(177 days)
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No
The provided text does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex pattern recognition).
No
Explanation: The device is indicated for diagnostic, assessment, and evaluation purposes related to pulmonary function and metabolism, not for treatment or therapy.
Yes
The device is indicated for "Differential diagnosis (heart/lungs)" and "Pulmonary Function testing," which are diagnostic activities.
Unknown
The provided 510(k) summary does not contain a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" section describes a "System," which often implies hardware components are involved in pulmonary function and metabolic testing. Without a device description, it's impossible to confirm if this system is solely software.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic) device. Here's why:
- Pulmonary Function and Metabolic Testing: The core function of the device is to perform pulmonary function and metabolic testing. These tests typically involve analyzing biological samples (like exhaled breath) to assess physiological processes.
- Specific Intended Uses: Many of the listed intended uses directly relate to diagnosing, monitoring, or evaluating medical conditions based on the results of these tests. Examples include:
- Differential diagnosis (heart/lungs)
- Disability assessment
- Rehabilitation evaluation
- Assessment of supplemental O2 requirement
- Evaluation of medication effects
- Pulmonary disability evaluation
- Bronchial challenge testing
- Exercise induced bronchial spasm
- Pre-surgical risk evaluation
- Bedside lung function
- Comparison to Predicate Devices: The statement that the device has the same indications for use as predicate products from Cardinal Health, a company known for medical devices, further supports its classification as a medical device, and likely an IVD given the nature of the tests performed.
While the "Device Description" is not available, the "Intended Use / Indications for Use" section strongly points towards the device being used to perform tests on biological samples to provide information for medical diagnosis, monitoring, or treatment. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.
· Differential diagnosis (heart/lungs)
· Disability assessment
• Rehabilitation evaluation
- · Exercise prescription
- · Sports medicine/research
- · Energy assessment, substrate utilization
- · Assessment of supplemental O2 requirement
- · Evaluation of medication effects
- · Pulmonary Function testing for adults and children
- · Document effectiveness of bronchodilator therapy
- Pulmonary disability evaluation
- · Industrial surveillance · Bronchial challenge testing
- · Exercise induced bronchial spasm
- · Pre-surgical risk evaluation
- Bedside lung function
Product codes (comma separated list FDA assigned to the subject device)
BTY
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
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Indicated Patient Age Range
paediatric and adult patients
Intended User / Care Setting
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Rust Manager Regulatory Affairs VIASYS Healthcare GmbH Leibnizstrasse 7 Hoechberg GERMANY 97204
AUG 2 0 2008
Re: K080510
Trade/Device Name: VIP Pulmonary Function System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: June 17, 2008 Received: June 19, 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 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.
1
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 Biometric'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 yours,
H. Kamuela Rener
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
2
Indications for Use
510(k) Number (if known): K
Device Name:
VIP Pulmonary Function System
Indications for Use:
The VIP Pulmonary Function System has been designed and labeled as having the same indications for use as one or more of the predicate products of Cardinal Health. The intended use involves performing physician-prescribed pulmonary function and metabolic testing on paediatric and adult patients. More specific intended uses are listed below.
· Differential diagnosis (heart/lungs)
· Disability assessment
• Rehabilitation evaluation
- · Exercise prescription
- · Sports medicine/research
- · Energy assessment, substrate utilization
- · Assessment of supplemental O2 requirement
- · Evaluation of medication effects
- · Pulmonary Function testing for adults and children
- · Document effectiveness of bronchodilator therapy
- Pulmonary disability evaluation
- · Industrial surveillance · Bronchial challenge testing
- · Exercise induced bronchial spasm
- · Pre-surgical risk evaluation
- Bedside lung function
Prescription Use X (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)
Will Malf fa M. Hubbard
(Division Sian-Um) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080510
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