(100 days)
Not Found
No
The description indicates a simple mechanical device for measuring peak expiratory flow rate, with no mention of AI or ML capabilities. The performance studies focus on standard device accuracy and safety testing.
No.
The device measures a patient's peak expiratory flow rate, which is a diagnostic or monitoring function, not a therapeutic one.
Yes
The device measures a patient's peak expiratory flow rate, which is used to monitor respiratory conditions, indicating its use in diagnosing or monitoring health conditions.
No
The device description explicitly states "A peak flow meter is a device used to measure a person's peak expiratory flow rate." This implies a physical device that measures airflow, not solely software. The performance studies also mention a "Clean Peak Flow Meter mouthpiece" and a "biological evaluation for Clean Peak Flow Meter mouthpiece," further indicating a hardware component.
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 Clean Peak Flow Meter measures a patient's peak expiratory flow rate by having the patient exhale directly into the device. This is a direct measurement of a physiological function (airflow from the lungs), not an analysis of a sample taken from the body.
- Intended Use: The intended use is to monitor respiratory conditions by measuring airflow, not by analyzing a biological sample.
Therefore, the Clean Peak Flow Meter falls under the category of a medical device that measures a physiological parameter, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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
from 6 years on up to 12 years (Children scale)
from 6 years on (Adult scale)
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)
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).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Range: 50 - 800 L/Min (adult)
50 - 380 L/Min (children)
Accuracy: +/- 10%
Intra device Precision: +/- 5%
Inter device Precision: +/- 5%
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
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
1
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.
2
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 MicroPeak
| with 510(k) # K030586 | ||
|---|---|---|
| MicroPeak with 510(k) # | ||
| K030586 | Clean Peak Flow Meter | |
| Intended Use | The MicroPeak 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: | ||
| Patients requiring the | ||
| measurement of peak | ||
| expiratory flow rate. | ||
| Environment of use: | ||
| Places where a patient | ||
| may require the | ||
| measurement of their | ||
| peak expriatory flow rate. | 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. |
3
| | | Environment of use:
Places where a patient
may require the
measurement of their
peak expriatory flow rate. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Single Patient Use | Identical |
| Mouthpiece
material | ABS | Polystyrol 454C |
| Housing
material | ABS | Identical |
| Measuring
principle | Tension Spring
Piston/Pointer | Identical |
| Performance | Range:
60 - 900 L/Min
Accuracy:
+/- 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 measurement
range for adults and a separate range for children. Also the
mouthpiece 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).
4
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.
5
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.
6
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
7
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:
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