(31 days)
Not Found
No
The summary describes a system for recording and monitoring MDI usage, focusing on data logging, transmission, and review. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is intended to record, store, and transmit usage events of an MDI, and to allow users to review this information, but it is explicitly stated that it is "not intended to diagnose or replace a diagnosis provided by a licensed physician" and "not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI." These statements indicate it does not provide direct therapy, diagnosis, or management of a condition.
No
The Intended Use / Indications for Use section explicitly states: "The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician."
No
The device description explicitly states "Electronic MDI Accessory" and the intended use mentions the "Asthmapolis Sensor which is an electronic accessory device". This indicates the system includes hardware components in addition to the software.
Based on the provided information, the Asthmapolis System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for recording and monitoring MDI usage, reviewing collected information, and sharing it with a physician. It explicitly states that the output is not intended to diagnose or replace a diagnosis. IVDs are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an "Electronic MDI Accessory," which is a device used in conjunction with a medication delivery system, not for analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The Asthmapolis System appears to be a medical device that falls under a different regulatory category, likely related to patient monitoring or medication adherence.
N/A
Intended Use / Indications for Use
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.
The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed.
The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.
The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Product codes
CAF
Device Description
Electronic MDI Accessory
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
Not Found
Intended User / Care Setting
physicians and patients
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)
Non-clinical testing has been carried out to cover functional verification and device performance. This included completion of software verification and validation procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the Asthmapolis System according to the requirements.
The Asthmapolis Sensor has successfully completed patient safety testing according to IEC 60601-1.
The Asthmapolis Sensor has successfully completed EMC testing according to IEC 60601-1-2.
The Asthmapolis System has successfully completed performance testing according to applicable standards and internal testing. Important to highlight in this summary, is the successful performance testing that was completed for wireless/Bluetooth technology in accordance with specifications and also with, "FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices". In addition, tests required for FCC licensing were successful.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
. JUL = =2 *2012
510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System
121609 510(k) Summary
| Submission Date: | March 8, 2012 | |
|---|---|---|
| Submitter: | Reciprocal Labs Corporation | |
| 612 W. Main Street, Ste. 201 | ||
| Madison, WI 53703 | ||
| Submitter and | ||
| Official Contact: | Ms. Inger L. Couture | |
| Chief Regulatory Officer | ||
| Reciprocal Labs | ||
| 612 W. Main Street, Ste. 201 | ||
| Madison, WI 53703 | ||
| +1 (608) 251-0470 | ||
| +1 (608) 338-0883 (fax) | ||
| Inger.Couture@asthmapolis.com | ||
| Manufacturing Site: | Reciprocal Labs Corporation | |
| 612 W. Main Street, Ste. 201 | ||
| Madison, WI 53703 | ||
| Trade Name: | Asthmapolis System | |
| Common Name: | Nebulizer | |
| Classification | ||
| Name: | NEBULIZER (DIRECT PATIENT INTERFACE) | |
| Classification | ||
| Regulation: | 21 CFR §868.5630 | |
| Product Code: | CAF | |
| Device Description: | Electronic MDI Accessory | |
| Substantially | ||
| Equivalent Devices: | SmartTrack System | K091803 |
1
510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System
Intended Use:
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.
The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed.
The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.
The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Technological characteristics of the Asthmapolis System and the SmartTrack System are largely equivalent. Similarities include the indications for use, basic principle of operation, data collection information, time of data recording via internal clock, utilization of software for varving types of data review and modification, dose counting characteristics and internal power source type.
The Asthmapolis System employs these technological characteristics in a similar way as the predicate device. Differences include the method used to detect sensor actuation, and the method used to send the usage data from the sensor to the database. These aspects of the device have been verified and validated in order to establish equivalent performance to the equivalent device. This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness.
Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device.
Technology Comparison:
2
510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System
| Performance
Testing Summary: | Non-clinical testing has been carried out to cover functional verification
and device performance. This included completion of software
verification and validation procedures, with performance testing of the
MDI actuation sensor system to ensure data is logged accurately for
MDI usage. This established correct functionality of the Asthmapolis
System according to the requirements. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software: | Software and Firmware for the Asthmapolis System was designed and
developed according to a robust software development process
aligned with "Design Control Guidance for Medical Device
Manufacturers", "The Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices", "Guidance
for Off the Shelf Software Use in Medical Devices", and verified and
validated using guidance from the "General Principles of Software
Validation" as recommended by FDA.
Test results indicate that the Asthmapolis System complies with its
predetermined specifications. |
| Electrical Safety: | The Asthmapolis Sensor has successfully completed patient safety
testing according to IEC 60601-1. |
| Electromagnetic
Compatibility
Testing: | The Asthmapolis Sensor has successfully completed EMC testing
according to IEC 60601-1-2. |
| Performance
Testing - Bench: | The Asthmapolis System has successfully completed performance
testing according to applicable standards and internal testing.
Important to highlight in this summary, is the successful performance
testing that was completed for wireless/Bluetooth technology in
accordance with specifications and also with, "FDA's Guidance on
Radio-Frequency Wireless Technology in Medical Devices". In
addition, tests required for FCC licensing were successful. |
3
510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System
Conclusion:
Hardware testing carried out for the Asthmapolis System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Asthmapolis System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and wireless technology in medical devices.
This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness.
Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
2 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Reciprocal Laboratories Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K121609
Trade/Device Name: Asthmapolis System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 18, 2012 Received: June 19, 2012
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Eederal Register.
•
નીમ
5
Page 2- Mr. Job
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 (OS) 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/ucml 15809.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 vours.
Rh fo.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known): K121609
Device Name: Asthmapolis System
Indications for use:
The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.
The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.
The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed.
The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.
The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
Prescription X AND/OR Use
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510/k) Numb
L. Schultheis
sion of Anesthesiology, General Hospital
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