Otsuka Digital Feedback Device-RW

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. August 11, 2023 Otsuka America Pharmaceutical, Inc. Nancy Teague Senior Director, Global Regulatory Affairs 2440 Research Boulevard Rockville, Maryland 20850 Re: K223463 Trade/Device Name: Otsuka Digital Feedback Device-RW Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW Dated: July 10, 2023 Received: July 10, 2023 Dear Nancy Teague: 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. {1}------------------------------------------------ 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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Shruti N. Mistry -S for Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223463 Device Name Otsuka Digital Feedback Device-RW #### Indications for Use (Describe) The Otsuka Digital Feedback Device-RW consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and timestamped patient-logged events, including events signaled by the co-incidence with, or co-ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW is intended to log, track and trend intake times. When co-ingested with medication, the tracking of intake times may be used as an aid to measure medication adherence. The Otsuka Digital Feedback Device-RW may instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications. | Type of Use (Select one or both, as applicable) | | | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------| | <table border="0"><tr><td><table border="0"><tr><td><input checked="true" type="checkbox"/></td><td> For activities under 30 CFR 901 Subpart J </td></tr></table></td><td><table border="0"><tr><td><input type="checkbox"/></td><td> For Construction Activities </td></tr></table></td></tr></table> | <table border="0"><tr><td><input checked="true" type="checkbox"/></td><td> For activities under 30 CFR 901 Subpart J </td></tr></table> | <input checked="true" type="checkbox"/> | For activities under 30 CFR 901 Subpart J | <table border="0"><tr><td><input type="checkbox"/></td><td> For Construction Activities </td></tr></table> | <input type="checkbox"/> | For Construction Activities | | <table border="0"><tr><td><input checked="true" type="checkbox"/></td><td> For activities under 30 CFR 901 Subpart J </td></tr></table> | <input checked="true" type="checkbox"/> | For activities under 30 CFR 901 Subpart J | <table border="0"><tr><td><input type="checkbox"/></td><td> For Construction Activities </td></tr></table> | <input type="checkbox"/> | For Construction Activities | | | <input checked="true" type="checkbox"/> | For activities under 30 CFR 901 Subpart J | | | | | | | <input type="checkbox"/> | For Construction Activities | | | | | | |X | 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 PRAStaff@fda.hhs.gov "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 | Submitted by: | Otsuka America Pharmaceutical, Inc. | |----------------------|------------------------------------------------------------------------------------------------------| | Address: | 2440 Research Blvd.<br>Rockville, MD 20850 | | Telephone: | 410-353-8778 | | Contact Name: | Nancy F. Teague<br>Senior Director, Global Regulatory Affairs<br>nancy.teague@otsuka-us.com | | Date Submitted: | 18 Nov 2022 | | Name of Device: | Otsuka Digital Feedback Device-RW | | Tradename: | Otsuka Digital Feedback Device-RW | | Common Name: | Ingestible Event Marker with wearable patch | | Classification Name: | Ingestible Event Marker, 21 CFR 880.6305 | | Product Code: | OZW | | Predicate Device: | Proteus Digital Health Feedback Device, K150494<br>Proteus Patch, Proteus Ingestible Sensor, K133263 | {4}------------------------------------------------ #### General Device Description: The Otsuka Digital Feedback Device-RW consists of three components: a wearable sensor, an ingestible sensor accessory, and software that aggregates, processes and enables display of data collected by the sensors. The wearable sensor is a body-worn sensor (also called the patch) that collects physiological and behavioral metrics such as heart rate, activity, body angle, and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. The wearable sensor in the Otsuka Digital Feedback Device-RW is a 2-component patch known as the RW2 wearable sensor or RW2 patch. The ingestible sensor is embedded inside an inactive tablet (the pill or sensor-enabled pill) for ease of handling and swallowing. After the ingestible sensor reaches the stomach, it activates and communicates its presence with a unique identifier (ID) to the wearable sensor. When the ingestible sensor is co-ingested with medication, the Otsuka Digital Feedback Device-RW is intended to log, track and trend medicine intake times to measure medication adherence. The software on a general computing device (eg, mobile device) receives the data from the body-worn sensor or patch for further processing and analysis of the behavioral and physiological metrics. The processed data is then sent to the user interface (UI) for display as well as being saved in a local record database for storage. For purposes of this 510(k), the changes from the predicate device to the