Who is the manufacturer of ASTHMA MONITOR AM3?

Carefusion Germany 234 GmbH filed the 510(k) submission for ASTHMA MONITOR AM3 (K092890).

What is the FDA product code for ASTHMA MONITOR AM3?

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 AM3?

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

What are the predicate devices for ASTHMA MONITOR AM3?

Asthma Monitor AM3 (K980876/A2); Asthma Monitor AM1+ / AM1+ BT (K090486).

Who can help prepare an FDA 510(k) submission like ASTHMA MONITOR AM3?

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 AM3

K092890 · Carefusion Germany 234 GmbH · BZG · Jan 13, 2010 · Anesthesiology

Device Facts

Record ID	K092890
Device Name	ASTHMA MONITOR AM3
Applicant	Carefusion Germany 234 GmbH
Product Code	BZG · Anesthesiology
Decision Date	Jan 13, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 868.1840
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduction wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmoner the respiration y status of numal beings in the areas astimal 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 600 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 AM3 / AM3 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 AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine.

Device Story

Handheld electronic spirometer; measures expiratory flow to calculate PEF and FEV1; stores up to 600 measurements and patient questionnaires. Used by patients in home, school, or clinical settings to monitor respiratory status; provides immediate feedback via traffic-light visual display based on physician-defined criteria. Data transmitted to PC via USB, serial, or Bluetooth for evaluation using AMOS software. Replaces manual peak flow meters and paper diaries; facilitates disease management and clinical research.

Clinical Evidence

Bench testing only. Safety and performance verified through FMEA, EMC testing (EN 60601-1-2), and software development per IEC 601-1-4.

Technological Characteristics

Handheld diagnostic spirometer; battery-operated (3x AAA). Materials: Polysterol 454C (housing), Bormed RG835 MO (mouthpiece). Connectivity: USB, Serial, Bluetooth (WML-C46 module, 2.4GHz FHSS). Display: LCD (255x160 dots). Software developed per IEC 601-1-4.

Indications for Use

Indicated for patients 4 years and older to monitor lung function (PEF, FEV1) and respiratory status 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 AM3 (K980876/A2)
Asthma Monitor AM1+ / AM1+ BT (K090486)

