(184 days)
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.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
This document describes a 510(k) premarket notification for the MicroPeak Peak Flow Meter. The following information is extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroPeak Peak Flow Meter are implicitly defined by its performance comparison to the Vitalograph Asmaplan+, a predicate device. The document states "The only difference is a small difference in the measurement range," implying that the MicroPeak device's performance attributes (accuracy, intra-device precision, inter-device precision) are considered acceptable if they match or are comparable to the predicate device's.
| Attribute | Acceptance Criteria (Predicate Device: Vitalograph Asmaplan+) | Reported Device Performance (MicroPeak) |
|---|---|---|
| Range | 50 - 800 L/M | 60 - 900 L/Min |
| Accuracy | +/- 10% | +/- 10% |
| Intra device Precision | +/- 5% | +/- 5% |
| Inter device Precision | +/- 5% | +/- 5% |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The comparison is based on the technical specifications of the device rather than a clinical study with a detailed test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention a ground truth established by experts for a test set. The validation appears to be based on engineering specifications and comparison to a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no described test set involving human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a measurement tool, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
The document implicitly describes the standalone performance of the device by listing its performance attributes (range, accuracy, precision). However, it does not detail a specific standalone study design or results beyond these specifications. The device itself is a mechanical measurement tool, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be based on engineering specifications and direct measurement capabilities of the device itself, compared against the known specifications of the predicate device. There is no mention of pathology, expert consensus (in the context of clinical interpretation), or outcomes data for performance validation in this submission.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a mechanical peak flow meter, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set mentioned.
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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 StreetLewiston, 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 peakexpiratory 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 | Intendeddevice | VitalographAsmaplan+ |
|---|---|---|
| UseIntended as a peak flow meter | Yes | Yes |
| Intended to measure peak expiratory flow | Yes | Yes |
| Design | ||
| Single patient Use | Yes | Yes |
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Comparison to predicate devices (continued)
| Attribute | Intendeddevice | VitalographAsmaplan+ |
|---|---|---|
| MaterialsHousing - ABS | Yes | Yes |
| Measuring Principle | Tension SpringPiston/Pointer | Tension SpringPiston/Pointer |
| PerformanceRangeAccuracyIntra device PrecisionInter 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
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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
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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
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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 √
Page 10
§ 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).