(380 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a standard PPG-based heart rate monitor without mentioning any AI/ML components or training/test data sets.
No
Explanation: The device is indicated for continuous monitoring of heart rate, which is a diagnostic or monitoring function, not a therapeutic one. It does not treat or alleviate a medical condition.
No
The device is a heart rate monitor, which provides continuous physiological measurements rather than diagnosing specific conditions or diseases.
No
The device description explicitly states it includes a sensor integrated into a cap and a monitor to display the signal and HR, indicating hardware components beyond just software.
Based on the provided information, the VS Newborn Heart Rate Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The VS Newborn Heart Rate Monitor is a non-invasive device that measures heart rate directly from the patient's forehead using photoplethysmography. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The device description and intended use clearly indicate direct patient monitoring. The device is placed on the newborn's head to continuously monitor heart rate.
- The technology used (photoplethysmography) is a non-invasive method for measuring physiological signals. It relies on light absorption and reflection through tissue, not on the analysis of biological samples.
Therefore, the VS Newborn Heart Rate Monitor falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Product codes
DOA
Device Description
The VS Newborn Heart Rate Monitor is a non-invasive device intended to continuously monitor heart rate (HR) in neonates immediately after delivery and in newborn intensive care units (NICU). The VS Newborn Heart Rate Monitor measures HR using reflectance photoplethysmography (PPG). The sensor is integrated into a single-use soft cap placed on the head of the newborn such that the sensor contacts the forehead of the newborn. The PPG signal and HR are displayed on the monitor. The VS Newborn Heart Rate Monitor is designed for use in hospitals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
reflectance photoplethysmography (PPG)
Anatomical Site
head of the patient / forehead of the newborn
Indicated Patient Age Range
neonatal patients / neonates / NICU newborns / C-section newborns
Intended User / Care Setting
direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility / hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The VS Newborn Heart Rate Monitor underwent clinical testing at the Nottingham University Hospitals NHS Trust, in Nottingham, England. Three phases of the study were 1) assessing the thermal properties of the cap component 2) testing device function with NICU newborns, and 3) testing device function with C-section newborns. The study assessed multiple endpoints including primary, secondary, and safety endpoints. The primary endpoint of the study was to demonstrate the reliability and accuracy (i.e., Bland-Altman limits of agreement) of the subject device. The secondary endpoints included acquisition time and to obtain feedback about the subject device from mothers and healthcare professionals. Finally, there were two safety endpoints that were also considered throughout the study: any sign of skin damage due to the device, and any other unanticipated adverse events attributed to the device. The subject device was compared to ECG electrodes (K024264) and the LNCS pulse oximetry sensors (K110723). Those two devices were connected to the CARESCAPE Monitor B450 (132533) which was connected to a laptop computer. The subject device was connected to the same laptop computer and all data recorded synchronously. In total, 74 newborns, 13 mothers, and 40 healthcare professionals participated in the study. The subject device was found to maintain temperature as well as the standard of care and was as reliable and accurate as the devices it was compared to. Furthermore, there were no signs of skin irritation or adverse events therefore demonstrating that the VS Newborn Heart Rate Monitor is safe.
Key Metrics
reliability and accuracy (i.e., Bland-Altman limits of agreement)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
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July 23, 2021
SurePulse Medical Limited % Allison Komiyama Prinicipal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K201887
Trade/Device Name: VS Newborn Heart Rate Monitor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA Dated: July 6, 2020 Received: July 8, 2020
Dear Allison Komiyama:
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
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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 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 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,
Jennifer Shih Kozen 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
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Indications for Use
510(k) Number (if known)
Device Name VS Newborn Heart Rate Monitor
Indications for Use (Describe)
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \u2612 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Surepulse. The logo consists of a stylized heartbeat symbol in blue, followed by the word "surepulse" in a gradient from blue to green. Below the word "surepulse" is the tagline "Every second counts" in a smaller, light gray font.
510(k) Summary
510(k) Summary
DATE PREPARED
July 6, 2020
MANUFACTURER AND 510(k) OWNER
SurePulse Medical Limited Medicity, D6 Thane Road, Nottingham, NG90 6BH, United Kingdom Telephone: Official Contact: James Carpenter, CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: Email: akomiyama@acknowledge-rs.com Website: www.AcKnowledge-RS.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | VS Newborn Heart Rate Monitor |
|---|---|
| Common Name: | Oximeter |
| Regulation Number: | 21 CFR 870.2700 |
| Class: | II |
| Product Code: | DQA |
| Premarket Review: | Anesthesiology |
| Review Panel: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
| ENT, Sleep Disordered Breathing, Respiratory and | |
| Anesthesia Devices (DHT1C) |
PREDICATE DEVICE IDENTIFICATION
The VS Newborn Heart Rate Monitor is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K091241 | Masimo Rainbow SET® Rad 87 CO-Oximeter and | |
| Accessories / Masimo Corporation | ✓ |
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Image /page/4/Picture/0 description: The image shows the logo for Surepulse. The logo consists of a stylized heartbeat symbol in blue, followed by the word "surepulse" in a gradient from blue to green. Below the word "surepulse" is the tagline "Every second counts" in a smaller, light gray font.
