Philips Biosensor BX100

{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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. April 16, 2020 Philips Medical Systems Suzanne Goodman Head of Quality and Regulatory 2 Canal Park Cambridge, Massachusetts 02141 Re: K192875 Trade/Device Name: Philips Biosensor BX100 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DRT, BZQ Dated: March 17, 2020 Received: March 18, 2020 #### Dear Suzanne Goodman: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (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 medical devices and radiation-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, Jennifer Shih Assistant Director (Acting) 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) K192875 Device Name Philips Biosensor BX100 #### Indications for Use (Describe) The Philips Biosensor BX100 is a physiological measurement device for use by healthcare professionals to aid in the treatment and management of patient conditions in general care areas of a hospital. The Philips Biosensor BX100 is intended for use by healthcare professionals on patients 18 years of age and older. This chest-worn biosensor collects, stores, and transmits physiological data and contextual parameters to a qualified backend system. Physiological data includes respiration rate and heart rate; contextual parameters include ambulation, activity level, and posture. 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}------------------------------------------------ # 5. 510(K) SUMMARY ## 510(k) SUMMARY This 510(k) summary was prepared in accordance with the requirements of 21 CFR 807.92. #### SUBMITTER I. | DATE PREPARED | April 14, 2020 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | APPLICANT | Philips Medical Systems<br>Connected Sensing Division<br>2 Canal Park, Cambridge, MA 02141<br>Tel.: 617-218-0802 | | OFFICIAL<br>CORRESPONDENT | Suzanne Goodman<br>Head of Quality and Regulatory<br>2 Canal Park, Cambridge, MA 02141<br>Tel.: (919) 608-6082<br>suzanne.goodman@philips.com | | II.<br>DEVICE INFORMATION | | | TRADE NAME | Philips Biosensor BX100 | | COMMON NAME | Wearable Biosensor | | CLASSIFICATION | Class II<br>21 CFR 870.2910, Radiofrequency physiological<br>signal transmitter and receiver.<br>21 CFR 870.2300, Cardiac monitor (including<br>Cardiotachometer and Rate Alarm).<br>21 CFR 868.2375, Breathing frequency monitor. | | PRODUCT CODE | DRG: Transmitters and Receivers, Physiological<br>Signal, Radiofrequency<br>DRT: Monitor, Cardiac (Incl. Cardiotachometer and<br>Rate Alarm)<br>BZQ: Monitor, Breathing Frequency | Image /page/3/Picture/7 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and four stars. The wavy lines are positioned horizontally, and the stars are placed on either side of the lines. {4}------------------------------------------------ #### III. PREDICATE INFORMATION | <b>PREDICATE DEVICE</b> | Primary Predicate: Philips Wearable Biosensor-G5<br>Solution (K181165) | |-------------------------|-----------------------------------------------------------------------------------------------| | | Secondary Predicate: Zephyr Technology Corporation<br>BioModule 3-M1 (K123658) | | | The predicate devices have not been subject to a design<br>related recall. | | <b>PRIOR SUBMISSION</b> | This is an original submission. There has been no prior<br>submission for the subject device. | Note that G10 was the internal Philips project name for the G10 and the BX100 are the same device. Philips Biosensor BX100, BX100, BX100 Biosensor and G10 are used interchangeably throughout this 510(k). #### DEVICE DESCRIPTION IV. The Philips Biosensor BX100 is a single patient use, small, lightweight, chest-worn sensor. which collects, stores and transmits physiological data and contextual parameters to a qualified backend system. The Philips Biosensor BX100 includes Bluetooth communication capabilities. The Philips Biosensor BX100 has an LED indicator and a power button, and requires integration into a qualified system. The Philips Biosensor BX100 sends the collected patient data wirelessly to a qualified system directly or indirectly through IT equipment. Physiological data provided by the Philips Biosensor BX100 includes respiration rate and heart rate; contextual parameters include ambulation, activity level and posture. The Biosensor has a 115hour wear life. #### V. INTENDED USE AND INDICATIONS FOR USE #### Intended Use Biosensor BX100 is a physiological measurement device to aid in the treatment and management of patient conditions. ## Indications for Use The Philips Biosensor BX100 is a physiological measurement device for use by healthcare professionals to aid in the treatment and management of patient conditions in general care areas of a hospital. The Philips Biosensor BX100 is intended for use