(336 days)
The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.
The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.
Here's an analysis of the acceptance criteria and study information for the Micro Diary Spirometer, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| FEV1 Accuracy | Passed |
| FVC Accuracy | Passed |
| FEV6 Accuracy | Passed |
| PEF Accuracy | Passed |
| Electrical Safety | Passed |
| EMC Testing | Passed |
Note: The document states that the device was tested to assure it "accurately measures lung function across the following standard spirometric measures: FEV1, FVC, FEV6, and PEF." It then explicitly states "All tests were passed successfully." No specific numerical thresholds for accuracy are provided in this summary.
Study Information
The provided document describes a non-clinical study to demonstrate substantial equivalence to a predicate device. No clinical studies were conducted or submitted.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "All tests were passed successfully," suggesting an adequate number of tests were performed to demonstrate compliance with accuracy requirements for the measured parameters (FEV1, FVC, FEV6, PEF).
- Data Provenance: Not explicitly stated, though being a non-clinical test, it would have been generated in a laboratory setting, likely in the US where the company is based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical test comparing the device's measurements against established standards for spirometric accuracy, not against expert interpretation of medical images or data.
4. Adjudication method for the test set:
- Not applicable. As a non-clinical test, there was no expert adjudication involved. The device's measurements were compared against objective reference values from a calibrated system.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not conducted as this is a diagnostic spirometer, not an AI-assisted diagnostic tool for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone non-clinical study was performed. The spirometer's accuracy was tested independently in a laboratory setting against objective standards for FEV1, FVC, FEV6, and PEF.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective reference values / calibrated standards. For non-clinical spirometry testing, the ground truth is established by highly accurate and calibrated equipment that simulates lung function parameters or directly measures them to a high degree of precision.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its function is based on physical measurement principles (turbine rotation) and engineering design.
9. How the ground truth for the training set was established:
- Not applicable. As mentioned above, there is no "training set" for this device.
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510(k) Summary
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a shield shape inside the circle.
CareFusion 22745 Savi Ranch Pa Yorba Linda, CA 92 714-283-2228 te 714-283-8424 fax www.carefusion.com
510(k) Summary
MAR - 7 2011
Device Name: Device Trade Name: Common/Classification Name: Diagnostic Spirometer Micro Diary Spirometer Diagnostic Spirometer
Contact Person and Submitter: Merritt Girgis CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 Phone: (714) 919-3286 Fax: (714)-283-8420 Email: merritt.girgis@carefusion.com
Substantial Equivalence
The Micro Diary Spirometer is substantially equivalent to the previous version of the Micro Diary Spirometer (K965042).
Description of the device
The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.
Indications for Use Statement
The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF.
Target Population
The device can be used on patients who require lung function measurements. These patients are usually suffering from diseases such as asthma and chronic obstructive pulmonary disorder. It can be utilized for patients from 4 years and older, providing that they are able to follow the medical practitioner's instructions.
Environment of Use
The environment of use is the hospital or a doctor's or medical practitioner's office or clinic or the patient's home.
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Technological Characteristics
The updated version of the Micro Diary Spirometer has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, which is previous version of the Micro Diary Spirometer (K965042).
Comparison of Technological Characteristics
As a result of tooling and component obsolescence, it was necessary to produce a direct replacement for the previous version of the Micro Diary Spirometer using current tooling and available copnoponents. Both devices perform standard spirometric measurements, and both are capable of recording the test results for review at a later time. The MicroDiary (new) and the older MicroDiary perform exactly the same functions and tests.
| Micro Diary (new) | Micro Diary (previous) | |
|---|---|---|
| Parent Company | CareFusion | CareFusion(FormerlyCardinal Health, Viasys,Micro Medical |
| Device Classificationname | Diagnostic Spirometer | Diagnostic Spirometer |
| 510(k) Number | New | K965042 |
| Indications for Use | Measures lung functionas follows: FEV1, FVC,FEV6, and PEF. | Measures lung functionas follows: FEV1, FVC,FEV6, PEF |
| Display Screen | LCD Display, B&W | LCD Display, B&W |
| User interface | 5 Keys – on, up, down,enter, and delete | 5 Keys – on, up, down,enter, and delete |
| Measurement Transducer | Turbine | Turbine |
| Power supply | Battery | Battery |
Nonclinical Testing
The Micro Diary Spirometer was tested to assure that it accurately measures lung function across the following standard spirometric measures: FEV1, FVC, FEV6, and PEF. All tests were passed successfully. Electrical Safety and Electromagnetic Compatibility testing was also performed and passed.
Clinical Testing
No clinical testing was submitted for device.
Conclusion
The testing has demonstrated that the device is as safe, as effective, and performs as well as or better than the legally marketed Micro Diary Spirometer (K965042).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Merritt Girgis Manager, Regulatory Affairs CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887
MAR - 7 2011
- Re: K100928
Trade/Device Name: Micro Diary Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: March 2, 2011 Received: March 3, 2011
Dear Mr. Girgis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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: registerion 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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Avena
Anthony Watson, B.S., M.S., M.B.A. 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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EXHIBIT A Statement of Indications for Use
510(k) Number (if known): Not known.
Device Name: Micro Diary Spirometer
Indications for Use: The Micro Diary Spirometer measures lung function using the following standard spirometric measures: FEV1, FVC, FEV6, and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.
Target Population: Patients requiring lung function measurements.
Environment of Use: Under the supervision of a medical practitioner.
AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
L. Schultheis
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anest Franks Devices Division Controi, Dental Devices
510(k) Number: K/00928
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Statement of Indications for Use
510(k) Number: K100928.
Device Name: Micro Diary Spirometer
Indications for Use: The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF.
Target Population: The device can be used on patients who require lung function measurements. These patients are usually suffering from diseases such as asthma and chronic obstructive pulmonary disorder. It can be utilized for patients from 4 years and older, providing that they are able to follow the medical practitioner's instructions.
Environment of Use: The environment of use is the hospital or a doctor's or medical practitioner's office or clinic or the patient's home.
X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
L. Schutter
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
§10(k) Number:
K 100 928
§ 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).