BioSticker System

K191614 · Biointellisense, Inc. · DRG · Dec 18, 2019 · Cardiovascular

Device Facts

• Record ID: K191614
• Device Name: BioSticker System
• Applicant: Biointellisense, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Dec 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis. The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological information. The BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients.

Device Story

BioSticker System is a wearable, adhesive-based remote monitoring device. It collects physiological data including heart rate, respiratory rate, and skin temperature. The device operates while the patient is at rest; it is not intended for use during significant motion or activity. Data are transmitted via wireless connection to a remote system for storage and analysis. Healthcare professionals use the system as an aid to diagnosis and treatment for general care patients. The device provides continuous physiological information to clinicians, facilitating remote monitoring in home or clinical environments. It is not for use in critical care settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance validation of the physiological monitoring capabilities.

Technological Characteristics

Wearable, adhesive-based physiological monitor. Measures heart rate, respiratory rate, and skin temperature. Wireless data transmission. Intended for use on patients at rest. Class II device (21 CFR 870.2910).

Indications for Use

Indicated for general care patients aged 21+ in home or healthcare settings for continuous collection of heart rate, respiratory rate, and skin temperature while at rest. Not for use on critical care patients or during significant motion/activity.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• VitalConnect Platform (K162333)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2019

BioIntelliSense Inc. Henry Leung Director of Quality 570 El Camino Real, Suite 200 Redwood City, California 94063

Re: K191614

Trade/Device Name: BioSticker System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: June 16, 2019 Received: June 18, 2019

Dear Henry Leung:

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) K191614

Device Name BioSticker System

## Indications for Use (Describe)

The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis.

The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological information. The BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment.

The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients.

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

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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