(100 days)
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 – 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
Here's a summary of the acceptance criteria and the study information based on the provided text for the Clean Peak Flow Meter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Clean Peak Flow Meter) |
|---|---|
| Range: 60 - 900 L/Min | Range: 50 - 800 L/Min (adult), 50 - 380 L/Min (children) |
| Accuracy: +/- 10% | Accuracy: +/- 10% |
| Intra-device Precision: +/- 5% | Intra-device Precision: +/- 5% |
| Inter-device Precision: +/- 5% | Inter-device Precision: +/- 5% |
Note: The differences highlighted indicate a slightly different measurement range for adults and a specific range for children, as well as a change in mouthpiece material. The accuracy and precision criteria remain the same and are met by the new device.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document states that the Clean Peak Flow Meter was "developed in accordance with the Cardinal Health development standard operating procedures (000490 06 – Design Control)" and that "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards." However, no details about specific testing methodologies, number of devices tested, or the nature of the data collected during these tests are provided within the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described primarily pertains to engineering performance characteristics of the device, not clinical performance requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As stated above, the listed tests are performance specification tests, not clinical evaluations that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a peak flow meter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, in essence, the performance testing described for the Clean Peak Flow Meter is a standalone assessment of the device's accuracy and precision according to its specifications. The device itself is an analog, mechanical measuring tool; there is no AI algorithm involved. The listed performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision) represent the device's capabilities when used as intended, without human intervention affecting its measurement output beyond the patient's breath.
7. The Type of Ground Truth Used
For the performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision), the ground truth would typically be established by:
- Reference Standards/Calibration Devices: Highly accurate calibration equipment or standardized airflow generators are used to provide known input values against which the peak flow meter's readings are compared. This allows for validation of its accuracy and precision.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Clean Peak Flow Meter is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and therefore not provided, as there is no "training set" for this mechanical device.
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510(k) Summary
AUG 2 1 2009
北
GENERAL INFORMATION
5.1 Type of Submission
Special 510(k) Submission
Submission date: 06/05/2009
5.2 Submitter
Name:
、
Cardinal Health Germany 234 GmbH (Owned by Cardinal Health Inc.)
Address:
Leibnizstrasse 7 D-97204 Hoechberg Germany
Contact person in Germany:
Thomas Rust Address: Cardinal Health Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germanv +49 931 49 72 - 383 Phone: FAX: +49 931 49 72 - 62383 Thomas.Rust@cardinalhealth.com E-mail
Contact person in the U.S .:
Address
Phone/Fax: E-mail
Thomas Gutlerrez Cardinal Health 207 INC 22745 Savi Ranch Parkway Yorba Linda, CA 92887-4668 714-283-8472 Thomas. Gutierrez@cardinalhealth.com
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5 510(k) Summary
5.3 Establishment Registration Number
9615102
5.4 Common Name or Classification Name Meter, Peak Flow, Spirometry (CFR 868.1860, Product Code BZH)
ર. ર Trade Name
Clean Peak Flow Meter
5.6 Classification
This is a Class II device
5.7 Classification Panel
73 Anesthesiology Part 868 Code BZH
5.8 Reason for Premarket Notification
Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm"
5.9 Legally predicate marketed devices MicroPeak K030586 / Code BZH
5.10 Predicate Device Company
Cardinal Health U. K. 232 Limited (Owned by Cardinal Health Inc.)
5.11 Device Description
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
5.12 Intended Use Statement
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population: Children scale / 50 - 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
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5 510(k) Summary
Adult scale / 50 -- 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use:
Places where a patient may require the measurement of their peak expriatory flow rate.
Required Components 5.13
Clean Peak Flow Meter User Manual
5.14 Summary Table of Comparision
| Comparison of the Clean Peak Flow Meter with the MicroPeakwith 510(k) # K030586 | ||
|---|---|---|
| MicroPeak with 510(k) #K030586 | Clean Peak Flow Meter | |
| Intended Use | The MicroPeak PeakFlow Meter simplymeasures a patient'speak expiratory flow ratein liters/minutes. This ishelpful in monitoringrespiratory conditionssuch as asthma.Targeted population:Patients requiring themeasurement of peakexpiratory flow rate.Environment of use:Places where a patientmay require themeasurement of theirpeak expriatory flow rate. | The Clean Peak FlowMeter simply measures apatient's peak expiratoryflow rate in liters/minutes.This is helpful inmonitoring respiratoryconditions such asasthma.Targeted population:Children scale / 50 - 380liters/minutesPatients requiring themeasurement of peakexpiratory flow rate from6 years on up to 12years.Adult scale / 50 - 800liters/minutesPatients requiring themeasurement of peakexpiratory flow rate from6 years on. |
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| Environment of use:Places where a patientmay require themeasurement of theirpeak expriatory flow rate. | ||
|---|---|---|
| Design | Single Patient Use | Identical |
| Mouthpiecematerial | ABS | Polystyrol 454C |
| Housingmaterial | ABS | Identical |
| Measuringprinciple | Tension SpringPiston/Pointer | Identical |
| Performance | Range:60 - 900 L/MinAccuracy:+/- 10%Intra device Precision:+/- 5%Inter device Precision:+/- 5% | Range:50 - 800 L/Min (adult)50 - 380 L/Min (children)Accuracy:+/- 10%Intra device Precision:+/- 5%Inter device Precision:+/- 5% |
| Differences | The only difference is a small difference in the measurementrange for adults and a separate range for children. Also themouthpiece material has changed. |
Summary of Device Testing 5.15
The following practices were followed and monitored for development of the Clean Peak Flow Meter:
:
The Clean Peak Flow Meter was developed in accordance with the Cardinal Health development standard operating procedures (000490 06 – Design Control).
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5 510(k) Summary
The risk analysis method used to assess the impact of the Clean Peak Flow Meter was a Failure Modes and Effects Analysis (FMEA).
Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards.
A biological evaluation for Clean Peak Flow Meter mouthpiece was done according ISO 10993 Standard.
5.16 Conclusions
.
Based on the above, Cardinal Health Germany 234 GmbH concludes that the Clean Peak Flow Meter is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use, and performs at least as well as the predicate device.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of a bird with three wing-like shapes above a wavy line.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Thomas Rust Manager Regulatory Affairs VIASYS Healthcare GmbH Leibnizstrasse 7 D-97204 Hoechberg GERMANY
AUG 2 1 2009
Re: K091412
Trade/Device Name: Clean Peak Flow Meter Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: July 20, 2009 Received: July 23, 2009
Dear Mr. Rust:
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 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. Rust
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); 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K091412
Device Name:
Clean Peak Flow Meter
Indications for Use
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 – 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Shattuck
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of
§ 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).