Who is the manufacturer of ASTHMA MONITOR MODEL, AM1?

Cardinal Health Germany 234 GmbH filed the 510(k) submission for ASTHMA MONITOR MODEL, AM1 (K090486).

What is the FDA product code for ASTHMA MONITOR MODEL, AM1?

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for ASTHMA MONITOR MODEL, AM1?

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

Who can help prepare an FDA 510(k) submission like ASTHMA MONITOR MODEL, AM1?

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.

ASTHMA MONITOR MODEL, AM1

K090486 · Cardinal Health Germany 234 GmbH · BZG · May 6, 2009 · Anesthesiology

Device Facts

Record ID	K090486
Device Name	ASTHMA MONITOR MODEL, AM1
Applicant	Cardinal Health Germany 234 GmbH
Product Code	BZG · Anesthesiology
Decision Date	May 6, 2009
Decision	SESE
Submission Type	Special
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.

Device Story

Handheld electronic peak flow meter; measures PEF and FEV1 during expiration; stores up to 400 measurements and 2000 entries; includes questionnaire functionality for patient-reported outcomes (e.g., Quality of Life). Used by patients at home, work, or school; operated by patients; data transmitted to PC via serial or Bluetooth (AM1+ BT model) for physician review using AMOS software. Provides numeric results and visual 'traffic light' feedback based on physician-defined criteria. Replaces manual peak flow meters and paper diaries; facilitates longitudinal monitoring of respiratory status to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included safety verification, risk analysis (FMEA), and EMC testing per EN 60601-1-2.

Technological Characteristics

Handheld electronic spirometer; battery-operated (3x AAA); housing material: Rotec ABS 1001FR VO; mouthpiece material: Polystyrol 454C; sensing principle: flow measurement; connectivity: Serial RS 232 (AM1+) or Serial/Bluetooth (AM1+ BT); software: AMOS PC software for data evaluation.

Indications for Use

Indicated for patients 4 years and older to monitor lung function (respiratory flows and volume) in asthma, COPD, occupational medicine, clinical trials, and disease management.

Regulatory Classification

Identification

A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

Predicate Devices

Asthma Monitor AM2 (K980676)

Submission Summary (Full Text)

