(191 days)
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.
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.
This document describes the Philips Biosensor BX100, a physiological measurement device. The provided text outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, supported by various performance data including clinical trials.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each parameter in a formal table; however, it implicitly defines performance targets by comparing the device's capabilities to its predicate devices and referencing relevant standards. The key physiological measurements are Heart Rate and Respiration Rate.
| Metric (Internal Acceptance Criteria Implied) | Reported Device Performance (from "Clinical Trials Summary" and "Comparison of Technological Characteristics") |
|---|---|
| Heart Rate Resolution | $\pm$ 1bpm |
| Heart Rate Range | 30 - 220 bpm |
| Heart Rate Accuracy | IEC 60601-2-47 and IEC 60601-2-27 compliant. The Philips Biosensor BX100 heart rate algorithm is the same algorithm previously cleared in the G5 biosensor. The algorithm has been enhanced to allow for accurate heart rate across a broader measurement range. |
| Respiration Rate Resolution | $\pm$ 1 rpm static (As Compared to Secondary Predicate) |
| Respiration Rate Accuracy | $\pm$ 3 rpm (excluding periods of undefined respiration rate due to patient talking, eating, or coughing, for example) as compared to capnography. This is within the range listed for the secondary predicate device ($\pm$ 2 rpm to $\pm$ 5 rpm). |
Other performance metrics for wear duration and environmental ranges are also mentioned in the comparison to predicate devices, suggesting these are also part of the acceptance criteria:
| Metric | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Wear Duration | No new questions raised with longer wear duration compared to 24 hours (predicate: G5). | 115 hours (subject device) vs 24 hours (predicate G5). Adhesive performance: average 6.7 days (excluding electrical) and 4.8 days (including electrical). |
| Shelf Life | No new questions raised with longer shelf-life duration compared to 3 months (predicate: G5). | 12 months (subject device) vs 3 months (predicate G5). |
| Atmospheric Range (Functionality) | Functionality maintained within specified range (Predicate: 50kPa to 106kPa). | 70kPa - 102kPa. Successfully tested after exposure to extreme environmental use conditions. |
| Operational Temperature Range | Functionality maintained within specified range (Predicate: 15° C to +35° C). | 10° C to +40° C. Successfully tested after exposure to extreme environmental use conditions. |
| Operational Humidity Range | Functionality maintained within specified range (Predicate: 15% to 95% non-condensing). | 10% to 95% non-condensing. Successfully tested after exposure to extreme environmental use conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Performance Testing:
- Philips G10 Biosensor Wear Study: 25 subjects.
- G10 Algorithm Validation Study: 53 subjects.
- Biocompatibility Testing:
- Cytotoxicity: Clinical study (25 subjects), Osmolarity evaluation, ISO 10993-10 irritation testing (3 animals), ISO 10993-10 sensitization testing (15 animals).
- Data Provenance: The document does not specify the country of origin for the clinical study data or if the studies were retrospective or prospective. Given the nature of a 510(k) submission for a new device, these would almost certainly be prospective clinical studies conducted specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts or their qualifications for establishing ground truth specifically for the algorithm validation study. It references "capnography" as the reference for respiration rate accuracy, implying a recognized medical measurement standard as ground truth, but doesn't detail human expert involvement in its establishment.
For biocompatibility, the tests are standard ISO procedures (animal studies, clinical subject reactions).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in ground truth establishment. It implies that the reference measurements (e.g., capnography) serve as the singular ground truth for algorithm validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not mentioned. The studies described are focused on validating the device's direct physiological measurement accuracy and wearability, not on how human readers/clinicians improve with AI assistance from this specific biosensor data. The device collects and transmits data to a backend system, suggesting it's an input to broader clinical decision-making, not an "AI assistance" tool in itself as might be seen for image analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the "G10 Algorithm Validation Study" appears to be a standalone performance study. The 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 implies evaluating the algorithm's performance directly against established reference measurements, without human interpretation as part of the primary evaluation endpoint.
7. The Type of Ground Truth Used
- Physiological Data (Respiration Rate, Heart Rate): Reference measurements from established methods, specifically capnography for respiration rate for the 53-subject algorithm validation study. The heart rate algorithm accuracy is stated to be compliant with IEC 60601-2-47 and IEC 60601-2-27.
- Adhesive Performance/Wear Study: Demonstrated by "average adhesive performance of 6.7 days (excluding electrical performance) and 4.8 days (including electrical performance) with no significant skin reactions." This suggests direct observation and measurement of wear duration and skin reaction.
