Galapogos

K200565 · Resmed Corp · BZD · Jan 17, 2021 · Anesthesiology

Device Facts

• Record ID: K200565
• Device Name: Galapogos
• Applicant: Resmed Corp
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Galapagos app is intended for patients who are prescribed a compatible ResMed S10 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.

Device Story

Galapagos is a mobile application interface for patients using compatible ResMed S10 platform devices. It functions as an optional software accessory to help patients acclimate to therapy by simulating pressure and mask fit using pre-determined, scaled inspiratory pressures. The app connects to the flow generator via Bluetooth to control therapy settings and acts as a communication pathway to the Machine Cloud Service (MCS) of AirView for data exchange. It is used in home or hospital settings by the patient. The output is displayed on the smartphone screen, allowing the patient to experience therapy settings before starting their actual prescribed treatment. It does not alter prescribed treatment settings or display usage/therapeutic values.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical verification and validation testing, including software V&V and predicate testing.

Technological Characteristics

Mobile software application; operates on smartphone; connects to compatible ResMed S10 flow generator via Bluetooth; utilizes HTTPS proxy for data transmission to Machine Cloud Service (MCS); software level of concern is Moderate.

Indications for Use

Indicated for patients prescribed a compatible ResMed S10 platform device to simulate therapy and acclimate to the device prior to using prescribed settings.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Monte Carlo (K160836)

Reference Devices

• AirView (K151901)

Submission Summary (Full Text)

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January 17, 2021

ResMed Corp Rose Malonzo Regulatory Affairs Specialist 9001 Spectrum Center Blyd San Diego, California 92123

Re: K200565

Trade/Device Name: Galapogos Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 18, 2020 Received: December 18, 2020

Dear Rose Malonzo:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200565

Device Name Galapagos

Indications for Use (Describe)

The Galapagos app is intended for patients who are prescribed a compatible ResMed S10 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Galapagos
Traditional 510(k)
Traditional 510(k)
K200565

510(k) SUMMARY
[As required by 21 CFR 807.92(c)]

| Date of Submission: | 13 January 2021 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name/Owner: | ResMed Corp<br>9001 Spectrum Center Blvd<br>San Diego, CA 92123<br>USA |
| Official Contact: | Rose Malonzo<br>Specialist, Regulatory Affairs<br>Tel: [phone]<br>[e-mail] |
| Device Trade Name: | Galapagos |
| Device Common Name: | Ventilator, Non-Continuous (Respirator) |
| Classification and<br>Classification Name: | II<br>Noncontinuous ventilator (IPPB) (21 CFR 868.5905) |
| Product Code: | 73 BZD |
| Predicate Device: | Monte Carlo (mobile application in the Menai System)<br>K160836 |
| Device Description: | Galapagos is a mobile interface where the patient can control the<br>device through pre-determined, scaled inspiratory pressures to help<br>them adjust to pressure and mask fit prior to starting their<br>prescribed therapy. |
| | In addition, Galapagos may also be used as a communication<br>pathway using the mobile Bluetooth connection to the compatible<br>flow generator in order to send and receive data. |
| Indications For Use: | The Galapagos app is intended for patients who are prescribed a<br>compatible ResMed S10 platform device to simulate therapy prior to<br>using their device with their prescribed settings. It is an optional<br>software accessory to allow patients to acclimate to their therapy<br>device. |

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Image /page/4/Picture/0 description: The image shows the logo for ResMed. The logo consists of a series of colored dots arranged in a curved line, transitioning from blue to red. Below the dots is the word "ResMed" in a bold, sans-serif font. The dots are arranged in a wave-like pattern, with the blue dots on the left and the red dots on the right.

### Non-clinical testing

Non-clinical verification and validation testing completed for Galapagos demonstrated that the device met all intended performance requirements. Testing included:

- Software verification and validation
- Predicate testing .

The non-clinical performance bench tests performed with Galapagos include testing against the nonfunctional requirements and end-to-end functional testing. The predicate testing conducted with Galapagos to the predicate Monte Carlo device (K160836) demonstrate substantial equivalence to the technology and operating principle of the devices.

### Clinical testing

Clinical tests were not required to demonstrate the safety and effectiveness of Galapagos.

### Substantial Equivalence

The subject and predicate device have similar intended use, technology, and operating principle.

The differences between the subject Galapagos device and the previously cleared predicate Monte Carlo app (K160836) are:

- Galapagos can deliver temporary pre-determined therapy settings, whereas Monte Carlo ● delivers the patient's prescribed therapy settings.
- . Galapagos is an optional accessory intended for use by patients to control the compatible flow generator (pre-determined therapy settings), whereas Monte Carlo is a required component of the flow generator device intended as the patient's user interface to control the device, as well as for clinicians to remotely configure the device (i.e., change prescribed therapy settings).
- Via the mobile bluetooth connection and HTTP proxy function, Galapagos is an additional . communication pathway to Machine Cloud Service (MCS) of AirView (K151901) to the compatible flow generator in order to send and receive data, similarly to the CAM (cellular) module within the compatible ResMed S10 device. This is considered a non-medical device MDDS function.

