(120 days)
Not Found
No
The summary describes a mobile application for controlling and monitoring an oxygen concentrator. There is no mention of AI or ML being used for data analysis, prediction, or any other function. The application appears to be a simple interface for device control and information display.
No
The document describes the Invacare Mobile Medical Application Accessory PICCOLO O2, which is an app to control and display settings for an oxygen concentrator. It explicitly states the app is not intended to be life supporting or life sustaining, and its purpose is to control settings and collect information, not directly provide therapy. The therapeutic device is the Invacare® Platinum® Mobile Oxygen Concentrator, which is the predicate device.
No
Explanation: The device, the Invacare Mobile Medical Application Accessory PICCOLO O2, is described as displaying device settings, controlling flow settings, and collecting device performance and usage information for maintenance/servicing purposes. It does not state that it analyzes symptoms, diagnoses conditions, or monitors physiological parameters for diagnostic purposes.
No
The device description explicitly lists "POC1 USB Bluetooth Dongle" as part of the submission, indicating a hardware component is included.
Based on the provided information, neither the Invacare® Platinum® Mobile Oxygen Concentrator nor the Invacare Mobile Medical Application Accessory PICCOLO O2 are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function:
- The Invacare® Platinum® Mobile Oxygen Concentrator is a therapeutic device that provides supplemental oxygen directly to the patient. It does not analyze any bodily specimens.
- The Invacare Mobile Medical Application Accessory PICCOLO O2 is an accessory that allows the patient to monitor and control the oxygen concentrator. It also collects device performance data, not patient diagnostic data from specimens.
- Intended Use: The intended use clearly states that the oxygen concentrator provides supplemental oxygen to patients with respiratory disorders and the mobile application displays device settings and collects device performance information. Neither mentions analyzing bodily fluids or tissues for diagnostic purposes.
Therefore, these devices fall under the category of therapeutic or monitoring devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Invacare® Platinum® Mobile Oxygen Concentrator: The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.
Invacare Mobile Medical Application Accessory PICCOLO O2: The Invacare® Mobile Medical Application Accessory PICCOLO O2 is intended for use with the Invacare® Platinum Mobile Oxygen Concentrator POC 1-100C device, to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level.
- . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
- . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices
- POC1 USB Bluetooth Dongle .
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
Adult Patient Only
Intended User / Care Setting
Home, institution, vehicle, or other environments outside the home.
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)
Design verification testing was performed on the subject device met the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise any new questions of safety and effectiveness.
Software Verification Testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following: Software verification testing was conducted on the subject device as recommended by the FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 – Medical device software -- Software Life Cycle Processes. Level of Concern for the subject device is Moderate.
Electrical Safety and Electromagnetic Compatibility (EMC) testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. In summary, the applicable testing demonstrates that the subject device is equivalent in electrical and electromagnetic safety performance to the predicate device.
Wireless Coexistence testing has been conducted in line with ANSI C63.27:2017 and IEC 60601-1-2 4th Edition. The function of the product is not impacted if disruption of the dongle wireless communication occurs.
Biocompatibility testing was performed on the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator (K160630) in accordance with FDA guidance document entitle "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 29, 2019
Invacare Corporation Elijah Wreh Regulatory Affairs Manager One Invacare Way Elyria, Ohio 44035
Re: K191159
Trade/Device Name: Invacare Platinum Mobile Oxygen Concentrator with Connectivity Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: July 29, 2019 Received: July 30, 2019
Dear Elijah Wreh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Federal Register.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191159
Device Name
Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
Indications for Use (Describe) Invacare® Platinum® Mobile Oxygen Concentrator
The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.
Invacare® Mobile Medical Application Accessory Piccolo O2
The Invacare® Mobile Medical Application Accessory PICCOLO O2 is intended for use with the Invacare® Platinum Mobile Oxygen Concentrator POC 1-100C device, to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/ servicing purposes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
510(k) Summary
K191159
SUBMITTER per 21 CFR 807.92(a)(1):
Invacare Corporation One Invacare Way Elyria, OH 44035 Phone: (440) 329-6840 Email: ewreh@invacare.com
CONTACT PERSON:
Elijah Wreh Regulatory Affairs Manager
MANUFACTURER:
Invacare Corporation 2101 E Lake Mary Blvd Sanford, FL 32773
Date Prepared per 21 CFR 807.92(a)(1):
April 30, 2019
DEVICE INFORMATION per 21 CFR 807.92(a)(2)
| Name of Device: | Invacare® Platinum® Mobile Oxygen Concentrator with
Connectivity |
|-----------------------|---------------------------------------------------------------------|
| Common or Usual Name: | Generator, Oxygen, Portable |
| Regulation Name: | Portable Oxygen Generator |
| Regulation Number: | 21 CFR 868.5440 |
| Regulatory Class: | 2 |
| Product Code: | CAW |
| PREDICATE DEVICE: | Invacare® Platinum® Mobile Oxygen Concentrator (K160630) |
| Patient Population: | Adult Patient Only |
4
DEVICE DESCRIPTION per 21 CFR 808.92(a)(4)
The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level.
- . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
- . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices
- POC1 USB Bluetooth Dongle .
INTENDED USE per 21 CFR 807.92(A)(5)
Invacare® Platinum® Mobile Oxygen Concentrator
Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental
oxygen to patients with respiratory disorders. Invacare
.® Platinum® Mobile Oxygen Concentrator can be used in a home, institution, vehicle, or other environments outside the home.
The device is not intended to be life supporting or life sustaining.
Invacare Mobile Medical Application Accessory PICCOLO 02
The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.
INDICATIONS FOR USE per FORM FDA 3881
Invacare® Platinum® Mobile Oxygen Concentrator
The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home.
5
Invacare Mobile Medical Application Accessory PICCOLO 02
The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended for use with the Invacare Platinum Mobile Oxygen Concentrator POC1-100C device, to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.
COMPARISON OF INDICATIONS FOR USE (IFU)
The Indications for Use statement for the subject device is the same as the previously cleared predicate device. The additional indications for use for Piccolo O2 Mobile Medical App are to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes. The determination was made based on Section 513(i)(1)(E)(i) of the FD&C Act.
COMPARISON of TECHNOLOGICAL CHARACTERISTICS with the PREDICATE DEVICE per 21 CFR 807.92(a)(6)
The device comparison showed that the subject device is substantially equivalent in intended use, design, materials, and operational principles to the previously cleared predicate device. The difference in technology between the previously cleared device and the subject device is the addition of wireless connectivity.
BASIS of SUBSTANTIAL EQUIVALENCE per 21 CFR 807.100(b)(2)(ii)(A)
The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, and other device related features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).
The subject device components are safe and effective as the predicate device and do not raise different questions of safety and effectiveness. The difference in technological characteristics induced by the software update does not raise new questions of safety and effectiveness. The
6
design verification testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate device: The data generated from the subject device design verification test reports support a finding of substantial equivalence regarding device comparison, wireless capability and coexistence, dimensional analysis, device specifications, and design characteristics.
7
Design Characteristics Comparison
| Design and Technological Characteristics | Subject Device | Predicate Device | |
|---|---|---|---|
| Device Name | Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity | Invacare® Platinum® Mobile Oxygen Concentrator | |
| Manufacturer | Invacare Corporation | Invacare Corporation | |
| 510(k) Number | Pending | K160630 | |
| Intended Use for Invacare® Platinum® | |||
| Mobile Oxygen Concentrator | Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide | ||
| supplemental oxygen to patients with respiratory disorders. Invacare® | |||
| Platinum® Mobile Oxygen Concentrator can be used in a home, | |||
| institution, vehicle, or other environments outside the home. The device is | |||
| not intended to be life supporting or life sustaining. | The Invacare® Platinum™ Mobile Oxygen Concentrator is intended to | ||
| provide supplemental oxygen to patients with respiratory disorders. The | |||
| Invacare® Platinum™ Mobile Oxygen Concentrator can be used in a home, | |||
| institution, vehicle, or other environments outside the home. | |||
| The device is not intended to be life supporting or life sustaining. | |||
| Indications for Use for Invacare® | |||
| Platinum® Mobile Oxygen Concentrator | Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide | ||
| supplemental oxygen to patients with respiratory disorders. The device can | |||
| be used in a home, institution, vehicle, or other environments outside the | |||
| home. | The Invacare® Platinum™ Mobile Oxygen Concentrator is intended to | ||
| provide supplemental oxygen to patients with respiratory disorders. The | |||
| device can be used in a home, institution, vehicle, or other environments | |||
| outside the home. | |||
| Intended Use for Invacare Mobile | |||
| Medical Application Accessory | |||
| PICCOLO O2 | The Invacare Mobile Medical Application Accessory PICCOLO O2 is | ||
| intended to allow patients via their Android™ or iOS™ mobile phone or | |||
| tablet to display device settings, control flow setting, and to collect device | |||
| performance and usage information for maintenance/servicing purposes. | None | ||
| Indications for Use for Invacare Mobile | |||
| Medical Application Accessory | |||
| PICCOLO O2 | The Invacare Mobile Medical Application Accessory PICCOLO O2 is | ||
| intended for use with the Invacare Platinum Mobile Oxygen Concentrator | |||
| POC1-100C device, to allow patients via their Android™ or iOSTM mobile | |||
| phone or tablet to display device settings, control flow setting, and to | |||
| collect device performance and usage information for | |||
| maintenance/servicing purposes. | None | ||
| Bluetooth | Bluetooth LE only | None | |
| Operating Environment | Home, institution, vehicle, or other environments outside the home | Home, institution, vehicle, or other environments outside the home | |
| Compatible Devices | Invacare® Platinum™ Mobile Oxygen Concentrator | Not Applicable | |
| Device Settings changed by software | |||
| App | Device operating mode Device usage (Display only) Change or Control Pulse Flow settings | None | |
| Design and Technological Characteristics | Subject Device | Predicate Device | |
| Sieve Bed Material | Synthetic zeolite | Synthetic zeolite | |
| Dimensions | Height | 9.45" max | 9.45" max |
| Width | 7.5" max | 7.5" max | |
| Depth | 3.88" max | 3.88" max | |
| Weight | 4.9 lbs nominal (with standard removable battery) | ||
| 120 seconds. | Supply bolus of O2 if no inhalation detected in 15 | ||
| seconds. Unit will shut down if no breath is detected for > | |||
| 120 seconds. |
8
9
DESIGN VERIFICATION TESTING DATA
Design verification testing was performed on the subject device met the performance requirements and is substantially equivalent to the predicate device identified throughout this submission and do not raise any new questions of safety and effectiveness.