{0}------------------------------------------------ 5 510(k) Summary K090486 # 510(k) Summary ## GENERAL INFORMATION MAY - 6 2009 #### Type of Submission 5.1 Special 510(k) Submission Submission date: 02/17/2009 #### 5.2 Submitter Name: Cardinal Health Germany 234 GmbH Address: Leibnizstrasse 7 D-97204 Hoechberg Germany ## Contact person in Germany: Address: Phone: FAX: E-mail Phone / FAX: E-mail Thomas Rust Cardinal Health Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 383 +49 931 49 72 - 62383 Thomas. Rust(@cardinalhealth.com Contact person in the U.S .: (Official Correspondent) Address Thomas Gutierrez Cardinal Health 22745 Savi Ranch Parkway Yorba Linda, CA 92887 (714) - 919 - 3342 Thomas. Gutierrez@cardinalhealth.com Cardinal Health AM1+ / AM1+ BT 4 1 Page 1 of 6 {1}------------------------------------------------ ### 5.3 Establishment Registration Number 9615102 ### Common Name or Classification Name 5.4 Diagnostic Spirometer (CFR 868.1840, Product Code BZG) ### 5,5 Trade Name Asthma Monitor AM1+ Asthma Monitor AM1+ BT ### ર.6 Device Classification This is a Class II device ### 5.7 Classification Panel 73 Anesthesiology Part 868 Code BZG ### Reason for Premarket Notification 5.8 Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm" ### Legally predicate marketed device 5.9 Asthma Monitor AM2 Code BZG K980676 #### Predicate Device Company 5.10 Cardinal Health Germany 234 GmbH #### 5.11 Device Description The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics: - Handheld device . - Battery operation . - Storing capacity of 400 measurements / 2000 entries . - Measurement Parameters: PEF and FEV1 . - Accuracy Flow: ± 5% or ± 20 l/min . - Accuracy Volume: ± 3% or ± 0.05 liter . - Data transmission to computer via Bluetooth and Serial (AM1+ BT) . - Data transmission to computer via Serial (AM1+) . - Flow sensor (single patient use) . - Mouthpiece (single patient use) . Cardinal Health ### - BT 42 Page 2 of 6 {2}------------------------------------------------ ## 5.12 Intended Use Statement The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission. ## 5.13 Reguired Components Asthma Monitor AM1+ / AM1+ BT Accessories User Manual Cardinal Health 43 Page 3 of 6 {3}------------------------------------------------ . : . : - : # 5.14 Summary Table of Comparison | | Asthma Monitor AM2 (K980876) | Asthma Monitor AM1+ / AM1+ BT | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Asthma Monitor AM2 from JAEGER is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM2 measures the flow during expiration serving for the calculation of further parameters as FEV1, FVC or FEF25-75. The AM2 is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEVI). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status .When enabled, the AM2 can be programmed with up to 12 questions, where the patient can select then from up to 7 different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM2 is designed to replace ordinary peak flow meter, diary and pencil by a single System. Easy handling, sturdy and handy design allow the Asthma Monitor AM2 being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. | The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission. | | Patient population | The Asthma Monitor can be used for patients from 4 years on and older. | Identical | | Dimensions (housing) | Length x Width x Height: 112*82*34 mm Weight: 145 g (batteries included) | Identical | | Display | LCD module Size: 46,0 x 18,4 mm 100 x 32 dots | identical | | Key-panel | Foil Key-panel (4 keys): - ESC (on/off) - UP-ARROW - DOWN-ARROW - OK | identical | | Housing | Material: Rotec ABS 1001FR VD | identical | | Integrated mouthpiece (Flow sensor) | Material: Rotec ABS 1001FR VO | Material: Polystyrol 454C | | Single Use mouthpiece (optional) | Material: Bormed RG835 MO | identical | | Performance (measurements) | Parameters: PEF / FEV1 / FVC / FEF25 / FEF50 FEF75 / FEF25-75 | Parameters: PEF / FEV1 | | Interface | Serial RS 232 | Serial RS 232 & Bluetooth | | Energy type | 3 x 1,5 (Micro AAA) | identical | | Operating Require- ments | PC software AMOS | Identical | . Cardinal Health . AM1+ / AM1+ BT . Page 4 of 6 . . . - {4}------------------------------------------------ ## 5 510(k) Summary 1 : 2 : 2 : : () . : . . - : Cardinal Health AM1+ / AM1+ BT : Page 5 of 6 {5}------------------------------------------------ ## 5.15 Summary of Device Testing The following practices were followed and monitored for development of the Asthma Monitor AM1+ with the Bluetooth data transmission: The Bluetooth data transmission for the above device 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 Asthma Monitor AM1+ / AM1+ BT with the additional Bluetooth data transmission was a Failure Modes and Effects Analysis (FMEA). Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. The EMC testing was performed according EN 60601-1-2. #### 5.16 Conclusions Based on the above, Cardinal Health Germany 234 GmbH concludes that the Asthma Monitor AM1+ / AM1+ BT is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices. # Cardinal Health . 46 Page 6 of 6 Page 6 of 6 Page 6 of 6 {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Cardinal Health Germany 234 GmbH C/O Mr. Thomas Gutierrez Director Regulatory Affairs Cardinal Health 207 Incorporated Regulatory Affairs, 1100 Bird Center Drive Palm Springs, California 92262 Re: K090486 Trade/Device Name: Asthma Monitor AM1+ Asthma Monitor AM1+B1 Regulation Number: 868,1840 Regulatory Class: II Product Code: BZG Dated: April 2, 2009 Received: April 6, 2009 Dear Mr. Gutierrez: 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 dcvice, 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. 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 {7}------------------------------------------------ ## Page 2- Mr. Gutierrez (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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. 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 Renner Susan Runner, D.D.S., M. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K090486 Device Name: Asthma Monitor AM1+ Asthma Monitor AM1+ BT Indications for Use: The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduciblity montal the long tenction (decemination of the AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. Serving for the Galcallon of farmer parame constitution of human beings in the areas assimma, The AM1+ / AM1+ BT is used to monitor the respiratory status of high stiring kri chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameties (e.g. PEF, FEN1). The patient is themica of the results by hall as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. the medion saves the results of a measurement (always with date and time) automatically in an i ne uevice saves the results of a measuromic (and on to 400 measurements. In addition, a interial catabase. The momery capacity to be of a software package (AMOS) to record systems questionally of Life" status. When enabled, the AM1+ BT can be programmed with a couple of the "Quality of the "battle" which shart can a couple of different in the standord IS. which the standard DC vising the quostons, whole the patiently be and can be transmitted for evaluation to a standard PC using the software package AMOS. Sultware package AMOO. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter diary AM1 / AM1+ BT being t ric XMT+ 7 threadling, sturdy and handy design allow the Asthma Monton AM1+ / AM1+ BT being uyerent. Eddy manaling, est work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission. Prescription Use X (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) Susan Pena (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 40 510(k) Number: K040416

ASTHMA MONITOR MODEL, AM1

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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ASTHMA MONITOR MODEL, AM1

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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