(238 days)
The Microlab spirometer is intended, for prescription use rno Mioreleb ope the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
The Microlab spirometry systems consists of the Microlab spirometer, digital volume transducer, transducer housing, AC power adapter, power supply cord, disposable cardboard mouthpieces, carrying case, quick start guide and operators manual. Optional accessories include calibration syringe, nose clips, serial cable and a serial to parallel converter for use of an external compatible printer.
Here's an analysis of the provided text regarding the Microlab Spirometer, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by) | Reported Device Performance |
|---|---|
| Accuracy and precision standards set by the American Thoracic Society (ATS) | "Performance testing was conducted to demonstrate compliance with the accuracy and precision standards set by the American Thoracic Society." |
| Electrical safety requirements per IEC60601-1-2 | "The device was tested to demonstrate conformance with IEC60601-1-2 requirements for electrical safety." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing related to ATS standards. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) for this testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The testing appears to be against established technical standards (ATS and IEC), rather than requiring expert-adjudicated ground truth derived from patient data.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the testing was against pre-defined technical standards rather than requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided document. The submission focuses on demonstrating technical compliance and substantial equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the testing described appears to be a standalone performance evaluation of the device against a set of predetermined technical standards (ATS for accuracy/precision and IEC for electrical safety). There is no indication of human-in-the-loop performance testing being conducted or required for this type of device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is the technical accuracy and precision standards set by the American Thoracic Society (ATS) and the electrical safety requirements of IEC60601-1-2. These are objective, pre-defined standards rather than patient-specific or expert-derived ground truth.
8. The Sample Size for the Training Set
This information is not applicable/provided. Spirometers are hardware devices that measure physiological parameters. They do not typically involve training sets in the machine learning sense. The "training" would be inherent in the device's design and calibration against established physical standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the reasons stated above. The device's "training" and calibration would be against physical standards and known physiological principles, not through a training dataset of medical images or patient outcomes.
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DEC - 1 2003
K03112
Non-Confidential Summary of Safety and Effectiveness April 4, 2003
| Micro Direct, Inc.803 Webster StreetLewiston, ME 04240 | Tel - (207) 786-7808 | Fax - (207) 786-7280 |
|---|---|---|
| ---------------------------------------------------------------- | ---------------------- | ---------------------- |
| Official contact: | David R. Staszak, President |
|---|---|
| Proprietary or Trade Name: | Microlab Spirometer |
| Common/Usual Name: | Spirometer |
| Classification Name: | 73 BZG – Diagnostic Spirometer |
| Intended device: | Diagnostic Spirometer |
| Predicate devices: | Micro Medical MicroDL Diarycard Spirometer |
Device description: The Microlab spirometry systems consists of the Microlab spirometer, digital volume transducer, transducer housing, AC power adapter, power supply cord, disposable cardboard mouthpieces, carrying case, quick start guide and operators manual. Optional accessories include calibration syringe, nose clips, serial cable and a serial to parallel converter for use of an external compatible printer.
Intended use: The Microlab spirometry system is intended, for prescription use only, to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The testing can be used in the detection and monitoring of certain lung diseases. The system is intended for use with pediatric and adult patients (4 to 99 years old) in hospitals, physician offices, laboratories and occupational health testing environments.
Comparison to predicate device: The Microlab spirometry system has the same technological characteristics of the referenced predicate device. In both devices, air flow is measured directly via a turbine sensor and then electronically integrated to obtain volume. Both devices then perform calculations to express the volume in clinically relevant terms, including comparisons to predicted normal values from published literature. The intended use for both devices is the same.
Summary of Testing: Performance testing was conducted to demonstrate compliance with the accuracy and precision standards set by the American Thoracic Society.
The device was tested to demonstrate conformance with IEC60601-1-2 requirements for electrical safety.
- Conclusion: The Microlab spirometry systems does not raise new questions of safety or effectiveness when compared to the legally marketed predicate device and is substantially equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle, with three stylized wing shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2003
Mr. David R. Staszak President Micro Direct, Incorporated 803 Webster Street Lewiston, Maine 04240
Rc: K031102
Trade/Device Name: Microlab Spirometer Regulation Number: 21 CFR 868.1840 Regulation Name: Spirometer, Diagnostic Regulatory Class: II Product Code: BZG Dated: September 24, 2003 Received: September 25, 2003
Dear Mr. Staszak:
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 - Mr. David R. Staszak
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 vour 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely vours.
Susan Runion
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 Statement
Ko31102 (To be assigned) 510(k) Number
Device Name:
Microlab Spirometer
Indications for Use:
The Microlab spirometer is intended, for prescription use rno Mioreleb ope the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (4 to 17 years) and adult (18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. Nartorhe for JXH 11/25/03
ision Sign-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: _K
Prescription Use √
Over-The-Counter Use OR (Per 21 CFR 801.109)
§ 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).