(195 days)
Not Found
No
The description mentions a "Cloud Algorithm" for extracting heart rates, but there is no mention of AI, ML, or any learning-based approach. The performance metrics and study design also do not suggest the use of AI/ML.
No
The device is described as a monitoring system for maternal and fetal heart rates, and its intended use explicitly states it is "not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor" and "not intended to be used for antepartum monitoring (e.g., non-stress testing)," indicating it is for diagnostic/monitoring purposes, not to provide therapy.
Yes
The device is indicated for monitoring maternal and fetal heart rates, and the Bloomlife Cloud processes this data into a report provided to clinics, which aids in assessing the health status of the mother and fetus, thus supporting a diagnosis.
No
The device description explicitly states that the system consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud. The Bloomlife Sensor is a hardware component that measures biopotential signals.
Based on the provided information, the Bloomlife MFM-Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Bloomlife MFM-Pro is a non-invasive external monitoring system that measures biopotential signals from the maternal abdomen to determine fetal and maternal heart rates. It does not analyze any biological specimens.
The device description and intended use clearly indicate that it is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later.
It is to be used by healthcare professionals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.
Bloomlife MFM-Pro is not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor.
Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non- stress testing).
Product codes
HGM
Device Description
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate (FHR) and maternal heart rate (MHR) during the antepartum period on pregnant women with a singleton pregnancy at 32 weeks gestation or later. The healthcare professional applies the device to the patient and uses Bloomlife MFM-Pro to generate the Bloomlife MFM-Pro report that provides 5 minutes of fetal heart rate (FHR) and maternal heart rate (MHR) monitoring to the clinic. A typical Bloomlife MFM-Pro session is expected to take 12 minutes; approximately 7 minutes to perform system quality checks and 5 minutes to record data. Signal quality checks continue during recording to ensure data quality.
Bloomlife MFM-Pro consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud.
The Bloomlife Sensor measures biopotential signals picked up on the abdominal surface using electrodes and transfers the data to the Bloomlife App via Bluetooth Low Energy.
The Bloomlife App is used by a healthcare professional to enter patient information, start'stop recording sessions, and get feedback on data quality and recording status during a recording. The App does not process or visualize data; it acts as a gateway for the raw data measured by the sensor.
The Bloomlife Cloud receives the data from the app, stores and processes the data into a Report, which is provided to the clinic via electronic fax. The Cloud Algorithm extracts the maternal heart rate from 50 bpm to 240 bpm within ±7 beats per minute, and fetal heart rate from 50 bpm to 240 bpm within ±10 beats per minute at a sample rate of 4 samples per second.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maternal abdomen
Indicated Patient Age Range
Pregnant women ≥32 gestational weeks
Intended User / Care Setting
healthcare professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The pivotal study was performed to demonstrate that Bloomlife MFM-Pro performs appropriately for its intended use. The pivotal study was started after design freeze and complete device verification of Bloomlife MFM-Pro.
The clinical study was conducted at two clinical sites in the USA. Female subjects aged > 18 years, with a singleton pregnancy, gestational age > 32 weeks and 0 days, and who signed the informed consent were included in the study. Participants were equipped with Bloomlife MFM-Pro and the Philips Avalon FM30, which was used as a "standard of cardiotocograph (CTG) monitoring device comparator. Only one recording per participant was allowed. The Bloomlife MFM-Pro 5minute Report data was used for the analysis.
Ninety-six (96) participants were included in the pivotal study. Sixty-one (61) participants were enrolled in the study and fifty-six (56) were included for analysis (full analysis set, FAS). The study population covered a wide range of gestational ages, from 32 weeks to full term gestation. More than half of the participants in the FAS population had a gestational age lower or equal to 36 weeks of gestation. More than half of the participants in the FAS population had a pre-pregnancy BMI greater or equal to 30 and were considered obese.
Using Bland-Altman Limits of Agreement (LoA) calculated on the MFM-Pro 5-minute Report data, the pivotal study demonstrated that for FHR, the lower limit of the 95% confidence interval (CI) of the lower agreement bound was -6.80 bpm, and the upper limit of the 95% CI of the upper agreement bound was 7.19 bpm. For MHR, the lower limit of the 95% CI of the lower limit of agreement was -2.00 bpm, and the upper limit of the 95% CI of the lower limit of agreement was 2.93 bpm. These values were within the pre-defined acceptable range of LoA for this pivotal study.
