(k) # K023796 | | |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MasterScreen Paed - Baby<br>Body with 510(k) # K023796 | MasterScreen Paed - Baby<br>Body with new features |
| Intended Use | The MS PAED - BABY BODY<br>is a neonatal lung function<br>measurement system that<br>utilizes a bodyplethysmograph.<br>It is intended to be used under<br>the direction of a physician. MS<br>PAED - BABY BODY may be<br>used in the clinic, doctors office,<br>or hospital. Patient populationthis device include only babies<br>and premature infants.<br>The MS PAED - BABY BODY,<br>or any of the accessories<br>supplied with it, is not to be<br>used, alone or in combination,<br>as a life support device, a life<br>support system, or as a critical<br>component in a life support<br>device or life support system. | The MasterScreen Paed - Baby<br>Body is a lung function<br>measurement system for<br>paediatric use. It is intended to<br>be used under the direction of a<br>physician. The MasterScreen<br>Paed - Baby Body may be used<br>in the clinic, doctor's office, or<br>hospital. Patient populations that<br>may benefit from the use of this<br>device include newborns<br>(neonate), infants, children and<br>adolescent.<br>The lung function measure-<br>ments including RTC and RV-<br>RTC can be performed in term<br>neonates (weight 3kg) up to<br>toddlers (weight 13kg). The<br>digital adult pneumotach with<br>shutter feature is for use with<br>children and adolescent from 4<br>up to 21 years. The device is AC<br>powered from 115V-240V / 50-<br>60Hz wall outlet. |
| Patient<br>population | Babies Premature Infants<br>from 4 to 40 lbs | Newborns (Neonate) Infants<br>from 4 to 40 lbs Children Adolescent up to 21 year |
| Performance<br>(Measurements) | Tital Breathing Analysis<br>Baby Bodyplethysmo-<br>graphy<br>[Functional Residual (FRC)<br>and Airway Resistance (Raw)<br>- Conductance (Gaw)] Resistance<br>Single Occlusion Technique<br>(SOT) and Double Occlusion<br>Technique (DOT) Compliance | Identical |
| | | |
| Software | • JLAB Version 4.5 | • JLAB Version 4.6 |
| Device<br>Specification | PT Paed S Flow range<br>0 to +/- 1500 ml/s Flow resolution<br>1 ml/s Flow accuracy<br>+/- 3% / +/- 4 ml/s Volume range<br>+/- 3000 ml Volume resolution<br>0,1 ml Deadspace<br>1,7 ml Mouth pressure Range<br>+/- 5 kPa Resolution<br>0,003 kPa Accuracy<br>+/- 2% Shutter Balloon material<br>Latex Balloon pressure<br>0,9 bar Balloon volume<br>0,7 ml Baby Body (Cabin) Length - weight - height<br>127cm - 71cm - 128cm Box volume<br>98 liters Box sensor<br>+/- 80 ml at 1000 hPa Resolution<br>0,04 ml Accuracy<br>+/- 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<br>510(k) # K072061 | MasterScreen Paed - Baby<br>Body with new features |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Performance<br>(New measure-<br>ments) | • Spirometry<br>• MVV<br>• Flow Volume<br>• R Occlusion<br>• Respiratory Muscle<br>Strength and Respiratory<br>Drive<br>(P.01 / Plmax / PEmax) | Identical |
| Device<br>Specification | PT Adult (MS-Paed only)<br>• Flow range<br>0 to +/- 20 l/s<br>• Flow resolution<br>0,01 l/s<br>• Flow accuracy<br>+/- 2% / 0,2 to 12 l/s<br>• Volume range<br>+/- 20 l<br>• Volume resolution<br>0,001 l<br>• Dead space<br>0,07 l | Identical |

| Comparison of MS Paed - Baby Body with the new features to Infant<br>Plethysmograph (IPL) with 510(k) # K011344 | | |
|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | Infant Plethysmograph (IPL)<br>with 510(k) # K011344 | MasterScreen Paed - Baby<br>Body with new features |
| Performance<br>(New measure-<br>ments) | • Rapid Thoracic<br>Compression (RTC)<br>• Raised Volume Rapid<br>Thoracic Compression<br>(RV-RTC) | • Rapid Thoracic<br>Compression (RTC)<br>• Raised Volume Rapid<br>Thoracic Compression<br>(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 [phone]. 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 [phone] or [phone] 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

Page 1 of