(433 days)
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.
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.
Here's an analysis of the provided text regarding the SpiroCard device, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Study Details for SpiroCard
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the SpiroCard. Instead, it relies on demonstrating "substantial equivalence" to a predicate device (PFM Professional 7000) and meeting "specifications" through testing.
However, based on the description, we can infer the primary performance expectation:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (PFM Professional 7000) for measuring breathing functions. | "The SpiroCard uses the same pneumotachometer mouthpiece and connecting tube as the predicate device...measures and calculates the results the same...The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy." |
| Ability to measure FVC, MVV, and SVC breathing functions accurately. | "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." |
| Implied: Accuracy of measurements comparable to predicate device. | "The pressure sensor is the same type but in a smaller package and of higher resolution and accuracy." (Suggests improved accuracy over predicate, but no specific numbers provided.) |
2. Sample Size for the Test Set and Data Provenance
The document states: "The SpiroCard and the predicate device were both tested using a Pulmonary Waveform Generator that produced American Thoracic Society Standard waveforms."
- Sample Size for Test Set: Not specified. The exact number of waveforms generated or the duration/number of tests performed is not mentioned.
- Data Provenance: Not applicable in the traditional sense, as it was a simulated study using a Pulmonary Waveform Generator, not human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this study was established by the American Thoracic Society Standard waveforms generated by the Pulmonary Waveform Generator. There were no human experts involved in establishing the "ground truth" for the test set of waveforms.
4. Adjudication Method for the Test Set
None. Since the "ground truth" was derived from standardized waveforms, there was no need for human adjudication. The device's output was compared directly against the known, standardized waveform parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the technical performance of the device itself against standardized waveforms, not on how human readers interact with or are influenced by the device's output. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Yes, a standalone performance study was done. The description of the testing against the Pulmonary Waveform Generator directly evaluates the device's (SpiroCard's) ability to measure and calculate spirometric parameters without human intervention or interpretation as part of the core measurement. The output of the device (measurements and calculations) was compared to the known values of the standard waveforms.
7. Type of Ground Truth Used
The type of ground truth used was standardized scientific waveforms (American Thoracic Society Standard waveforms).
8. Sample Size for the Training Set
Not applicable/Not specified. The SpiroCard is described as a diagnostic spirometer that measures and calculates breathing functions based on physical principles (pressure produced by a pneumotachometer, correction factors, and formulas). It does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. Its "knowledge" is embedded in its design, specific sensors, and pre-programmed algorithms/formulas.
9. How Ground Truth for the Training Set Was Established
Not applicable. As the device does not appear to use a machine learning model requiring a training set, the concept of establishing ground truth for a training set does not apply here. The device's functionality is based on established physiological principles and measurement techniques.
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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 .
§ 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).