Related Devices

K090486 — ASTHMA MONITOR MODEL, AM1 · Cardinal Health Germany 234 GmbH · May 6, 2009
K980876 — ASTHMA MONITOR AM2 · Erich Jaeger GmbH & Co. KG · Aug 14, 1998
K183479 — Asthma Monitor AM3 · Eresearch Technology · Oct 3, 2019
K133722 — ASTHMA MONITOR AM3 · Eresearch Technology · May 8, 2014
K170281 — MSA100BT Peak Flow Meter · Beijing M&B Electronic Instruments Co., Ltd. · Oct 6, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ K0928&J # 510(k) Summary JAN 1 3 2010 ## GENERAL INFORMATION ### 5.1 Type of Submission Special 510(k) Submission Submission date: 09/03/2009 #### 5.2 Submitter Name: CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH) Address: Phone: FAX: E-mail E-mail Leibnizstrasse 7 D-97204 Hoechberg Germany ## Contact person in Germany: Address: Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany +49 931 49 72 - 361 +49 931 49 72 - 62361 Elmar. Niedermeyer@carefusion.com Contact person in the U.S .: (Official Correspondent) Thomas Gutierrez Address Phone/Fax: CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 Thomas. Gutierrez@carefusion.com . - {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 AM3 / AM3 BT - 5.6 Device Classification This is a Class II device #### 5.7 Classification Panel 73 Anesthesiology Part 868 Code BZG #### 5.8 Reason for Premarket Notification Device modification to an existing Cardinal Health - device regarding "The New 510(k) Paradigm" -- Additional data transfer to computer by blue tooth -- ### 5.9 Legally predicate marketed device Asthma Monitor AM3 K980676/A2 Code BZG Asthma Monitor AM1+ / AM1+ BT K090486 Code BZG ### Predicate Device Company 5.10 CareFusion Germany 234 GmbH (formerly: Cardinal Health Germany 234 GmbH) #### Device Description 5.11 The Asthma Monitor AM3 is a medical device (peak flow meter with symptom diary) providing following characteristics: - . Handheld device - Battery operation ● - Storing capacity of 400 measurements . - Storing capacity of 200 sets of questionnaires (each 12) o - Measurement Parameters: PEF and FEV1 ● - Accuracy Flow: ± 5% or ± 20 l/min ● - Accuracy Volume: ± 3% or ± 0.05 liter ● - Data transmission to computer via USB, Bluetooth and Serial . - Flow sensor (single patient use) - Mouthpiece (single patient use) . {2}------------------------------------------------ #### 5.12 Intended Use Statement The Asthma Monitor AM3 / AM3 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 AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM3 / AM3 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 AM3 / AM3 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 AM3 / AM3 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 AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. ### · 5.13 · Required Components AM3 / AM3 BT measurement device Accessories User Manual {3}------------------------------------------------ ## 5.14 Summary Table of Comparison ## a) Comparison with Asthma Monitor AM3 with 510(k) K980876/A2 | | Asthma Monitor AM3 (K980876/A2) | Asthma Monitor AM3 with Bluetooth | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Indications for Use | The Asthma Monitor AM 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 AM measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM 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 AM 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 AM 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 AM being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and | identical | | 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*37 mm Weight: 167 g (batteries included) | identical | | Display | LCD module Size: 54,0 x 33,5 mm 255 x 160 dots | identical | | Key-panel | Foil Key-panel (4 keys): - ESC (on/off) - UP-ARROW - DOWN-ARROW - OK | identical | | Integrated mouthpiece (material) | Polysterol 454C | identical | | Single Use mouthpiece (material) | Bormed RG835 MO | identical | | Performance (measurements) | Parameters: PEF FEV1 | identical | | Interface | Serial RS 232 & USB | Serial RS 232 & USB & Blue- tooth | | Energy type | 3 x 1,5 (Micro AAA) | identical | | Operating Require- ments | PC software AMOS | identical | | | Asthma Monitor AM1+ / AM1+ BT K090486 | Asthma Monitor AM3 with Bluetooth | | Bluetooth interface | WML-C46 (Manufactured by Mitsumi Electric Co. LTD) | Identical | | Bluetooth Power Supply | 3.3 Vdc | Identical | | Bluetooth Transmit Power | 2.65 dBm E.I.R.P. | Identical | | Bluetooth Frequency Range | 2.402GHz - 2.480GHz | Identical | | Bluetooth Modulation Technique | Frequency Hopping Spread Spectrum (FHSS) (GFSK) | Identical | | Bluetooth Number of Channels | 79 | Identical | | Bluetooth Dwell Time | <= 0.4s | Identical | | Bluetooth Operating Mode | Point-to-Point | Identical | | Bluetooth Data Rate | 741 Kps (Highest Mode) | Identical | | Bluetooth Antenna Type | Chip Antenna | Identical | | Bluetooth Antenna Gain | 2.0 dBi | Identical | {4}------------------------------------------------ : تر . 、" CareFusion Germany 234 GmbH АМЗ / АМЗ ВТ 1 {5}------------------------------------------------ ## Discussion to the table above: The insignificant difference to the AM3 K980876/A2 is: - Bluetooth is used for data transfer to the computer as an additional . possibility besides the serial and USB interface communication. b) Comparison with Asthma Monitor AM1+ / AM1+ BT with 510(k) K090486 {6}------------------------------------------------ ## Discussion to the table above: The similarity to the AM1+ / AM1+ BT is found as: - Bluetooth is used for data transfer. The Bluetooth module for the AM3 . device is identical to the Bluetooth module in the AM1+ / AM1+ BT. Both devices work with the Bluetooth module WML-C46 manufactured by Mitsume Electric Co. LTD. As a consequence of this all Bluetooth - 4 parameters of the AM3 BT are identical to the predicate device AM1+ BT. ### 5.15 Summary of Device Testing The following practices were followed and monitored for development of the Asthma Monitor AM3 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 09 - Design Control). - The risk analysis method used to assess the impact of Asthma Monitor . AM3 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. - The software was developed according to the IEC 601-1-4 Standard. . #### 5.16 Conclusions Based on the above, CareFusion Germany 234 GmbH concludes that the Asthma Monitor AM3 with the "Bluetooth" data transmission module 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. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a bird, possibly an eagle, with its wings spread, symbolizing protection and care. The seal is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Ms. Elmar Niedermeyer Regulatory Affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg GERMANY 97204 Re: K092890 Trade/Device Name: AM3 AM3BT Regulation Number: 21CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: December 3, 2009 Received: December 14, 2009 Dear Ms. Nidermeyer: 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. JAN 1 3 2010 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. {8}------------------------------------------------ ## Page 2- Ms. Nidermeyer 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. ph for Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K Device Name: AM3 AM3 BT Indications for Use: The Asthma Monitor AM3 / AM3 BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproduction wherever and whenever is a need of. The AM3 / AM3 BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM3 / AM3 BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmoner the respiration y status of numal beings in the areas astimal 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 600 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 AM3 / AM3 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 AM3 / AM3 BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the AM3 / AM3 BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. 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) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | 4092890 | |----------------|-----------| | | Page 1 of |