510(k) Summary DEVICE DESCRIPTION
The VS Newborn Heart Rate Monitor is a non-invasive device intended to continuously monitor heart rate (HR) in neonates immediately after delivery and in newborn intensive care units (NICU). The VS Newborn Heart Rate Monitor measures HR using reflectance photoplethysmography (PPG). The sensor is integrated into a single-use soft cap placed on the head of the newborn such that the sensor contacts the forehead of the newborn. The PPG signal and HR are displayed on the monitor. The VS Newborn Heart Rate Monitor is designed for use in hospitals.
INDICATIONS FOR USE
The VS Newborn Heart Rate Monitor is indicated for the continuous monitoring of heart rate in neonatal patients. The device uses reflectance photoplethysmography to determine heart rate. The sensor is integrated into a cap placed on the head of the patient. The VS Newborn Heart Rate Monitor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
SurePulse believes that the VS Newborn Heart Rate Monitor is substantially equivalent to the predicate device based on the information summarized here:
The subject device has a similar design and uses similar materials as the device cleared in K091241. The subject device has an equivalent intended use and similar technological characteristics as the device cleared in K091241. Unlike the predicate device that uses both green visible light and infrared light to measures heart rate and pulse oximetry, the VS Newborn Heart Rate Monitor only uses green visible light to determine heart rate. Unlike the predicate which is indicated for neonates, pediatric, infant, and adult populations, the VS Newborn Heart Rate Monitor is indicated for neonates only. To address the differences in technological characteristics, the subject device underwent biocompatibility testing, performance bench testing, and a clinical study.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the VS Newborn Heart Rate Monitor.
Patient-contacting material was subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing with a risk management process.
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Image /page/5/Picture/0 description: The image shows the logo for Surepulse. The logo features a stylized heartbeat symbol in blue, followed by the word "surepulse" in a gradient from blue to green. Below the word "surepulse" is the tagline "Every second counts" in a smaller, light gray font.
510(k) Summary
The following tests were performed to demonstrate safety based on current industry standards:
- . Basic safety and essential performance (per ISO 60601-1)
- Electromagnetic disturbances (per IEC 60601-1-2) .
- . Usability (per IEC 62366-1 and IEC 60601-1-6)
- Safety requirements for batteries (per IEC 62133)
- Basic safety and essential performance of pulse oximeter equipment (per ISO 80601-2-61)
- LED safety (per IEC 62471)
- o Algorithm (per JIS T 1303)
The results of these tests indicate that the VS Newborn Heart Rate Monitor is substantially equivalent to the predicate devices.
SUMMARY OF CLINICAL TESTING
The VS Newborn Heart Rate Monitor underwent clinical testing at the Nottingham University Hospitals NHS Trust, in Nottingham, England. Three phases of the study were 1) assessing the thermal properties of the cap component 2) testing device function with NICU newborns, and 3) testing device function with C-section newborns. The study assessed multiple endpoints including primary, secondary, and safety endpoints. The primary endpoint of the study was to demonstrate the reliability and accuracy (i.e., Bland-Altman limits of agreement) of the subject device. The secondary endpoints included acquisition time and to obtain feedback about the subject device from mothers and healthcare professionals. Finally, there were two safety endpoints that were also considered throughout the study: any sign of skin damage due to the device, and any other unanticipated adverse events attributed to the device. The subject device was compared to ECG electrodes (K024264) and the LNCS pulse oximetry sensors (K110723). Those two devices were connected to the CARESCAPE Monitor B450 (132533) which was connected to a laptop computer. The subject device was connected to the same laptop computer and all data recorded synchronously. In total, 74 newborns, 13 mothers, and 40 healthcare professionals participated in the study. The subject device was found to maintain temperature as well as the standard of care and was as reliable and accurate as the devices it was compared to. Furthermore, there were no signs of skin irritation or adverse events therefore demonstrating that the VS Newborn Heart Rate Monitor is safe.
CONCLUSION
Based on the testing performed, including biocompatibility, electrical safety, and clinical testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed VS Newborn Heart Rate Monitor are assessed to be substantially equivalent to the predicate device.