(182 days)
Not Found
No
The summary describes a standard electronic spirometer and does not mention any AI or ML capabilities.
No
The primary function of the device is to measure lung functions, not to treat a condition. While the measurements can be used for diagnosis or monitoring, the device itself does not effect therapy.
Yes
Explanation: The device measures lung functions (FEV1, FVC, and PEF), which are used to assess the state of a patient's lungs and aid in the diagnosis of respiratory conditions.
No
The device description explicitly states it is a "hand-held portable electronic spirometer," which indicates a physical hardware component is involved in the measurement of lung functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: This device measures lung functions (FEV1, FVC, PEF) directly from the patient's breath. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure lung functions and transfer the data, not to diagnose a condition based on analysis of a biological sample.
- Anatomical Site: The anatomical site is the lung, which is where the measurement is taken directly, not a source of a sample for in vitro analysis.
Therefore, this device falls under the category of a medical device used for physiological measurement, but it is not an IVD.
N/A
Intended Use / Indications for Use
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1, FVC, and PEF.
To measure lung functions - FEV1, FVC, and PEF and to effect historical serial transfer of measured test indices to PC compatible computers
Product codes (comma separated list FDA assigned to the subject device)
73 BZG
Device Description
A hand-held portable electronic spirometer measuring FEV1, FVC, and PEF.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinician in environments such as the home or hospital.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing None applicable
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.
Micro Medical Micro Spirometer - K963035
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
K9605042
JUN 17 1997
Non-Confidential Summary of Safety and Effectiveness December 15, 1996
page 1 of 2
| Micro Direct, Inc.
840 Pownal Road
| Auburn, ME 04210 | Tel - (207) 786-7808 | Fax - (207) 786-7280 |
|---|---|---|
| Official contact: | David R. Staszak, President | |
| Proprietary or Trade Name: | MicroDL DiaryCard Spirometer | |
| Common/Usual Name: | Diagnostic Spirometer | |
| Classification Name: | 73 BZG - Diagnostic Spirometer | |
| Intended device: | Diagnostic Spirometer | |
| Predicate devices: | Micro Medical Micro Spirometer - K963035 | |
| Device description: | A hand-held portable electronic spirometer measuring | |
| FEV1, FVC, and PEF. |
Indicated use:
� i
f
The intended device takes spirometer readings of a patient during exhalation. The output readings are FEV1, FVC, and PEF.
Targeted population:
Patients requiring lung function evaluations.
Environment of use:
Places where a qualified clinician desires to take these lung measurements - FEV1, FVC, and PEF.
Comparison to predicate devices:
| Attribute | Intended device | Micro Medical Micro Spirometer |
|---|---|---|
| Use | ||
| Intended as a spirometer | Yes | Yes |
| Intended to measure | ||
| lung function FEV1, FVC, and PEF | Yes | FEV1 and FVC |
1
Non-Confidential Summary of Safety and Effectiveness December 15, 1996
page 2 of 2
Comparison to predicate devices (continued)
イ・
| Attribute | Intended
device | Micro Medical
Micro Spirometer |
|-------------------------------------------------------------------------------------|--------------------|-----------------------------------|
| Use (continued)
Indicated for measuring
patients lung function | Yes | Yes |
| Indicated for use by a clinician
in environments such as the
home or hospital | Yes | Yes |
| Manufactured by Micro Medical | Yes | Yes |
| Design
Transducer - flow sensing turbine | Yes | Yes |
| Output | RS232 | No |
| Flow range LPs BTPS 0-12 | Yes | Yes |
| Volume range liters 0-9.99 | Yes | Yes |
| Test Parameters | FEV1, FVC, PEF | FEV1, FVC |
| Accuracy +/- 3 | Yes | Yes |
| Display LCD | Yes | Yes |
| Transducer cleaned after use | Yes | Yes |
| Utilizes paper mouthpiece | Yes | Yes |
| Materials
Same materials as K963035 | Yes | Yes |
| Performance Testing
None applicable | Yes | Yes |
Differences
The only differences are the addition of the displayed test parameter of PEF (Peak Expired Flow) and the ability to retain the test values in memory for later review.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a person with outstretched arms, with three wavy lines below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1997
Mr. David R. Staszak Micro Direct, Inc. 840 Pownal Road P.O. Box 239 Auburn, Maine 04212-0239
Re: *K965042 MicroDL DiaryCard Spirometer Regulatory Class: II (two) Product Code: 73 BZG March 17, 1997 Dated: Received: March 19, 1997
Dear Mr. Staszak:
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 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, Druq, 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 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 (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 to 895. A substantially equivalent determination assumes compliance with the Cood Manufacturing Practice for Medical Devices. General (GMF) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
3
Page 2 - Mr. David R. Staszak
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 regulation 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number | K965042 (To be assigned) |
|---|---|
| Device Name: | MicroDL DiaryCard Spirometer |
| Indications for Use: | To measure lung functions - FEV 1 , FVC, and PEF |
| and to effect historical serial transfer of measured test | |
| indices to PC compatible computers | |
| Targeted population: | Patients requiring lung function measurements |
| Environment of use: | Places where a qualified clinician desires to take |
| these lung measurements - FEV 1 , FVC, and PEF. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory,
Devices alogical Devices Division of Carchological Devices
and Neurological Devices & La ×965042
510(k) Number _
Prescription Use (Per 21 CFR 801.109)
、
. ) :
OR
Over-The-Counter Use __