by healthcare professionals on patients 18 years of age and older. This chest-worn biosensor collects, stores, and transmits physiological data and contextual parameters to a qualified backend system. Physiological data includes respiration rate and heart rate; contextual parameters include ambulation, activity level, and posture. Image /page/4/Picture/13 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield. {5}------------------------------------------------ The Indications for Use statement for the Philips Biosensor BX100 is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the subject device nor do they affect the substantial equivalence of the subject device relative to the predicate. Both the subject device and predicate devices have intended use of collecting and transmitting physiological measurements by acquiring electrical signals from the skin surface. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Philips Biosensor BX100 has the following similarities to the legally marketed primary predicate device (Philips Wearable Biosensor G5 Solution): - . Same intended use - Same operating principle . - Same technology ● See Table 5-1 for a comparison of the Philips Biosensor BX100 to the primary predicate device, Philips Wearable Biosensor-G5 Solution (K181165). The secondary predicate (BioModule 3-MI) is used for comparison of the respiration rate features. | Similarities | | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Scientific Concept | The scientific concept is based upon deriving physiological signals<br>by continuously acquiring surface electrical waveforms related to<br>cardiac excitations through electrodes. The subject device includes<br>also includes a tri-axial accelerometer. These signals are further<br>processed by embedded firmware. | | Reusable, Single-Use | Fully disposable single-use device with encapsulated electrode<br>technology and puck. | | Electrodes | Two fully encapsulated electrodes and biocompatible adhesive<br>materials used for adhesion and electrical contact. | | Device Placement Location | Devices are both placed on the chest. | | Analog or digital technology | Analog physiological signals converted to digital. | | Computer Processing | On-sensor signal processing through firmware. | | Storage of recorded signals | Data storage and transfer capabilities. | | Radio frequency telemetry | Bluetooth® Transmitter/Receiver. | | Power | Battery operated, disposable battery. | | Alarm management | Not an alarming device. | | IEC 60601-1 | Portable, Body-worn, CF-Applied Part Internally powered. | | IEC 60601-1-2 | RF emission CISPR 11: Group 1, Class B. | | Parameters Measured | The Philips Biosensor BX100 heart rate algorithm is the same<br>algorithm previously cleared in the G5 biosensor. The algorithm has<br>been enhanced to allow for accurate heart rate across a broader<br>measurement range. The Philips Biosensor BX100 is substantially<br>equivalent to the G5 Biosensor with respect to the heart rate<br>measurement feature. The Philips Biosensor BX100 also measures<br>activity level and posture.<br><br>The Philips Biosensor BX100 subject device is substantially<br>equivalent to the secondary predicate BioModule 3-MI as it relates<br>to the function of providing respiration rate. | | Heart Rate Resolution | $\pm$ 1bpm | | Heart Rate Range | 30 - 220 bpm | | Heart Rate Accuracy | IEC 60601-2-47 and IEC 60601-2-27 | | Respiration Rate Resolution<br>(As Compared to Secondary Predicate) | $\pm$ 1 rpm static | | Respiration Rate Accuracy<br>(As Compared to Secondary Predicate | $\pm$ 3 rpm (excluding periods of undefined respiration rate due to<br>patient talking, eating, or coughing, for example) for subject device.<br>This is within the range listed for the secondary predicate device<br>( $\pm$ 2 rpm to $\pm$ 5 rpm). | | Differences | | | Respiration Rate Range<br>(As Compared to Secondary<br>Predicate) | Both the subject device and the secondary predicate measure<br>respiration rate as high as 40 rpm. The Philips Biosensor BX100<br>measures respiration rate as low as 3 rpm compared to the<br>BioModule's 6 rpm. This difference does not alter the<br>substantial equivalence of the device. | | Respiration Rate Range<br>(As Compared to Secondary<br>Predicate) | Both the subject device and the secondary predicate measure<br>respiration rate as high as 40 rpm. The Philips Biosensor BX100<br>measures respiration rate as low as 3 rpm compared to the<br>BioModule's 6 rpm. This difference does not alter the<br>substantial equivalence of the device. | | Wear Duration | The primary predicate device G5 Biosensor can be worn for 24<br>hours. The subject device can be worn for 115 hours.