(475 days)
Not Found
No
The description focuses on standard pulse oximetry technology using optical sensors and light absorption principles. There is no mention of AI, ML, or any related techniques for data processing or interpretation.
No.
The intended use of the device is for spot-check and/or continuous data collection of oxygen saturation and pulse rate, not for providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)". The collection of this physiological data provides information about a patient's health status, which is a key characteristic of a diagnostic device. While it doesn't state it diagnoses a specific disease, it provides data essential for diagnosis.
No
The device description clearly details physical hardware components, including an optical sensor, LEDs, a spring mechanism, and an elastic structure, which are integral to its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Circul™ pro Ring Function: The circul™ pro Ring is a non-invasive device that measures oxygen saturation and pulse rate directly from the body through the index finger. It does not examine specimens derived from the human body in vitro.
The device description and intended use clearly indicate that it is a pulse oximeter, which is a type of medical device used for physiological monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs:
- Red: with a wavelength of 660 nm ± 10 nm
- Infrared: with a wavelength of 940 nm ± 20 nm
The wavelength beyond this range has a certain impact on the accuracy of the measurement results. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
index finger
Indicated Patient Age Range
adult patients
Intended User / Care Setting
home environments
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
A clinical study was performed per clause 201.12.1 of ISO 80601-2-61:2017, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The study enrolled a total of twelve subjects, four of which had dark pigmentation (33.3%). In the study, the subjects' blood oxygen saturation was measured using the circul pro Ring and the values were then compared with arterial saturation values recorded by a Blood Oxygen, Electrolyte, and Metabolite Analyzer.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing:
Study Type: Clinical study per clause 201.12.1 of ISO 80601-2-61:2017
Sample Size: 12 subjects (4 with dark pigmentation)
Standalone Performance: The Accuracy Root Mean Square (ARMS) of the blood oxygen saturation measured by the circul pro Ring was 1.85%, within the range of
§ 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).
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2023
BodiMetrics, LLC % Michael Nilo President & Prinicipal Consultant Nilo Medical Consulting Group, LLC 3491 Denny Street Pittsburgh, Pennsylvania 15201
Re: K221361
Trade/Device Name: circul™ pro Ring Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: August 11, 2023 Received: August 14, 2023
Dear Michael Nilo:
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
1
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 (OS) 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, Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
D-2
510(k) Number (if known) K221361
Device Name circul™ pro Ring
Indications for Use (Describe)
The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/ or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
This 510(k) Summary was prepared in accordance with 21 CFR 807.92
Date Prepared 1.
December 2022
Submitter 2.
| Applicant: | BodiMetrics, LLC
1601 N. Sepulveda Blvd, Suite 839
Manhattan Beach, CA 90266 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Mark Goettling
CEO, CFO, and Co-Founder
Phone: (818) 268-6828
Email: mgoettling@bodimetrics.com |
| Application
Correspondent: | Michael Nilo
President and Principal Consultant, Nilo Medical Consulting Group
Phone: (717) 421-4396
Email: michael.nilo@nilomedicalconsulting.com |
3. Proposed Device Information
| Trade Name: | circul TM pro Ring |
|---|---|
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter |
| Regulation No.: 21 CFR 870.2700 | |
| Product Code: DQA | |
| Class: II |
4. Predicate Device Information
| Trade Name: | Belun Ring BLR-100X |
|---|---|
| 510(k) Number: | K211407 |
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter |
| Regulation No.: 21 CFR 870.2700 | |
| Product Code: DQA | |
| Class: II |
4
| Trade Name: | Oxiband (Checkme) O2 Pulse Oximeter |
|---|---|
| 510(k) Number: | K191088 |
| Common Name: | Oximeter |
| Device Classification: | Name: Oximeter |
| Regulation No.: 21 CFR 870.2700 | |
| Product Code: DQA | |
| Class: II |
Reference Device Information ട്.
