ID-Cap System

K183052 · Etectrx, Inc. · OZW · Dec 6, 2019 · General Hospital

Device Facts

• Record ID: K183052
• Device Name: ID-Cap System
• Applicant: Etectrx, Inc.
• Product Code: OZW · General Hospital
• Decision Date: Dec 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6305
• Device Class: Class 2

Indications for Use

The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.

Device Story

The ID-Cap System tracks medication adherence by detecting ingestion events. The system comprises an ID-Capsule (standard pharmaceutical shell containing an ID-Tag sensor) and a wearable ID-Cap Reader. Upon ingestion, stomach electrolytes activate the bio-galvanically powered ID-Tag, which emits a low-power RF digital message. The wearable Reader, worn as a pendant on a lanyard, detects this RF signal, verifies the ingestion event, and assigns a unique ID. Data is transmitted via Bluetooth Low Energy (BLE) to a mobile app/display system for patient and clinician review. Unlike skin-patch predicates, the Reader requires no direct skin contact. Clinicians use the logged intake data to monitor adherence. The system is intended for ambulatory use in clinical or research settings. It does not collect physiological metrics.

Clinical Evidence

Clinical studies evaluated 18-79 year old participants (mean 41.9 years). Primary endpoints included Positive Detection Accuracy (PDA) of 95.0% and Negative Detection Accuracy (NDA) of 100%. Safety analysis showed 10.2% of subjects experienced mild adverse events (0.6% of ingestions). Post-ingestion X-rays confirmed non-retention of ID-Tags. No severe adverse events related to the system were reported. The study demonstrated the device does not raise different questions of safety and effectiveness compared to the predicate.

Technological Characteristics

System includes an ingestible sensor (ID-Tag) on a flexible substrate (22.5mm x 9.5mm x 60µm) and a wearable Reader (97mm x 47mm x 23mm, 78g). Sensing principle: bio-galvanic activation by stomach fluid. Communication: RF digital messages to Reader, then BLE to external devices. Reader power: rechargeable Lithium Polymer battery. Biocompatibility: ISO 10993-1 compliant. Electrical safety: IEC 60601-1, IEC 60601-1-11. EMC: IEC 60601-1-2 (4th Ed). Wireless: ANSI C63.27 2017.

Indications for Use

Indicated for ambulatory recording of ingestion events via an ingestible sensor (ID-Tag) for clinical and research applications. Intended for patients (18-79 years old) requiring tracking and trending of medication intake times. Contraindicated for simultaneous ingestion of multiple ID-Capsules.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Proteus Personal Monitor including Ingestion Event Marker is subject to the following special controls:

*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.

Predicate Devices

• Proteus Digital Health Feedback Device (K150494)

Submission Summary (Full Text)

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December 6, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

etectRx, Inc. Paul Dryden Consultant 747 SW 2nd Ave Suite 365T, IMB 24 Gainesville, Florida 32601

Re: K183052

Trade/Device Name: ID-Cap System Regulation Number: 21 CFR 880.6305 Regulation Name: Ingestible Event Marker Regulatory Class: Class II Product Code: OZW Dated: November 26, 2019 Received: November 27, 2019

Dear Paul Dryden:

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,

for Jessica Paulsen 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)

K183052

Device Name

ID-Cap System

Indications for Use (Describe)

The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule,

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

JOver-The-Counter Use (21 CFR 801 Subpart C)

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| Official Contact: | Susan Baumgartner, PharmD, MBA<br>VP, Product Management & Regulatory Affairs<br>etectRx, Inc.<br>747 SW 2nd Ave Suite<br>365T, IMB 24<br>Gainesville, FL 32601<br>Tel – [phone] x110 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | ID-Cap System |
| Common/Usual Name: | Ingestible event marker |
| Classification Name: | 21 CFR 880.6305<br>OZW – Ingestible event marker Class<br>II |
| Predicate Devices: | K150494 – Ingestion Event Marker (IEM) Data<br>recorder (Patch) |

#### Device Description

The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader.

The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician.

The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor).

The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.

#### Indications for Use

The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical and research applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events signaled by the co-incidence with or coingestion with the ID-Capsule, is desirable.

#### Comparison of ID-Cap System to Predicate

We present in Tables 1 - 5 a comparison of the subject device compared to the predicate.

