Who is the manufacturer of CLEAN PEAK FLOW METER?

Viasys Healthcare GmbH filed the 510(k) submission for CLEAN PEAK FLOW METER (K091412).

What is the FDA product code for CLEAN PEAK FLOW METER?

BZH. It is classified under 21 CFR 868.1860 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for CLEAN PEAK FLOW METER?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CLEAN PEAK FLOW METER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CLEAN PEAK FLOW METER

K091412 · Viasys Healthcare GmbH · BZH · Aug 21, 2009 · Anesthesiology

Device Facts

Record ID	K091412
Device Name	CLEAN PEAK FLOW METER
Applicant	Viasys Healthcare GmbH
Product Code	BZH · Anesthesiology
Decision Date	Aug 21, 2009
Decision	SESE
Submission Type	Special
Regulation	21 CFR 868.1860
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Clean Peak Flow Meter is a handheld device for measuring peak expiratory flow rate (PEFR) in liters/minute. Used by patients to monitor respiratory conditions like asthma in any environment. Device utilizes a mechanical tension spring and piston/pointer mechanism to provide a visual reading of flow rate. Patient exhales into the mouthpiece; airflow moves the piston against the spring; pointer indicates the peak flow value on a scale. No electronic or software components. Device is single-patient use. Benefits include self-monitoring of respiratory status to assist in asthma management.

Clinical Evidence

Bench testing only. Performance verified through range, accuracy (+/- 10%), and precision (+/- 5%) testing. Biological evaluation of mouthpiece material conducted per ISO 10993. Risk assessment performed via Failure Modes and Effects Analysis (FMEA).

Technological Characteristics

Mechanical peak flow meter. Materials: Polystyrol 454C (mouthpiece), ABS (housing). Measuring principle: Tension spring with piston/pointer. Range: 50-800 L/min (adult), 50-380 L/min (children). Accuracy: +/- 10%. Precision: +/- 5%. No energy source, software, or connectivity.

Indications for Use

Indicated for patients aged 6 years and older requiring peak expiratory flow rate measurement for monitoring respiratory conditions like asthma. Children scale: 6-12 years (50-380 L/min). Adult scale: 6+ years (50-800 L/min).

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

MicroPeak (K030586)

Related Devices

K101380 — RXPEAKFLOW · Noble Marketing · Sep 13, 2010
K030586 — MICROPEAK · Micro Direct, Inc. · Aug 27, 2003
K970507 — PEAK FLOW METER · Intl. Medical, Inc. · Jun 13, 1997
K172804 — Besmed Peak Flow Meter · Besmed Health Business Corp · Jan 11, 2018
K980443 — PEAK FLOW METER MINIMAX · The D&T, Inc. · Apr 30, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ K091412 # 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: Page 1 of