(433 days)
Not Found
No
The description explicitly states that the device uses the same formulas and correction factors as the predicate device and does not mention any AI or ML components.
No.
The device is described as a "diagnostic spirometry device," and its purpose is to "assist the physician in diagnosing and treating respiratory diseases." It does not directly provide therapy; rather, it aids in the diagnostic process.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic Spirometry" and "Device Functionality: Diagnostic Spirometry." The "Device Description" also refers to it as a "spirometry diagnostic device" that assists physicians in "diagnosing and treating respiratory diseases."
No
The device description explicitly states that the SpiroCard uses a pneumotachometer mouthpiece, connecting tube, and a pressure sensor, which are hardware components. The main difference highlighted is the form factor (PC Card) and the reliance on a host computing device for the interface, but it still includes physical measurement hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Diagnostic Spirometry." This clearly indicates a diagnostic purpose.
- Device Functionality: The device measures "breathing functions" and provides information that "assists the physician in diagnosing and treating respiratory diseases." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Spirometric Parameters: The device measures specific physiological parameters (FVC, MVV, SVC, FEF) related to lung function, which are used in the diagnosis of respiratory conditions.
- Environment of Use: While it includes home use, it also includes hospital and clinical use, which are common settings for diagnostic testing.
- Prescription device: Being a prescription device further suggests its use in a clinical context for diagnosis.
While the device measures breathing directly from the patient (not a specimen derived from the body in the traditional sense of blood or tissue), the regulatory definition of an IVD can encompass devices that measure physiological parameters for diagnostic purposes. Spirometry is a well-established diagnostic test for respiratory diseases.
Therefore, based on the provided information, the SpiroCard fits the description of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- To be used as a Diagnostic Spirometer, measuring FVC, MVV and SVC breathing functions.
- Diagnostic Spirometry . Patient Population: Male/Female, Podistric to Adult . Device Functionality: Diagnostic Spirometry ● Spirometric Parameters: FVC, MVV, SVC, and FEF ● . Environment of Use: Hospital, Clinical and Home Use Prescription device by a physician ●
Product codes (comma separated list FDA assigned to the subject device)
73 BZG
Device Description
The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases.
The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy.
The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Podistric to Adult
Intended User / Care Setting
Hospital, Clinical and Home Use
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
- TESTS: The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of both tests supported substantial equivalence and met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
OCT 28 1998 510(k) SUMMARY
| MANUFACTURE'S | |
|---|---|
| ADDRESS: | Mailing - PO Box 47304 |
| Facilities - 14030 23rd Ave. North | |
| Plymouth, MN 55447 | |
| PHONE NUMBER: | (612) 559-8492 |
| FAX NUMBER: | (612) 559-2961 |
| CONTACT: | Kevin J. Driscoll, Quality Assurance, Regulatory Affairs |
| Ext: 924 | |
| TRADE NAME: | SpiroCard |
| CLASSIFICATION NAME: | Diagnostic Spirometer |
| CLASSIFICATION: | Class II, according to 21 CFR, 868.1840 |
| MODIFICATION OF | 510(k) #K932278 Advanced Medical Systems Corp |
PFM Professional 7000
DEVICE SUMMARY:
The SpiroCard is a spirometery diagnostic device that measures the breathing functions of The volume and rate of exhalation and inhalation is measured and calculated by the patients. spirometer. Information provided by the spirometer assists the physician in diagnosing and treating respiratory diseases.
The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device so that no new materials are introduced to the patient. The SpiroCard measures and calculates the results the same as the predicate device using the pressure produced by the pneumotachometer, the same correction factors and formulas for final results. The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy.
The main difference is that the SpiroCard is in a PC Card package and that the reporting and user interface will be completely handled by a host computing device whereas the PFM-7000 was a desktop standalone device with a keypad, processor and displays built in.
- TESTS: The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms. The results of both tests supported substantial equivalence and met specifications.
- To be used as a Diagnostic Spirometer, measuring FVC, MVV and SVC INTENDED USE: breathing functions.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1998
Mr. Kevin J. Driscoll QRS Diagnostic, LLC 14755 27th Avenue North Plymouth, MN 55447
Re : K973138 SpiroCard Requlatory Class: II (two) Product Code: 73 BZG Dated: July 31, 1998 Received: August 5, 1998
Dear Mr. Driscoll:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Kevin J. Driscoll
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K973138
Device Name: SpiroCard
Indications for Use:
- Diagnostic Spirometry .
- Patient Population: Male/Female, Podistric to Adult .
- Device Functionality: Diagnostic Spirometry ●
- Spirometric Parameters: FVC, MVV, SVC, and FEF ●
- . Environment of Use: Hospital, Clinical and Home Use
- Prescription device by a physician ●
PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lark Mudos 10-28-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, > Prescription Use and Neurological Devices OVER-THE-COUNTER USE (optional Form 1-2-96) 510(k) Number .