<br><br>While the wear duration is longer in the subject device, there are<br>no new questions raised with the longer wear duration. Both the<br>subject and predicate device need to address the risk of insufficient<br>adhesive performance via electrical contact with the skin over the<br>duration of use. The standard defines long term monitoring as "a<br>period of days". The electrodes for the predicate device and the<br>subject device both support long term monitoring. | | Shelf Life | The primary predicate device G5 has a shelf life of 3 months. The subject device has a shelf life of 12 months. While the shelf life is longer in the subject device compared to the G5, there are no new questions raised with the longer shelf-life duration. Both the subject and predicate device address the risk of degradation of the device during storage and out of pouch.<br>Shelf-life testing of the subject device demonstrated substantially equivalent performance to the predicate device after the stated shelf-life. | | Materials | The only difference in materials between the Philips Biosensor BX100 and the primary predicate G5 is a change in hydrocolloid adhesive. Biocompatibility testing in accordance with ISO 10993-1 and clinical study data demonstrate that the Philips Biosensor BX100 is safe for use on intact skin for the proposed wear duration. | | Atmospheric Range | The primary predicate device has an atmospheric range of 50kPa to 106kPa, and the subject device has an atmospheric range of 70 kPa - 102kPa. While the subject and predicate device have a slight difference in labeled atmospheric use range, this does not affect the substantial equivalence of the device. Philips Biosensor BX100 functionality was successfully tested after exposure to extreme environmental use conditions. | | Operational Temperature Range | The primary predicate device has an operational temperature range of 15° C to +35° C, and the subject device has an operational temperature range of 10° C to +40° C. While the subject and predicate device have a slight difference in labeled operational temperature range, this does not affect the substantial equivalence of the device. Philips Biosensor BX100 functionality was successfully tested after exposure to extreme environmental use conditions. | | Operational Humidity Range | The primary predicate device has an operational humidity range of 15% to 95% non-condensing, and the subject device has an operational humidity range of 10% to 95% non-condensing. While the subject and predicate device have a slight difference in labeled operational humidity range, this does not affect the substantial equivalence of the device. Philips Biosensor BX100 functionality was successfully tested after exposure to extreme environmental use conditions. | Table 5-1. Comparison of Technological Features with the Primary Predicate Device Image /page/5/Picture/12 description: The image features the Philips logo, which is a shield-shaped emblem in a vibrant blue color. The word "PHILIPS" is prominently displayed in bold, white letters at the top of the shield. Below the text, there are stylized wavy lines that resemble sound waves or water, with two four-pointed stars positioned above and below the waves, adding a sense of dynamism and innovation to the logo. {6}------------------------------------------------ Image /page/6/Picture/3 description: The image shows the Philips logo. The logo is a blue shield shape with the word "PHILIPS" written in white at the top. Inside the shield, there are two wavy lines and two stars. {7}------------------------------------------------ Section 5- 510(k) Summary ## VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Bench Testing and Shelf life Bench testing was performed to verify system level device specifications, mechanical and electrical specifications, and packaging integrity. Applicable bench testing was repeated after 12 months of aging to support the labeled shelf life claim for the Philips Biosensor BX100. Image /page/7/Picture/8 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are three horizontal wavy lines that resemble water. Above and below the wavy lines, there are four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield. {8}------------------------------------------------ The Biosensor BX100 was integrated with a custom tool as a proxy for a qualified backend The tool mimicked the functionality of a backend system including bluetooth system. interface and a user interface capable of displaying the data output of the device (heart rate, respiration rate, activity type, activity level, posture and error messaging). ## Biocomnatibility The Philips Biosensor BX100 is a chest-worn biosensor that has contact with intact skin for up to 120 hours (5 days). In accordance with ISO 10993-1 (2018), the Philips Biosensor BX100 is classified as a surface-contacting device with prolonged (> 24 hours to 30 