The pivotal results demonstrate that Bloomlife MFM-Pro accuracy is acceptable and comparable to the CTG comparator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For FHR, the lower limit of the 95% confidence interval (CI) of the lower agreement bound was -6.80 bpm, and the upper limit of the 95% CI of the upper agreement bound was 7.19 bpm. For MHR, the lower limit of the 95% CI of the lower limit of agreement was -2.00 bpm, and the upper limit of the 95% CI of the lower limit of agreement was 2.93 bpm.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA 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.
February 13, 2023
Bloom Technologies NV % Roberto Cunha Head of Regulatory and Compliance Bloomlife, Inc. 181 2nd Street San Francisco, CA 94105
Re: K222327
Trade/Device Name: Bloomlife MFM-Pro Regulation Number: 21 CFR§ 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: II Product Code: HGM Dated: December 31, 2022 Received: January 6, 2023
Dear Roberto Cunha:
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222327
Device Name Bloomlife MFM-Pro
Indications for Use (Describe)
Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later.
It is to be used by healthcare professionals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.
Bloomlife MFM-Pro is not intended for use in critical care situations or those patients hospitalized for or suspected to have preterm labor.
Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non- stress testing).
| 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)
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K22327 Page 1 of 6
510(k) Summary - K222327
1. Submitter Information
| Applicant: | Bloom Technologies NV
Phone: (561) 305-9029 |
|------------|------------------------------------------------|
| Address: | Schiepse Bos 6
3600 Genk
Belgium |
2. Correspondent Information
| Contact: | Roberto Cunha
Bloomlife Inc. |
|----------|---------------------------------|
| Phone: | (561) 305-9029 |
| Email: | roberto@bloom-life.com |
-
- Date prepared: February 13, 2023
4. Device Information
| Device Name: | Bloomlife MFM-Pro |
|---|---|
| Common Name: | Maternal-Fetal Monitor |
| Regulation Number: | 21 CFR 884.2740, |
| Regulation Name: | Perinatal monitoring system and accessories. |
| Product Code: | HGM (System, Monitoring, Perinatal) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | Sense 4 Baby System, Model B- |
|---|---|
| 510(k) Number: | K132918 |
| Manufacturer: | SENSE4BABY Inc. |
The predicate device has not been subject to a design-related recall.
6. Device Description
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate (FHR) and maternal heart rate (MHR) during the antepartum period on pregnant women with a singleton pregnancy at 32 weeks gestation or later. The healthcare professional applies the device to the patient and uses Bloomlife MFM-Pro to generate the Bloomlife MFM-Pro report that provides 5 minutes of fetal heart rate (FHR) and maternal heart rate (MHR) monitoring to the clinic. A typical Bloomlife MFM-Pro session is expected to take 12 minutes; approximately 7 minutes to perform system quality checks and 5 minutes to record data. Signal quality checks continue during recording to ensure data quality.
4
Bloomlife MFM-Pro consists of three main components: the Bloomlife Sensor, the Bloomlife App, and the Bloomlife Cloud.
The Bloomlife Sensor measures biopotential signals picked up on the abdominal surface using electrodes and transfers the data to the Bloomlife App via Bluetooth Low Energy.
The Bloomlife App is used by a healthcare professional to enter patient information, start'stop recording sessions, and get feedback on data quality and recording status during a recording. The App does not process or visualize data; it acts as a gateway for the raw data measured by the sensor.
The Bloomlife Cloud receives the data from the app, stores and processes the data into a Report, which is provided to the clinic via electronic fax. The Cloud Algorithm extracts the maternal heart rate from 50 bpm to 240 bpm within ±7 beats per minute, and fetal heart rate from 50 bpm to 240 bpm within ±10 beats per minute at a sample rate of 4 samples per second.
7. Indications For Use
Bloomlife MFM-Pro is indicated for monitoring of maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period for singleton pregnancies 32 weeks gestation or later.