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# Table 1 – Comparison - High-Level System

| | Predicate<br>K150494 | Subject Device | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Proteus Digital Health Feedback Device | ID-Cap System | Identical |
| Classification | Ingestible Event Marker<br>(21 CFR 880.6305) | Ingestible Event Marker<br>(21 CFR 880.6305) | |
| Product Code | OZW, DXH | OZW | Product code DXH is not relevant for<br>the subject device, since the subject<br>device does not include a telephone<br>electrocardiograph transmitter and<br>receiver. |
| System Components | Ingestion Event Marker (IEM)<br>Data recorder (Patch)<br>Software | ID-Capsule (with ID-Tag)<br>ID-Cap Reader<br>Software | Similar components. An ingestible<br>sensor, a wearable data recorder, and<br>software |
| Indications for Use | The Proteus Digital Health Feedback<br>Device consists of a miniaturized,<br>wearable sensor for ambulatory recording<br>of physiological and behavioral metrics<br>such as heart rate, activity, body angle<br>relative to gravity (body position), and<br>time-stamped patient logged events,<br>including events signaled by the co-<br>incidence with, or co-ingestion with, the<br>ingestible sensor accessory. When the<br>ingestible sensor is ingested, the Proteus<br>Digital Health Feedback Device is<br>intended to log, track and trend intake<br>times. When co-ingested with medication,<br>the tracking and trending of intake times<br>may be used as an aid to measure<br>medication adherence. The Proteus<br>Digital Health Feedback Device may be<br>used in any instance where quantifiable | The ID-Cap System consists of a<br>wearable reader for ambulatory<br>recording of events signaled by<br>swallowing the ID-Capsule which<br>contains the ID-Tag, an ingestible sensor.<br>The ID-Cap System is intended to log,<br>track, and trend intake times and enables<br>unattended data collection for clinical<br>applications. The ID-Cap System may be<br>used in any instance where quantifiable<br>analysis of ingestion events, including<br>events signaled by the co-incidence with<br>or co-ingestion with the ID-Capsule, is<br>desirable. | The indications for use of the subject<br>device are a subset of the indications<br>for use of the predicate. |
| | Predicate | Subject Device | Comments |
| | K150494 | | |
| | analysis of event-associated physiological<br>and behavioral metrics is desirable and<br>enables unattended data collection for<br>clinical and research applications. | | |
| Patient Population | Based on current labeling, clinical study<br>volunteers were 21–85 years old (mean:<br>44.6 years). | Clinical study participants were 18 – 79<br>years old (mean 41.9 years), stratified by<br>gender and BMI. | Similar |
| Environment of Use | Ambulatory use<br>Unattended data collection for clinical<br>and research applications<br>Do not wear during airplane travel<br>Intended for use in specified<br>electromagnetic environment | Ambulatory use<br>Unattended data collection for clinical<br>and research applications<br>Not intended for use on aircraft<br>Intended for use in specified<br>electromagnetic environment | Identical<br>Neither is designed for use in aircraft |
| Prescription use | Yes | Yes | Identical |

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## Table 2 – Comparison - Technological Characteristics – Ingestible Sensor

