(70 days)
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.
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) .
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document, K090486, focuses on demonstrating substantial equivalence to a predicate device (Asthma Monitor AM2, K980676) rather than presenting specific acceptance criteria and performance data for the Asthma Monitor AM1+ / AM1+ BT. The summary highlights that the new device performs "at least as well as the predicate devices" based on the tests conducted.
However, based on the "Device Description" on page 2, the following performance specifications for the PM1+/PM1+ BT are stated, which implicitly serve as acceptance criteria that the device must meet:
| Acceptance Criteria (from Device Description) | Reported Device Performance (from Device Description) |
|---|---|
| Accuracy Flow: ± 5% or ± 20 l/min | ± 5% or ± 20 l/min |
| Accuracy Volume: ± 3% or ± 0.05 liter | ± 3% or ± 0.05 liter |
| Storing capacity of measurements | 400 measurements / 2000 entries |
| Measurement Parameters | PEF and FEV1 |
The document does not elaborate on how these specific accuracy criteria were assessed or explicitly state "reported performance" as a distinct section for these values in reference to a specific study. Instead, the "Summary of Device Testing" section broadly states that "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards," implying these performance characteristics were verified.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective) for performance evaluation. The testing described is primarily focused on design control and safety, not a clinical performance study with a defined test set of patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This type of device (diagnostic spirometer) typically relies on objective physical measurements rather than expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there is no described test set involving human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The device is a diagnostic spirometer for objective measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation in an MRMC setting.
6. Standalone Performance Study:
A standalone performance study for the algorithm (the underlying measurement and calculation engine) is implicitly indicated by the stated "Accuracy Flow" and "Accuracy Volume" specifications. These are inherent performance characteristics of the device's measurement capabilities. However, specific details of such a study (e.g., methodology, sample size, conditions) are not provided in the summary. The document mentions "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards," which can be interpreted as part of standalone testing.
7. Type of Ground Truth Used:
The ground truth for the performance of a diagnostic spirometer like the Asthma Monitor AM1+ / AM1+ BT would typically be established through reference standards or highly accurate laboratory calibration equipment for flow and volume measurements, rather than expert consensus, pathology, or outcomes data, which are relevant to image-based diagnostics or clinical efficacy. The document does not explicitly state the ground truth method, but this is the standard for such devices.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. This device is a measurement device with a specific algorithm for calculating parameters like PEF and FEV1, not a machine learning or AI device that typically involves a "training set."
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the method for establishing its ground truth is not applicable or described.
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5 510(k) Summary
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:
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
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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) .
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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
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5.14 Summary Table of Comparison
| Asthma Monitor AM2(K980876) | Asthma Monitor AM1+/ AM1+ BT | |
|---|---|---|
| Indicationsfor Use | The Asthma Monitor AM2 from JAEGER isan electronic measurement device tomonitor the lung function (determination ofthe respiratory flows and volume) with highreproducibility wherever andwhenever is a need of. The AM2measures the flow during expirationserving for the calculation of furtherparameters as FEV1, FVC or FEF25-75.The AM2 is used to monitor the respiratorystatus of human beings in the areasasthma, chronic obstructive pulmonarydisorder and in areas like occupationalmedicine, clinical trials and diseasemanagement.The patient is informed of the results bynumeric values for selected parameters(e.g. PEF, FEVI).Furthermore a visual control unit,displayed as a kind of traffic lights, allowsan immediate indication of themeasurement based on criteria defined bythe patient's physician.The device saves the results of ameasurement (always with date and time)automatically in an internal database. Thememory capacity is designed to store upto 400 measurements. In addition, aquestionnaire functionality can be calledup by the use of a software package(AMOS) to record e.g. the "Quality of Life"status .When enabled, the AM2 can beprogrammed with up to 12 questions,where the patientcan select then from up to 7 differentanswers. This information is also stored inthe internal databaseand can be transmitted for evaluation to astandard PC using the software packageAMOS.The AM2 is designed to replace ordinarypeak flow meter, diary and pencil by asingle System. Easy handling, sturdy andhandy design allow the Asthma MonitorAM2 being used almost everywhere: atwork, at home, in school, for expertsopinion, research or clinical trial purposesand in occupational medicine. | The Asthma Monitor AM1+ / AM1+ BTfrom Cardinal Health is an electronicmeasurement device to monitor the lungfunction (determination of the respiratoryflows and volume) with high reproducibilitywherever and whenever is a need of. TheAM1+ / AM1+ BT measures the flowduring expiration serving for thecalculation of further parameters as FEV1.The AM1+ / AM1+ BT is used to monitorthe respiratory status of human beings inthe areas asthma, chronic obstructivepulmonary disorder and in areas likeoccupational medicine, clinical trials anddisease management.The patient is informed of the results bynumeric values for selected parameters(e.g. PEF, FEV1). Furthermore a visualcontrol unit, displayed as a kind of trafficlights, allows an immediate indication ofthe measurement based on criteriadefined by the patient's physician.The device saves the results of ameasurement (always with date and time)automatically in an internal database. Thememory capacity is designed to store upto 400 measurements. In addition, aquestionnaire functionality can be calledup 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 ofquestions, where the patient can selectthen from a couple of different answers.This information is also stored in theinternal database and can be transmittedfor evaluation to a standard PC using thesoftware package AMOS.The AM1+ / AM1+ BT is designed toreplace ordinary peak flow meter, diaryand pencil by a single system. Easyhandling, sturdy and handy design allowthe Asthma Monitor AM1+ / AM1+ BTbeing used almost everywhere: at work, athome, in school, for experts opinion,research or clinical trial purposes and inoccupational medicine.The AM1+ operates with serial datatransmission whereas the AM1+ BT canbe operated with serial and Bluetooth datatransmission. |
| Patientpopulation | The Asthma Monitor can be used forpatients from 4 years on and older. | Identical |
| Dimensions(housing) | Length x Width x Height:1128234 mmWeight:145 g (batteries included) | Identical |
| Display | LCD moduleSize: 46,0 x 18,4 mm100 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 |
| Integratedmouthpiece(Flow sensor) | Material:Rotec ABS 1001FR VO | Material:Polystyrol 454C |
| Single Usemouthpiece(optional) | Material:Bormed RG835 MO | identical |
| Performance(measurements) | Parameters:PEF / FEV1 / FVC / FEF25 / FEF50FEF75 / FEF25-75 | Parameters:PEF / FEV1 |
| Interface | Serial RS 232 | Serial RS 232 & Bluetooth |
| Energy type | 3 x 1,5 (Micro AAA) | identical |
| OperatingRequire-ments | PC software AMOS | Identical |
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5 510(k) Summary
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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.
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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
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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
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Indications for Use
510(k) Number (if known):
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
§ 868.1840 Diagnostic spirometer.
(a)
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.(b)
Classification. Class II (performance standards).