(184 days)
Not Found
No
The summary describes a simple peak flow meter, a mechanical device for measuring airflow, with no mention of AI/ML terms or capabilities.
No
The device measures a physiological parameter (peak expiratory flow rate) for monitoring purposes, which is diagnostic or for management, not therapeutic in nature. It does not treat or alleviate a medical condition.
Yes
Explanation: The device measures peak expiratory flow rate, which is used to monitor respiratory conditions. This provides information to help understand a patient's health status, which is a diagnostic purpose.
Unknown
The provided summary describes the intended use and general function of a peak flow meter but lacks details about the specific device implementation. It doesn't explicitly state whether the device is purely software or if it includes hardware components for measurement. The predicate device is a traditional peak flow meter, which is a hardware device, further suggesting the possibility of a hardware component in the described device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device measures a physical parameter (peak expiratory flow rate) directly from the patient's breath. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to monitor a respiratory condition by measuring a physical output from the patient, not by analyzing a biological sample.
Therefore, a peak flow meter, as described, falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.
Product codes (comma separated list FDA assigned to the subject device)
73 BZH
Device Description
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K030586" and is written in black ink on a white background. The text is slightly rotated, with the top right corner being higher than the bottom left.
Image /page/0/Picture/2 description: The image shows the logo for Micro Direct. The word "Micro" is stacked on top of the word "Direct". Above the word "Micro" is a black square. The text is in a simple sans-serif font.
Non-Confidential Summary of Safety and Effectiveness February 18, 2003
page 1 of 2
| Micro Direct, Inc.
803 Webster Street
| Lewiston, ME 04240 | ||
|---|---|---|
| Tel - (207) 786-7808 | Fax - (207) 786-7280 | |
| Official contact: | David R. Staszak, President | |
| Proprietary or Trade Name: | MicroPeak | |
| Common/Usual Name: | Peak Flow Meter | |
| Classification Name: | BZH - Meter, Peak Flow | |
| Intended device: | Peak Flow Meter | |
| Predicate devices: | Vitalograph Asmaplan+ - K781922 | |
| Device description: | A peak flow meter is a device used to measure a person's peak | |
| expiratory flow rate. |
Indicated use:
The intended device measures a patient's peak expiratory flow rate.
Targeted population:
Patients requiring the measurement of peak expiratory flow.
Environment of use:
Anywhere that a patient may require the measurement of peak expiratory flow.
Comparison to predicate devices:
| Attribute | Intended
device | Vitalograph
Asmaplan+ |
|------------------------------------------|--------------------|--------------------------|
| Use
Intended as a peak flow meter | Yes | Yes |
| Intended to measure peak expiratory flow | Yes | Yes |
| Design | | |
| Single patient Use | Yes | Yes |
1
Comparison to predicate devices (continued)
| Attribute | Intended
device | Vitalograph
Asmaplan+ |
|--------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------|
| Materials
Housing - ABS | Yes | Yes |
| Measuring Principle | Tension Spring
Piston/Pointer | Tension Spring
Piston/Pointer |
| Performance
Range
Accuracy
Intra device Precision
Inter device Precision | 60 - 900 L/Min
+/- 10%
+/- 5%
+/- 5% | 50 - 800 L/M
+/- 10%
+/- 5%
+/- 5% |
Differences
The only difference is a small difference in the measurement range
2
Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN JUSTICE - USA" around the edge. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Mr. David R. Staszak President Micro Direct, Incorporated 803 Webster Street Lewiston, Maine 04240
Re: K030586
Trade/Device Name: MicroPeak Regulation Number: 21 CFR 868.1860 Regulation Name: Peak Flow Meter for Spirometry Regulatory Class: II Product Code: 73 BZH Dated: May 30, 2003 Received: June 3, 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.
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
3
Page 2 - Mr. Staszak
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 your 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 yours,
Susan Ruane
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number | K030586 (To be assigned) |
|---|---|
| Device Name: | MicroPeak Peak Flow Meter |
| Indications for Use: | The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma. |
| Targeted population: | Patients requiring the measurement of peak expiratory flow rate. |
| Environment of use: | Places where a patient may require the measurement of their peak expiratory flow rate. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rurr
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use √
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