6. Device Description
The circul™ pro Ring is a small, wearable, non-invasive, wireless device that the user wears on one finger. The ring features an adjustable fit (by means of multiple ring sizes (S, L, XL) and a spring fit) for comfort and can be worn on any finger on either hand. The circul pro Ring relies on an optical sensor to detect oxygen saturation (SpO2) and pulse rate (PR). The sensor uses two wavelengths of LEDs:
- Red: with a wavelength of 660 nm ± 10 nm
- Infrared: with a wavelength of 940 nm ± 20 nm ●
The wavelength beyond this range has a certain impact on the accuracy of the measurement results. The blood oxygen percentage is calculated based on measuring the passage of the two wavelengths of light (with different absorption rates) through the body, also known as Reflective Oximetry. The integrated sensor technology works to determine the blood oxygen content by determining the light absorption when the skin is illuminated. The circul pro Ring features a spring mechanism, and the elastic structure of the embedded sensor and inner arch of the ring are ergonomically shaped to offer a snug fit, preventing it from slipping off the finger, stabilizing the sensor on the 'belly' of the finger, and minimizing twisting of the ring on the wearer's finger. This also helps to reduce the likelihood of poor SpO2 readings in patients with darker skin pigments.
7. Indications for Use
The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
5
Comparison of Technical Characteristics with the Predicate Device 8.
| Comparison Element | Subject Device
circul pro Ring | Predicate Device
Belun Ring BLR 100X | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic Elements | | | | |
| Product Name | Pulse Oximeter | Pulse Oximeter | Pulse Oximeter | Identical |
| Manufacturer | Hangzhou Megasens
Technology Company,
Ltd. | Belun Technology
Company Ltd. | Shenzen Viatom
Technology Co., Ltd. | N/A |
| FDA 510(k) Document
Number | K221361 | K211407 | K191088 | N/A |
| Regulation Number | 870.2700 | 870.2700 | 870.2700 | Identical |
| Classification | II | II | II | Identical |
| Classification Name | Oximeter | Oximeter | Oximeter | Identical |
| Product Code | DQA | DQA | DQA | Identical |
| Comparison Element | Subject Device | Predicate Device | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
| | circulTM pro Ring | Belun Ring BLR 100X | | |
| Intended Use | The circulTM pro Ring is a
wireless, non-invasive, and
stand-alone pulse oximeter
intended to be used for
spot-check and/or
continuous data collection
of oxygen saturation of
arterial hemoglobin (SpO2)
and pulse rate (PR) through
the index in adult patients.
It can be used in hospitals
and home environments for
up to twelve hours in non-
motion and well perfused
conditions. It is not
intended for single-use and
out-of-hospital transport
use and does not have
alarms. | Belun Ring BLR-100X is a
wireless, non-invasive and
stand-alone pulse oximeter
intended to be used for
continuous data collection
and recording of oxygen
saturation of arterial
hemoglobin (SpO2) and the
pulse rate of adult patients
through index finger in
hospital and home
environment for up to ten
hours, during no motion
and motion conditions, and
for patients who are well or
poorly perfused. It is not
intended for single-use and
out-of-hospital transport
use and does not have
alarms. | The Oxiband Pulse
Oximeter is a wrist pulse
oximeter indicated for use
in measuring, displaying,
storing and transmitting
functional oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate for adult patients.
It is intended for spot-check
and/or continuous data
collection, and not
continuous monitoring. It
can be used in sleep labs,
long-term care, hospitals
and home use. | Substantially Equivalent
Both the subject and predicate device share the
indication for collection of oxygen saturation or
arterial hemoglobin (SpO2) and pulse rate (PR)
through the index finger and are therefore considered
substantially equivalent.
The subject device's indication statement reflects its
functionality, in that the subject device is not intended
for motion conditions. Use of the subject device for
up to twelve hours is supported by testing which
demonstrated safe and effective performance under
these conditions. Also, the performance of the subject
device was not evaluated in poorly perfused subjects
and the indication reflects this. The subject device is
used for spot-check or continuous data collection, and
not continuous monitoring whereas the predicate
device is indicated for continuous data collection. The
subject device shares the same indication as the
legally marketed reference device for use conditions
and is therefore considered substantially equivalent.