Risk Management
Risk Management has been conducted in accordance with ISO 14971:2007 - Medical Devices -Application of Risk Management to Medical Devices for the subject Invacare® Platinum® Mobile Oxygen Concentrator. The Risk Management Report provides guidance on the principal factors to consider in conducting a risk-based assessment to determine risk associated with the subject device's risk profile. The Risk Management Report involves describing the relationships between a hazard and the ultimate consequences in terms of physical injury or damage. Based on the risk-based assessment performed, the subject device's risk profile remained unchanged and there is no significant impact on the safety or effectiveness of the subject device.
Software Verification Testing
Software Verification Testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following: Software verification testing was conducted on the subject device as recommended by the FDA's guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304:2006 – Medical device software -- Software Life Cycle Processes.
Level of Concern: The Level of Concern for the subject device is Moderate.
10
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and Electromagnetic Compatibility (EMC) testing was performed to evaluate the functionality of the design, materials, and operational principles of the subject device. This includes the following:
- AAMI ES60601-1: Medical Electrical Equipment Part 1: General Requirements for . Basic Safety and Essential Performance
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Basic . Safety & Essential Performance
- ISO 80601-2-67: Medical Electrical Equipment Part 2-67: Particular Requirements ● for Basic Safety and Essential Performance of Oxygen Conserving Equipment
- ISO 80601-2-69 Medical electrical equipment Part 2: Particular Requirements for the Basic Safety and Essential Performance of Oxygen Concentrator Equipment
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for . Basic Safety and Essential performance – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-6: Medical Electrical Equipment Part 1-6 General Requirements for Safety . - Collateral Standard: Usability
- . IEC 62366: Medical Devices – Application of Usability Engineering to Medical Devices
- IEC 60601-1-8: Medical Electrical Equipment General Requirements for Basic Safety . and Essential Performance – Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems
- IEC 60601-1-11 Medical electrical equipment Part 1-11: General Requirements for . Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
In summary, the applicable testing demonstrates that the subject device is equivalent in electrical and electromagnetic safety performance to the predicate device.
Wireless Coexistence and Cybersecurity
Wireless Coexistence testing has been conducted in line with ANSI C63.27:2017 and IEC 60601-1-2 4th Edition. The function of the product is not impacted if disruption of the dongle wireless communication occurs. Cybersecurity software documentation was created for subject Invacare Mobile Medical Application Accessory PICCOLO O2 device according to FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 18, 2018.
11
Biocompatibility Testing
Biocompatibility testing was performed on the previously cleared Invacare® Platinum® Mobile
Oxygen Concentrator (K160630) in accordance with FDA guidance document entitle "Use of
International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 :
Evaluation and testing within a risk management process." The battery of testing was performed
to the following FDA recognized consensus standards:
- AAMI / ANSI / ISO 10993 1:2009/(R) 2013, Biological Evaluation of Medical Devices ● - Part 1: Evaluation and Testing within a Risk Management Process
- . AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity
- AMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: ● Tests for Skin Irritation
- AAMI / ANSI / ISO 10993-11:2006/(R)2010, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- ISO 14971:2007, Medical Devices Application of Risk Management to Medical ● Devices
- . ISO 18562-2:2017, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 2: Tests for Emissions of Particulate Matter
- . ISO 18562-3:2017, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Part 3: Tests for Emissions of Volatile Organic Compounds
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required for this submission.
CONCLUSIONS per 21 CFR 807.92(b)(3)
The subject device has the same intended use and similar technological characteristics as the predicate device. The difference in technology between the previously cleared device and the subject device is the addition of wireless connectivity.
The design verification data support the safety and performance of the subject device and demonstrate that the subject device will perform as intended in the specified use conditions. The results of the performance testing, software and cybersecurity validation, and risk analysis demonstrate that the subject device is substantially equivalent to the proposed predicate device without raising new questions of safety and effectiveness.