Who is the manufacturer of Capsule Surveillance System?

Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. filed the 510(k) submission for Capsule Surveillance System (K213335).

What is the FDA product code for Capsule Surveillance System?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Capsule Surveillance System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Capsule Surveillance System?

Decisio Health, Inc.'s Decision Health Patient Dashboard (K142106).

Who can help prepare an FDA 510(k) submission like Capsule Surveillance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Capsule Surveillance System

K213335 · Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. · MWI · Jan 14, 2022 · Cardiovascular

Device Facts

Record ID	K213335
Device Name	Capsule Surveillance System
Applicant	Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.
Product Code	MWI · Cardiovascular
Decision Date	Jan 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action.

Device Story

Clinical decision support system; integrates data from medical devices and healthcare information systems (EMR). Operates via standardized, user-defined clinical rules/protocols to generate alerts. Used in hospital settings by physicians and medical staff. Accessed via dedicated workstation (kiosk mode) or web browser (remote display). Provides multi-patient matrix views and single-patient detailed views. Assists clinicians in timely, informed decision-making; supports secondary monitoring for immediate clinical action or remote display of physiological data. Benefits include improved clinical oversight and workflow efficiency.

Clinical Evidence

No clinical data. Bench testing only. Evidence includes human factors/usability testing, software verification/validation per IEC 62304, and alarm system testing per IEC 60601-1-8.

Technological Characteristics

Clinical decision support software; integrates data via HL7 feeds. Operates on workstations or web-based platforms. Complies with ANSI AAMI IEC 62304 (software lifecycle) and ANSI AAMI IEC 62366-1 (usability). Rule-based alert generation based on customer-defined clinical protocols.

Indications for Use

Indicated for use by clinical physicians or appropriate medical staff under the direction of physicians in healthcare facilities to integrate, analyze, and display physiological data (e.g., pulse, respiratory rate, SpO2, temperature, blood pressure) for clinical decision support and secondary monitoring.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

Decisio Health, Inc.'s Decision Health Patient Dashboard (K142106)

Reference Devices

Cardiopulmonary Corp.'s Bernoulli Enterprise Software (K130208)

Related Devices

K210160 — AlertWatch:AC · Alertwatch, Inc. · Sep 10, 2021
K142106 — DECISIO HEALTH PATIENT DASHBOARD · Decisio Health, Inc. · Jan 18, 2015
K233133 — Talis EMR with Talis +ACG (Talis EMR with +ACG) · Talis Clinical, LLC · Apr 1, 2024
K140339 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM · Covidien · Apr 10, 2014
K240756 — AITRICS-VC · Aitrics Co., Ltd. · Jul 23, 2024

Submission Summary (Full Text)

