(270 days)
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No
The document describes standard pulmonary function testing equipment and does not mention AI, ML, or related concepts.
No
The device is used for measurement and data collection of lung function parameters to support diagnosis, not for treating any condition.
Yes
The device is described as providing "data / information and supports help for a diagnosis," directly indicating its role in the diagnostic process.
No
The description explicitly mentions "system" and "measurements" of lung function parameters, including Spirometry/Flow-Volume/Resistance, lung diffusion, and bodyplethysmography. These measurements typically require hardware components (like spirometers, diffusion gas analyzers, and body plethysmographs) to acquire the physiological data. While software is undoubtedly involved in data collection, processing, and presentation, the description implies a system that includes hardware for data acquisition, not just software operating on existing data.
Based on the provided information, the Masterscreen PFT Body is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Masterscreen PFT Body Function: The Masterscreen PFT Body measures lung function parameters directly from the patient's body (in vivo) through breathing maneuvers. It does not analyze specimens taken from the body.
Therefore, while it provides data that supports diagnosis, it does so through direct measurement of physiological function, not through the in vitro examination of specimens.
N/A
Intended Use / Indications for Use
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.
MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).
MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.
Product codes
JEH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lung
Indicated Patient Age Range
from 4 years on and older
Intended User / Care Setting
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1760 Volume plethysmograph.
(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2008
VIASYS Healthcare GmbH C/O Ms. Yvette Lloyd Regulatory Affairs Manager VIASYS Respiratory Care, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887
Re: K072061
Trade/Device Name: MasterScreen PFT Body MasterScreen PFT CT MasterScreen PFT Regulation Number: 21 CFR 868.1760 Regulation Name: Volume Plethysmograph Regulatory Class: II Product Code: JEH Dated: April 8, 2008 Received: April 11, 2008
Dear Ms. Lloyd:
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 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.
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Page 2 - Ms. Lloyd
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.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
Enclosure
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Indications for Use
510(k) Number (if known): K072061
Device Name:
MasterScreen PFT Body MasterScreen PFT CT MasterScreen PFT
Indications for Use:
The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.
MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).
MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
The MS-PFT Body 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)
Concurrence of, SBIR/STTR, Office & Device Evaluation
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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