(271 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as using a pre-programmed algorithm based on Pulse Wave Transit Time (PWTT), which is a traditional signal processing technique, not AI/ML.
No
The device is a noninvasive blood pressure monitor designed for collecting and tracking pulse rate and blood pressure data, not for providing therapy or treatment.
Yes
The device measures and tracks blood pressure and pulse rate, providing data for review by healthcare professionals to assess physiological conditions.
No
The device description explicitly states that the Biobeat BB-613-BPM includes a "sensor device that is attached to the patient's chest to collect physiological data" and uses "a light source (LEDs), and sensor array on the backside of the device" to measure physiological parameters. This indicates the presence of physical hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Biobeat BB-613-BPM is a noninvasive device that measures physiological parameters (blood pressure and pulse rate) directly from the patient's body using light reflectance technology. It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring blood pressure and pulse rate in adults by healthcare professionals and patients, not for analyzing biological samples for diagnostic purposes.
The device is a medical device, specifically a noninvasive blood pressure monitor, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.
Product codes
DXN, DXG, DQA, DRG
Device Description
The Biobeat BB-613-BPM includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes. In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest-patch attached to the skin
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare professionals and patients in hospitals, clinics, long-term care and at home.
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 Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including Software validation per FDA guidance, General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff (January 11, 2002).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement Range, PR/HR: 40 to 250 bpm
Arms, PR: ±3%
Measurement Range, BP: 60 - 220 for SBP, 40 - 110 for DBP
Accuracy blood pressure: ±5 mmHg
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 14, 2025
BioBeat Technologies Ltd. % John Smith Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20003
Re: K241066
Trade/Device Name: BB-613-BPM Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 18, 2024 Received: April 18, 2024
Dear John Smith:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Robert T. Kazmierski -S
for
LCDR Stephen Browning 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
3
Indications for Use
510(k) Number (if known) K241066
Device Name BB-613-BPM
Indications for Use (Describe)
The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires callbration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K241066
510(k) SUMMARY
Biobeat Technologies Ltd.'s Biobeat BB-613-BPM
Submitter:
Biobeat Technologies Ltd. 22 Efal Street Petah Tikva lsrael 4951122
Phone: +972 3 933 3022 Facsimile: +972 77 460 1636
Contact Person: Johanan May
Date Prepared: January 14, 2025
Name of Device: Biobeat BB-613-BPM
Common or Usual Name: Noninvasive Blood Pressure Measurement System
Classification Name/Product Code:
- 870.1130 Noninvasive blood pressure measurement system, DXN ●
- 870.1435 Computer, Diagnostic, Pre-Programmed, Single-Function, DXG ●
- 870.2700 Oximeter, DQA ●
- 870.2910 Radiofrequency physiological signal transmitter and receiver, DRG .
Requlatory Class: Class II
Predicate Devices
BB-613 WP (K190792) Biobeat Platform-2 (K222010)
System Description
The Biobeat BB-613-BPM includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes.
In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.
5
Indications for Use
The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDAcleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.
Summary of Technological Characteristics
The subject and predicate devices are all intended to measure and display blood pressure. The subject device uses identical technology (i.e., the same sensor units and algorithms) for measuring pulse rate and blood pressure compared to the predicate devices cleared in K190792 (BB-613 WP - wrist and patch devices) and K222010 (Biobeat Platform-2), also manufactured by Biobeat. Both these predicates and the subject devices are skin attached devices intended to collect the data. In addition to the predicate devices, an updated software was added for the 24-hour measuring of blood pressure.
There have been no physical modifications to the BB-613-BPM Patch itself as compared to the versions cleared in K190792 and K222010.
The subject device is supplied and used non-sterile, just like the predicate devices. The subject device uses software to control the device and display the results. The new software elements have been documented and validated per FDA guidance. The subject device contains electronics that present an electrical hazard and EMC risks. As the electronic components are identical to the predicate devices cleared in K190792 and K222010, repeated EMC or safety testing was not needed.
In sum, although there are minor differences in the technological characteristics, these differences do not raise different questions of safety or effectiveness, and the provided testing establishes equivalent performance as compared to the predicate devices.