| | Predicate<br>K150494 | ID-Cap System | Comments |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Ingestion Event Marker | ID-Capsule (capsule containing the ID-<br>Tag, an ingestible sensor) | |
| Ingestible Sensor | Integrated circuit (IC) with attached 5<br>mm diameter x 300µm semi-rigid<br>insulating skirt disk (excipient skirt) | ID-Tag is a 22.5 mm x 9.5 mm x 60<br>microns (L x W x H) flexible substrate<br>with printed antenna, attached IC and<br>capacitor | Different physical characteristics of<br>ingestible sensor - Both are ICs<br>mounted on a small, thin substrate. |
| Basic Technology | Bio-galvanically powered ingestible<br>circuit | Bio-galvanically powered<br>ingestible circuit | Similar |
| Method of Signal<br>Communication | Volume conduction communication<br>High frequency AC (alternating<br>current) | Very low power digital radio frequency<br>(RF) messages | Different method of signal<br>communication, but fundamentally a<br>low-powered signal |
| Electrical Power Source | Differential metal contacts (Mg-CuCl)<br>activated by electrolytes in stomach<br>fluid<br>Mineral biogalvanic | Differential metal contacts (Mg-AgCl)<br>activated by electrolytes in stomach fluid<br>Mineral biogalvanic | Similar means of powering but using<br>different metal technology |
| Activation | When wet in stomach | When wet in stomach | Similar activation |
| Time to Detect | 1.0 minute (mean) in direct<br>observation clinical study | 6.4 minutes (mean) for ID-Tag<br>encapsulated in ID-Capsule in direct<br>observation clinical study | The capsule takes ~ 6 minutes to<br>dissolve vs. the predicate which is not<br>encapsulated; however, the duration of<br>detected signal is longer for the subject<br>device. |
| Duration of Detected Signal | 7.29 minutes (mean) in direct<br>observation clinical study | 27.9 minutes (mean) from first detection<br>in direct observation clinical study | Subject device has a longer duration of<br>detection |
| Signaling Control | 1 mm x 1 mm x 0.3 mm<br>complementary metal-oxide<br>semiconductor (CMOS) IC | 1 mm x 1 mm x 0.3 mm complementary<br>metal-oxide semiconductor (CMOS) IC | Similar |
| Oral Delivery Vehicle | Ingestible sensor is attached to an inert<br>pharmaceutical excipient tablet | Ingestible sensor is encapsulated in a<br>standard pharmaceutical capsule shell | Similar – Oral delivery vehicles for<br>both are inert and listed in the FDA<br>inactive ingredient database |
| | Predicate<br>K150494 | ID-Cap System | Comments |
| Swallowable Size and<br>Weight | Round pill<br>Size: 6.5 mm x 2.0 mm<br>Weight: 80 mg | Capsule<br>Size and weight below for size 00 gelatin<br>capsule<br>Size:<br>Locked length = 23.5 mm<br>Cap diameter = 8.56 mm<br>Body diameter = 8.21 mm<br>Weight: 24.3 mg | The subject device is delivered in a<br>standard pharmaceutical capsule shell,<br>while the predicate is a tablet<br>configuration. |
| Patient-Contacting<br>Material | Tested per ISO 10993-1 | Tested per ISO 10993-1 | Testing per ISO 10993, and all patient-<br>contacting materials found<br>biocompatible |
| Data Transmitted from the<br>Sensor | Digital signaling information,<br>including unique ID for the ingestible<br>sensor | Digital signaling information consisting of<br>RF signals with encoded digital data | Similar data transmitted. See row<br>below for unique ID discussion. |
| Unique ID for Sensor | Each sensor is encoded with a unique<br>ID which is recorded by the patch. | The ID-Tag sends RF messages to the<br>Reader which assigns a unique ingestion<br>event ID number to the ID-Tag messages<br>received. | Unique ID is generated within the<br>Reader vs. pre-assigned to the<br>ingestible sensor.<br>Simultaneous ingestions of multiple<br>ID-Capsules are not recommended with<br>the subject device. |
| Excretion | Chip excreted via GI tract | ID-Tag excreted via GI tract | Similar<br>Safety demonstrated in clinical studies<br>with post-ingestion X-ray confirmation<br>of non-retention of ID-Tags. |
| Maximum Number of<br>Ingestions per Day | Do not exceed more than 30 ingestions<br>per day. | No more than five ingestions per day, with<br>a minimum of 90 minutes between ID-<br>Capsule ingestions to ensure that each ID-<br>Tag is appropriately identified and each<br>ingestion event is detected. | Single ingestions with a minimum of<br>90 minutes between ingestions for the<br>subject device. |
| | Predicate<br>K150494 | ID-Cap System | Comments |
| Common name | Proteus Personal Monitor (Patch) | ID-Cap Reader | |
| Data Recorder Description | Adhesive patch worn on the skin | Pendant hanging from a lanyard worn<br>around the neck | The subject device Reader is not<br>attached to the patient's skin. |
| Function | Receives, stores, and wirelessly sends<br>ingestion confirmation data to a<br>general computing device | Receives, stores, and wirelessly sends<br>ingestion confirmation data to a general<br>computing device | Similar |
| Form Factor | Body-worn sensor attached to the skin<br>with an adhesive patch | Pendant hanging in front of the chest<br>from a lanyard placed loosely around the<br>neck | Similar, except predicate is an<br>adhesive patch placed on the patient's<br>skin |
| Memory and Data Storage | Stores data<br>Ovoid patch 4 MB or 16 MB;<br>Rectangular patch 16 MB | Stores data<br>8 MB | Similar<br>Storage capacity is adequate for the<br>intended use. |
| Size | One-Piece Ovoid Patch:<br>102 mm x 60 mm x 9.8 mm or<br>102 mm x 60 mm x 6.3 mm<br>Two-Piece Rectangular Patch:<br>98 mm x 42 mm x 11 mm | 97 mm x 47 mm x 23 mm | Similar - Both are small and wearable.<br>The subject device can be easily taken<br>off between ingestions. |