device subject of this 510(k) are the wearable sensor and the software for the UI display. The ingestible sensor remains the same from the predicate device. #### Indications for Use: The Otsuka Digital Feedback Device-RW consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending times may be used as an aid to measure medication adherence. The Otsuka Digital Feedback Device-RW may be used in any instance where {5}------------------------------------------------ quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications. | Product Name | Otsuka Digital Feedback<br>Device-RW with RW2 Patch<br>(Subject Device of this<br>510(k)) | Proteus Digital Health Feedback<br>Device with DW5 Patch | Proteus RW1 Patch<br>Including Ingestible Sensor | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K223463 | K150494 | K133263 | | Patch Detection<br>Capability | Improved algorithm from<br>DW5 patch which allows for<br>expanded wear location to<br>either side of the torso. | Algorithm allows for patch to be<br>worn on the left side of the torso | Algorithm allows for patch to<br>be worn on the left side of the<br>torso | | Materials/Layer<br>Construction | RW2 uses skin adhesive<br>MED5750A and Hydrogel<br>Axelgaard AG625. Skin<br>contacting materials pass<br>ISO 10993 testing for<br>irritation, cytotoxicity and<br>sensitization, and/or has been<br>used in another 510(k)-cleared<br>product for similar skin contact<br>use. | DW5 uses skin adhesive<br>MED5750A, Hydrogel Covidien<br>RG-63B and a hydrocolloid foam<br>top. All skin contacting materials<br>pass ISO 10993 testing for<br>irritation, cytotoxicity and<br>sensitization | RW1 uses skin adhesive<br>MED5750A and Hydrogel<br>Covidien RG-63B. All skin<br>contacting materials pass ISO<br>10993 testing for irritation,<br>cytotoxicity and sensitization | | Battery Life | 7-day battery life | 7-day battery life | 30-day battery life | | Dimension: | Thickness - 8.2 mm<br>Length - 110 mm<br>Width - 53 mm | Thickness - 6.3 mm<br>Length - 102 mm<br>Width - 60 mm | Thickness - 11 mm<br>Length - 97.5 mm<br>Width - 42 mm | | Shelf Life | 3 years | 3 years | 1 year | | Event Marker | Ingestible event marker | Ingestible event marker | Ingestible event marker | | Accelerometer | 3-axis accelerometry | 3-axis accelerometry | 3-axis accelerometry | | Hardware<br>(Ingestible<br>Sensor) | Ingestible event marker | Ingestible event marker | Ingestible event marker | | Hardware<br>(Wearable<br>Sensor) | Wearable, physiologic sensor;<br>2-component patch | Wearable, physiologic sensor;<br>1-component patch | Wearable, physiologic sensor;<br>2-component patch | | Firmware<br>(Wearable<br>Sensor) | Collects data from sensor,<br>performs data processing,<br>stores data until wireless<br>connection is available, sends<br>data to general computing<br>device | Collects data from sensor,<br>performs data processing, stores<br>data until wireless connection is<br>available, sends data to mobile<br>device | Collects data from sensor,<br>performs data processing,<br>stores data until wireless<br>connection is available, sends<br>data to mobile device | | Software | Aggregates, processes and<br>enables display of data<br>collected by sensors | Aggregates, processes and<br>displays data collected by sensors | Aggregates, processes and<br>displays data collected by<br>sensors | | Data Telemetry | Bluetooth Technology | Bluetooth Technology | Bluetooth Technology | | Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | ISO 10993 compliant | | Product Name | Otsuka Digital Feedback<br>Device-RW with RW2 Patch<br>(Subject Device of this<br>510(k)) | Proteus Digital Health Feedback<br>Device with DW5 Patch | Proteus RW1 Patch<br>Including Ingestible Sensor | | 510(k) Number | K223463 | K150494 | K133263 | | Electrical<br>Safety/EMC | IEC 60601-1/IEC 60601-1-2<br>compliant | IEC 60601-1/IEC 60601-1-2<br>compliant | IEC 60601-1/IEC 60601-1-2<br>compliant | ## Technological Characteristics: {6}------------------------------------------------ Abbreviations: EMC = electromagnetic compatibility; TBD = to be determined #### Summary of Non-Clinical Performance Data: Risk evaluations and verification and validation testing were conducted for each feature that differed from the predicate devices, Proteus Digital Health Feedback Device (K150494) and Proteus Patch, Proteus Ingestible Sensor (K133263), to the Otsuka Digital Feedback Device-RW. The results demonstrate that the acceptance criteria for firmware verification, mechanical verification, electrical verification, biocompatibility evaluation, and system verification testing were met. #### Summary of Clinical Performance Data: Clinical studies were conducted to support the expanded wear location of the patch to include the entire front abdomen. However, new clinical studies were not performed to support the changes proposed in this submission. ### Conclusion: Based on the indication for use statement, technological characteristics, risk evaluations, and device verification and validation testing, the Otsuka Digital Feedback Device-RW does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate devices.