It is to be used by healthcare professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.
Bloomlife MFM-Pro is not intended for use in critical care situations or in laboring patients or those patients hospitalized for or suspected to have preterm labor.
Bloomlife MFM-Pro is not intended to be used for antepartum monitoring (e.g., non-stress testing).
8. Comparison of the Subject and Predicate Device Intended Use and Technological Characteristics
| Feature | Proposed Device | Primary Predicate Device |
|---|---|---|
| Device name | Bloomlife MFM-Pro | Sense 4 Baby System, Model B+ |
| 510(k) Number | K222327 | K132918 |
| Manufacturer | Bloom Technologies NV | Sense4Baby. Inc. |
| Classification | 884.2740 | 884.2740 |
| Classification | ||
| Name | Perinatal monitoring system | |
| and accessories | Perinatal monitoring system and | |
| accessories | ||
| Device Type | Maternal-Fetal Monitor | Maternal-Fetal Monitor |
| Product Code | HGM | HGM |
| Intended Use/ | ||
| Indications for use | Bloomlife MFM-Pro is | |
| indicated for monitoring of | ||
| maternal heart rate (MHR) | ||
| and fetal heart rate (FHR) | ||
| during the antepartum period | ||
| for singleton pregnancies 32 | ||
| weeks gestation or later. | ||
| It is to be used by healthcare | ||
| professionals in hospitals, | ||
| clinics, physicians' offices, | ||
| antepartum rooms, and in the | ||
| patient's home on the order | ||
| of a physician. | ||
| Bloomlife MFM-Pro is not | ||
| intended for use in critical | ||
| care situations or in laboring | ||
| patients or those patients | ||
| hospitalized for or suspected | ||
| to have preterm labor. | ||
| Bloomlife MFM-Pro is not | ||
| intended to be used for | ||
| antepartum monitoring (e.g., | ||
| non- stress testing). | The Sense4Baby System Model | |
| B+ is indicated for monitoring of | ||
| maternal and fetal physiologic | ||
| parameters during the antepartum | ||
| period. It is to be used by | ||
| healthcare professionals in | ||
| hospitals, clinics, physicians' | ||
| offices, antepartum rooms, and in | ||
| the patients' home on the order of | ||
| a physician. | ||
| Intended patient | ||
| population | Pregnant women ≥32 | |
| gestational weeks | Pregnant women ≥24 gestational | |
| weeks | ||
| Prescription use | For medical personnel on the | |
| order of physician | For medical personnel on the order | |
| of physician | ||
| Patient interface | Maternal abdomen connected | |
| to surface ECG-like | ||
| biopotential sensors | Maternal abdomen | |
| connected to sensor with | ||
| Piezo-electric crystals | ||
| Environment of | ||
| use | Health care setting or home | Health care setting or home |
| Data Collected | Fetal heart rate, maternal heart | |
| rate | Fetal heart rate, maternal heart rate, | |
| uterine activity | ||
| Sterility | Provided non-sterile | Provided non-sterile |
| Use / Reuse | Reusable | Reusable |
| Technology | ||
| Employed | Transabdominal | |
| electrocardiography signals | Pulsed Doppler Ultrasound | |
| Relative pressure sensor | ||
| (tocodynamometer) | ||
| Monitoring Report | 5 minutes | 30 minutes |
| Information | ||
| Displayed On | Report via electronic fax | Web based portal |
| Power Source | Rechargeable battery | Rechargeable battery |
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6
Table 1. Comparison of new device to predicate device
The subject and predicate device have different indications for use statement, but have the same intended use - to monitor maternal heart rate (MHR) and fetal heart rate (FHR) during the antepartum period. The predicate device is indicated for use for both fetal/maternal heart rate monitoring and uterine activity monitoring, whereas the subject device is indicated for fetal/maternal heart rate monitoring only. However, as both the subject and predicate device are intended to be used for fetal/maternal heart rate monitoring, the lack of uterine activity monitoring does not raise different questions of safety and effectiveness as it pertains to the function of the device. In addition, the subject device is intended to be used for a maximum of 12 minutes (7 minutes to perform quality checks and 5 minutes to record data), rather than 30 minutes as indicated for the predicate device. This is not a new intended use, as both the subject and predicate device are used to document fetal and maternal heart rate activity.