days) contact with intact skin. Evaluation endpoints and detailed tests were selected in accordance with FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2016). Table 5-2 below details the biocompatibility endpoints evaluated, along with the corresponding tests completed. ## Cytotoxicity Testing/Evaluation Summary The Biosensor BX100 uses a hydrocolloid adhesive that is incompatible with current ISO 10993-5 MEM elution methods for evaluating cytotoxicity due to cell lysis with high salt concentration in the extract medium. The pass results of a clinical study (25 subject), osmolarity evaluation, ISO 10993-10 irritation testing (3 animals tested, initial exposure for 5 days) and ISO 10993-10 sensitization testing (Buehler Method closed patched sensitization study, 15 animals, induction 3 times per week for 3 consecutive weeks, challenged at 14 days) demonstrate biocompatibility for use on intact skin per ISO 10993-1: 2018. | Evaluation<br>Endpoint | Tests Performed | Applicable<br>Standard | |------------------------|-------------------------------------------------------------|------------------------| | Sensitization | ISO Guinea Pig Maximization Sensitization Test | ISO 10993-10 | | Irritation | ISO Skin Irritation Study in Rabbits (24 hour and 120 hour) | ISO 10993-10 | | Cytotoxicity | Cytotoxicity- MEM Elution Method (72 hour extraction) | ISO 10993-5 | ## Software Verification and Validation Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). The Philips Biosensor BX100 Software Level of Concern was determined to be Moderate, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator. Image /page/8/Picture/11 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two four-pointed stars. The word "PHILIPS" is written in white at the top of the shield. {9}------------------------------------------------ #### Electromagnetic Compatibility and Electrical Safetv Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the Philips Biosensor BX100. The device complies with the applicable requirements within the ANSI AAMI ES60601-1, IEC 60601-2-27, and IEC 60601-2-47 standards for safety and the ANSI AAMI IEC 60601-1-2 standard for EMC. Additional wireless and co-existence testing per US FCC CFR 47 Part 15 and ANSI IEEE C63.27 was conducted to demonstrate substantial equivalence of the Philips Biosensor BX100 radio frequency wireless technology features. #### Clinical Performance Testing Philips conducted clinical studies in support of the Philips Biosensor BX100. The Philips G10 Biosensor Wear Study was conducted to evaluate design requirements for the Philips Biosensor BX100 (G10). This study enrolled 25 subjects, who wore the Philips Biosensor BX100 for a period of 7-10 days. The primary objective of the wear study was to establish the adhesive performance (duration of use) of the Philips Biosensor BX100. A second study, the G10 Algorithm Validation Study, was conducted to acquire physiological and contextual data using the Philips Biosensor BX100 and reference measurements to validate design specifications related to Biosensor software algorithms. This study enrolled 53 subjects, who wore the Philips Biosensor BX100 for approximately 2 hours. In addition to the studies described above, usability and human factors testing was performed for the Philips Biosensor BX100 in accordance with IEC 62366-1, the 2016 Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Medical Devices, and ANSI/AAMI HE75. ## Clinical Trials Summary In a wear study of 25 subjects conducted with the Biosensor BX100 an average adhesive performance of 6.7 days (excluding electrical performance) and 4.8 days (including electrical performance) was demonstrated with no significant skin reactions. In an algorithm validation study of 53 subjects respiratory rate algorithm accuracy within +3 breaths per minute was demonstrated as compared to capnography. #### VIII. CONCLUSIONS The results of the substantial equivalence assessment, taken together with non-clinical bench and shelf life testing, biocompatibility, electrical safety and electromagnetic compatibility, software testing, and clinical performance testing demonstrate that the Philips Biosensor BX100 does not raise different questions of safety and effectiveness when compared to the predicate, performs as intended, and has performance characteristics that are substantially equivalent to the Philips Wearable Biosensor-G5 Solution and Zephyr Technology Corporation BioModule 3- MI predicate devices. Image /page/9/Picture/11 description: The image shows the Philips logo, which consists of a blue shield shape. Inside the shield, there are two horizontal wavy lines representing water. Above and below the water lines, there are four-pointed stars. The word "PHILIPS" is written in white at the top of the shield.