| Characteristic | Predicate device:<br>Monte Carlo | Subject Device:<br>Galapagos | Substantial Equivalence |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer:<br>ResMed Ltd | Manufacturer:<br>ResMed Corp | |
| | 510(k) Number:<br>K160836 | 510(k) Number:<br>K200565 | |
| Indications for<br>Use | Monte Carlo is a mobile<br>application for patients to<br>remotely operate a prescribed<br>compatible ResMed machine<br>and transfer, analyze and<br>display usage and therapeutic<br>information. Monte Carlo also<br>allows healthcare<br>professionals to remotely<br>configure compatible OSA<br>therapy devices. | The Galapagos app is<br>intended for patients<br>who are prescribed a<br>compatible ResMed<br>S10 platform device to<br>simulate therapy prior to<br>using their device with<br>their prescribed<br>settings. It is an optional<br>software accessory to<br>allow patients to<br>acclimate to their<br>therapy device. | Difference in the indications for<br>use does not impact the safety or<br>efficacy of the subject device<br>since the subject device<br>functionality is a limited subset of<br>the predicate. |
| Characteristic | Predicate device:<br>Monte Carlo | Subject Device:<br>Galapagos | Substantial Equivalence |
| | Manufacturer:<br>ResMed Ltd | Manufacturer:<br>ResMed Corp | |
| | 510(k) Number:<br>K160836 | 510(k) Number:<br>K200565 | |
| Regulation<br>Number | 21 CFR §868.5905 | 21 CFR §868.5905 | Yes. Identical. |
| Classification<br>Name | Noncontinuous ventilator (IPPB) | Noncontinuous<br>ventilator (IPPB) | Yes. Identical. |
| FDA Product<br>Code | 73 BZD | 73 BZD | Yes. Identical. |
| Prescription Use | Yes | Yes | Yes. Identical. |
| Intended<br>Environment of<br>Use | Hospital/home | Hospital/Home | Yes. Identical. |
| Patient<br>Contacting | No, Monte Carlo is software. | No, Galapagos is<br>software. | Yes. Identical. |
| Display Type | Smartphone display | Smartphone display | Yes. Identical. |
| Therapy Device<br>Connection<br>Requirement | Yes. Monte Carlo app must be<br>connected to a compatible<br>therapy device for usage. | Yes. Galapagos app<br>must be connected to a<br>compatible therapy<br>device for usage. | Yes. Identical. |
| Mask Information<br>Requirement | Yes. Monte Carlo app requires<br>patient to provide mask type<br>for usage. | Yes. Galapagos app<br>requires patient to<br>provide mask type for<br>usage. | Yes. Identical. |
| Performance Testing - Patient Use | | | |
| Displays<br>Usage and<br>Therapeutic<br>Values | Yes. | No. | Difference in limited functionality<br>of the subject device does not<br>impact the safety or efficacy of the<br>Galapagos app.<br>The Galapagos app is not<br>intended to alter treatment<br>settings. |
| Treatment<br>Settings | Ramp time, EPR On/Off | Not available | |
| Performance<br>Testing - Clinical<br>Use | Same as Patient Use features. | Clinician access not<br>available for Galapagos. | Difference in limited functionality<br>of the subject device does not<br>impact the safety or efficacy of the<br>Galapagos app. |
| Device Control | Yes. Monte Carlo can control<br>the connected therapy device. | Yes. Galapagos can<br>control the connected<br>therapy device. | Yes. Galapagos has limited<br>device control capabilities as it<br>delivers temporary pre-determined<br>therapy settings, whereas Monte<br>Carlo delivers the patient's<br>prescribed therapy settings. |
| Communication<br>Pathways | Bluetooth and HTTPS<br>(cellular or wireless internet<br>connection) | Bluetooth and HTTPS<br>(cellular or wireless<br>connection) | Yes. Identical. |
| Characteristic | Predicate device:<br>Monte Carlo<br>Manufacturer:<br>ResMed Ltd<br>510(k) Number:<br>K160836 | Subject Device:<br>Galapagos<br>Manufacturer:<br>ResMed Corp<br>510(k) Number:<br>K200565 | Substantial Equivalence |
| Device data to<br>app<br>communication<br>pathway | Device data transfers directly<br>to Monte Carlo app. | Device data transfers to<br>Machine Cloud Service<br>(MCS) via Galapagos. | Inclusion of MCS in the data<br>pathway does not impact the<br>safety or efficacy of the subject<br>device. |
| App Download<br>Availability | Apple App Store | Google Play Store | Difference in mobile app store<br>availability does not impact the<br>safety or efficacy of Galapagos. |
| Therapy Settings<br>Changes | Yes | No | Difference in limited functionality<br>of the subject device does not<br>impact the safety or efficacy of the<br>Galapagos app.<br>The Galapagos app is not<br>intended to alter treatment<br>settings. |
| Adjust Comfort<br>Settings | Yes | No | Difference in limited functionality<br>of the subject device does not<br>impact the safety or efficacy of the<br>Galapagos app.<br>The Galapagos app is not<br>intended to alter treatment<br>settings. |
| Level of Concern | Moderate | Moderate | Yes. Identical. |

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Image /page/5/Picture/0 description: The image shows the logo for ResMed. The logo consists of the word "ResMed" in a bold, sans-serif font. Above the word is a curved line made up of a series of dots that transition in color from blue to red. The dots are arranged in a wave-like pattern.

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Image /page/6/Picture/0 description: The image contains the logo for ResMed. The logo consists of a curved line made up of a series of colored dots, transitioning from blue to red. Below the line of dots is the word "ResMed" in a bold, sans-serif font.

Galapagos Traditional 510(k) K200565

# Substantial Equivalence Conclusion

Galapagos has a similar intended use, technology, and operating principle as the predicate device. The differences in the intended use and technology between the subject and predicate devices do not impact or raise new questions of safety or efficacy. The non-clinical performance data provided in this submission supports the determination that Galapagos is substantially equivalent to the predicate Monte Carlo device (K160836).