6
| Device (K
number) | Subject Device
Biobeat BB-613-
BPM Patch | Predicate Device
Biobeat
Platform-2
(K222010) | Predicate Device
BB-613 WP
(K190792) | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for
use | The Biobeat BB-613-
BPM is a noninvasive
24-hour blood pressure
monitor which provides
a notification to the user
every 15 minutes over a
24 hour period for user-
initiated measurements.
It includes a device and
a platform (BPM) for use
in adults by healthcare
professionals, for
collection of pulse rate
and tracking changes in
blood pressure based
on Pulse Wave Transit
Time (PWTT) in
hospitals, clinics, long-
term care and at home.
The BB-613-BPM tracks
changes in blood
pressure and requires
calibration using an
FDA-cleared
oscillometric blood
pressure monitor. The
data from the Biobeat
BB-613-BPM can be
accessed through the
Biobeat platform for
review by a healthcare
professional or can be
downloaded as a report.
The device is not
intended to be used on
critical care patients. | The Biobeat Platform-2
is a wireless
noninvasive remote
monitoring system
intended for use by
healthcare professionals
for spot check collection
of physiological data in
home and healthcare
settings. This can
include, functional
oxygen saturation of
arterial hemoglobin
(%SpO2), pulse rate,
blood pressure,
respiration rate (RRp),
hemodynamic
parameters (stroke
volume, cardiac output),
and body temperature.
The Biobeat Platform-2
tracks changes in blood
pressure based on
Pulse Wave Transit
Time (PWTT) which is
obtained utilizing pulse
measurements from the
integrated SpO2 sensor,
following a calibration
process using an FDA-
cleared oscillometric
blood pressure monitor.
The Biobeat Platform-2
is intended for spot-
checking and tracking
changes of adult
patients in hospitals,
clinics, long-term care,
and at home. The data
from the Biobeat
Platform-2 are intended
for use by healthcare
professionals as an aid
to diagnosis and
treatment. The device is
not intended for use on
critical care patients. | The BB-613 WP is a
wrist-worn or skin
attached device
indicated for use in
measuring and
displaying functional
oxygen saturation of
arterial hemoglobin
(%SpO2) and pulse
rate.
The BB-613WP can
also track changes in
blood pressure based
on Pulse Wave Transit
Time (PWTT) which is
obtained utilizing pulse
measurements from the
integrated SpO2 sensor,
following a calibration
process using
oscillometric blood
pressure monitor.
The BB-613WP is
intended for spot
checking of adult
patients in hospitals,
clinics, long-term care,
and home use. | |
| Use Population | Adults | Adults | Adults | |
| BIOBEAT Technologies LTD. | | K241066 | Biobeat BB-613-BPM | |
| Device (K
number) | Subject Device
Biobeat BB-613-
BPM Patch | Predicate Device
Biobeat
Platform-2
(K222010) | Predicate Device
BB-613 WP
(K190792) | |
| Use
Environment | Hospitals, clinics, long-
term care, and home use | Hospitals, clinics, long-
term care, and home use | Hospitals, clinics, long-
term care, and home use | |
| Monitoring | Spot-checking | Spot-checking | Spot-checking | |
| Device
(K number) | Subject Device
Biobeat BB-613-
BPM Patch | Predicate Device
Biobeat
Platform-2
(K222010) | Predicate Device
BB-613 WP
(K190792) | |
| Principle of
Operation | Pulse reflectance
technology, four LED (red
- IR) and photo diode
absorbs reflected light.
Tracking changes of blood
pressure is done by pulse
wave transit time (PWTT)
which is obtained utilizing
pulse measurements from
the integrated skin
attached SpO2 sensor. | Pulse reflectance
technology, four LED (red - IR) and photo diode
absorbs reflected light.
Tracking changes of blood
pressure is done by pulse
wave transit time (PWTT)
which is obtained utilizing
pulse measurements from
the integrated skin
attached SpO2 sensor.
RRp measured by | Pulse reflectance
technology, four LED (red - IR) and photo diode
absorbs reflected light.
Tracking changes of blood
pressure is done by pulse
wave transit time (PWTT)
which is obtained utilizing
pulse measurements from
the integrated skin
attached SpO2 sensor. | |
| | | analyzing cyclic variations
in the
photoplethysmogram due
to respiration.
