(268 days)
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.
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.
The provided text describes the Otsuka Digital Feedback Device-RW, which is an ingestible event marker with a wearable patch. The primary function highlighted is logging and trending medication intake times to aid in measuring medication adherence, as well as tracking physiological and behavioral metrics.
However, the document is an FDA 510(k) clearance letter and its associated summary. While it mentions "acceptance criteria" for "firmware verification, mechanical verification, electrical verification, biocompatibility evaluation, and system verification testing," it does not provide specific numerical acceptance criteria for the device's performance in its intended use (i.e., accurately tracking ingestion or medication adherence). It also clarifies that no new clinical studies were performed to support the changes in this submission, indicating that the performance data for the core functionality would likely be derived from previous predicate device studies or non-clinical testing.
Therefore, many of the requested details about a study proving the device meets acceptance criteria related to its clinical performance (e.g., accuracy of ingestion detection, improved human reader performance with AI) cannot be extracted directly from this document. The document focuses on showing substantial equivalence to a predicate device, based on similar technology, non-clinical testing, and existing clinical data from the predicate for some aspects.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions acceptance criteria were met for:
- Firmware verification
- Mechanical verification
- Electrical verification
- Biocompatibility evaluation
- System verification testing
No specific numerical acceptance criteria or performance metrics related to the core function of "logging, tracking, and trending intake times" or "measuring medication adherence" are provided in this document. The document states "The results demonstrate that the acceptance criteria for firmware verification, mechanical verification, electrical verification, biocompatibility evaluation, and system verification testing were met," but it does not quantify these.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "However, new clinical studies were not performed to support the changes proposed in this submission." It implies that any performance data for the core functions relies on the predicate devices. Therefore, details about sample size, provenance, and retrospective/prospective nature of a new clinical test set are not available in this document.
The document mentions: "Clinical studies were conducted to support the expanded wear location of the patch to include the entire front abdomen." This suggests some clinical data was generated for this specific change, but details on sample size, design, or performance metrics for that specific study are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no new clinical study on the primary function is detailed, and the document does not describe efforts to establish ground truth with experts for the device's performance (e.g., in medication adherence).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study on the primary function is detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ingestible event marker and wearable sensor, not an AI-assisted diagnostic imaging device that would typically involve human "readers" interpreting images. Its purpose is data collection (ingestion times, physiological metrics), not interpretation by human experts.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is essentially a "standalone" data collection system. It's intended to continuously log data without constant human intervention.
- Performance: The document indicates non-clinical verification and validation testing was done (firmware, mechanical, electrical, system testing), and those "acceptance criteria were met." However, no quantifiable performance metrics for the device's accuracy in detecting ingestion events are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the method for establishing ground truth for ingestion events or medication adherence from any past studies. Given the nature of the device (detecting ingestion), ground truth likely involves direct observation or very high-fidelity data from a controlled setting.
8. The sample size for the training set
Not applicable to this document. The document describes a medical device cleared via 510(k), not an AI/ML model for which a "training set" in the computational sense would be explicitly outlined. While the device contains firmware and software, the development process and data used for its internal algorithms are not detailed here as a separate "training set."
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
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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.
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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
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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) | ||||||
|---|---|---|---|---|---|---|
| For activities under 30 CFR 901 Subpart J For Construction Activities | For activities under 30 CFR 901 Subpart J | For activities under 30 CFR 901 Subpart J | For Construction Activities | For Construction Activities | ||
| For activities under 30 CFR 901 Subpart J | For activities under 30 CFR 901 Subpart J | For Construction Activities | For Construction Activities | |||
| For activities under 30 CFR 901 Subpart J | ||||||
| For Construction Activities |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitted by: | Otsuka America Pharmaceutical, Inc. |
|---|---|
| Address: | 2440 Research Blvd.Rockville, MD 20850 |
| Telephone: | 410-353-8778 |
| Contact Name: | Nancy F. TeagueSenior Director, Global Regulatory Affairsnancy.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, K150494Proteus Patch, Proteus Ingestible Sensor, K133263 |
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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
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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 FeedbackDevice-RW with RW2 Patch(Subject Device of this510(k)) | Proteus Digital Health FeedbackDevice with DW5 Patch | Proteus RW1 PatchIncluding Ingestible Sensor |
|---|---|---|---|
| 510(k) Number | K223463 | K150494 | K133263 |
| Patch DetectionCapability | Improved algorithm fromDW5 patch which allows forexpanded wear location toeither side of the torso. | Algorithm allows for patch to beworn on the left side of the torso | Algorithm allows for patch tobe worn on the left side of thetorso |
| Materials/LayerConstruction | RW2 uses skin adhesiveMED5750A and HydrogelAxelgaard AG625. Skincontacting materials passISO 10993 testing forirritation, cytotoxicity andsensitization, and/or has beenused in another 510(k)-clearedproduct for similar skin contactuse. | DW5 uses skin adhesiveMED5750A, Hydrogel CovidienRG-63B and a hydrocolloid foamtop. All skin contacting materialspass ISO 10993 testing forirritation, cytotoxicity andsensitization | RW1 uses skin adhesiveMED5750A and HydrogelCovidien RG-63B. All skincontacting materials pass ISO10993 testing for irritation,cytotoxicity and sensitization |
| Battery Life | 7-day battery life | 7-day battery life | 30-day battery life |
| Dimension: | Thickness - 8.2 mmLength - 110 mmWidth - 53 mm | Thickness - 6.3 mmLength - 102 mmWidth - 60 mm | Thickness - 11 mmLength - 97.5 mmWidth - 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(IngestibleSensor) | Ingestible event marker | Ingestible event marker | Ingestible event marker |
| Hardware(WearableSensor) | Wearable, physiologic sensor;2-component patch | Wearable, physiologic sensor;1-component patch | Wearable, physiologic sensor;2-component patch |
| Firmware(WearableSensor) | Collects data from sensor,performs data processing,stores data until wirelessconnection is available, sendsdata to general computingdevice | Collects data from sensor,performs data processing, storesdata until wireless connection isavailable, sends data to mobiledevice | Collects data from sensor,performs data processing,stores data until wirelessconnection is available, sendsdata to mobile device |
| Software | Aggregates, processes andenables display of datacollected by sensors | Aggregates, processes anddisplays data collected by sensors | Aggregates, processes anddisplays data collected bysensors |
| Data Telemetry | Bluetooth Technology | Bluetooth Technology | Bluetooth Technology |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | ISO 10993 compliant |
| Product Name | Otsuka Digital FeedbackDevice-RW with RW2 Patch(Subject Device of this510(k)) | Proteus Digital Health FeedbackDevice with DW5 Patch | Proteus RW1 PatchIncluding Ingestible Sensor |
| 510(k) Number | K223463 | K150494 | K133263 |
| ElectricalSafety/EMC | IEC 60601-1/IEC 60601-1-2compliant | IEC 60601-1/IEC 60601-1-2compliant | IEC 60601-1/IEC 60601-1-2compliant |
Technological Characteristics:
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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.
§ 880.6305 Ingestible event marker.
(a)
Identification. An ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible and non-toxic;
(2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device;
(3) Appropriate analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless performance, and electrical safety; and
(4) Labeling must include a detailed summary of the nonclinical and clinical testing pertinent to use of the device and the maximum number of daily device ingestions.