- Biocompatibility: Established through standard in-vitro (cytotoxicity, though with noted method incompatibility due to device material) and in-vivo (animal irritation and sensitization studies, and a clinical study on human subjects) tests against ISO standards.
- Bench Testing: Verifying system-level device specifications, mechanical and electrical specifications, and packaging integrity.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This submission is for a medical device that measures physiological parameters. While it contains "algorithms" for processing these signals, it is treated more like a sensor/monitor than a complex AI/ML diagnostic tool that would typically have a distinct training phase documented for regulatory submission. The algorithms are likely signal processing and filtering algorithms, rather than machine learning models that require large labeled training datasets in the conventional sense.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned in the provided text, no information is available on how its ground truth might have been established.
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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
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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
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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)
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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 SystemsConnected Sensing Division2 Canal Park, Cambridge, MA 02141Tel.: 617-218-0802 |
| OFFICIALCORRESPONDENT | Suzanne GoodmanHead of Quality and Regulatory2 Canal Park, Cambridge, MA 02141Tel.: (919) 608-6082suzanne.goodman@philips.com |
| II.DEVICE INFORMATION | |
| TRADE NAME | Philips Biosensor BX100 |
| COMMON NAME | Wearable Biosensor |
| CLASSIFICATION | Class II21 CFR 870.2910, Radiofrequency physiologicalsignal transmitter and receiver.21 CFR 870.2300, Cardiac monitor (includingCardiotachometer and Rate Alarm).21 CFR 868.2375, Breathing frequency monitor. |
| PRODUCT CODE | DRG: Transmitters and Receivers, PhysiologicalSignal, RadiofrequencyDRT: Monitor, Cardiac (Incl. Cardiotachometer andRate Alarm)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.
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III. PREDICATE INFORMATION
| PREDICATE DEVICE | Primary Predicate: Philips Wearable Biosensor-G5Solution (K181165) |
|---|---|
| Secondary Predicate: Zephyr Technology CorporationBioModule 3-M1 (K123658) | |
| The predicate devices have not been subject to a designrelated recall. | |
| PRIOR SUBMISSION | This is an original submission. There has been no priorsubmission 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.
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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 signalsby continuously acquiring surface electrical waveforms related tocardiac excitations through electrodes. The subject device includesalso includes a tri-axial accelerometer. These signals are furtherprocessed by embedded firmware. |
| Reusable, Single-Use | Fully disposable single-use device with encapsulated electrodetechnology and puck. |
| Electrodes | Two fully encapsulated electrodes and biocompatible adhesivematerials 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 samealgorithm previously cleared in the G5 biosensor. The algorithm hasbeen enhanced to allow for accurate heart rate across a broadermeasurement range. The Philips Biosensor BX100 is substantiallyequivalent to the G5 Biosensor with respect to the heart ratemeasurement feature. The Philips Biosensor BX100 also measuresactivity level and posture.The Philips Biosensor BX100 subject device is substantiallyequivalent to the secondary predicate BioModule 3-MI as it relatesto 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(As Compared to Secondary Predicate) | $\pm$ 1 rpm static |
| Respiration Rate Accuracy(As Compared to Secondary Predicate | $\pm$ 3 rpm (excluding periods of undefined respiration rate due topatient talking, eating, or coughing, for example) for subject device.This is within the range listed for the secondary predicate device( $\pm$ 2 rpm to $\pm$ 5 rpm). |
| Differences | |
| Respiration Rate Range(As Compared to SecondaryPredicate) | Both the subject device and the secondary predicate measurerespiration rate as high as 40 rpm. The Philips Biosensor BX100measures respiration rate as low as 3 rpm compared to theBioModule's 6 rpm. This difference does not alter thesubstantial equivalence of the device. |
| Respiration Rate Range(As Compared to SecondaryPredicate) | Both the subject device and the secondary predicate measurerespiration rate as high as 40 rpm. The Philips Biosensor BX100measures respiration rate as low as 3 rpm compared to theBioModule's 6 rpm. This difference does not alter thesubstantial equivalence of the device. |
| Wear Duration | The primary predicate device G5 Biosensor can be worn for 24hours. The subject device can be worn for 115 hours.While the wear duration is longer in the subject device, there areno new questions raised with the longer wear duration. Both thesubject and predicate device need to address the risk of insufficientadhesive performance via electrical contact with the skin over theduration of use. The standard defines long term monitoring as "aperiod of days". The electrodes for the predicate device and thesubject 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.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.
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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.
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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.
| EvaluationEndpoint | Tests Performed | ApplicableStandard |
|---|---|---|
| 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.
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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.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).