Body temperature
measured with
thermistors. | | |
| Outputs | Pulse Rate (PR)
Blood Pressure (BP) | Oxygen Saturation
(SpO2)
Pulse Rate (PR)
Blood Pressure (BP)
Respiration Rate (RRp)
Body Temperature
Hemodynamic
parameters including:
Cardiac Output (CO)
Stroke Volume (SV) | Oxygen Saturation
(SpO2)
Pulse Rate (PR)
Blood Pressure (BP) | |
| Measurement
site | Chest-patch attached to
the skin | Chest-patch attached to
the skin | Wrist watch or Chest-patch
attached to the skin | |
| Body
attachment
method | Adhesive patch | Adhesive patch | Wrist watch or Adhesive
patch | |
| Measurement
type | Spot | Spot | Spot | |
| Emitted light
peak
wavelength | 880nm (IR), 650nm
(Red) | 880nm (IR), 650nm
(Red) | 880nm (IR), 650nm
(Red) | |
Table 7.1: Comparison of Intended Use
7
8
| Table 7.2: Comparison of Technological Characteristics: | ||||
|---|---|---|---|---|
| Device | ||||
| (K number) | Subject Device | |||
| Biobeat BB-613- | ||||
| BPM Patch | Predicate Device | |||
| Biobeat | ||||
| Platform-2 | ||||
| (K222010) | Predicate Device | |||
| BB-613 WP | ||||
| (K190792) | ||||
| Measurement | ||||
| Range, | ||||
| PR/HR | 40 to 250 bpm | 40 to 250 bpm | 40 to 250 bpm | |
| Arms, PR | ±3% | ±3% | ±3% | |
| Measurement | ||||
| Range, BP | 60 - 220 for SBP, | |||
| 40 - 110 for DBP | 0 - 299 mmHg | 0 – 299 mmHg | ||
| Accuracy | ||||
| blood | ||||
| pressure | ±5 mmHg | ±5 mmHg | ±5 mmHg | |
| Single use | Yes | Yes | Skin patch - Yes | |
| Wrist watch - No | ||||
| Wireless BLE | Yes | Yes | Yes | |
| Operation | ||||
| time | 24 hours | 120 hours | 120 hours | |
| Contact | ||||
| material | Polycarbonate, | |||
| photodiode window, | ||||
| silicone, adhesive unit | Polycarbonate, | |||
| photodiode window, | ||||
| silicone, adhesive unit | Polycarbonate, photodiode | |||
| window, silicone, adhesive | ||||
| unit for the skin patch | ||||
| Application | ||||
| Method | The device is attached | |||
| to the chest skin using a | ||||
| biocompatible adhesive | ||||
| unit | The device is attached to | |||
| the chest skin using a | ||||
| biocompatible adhesive | ||||
| unit | The device is attached to | |||
| the chest skin using a | ||||
| biocompatible adhesive | ||||
| unit or to the wrist using a | ||||
| silicone band | ||||
| Sterility | Supplied and used non- | |||
| sterile | Supplied and used non- | |||
| sterile | Supplied and used non- | |||
| sterile | ||||
| Data display | Handheld display unit | |||
| (e.g., tablet) running the | ||||
| Biobeat software | Handheld display unit | |||
| (e.g., tablet) running the | ||||
| Biobeat software | Handheld display unit (e.g. | |||
| tablet) running the Biobeat | ||||
| software | ||||
| Data storage | Yes, but can transmit the | |||
| data to a handheld | ||||
| device for storage and | ||||
| analysis | Yes, but can transmit the | |||
| data to a handheld device | ||||
| for storage and analysis | Yes, but can transmit the | |||
| data to a handheld device | ||||
| for storage and analysis |
9
10
Performance Data
The Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including:
- . Software validation per FDA guidance, General Principles of SoftwareValidation; Final Guidance for Industry and FDA Staff (January 11, 2002)
Conclusions
The Biobeat BB-613-BPM is as safe and effective as its predicate devices. The minor technological differences between the Biobeat BB-613-BPM and its predicate devices cleared in K190792 and K222010, namely adding notifications to the user to allow for 24-hour, patient initiated measurements, raise no new issues of safety or effectiveness. Performance data demonstrate that the Biobeat BB-613-BPM is as safe and effective as the predicates. Thus, the Biobeat BB-613-BPM is substantially equivalent.