| Weight | Ovoid Patch 10 g or 11 g<br>Rectangular Patch 16 g | 78 g | |
| Battery Type | Lithium Manganese (LiMn) Coin Cell | Rechargeable Lithium Polymer | Similar - The subject device is a<br>rechargeable unit, whereas the<br>predicate is a one-time use, disposable<br>unit. |
| Battery Life | Data recording for 5-7 days | Rechargeable battery designed to last at<br>least 36 hours on a full charge;<br>Qi-compliant wireless charger included<br>with Reader | Similar – Battery life is adequate for<br>intended use. |
| Data Reception | Wireless, skin contact required | Wireless, skin contact not required | Subject device does not require skin<br>contact. |
| | Predicate<br>K150494 | ID-Cap System | Comments |
| Data Recorded | Time-stamped, patient-logged events,<br>including events signaled by<br>swallowing the Ingestion Event<br>Marker (IEM) accessory<br><br>Records digital ID and date and time<br>of ingestion confirmation<br><br>Records heart rate, activity, body angle<br>relative to gravity (body position),<br>temperature, heart rate variability,<br>respiratory rate, and inter-electrode<br>impedance | Time-stamped, patient-logged events,<br>including events signaled by swallowing<br>the ID-Capsule<br><br>Records assigned ingestion event ID<br>number and date and time of ingestion<br>confirmation<br><br>No physiological metrics collected<br>Records Reader status and channel<br>communication information | The ingestion event marking is similar.<br>The subject device does not capture<br>physiological metrics. |
| Device Monitoring | Inter-electrode impedance helps<br>determine proper wearing of patch for<br>detection | Reader messages communicate device<br>status.<br>Accelerometer (motion detection)<br>provides insight into patient use of<br>Reader and whether user is wearing it. | The subject device Reader is less<br>position and placement dependent than<br>the predicate device. |
| Manual Event Logging | Manually press an event marker button<br>on the Patch<br>Sensor technology: patient-activated<br>button<br>Method: digital pulse | Not on the ID-Cap Reader, but available<br>in the ID-Cap App | The subject device does not have a<br>manual event logging feature itself;<br>however, the ID-Cap App does. |
| Data Communication | Wirelessly sends data to a general<br>computing device via Bluetooth | Wirelessly sends data to a general<br>computing device via Bluetooth Low<br>Energy (BLE) protocol | Similar methods |
| User Interface | Patch button initiates communication<br>to mobile computing device<br>Manual event marker button<br>Indicator light | Single on/off/standby button - once<br>turned on, device is ready for use<br>Tri-color LED indicator light | Similar - Simple user interface |
| Reusable Components /<br>Disposal | Single-use only | Reusable | The subject device Reader is reusable. |
| | Predicate<br>K150494 | ID-Cap System | Comments |
| Biocompatibility and Toxicity Testing | | | |
| Biocompatibility and<br>Toxicity -Data Recorder<br>(Reader) | Patch is attached to the patient's skin<br>Tested and demonstrated to be<br>biocompatible and non-toxic | Reader has no direct attachment to the<br>patient<br>Tested and demonstrated to be<br>biocompatible and non-toxic | ISO 10993 testing performed includes:<br>cytotoxicity, sensitization, and<br>irritation testing. |
| Biocompatibility and<br>Toxicity - Ingestible Sensor | Ingestible sensor demonstrated to be<br>biocompatible and non-toxic | Ingestible sensor demonstrated to be<br>biocompatible and non-toxic | ISO 10993 testing performed includes:<br>cytotoxicity, sensitization, irritation,<br>pyrogenicity, implantation, acute<br>systemic toxicity, and subacute<br>systemic toxicity. |
| Additional biocompatibility<br>testing | Chemical characterization with risk-<br>based toxicity assessment | Chemical characterization with risk-<br>based toxicity assessment | Testing and assessment performed |
| Electrical Safety, EMC, and Battery Testing | | | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1:2005 (3rd Edition) IEC<br>60601-1-11:2015 | Tested to applicable standards and<br>passed |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | IEC 60601-1-2:2014 (4th Edition and<br>home use levels)<br>JIS T 0601-1-2 (12th Edition 2012) | Tested to applicable standards and<br>passed |
| Wireless Coexistence<br>Performance | Tested | ANSI C63.27 2017 Wireless<br>Coexistence | Testing performed and acceptable |
| Spectrum Compatibility<br>and RF Safety | N/A | FCC and Industry Canada Grant of<br>Authorization received - relevant<br>Rules Parts and Radio Systems<br>Specifications | Testing performed and acceptable |
| Mechanical and Electrical Performance | | | |
| Impact Resistance | Passed | IEC 60601-1:2005 (3rd Edition) IEC<br>60601-1-11:2015 | Testing performed and results<br>acceptable |
| Performance of Antenna<br>Used in IEM | Mechanical strength<br>Residual solvent of disc material<br>Friability<br>Electrical properties of disc | Mechanical strength<br>N/A<br>N/A<br>Electrical properties | Applicable testing performed and<br>results acceptable |
| | Predicate<br>K150494 | ID-Cap System | Comments |
| Non-Clinical Performance<br>Testing of Ingestible Sensor | Tested for activation time and lifetime<br>after activation | Tested for activation time and lifetime<br>after activation | Applicable testing performed and<br>results acceptable |
| Signal Reception<br>Performance of Data<br>Recorder | High frequency (HF) and low<br>frequency (LF) signal chain<br>performance tests | Reader bench testing | Applicable testing performed and<br>results acceptable…