{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 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. January 14, 2022 Capsule Surveillance Technologies, SAS /Capsule Tech, Inc. Peter Kelley Director Quality & Regulatory 300 Brickstone Square Suite 203 Andover, Massachusetts 01810 Re: K213335 Trade/Device Name: Capsule Surveillance System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: December 13, 2021 Received: December 15, 2021 Dear Peter Kelley: 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for LCDR Stephen Browning 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) Device Name Capsule Surveillance System Indications for Use (Describe) Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action. Type of Use (Select one or both, as applicable) 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 | | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------| | I. SUBMITTER | | | | | Date Prepared | October 1st, 2021 | | | | Submitter/Owner | Capsule Technologies, SAS / Capsule Tech, Inc. FDA Establishment Number: 3003630387 300 Brickstone Square Suite 203 Andover, MA 01810 USA Phone: 978-697-4364 | | | | Key Contact | Peter Kelley Director Quality & Regulatory peter.kelley@philips.com | | | | 510(k) Submission Type | This is a traditional 510(k). | | | | II. DEVICE | | | | | Trade Name | Capsule Surveillance System | | | | Common Name | Physiological Monitor | | | | Classification Name | Panel & Name: Cardiovascular (OHT2) Subpart & Division: Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A) 21 CFR 870.2300 Regulatory Class: Class II Product Code: MWI | | | | III. PREDICATE DEVICE | | | | | | 510(k) No. | Company Name Device Name | Product Code | | Predicate Device | K142106 | Decisio Health, Inc.'s Decision Health Patient Dashboard | MWI | | Reference Device | K130208 | Cardiopulmonary Corp.'s Bernoulli Enterprise Software | MHX, MSX, PFY | {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION ## Capsule Surveillance System - description of the device per 21 CFR 807.92(a) (4) The Capsule Surveillance System is a clinical decision support device that integrates data from multiple sources including medical devices and healthcare information systems. The Capsule Surveillance Systems offers two methods of accessing the clinical application: - . A workstation which is a dedicated desktop used exclusively to run the Capsule Surveillance System clinical application in kiosk mode. - . The remote display which is any machine that accesses the Capsule Surveillance System via a web browser. Use of the Capsule Surveillance System allows for simultaneous monitoring of different patients in a clinical setting, providing information from integrated data sources that monitor physiological parameters such as, pulse, respiratory rate, SpO2, temperature, and blood pressure. #### V. INDICATIONS FOR USE ## Intended Use as required per 21 CFR 807.92(a)(5) The Capsule Surveillance is a clinical decision support device that integrates, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action. ### Comparison of Intended Uses for Subject Device and Predicate | Name | Indications for Use/Intended Use | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Capsule Surveillance System Subject Device | The Capsule Surveillance is a clinical decision support device that integrates, analyzes, and displays data from multiple sources including medical devices and healthcare information systems. It uses standardized rules that are based on customers approved clinical practices, protocols, and policies to create clinically relevant alerts in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians. It is | {5}------------------------------------------------ | | not intended to replace clinicians' judgment, but rather to assist clinicians in making timely, informed, higher quality decisions. | |----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Capsule Surveillance may be configured for secondary monitoring and alerting intended to be relied upon in deciding to take immediate clinical action. | | | Capsule Surveillance may also be configured for remote display of physiological data and alerts not intended to be relied upon in deciding to take immediate clinical action. | | K142106 Decisio Health Patient Dashboard Predicate | The Decisio Health Patient Dashboard is a decision support device indicated for aggregating, displaying, and managing physiologic and other patient information. This information is generated by third party medical devices and patient information systems. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities. The Decisio Health Patient Dashboard is intended for use by clinicians in healthcare facilities. | | VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | | |----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similarities | | | Item of Comparison | Description/Rationale | | Target Populations | Both devices are intended to be used by trained clinicians. | | Environment of Use | Both devices are intended to be used in a hospital setting. | | Matrix and Detailed Views | Both devices allow for matrix or multi-patient simultaneous monitoring, as well as detailed views/monitoring of single patients. | | Data Input | Both devices use input from EMR systems as well as medical devices via HL7 feed for monitoring | | Differences | | | Item of Comparison | Description/Rationale | | Methods for Accessing the Application | The subject Capsule Surveillance System allows access via a workstation or remotely via a web browser. The predicate Decisio Health Patient Dashboard allows access through a computer, while also permitting access through a patient monitor or mobile device. | # Substantial Equivalence Summary Operational and technological characteristics form the basis for the determination of substantial equivalence of the Capsule Surveillance System with the legally marketed predicate devices (K142106). The Capsule Surveillance System is substantially equivalent to the predicate devices. {6}------------------------------------------------ #### PERFORMANCE DATA VII. ### Non-Clinical Tests - Harmonized Standards The Capsule Surveillance System has passed all safety tests for demonstrated compliance with the harmonized standards below. | Standard | FDA Recognition # | Title # | |--------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------| | ANSI AAMI IEC 62304:2006/A1:2016 | 13-79 | Medical device software – Software life cycle processes [Including Amendment 1 (2016)] | | ANSI AAMI IEC 62366- 1:2015+AMDI:2020 (Consolidated Text) | 5-129 | Medical devices - Part 1 Application of usability engineering to medical devices, including Amendment 1 | # Non-clinical Bench Tests Human factors and usability testing has been completed. Furthermore, testing in compliance with IEC 60601-1-8 for requirements for alarm systems in medical electrical equipment and medical electrical systems was completed, as well as certification to IEC 62304 for software lifecycle and IEC 62366. No new issues of safety or effectiveness are introduced as a result of using this device. # Clinical Studies The Capsule Surveillance System, like the predicate device, did not require clinical trials. FDA recognized standards, FDA guidance documents, harmonized standards, verification and validation, software validation, usability validation, and risk management activities have taken place for the Capsule Surveillance System. Based upon the design, intended use, indications for use, classification, usability and safety testing the Capsule Surveillance System is substantially equivalent to the listed predicate device. No new issues of safety or effectiveness are introduced as a result of using this device. #### CONCLUSIONS VIII. The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and electromagnetic compatibility, software verification and validation, {7}------------------------------------------------ human factors and usability demonstrate that the Capsule Surveillance System does not raise additional questions of safety and effectiveness when compared to the predicate, performs as intended, and has performance characteristics that are substantially equivalent to the Decision Health Patient Dashboard predicate device.