The subject and predicate device have different technological characteristics, including different patient interfaces, data outputs, methods of display, sensors, hardware, and length of monitoring reports. The different technological characteristics do not raise different questions of safety and effectiveness and can be addressed through performance testing.
9. Performance Data
Non-Clinical Performance Data
The following non-clinical performance data were provided to support substantial equivalence to the predicate device:
- . Electronic testing
- o Electrical safety testing (IEC 60601-1), including external defibrillation safety testing
7
- Electrical safety testing Usability (IEC 60601-1-6) о
- Electrical safety testing Home Healthcare Environment (IEC 60601-1-11) o
- Electromagnetic testing (IEC 60601-1-2) O
- Heart rate processing, measurement and immunity to electromagnetic interference о (IEC 60601-2-27 and IEC 606001-2-47)
- Battery safety (IEC 62133-2) O
- ECG Trunk Cables and Patient Leadwires (ANSI AAMI EC53) O
- Electrical interface and electronic parts testing o
- o Bluetooth functionality
- o Hardware testing for relevant use cases
- Wireless Coexistence (ANSI C63.27, AAMI TIR69) ●
- Functional system testing, including hardware and software .
- Shipping testing (ASTM D4169-16)
- Software verification and validation based on the recommendations of the 2005 guidance . document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices":
- · Software cybersecurity assessment/testing based on FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", October 2014.
- · Cleaning and disinfection information based on the recommendations of the 2015 guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- · Biocompatibility testing per the recommendations of the 2020 guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process" as follows:
- Cytotoxicity ISO 10993-5:2009/2014 o
- o Sensitization - ISO 10993-10:2010
- Irritation ISO 10993-10:2010 o
- · Use-Life testing of the Bloomlife MFM Pro reusable components to support 5-year use-life. Testing was conducted by conditioning the device (repeat charge/discharge cycles) to ensure functionality at the end of stated use-life period.
- Human Factors testing per the recommendations of the 2016 guidance document "Applying . Human factors and Usability Engineering to Medical devices".
Clinical Performance Data
The pivotal study was performed to demonstrate that Bloomlife MFM-Pro performs appropriately for its intended use. The pivotal study was started after design freeze and complete device verification of Bloomlife MFM-Pro.
8
The clinical study was conducted at two clinical sites in the USA. Female subjects aged > 18 years, with a singleton pregnancy, gestational age > 32 weeks and 0 days, and who signed the informed consent were included in the study. Participants were equipped with Bloomlife MFM-Pro and the Philips Avalon FM30, which was used as a "standard of cardiotocograph (CTG) monitoring device comparator. Only one recording per participant was allowed. The Bloomlife MFM-Pro 5minute Report data was used for the analysis.
Ninety-six (96) participants were included in the pivotal study. Sixty-one (61) participants were enrolled in the study and fifty-six (56) were included for analysis (full analysis set, FAS). The study population covered a wide range of gestational ages, from 32 weeks to full term gestation. More than half of the participants in the FAS population had a gestational age lower or equal to 36 weeks of gestation. More than half of the participants in the FAS population had a pre-pregnancy BMI greater or equal to 30 and were considered obese.
Using Bland-Altman Limits of Agreement (LoA) calculated on the MFM-Pro 5-minute Report data, the pivotal study demonstrated that for FHR, the lower limit of the 95% confidence interval (CI) of the lower agreement bound was -6.80 bpm, and the upper limit of the 95% CI of the upper agreement bound was 7.19 bpm. For MHR, the lower limit of the 95% CI of the lower limit of agreement was -2.00 bpm, and the upper limit of the 95% CI of the lower limit of agreement was 2.93 bpm. These values were within the pre-defined acceptable range of LoA for this pivotal study.
The pivotal results demonstrate that Bloomlife MFM-Pro accuracy is acceptable and comparable to the CTG comparator.
10. Conclusion
The results of the performance testing described above demonstrate that the Bloomlife MFM-Pro is as safe and effective as the predicate device and supports a determination of substantial equivalence.