Although the subject device proposes a longer
performance window and does not seek indication for
motion or poorly perfused conditions relative to the
predicate device, the differences in the proposed
indication does not raise different questions of safety
or effectiveness as the performance of the subject
device is adequately supported by test data. |
| Technology | | | | |
| Technology Type | Reflective Light | Reflective Light | Reflective Light | Identical |
| Intended Application Site | Finger | Finger | Finger | Identical |
| Comparison Element | Subject Device
circul pro Ring | Predicate Device
Belun Ring BLR 100X | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
| Measurement Wavelength | | | | |
| Red | $660 nm \pm 10 nm$ | $658 nm \pm 2 nm$ | Not Reported | Substantially Equivalent |
| Infrared | $940 nm \pm 20 nm$ | $886 nm \pm 6 nm$ | Not Reported | Although the measurement wavelengths of the subject
and predicate device differ slightly, the ability of the
subject device to perform accurate measurements was
confirmed by meeting the requirements ISO 80601-2-
61 as well as a clinical validation which included
darkly pigmented subjects. Therefore, the minor
differences between the measurement wavelength of
the subject and predicate devices do not raise different
questions of safety or effectiveness. |
| Performance | | | | |
| Interface | Bluetooth (BLE 4.1) | • USB
• Bluetooth | Bluetooth | Substantially Equivalent |
| User Interface | Via mobile application | Via host program interface | Not reported | Substantially Equivalent
The user interface of the subject and predicate device
are similar, and the ability of the subject device to
perform and report accurate measurements was
confirmed by meeting the requirements ISO 80601-2-
61 as well as a clinical validation. Therefore, the
minor differences between the subject and predicate
device interfaces do not raise different questions of
safety or effectiveness. |
| Battery | 3.7 V Lithium Battery | 3.7 V Lithium Battery | Lithium Rechargeable
Battery | Substantially Equivalent |
| Power Supply
Requirement | 5 V DC (minimum) | 3.1 V - 4.2 V DC | Not reported | Substantially Equivalent
The differences in power supply requirements do not
raise different questions of safety or effectiveness. |
| Comparison Element | Subject Device
circul pro Ring | Predicate Device
Belun Ring BLR 100X | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
| SpO2 Measurement
Range | 70% - 100% | 70% - 100% | Not reported | Substantially Equivalent
The SpO2 measurement range of the subject device is
similar to the SpO2 measurement range of the
predicate and reference devices. The SpO2
measurement of the subject device meets the
requirements of the ISO 80601-2-61. |
| SpO2 Accuracy | $\pm$ 3.5% (SpO2 within 70% -
100% range) | $\pm$ 2.7% | 70% - 100%: $\pm$ 2%
(Arms:1.88)
70%-80%: $\pm$ 3%
80%-90%: $\pm$ 2%
90%-100%: $\pm$ 2%
0%-69%: not defined | Substantially Equivalent
The SpO2 measurement accuracy of the subject
device is similar to the SpO2 measurement accuracy
of the predicate and reference devices. The SpO2
measurement of the subject device meets the
requirements of the ISO 80601-2-61, so the difference
does not affect the safety and effectiveness of the
subject device. |
| PR Measurement Range | 30 bpm – 240 bpm | 30 bpm – 250 bpm | 30 bpm – 250 bpm | Substantially Equivalent
The PR measurement range of the subject device is
similar to the PR measurement range of the predicate
and reference devices. The PR measurement of the
subject device meets the requirements of the ISO
80601-2-61, so the difference does not affect the
safety and effectiveness of the subject device. |
| PR Accuracy | $\pm$ 2% or $\pm$ 2 bpm,
whichever is greater | $\pm$ 2.5bpm or $\pm$ 2%, which is
larger | $\pm$ 2bpm or $\pm$ 2%, whichever
is greater | Substantially Equivalent
The PR measurement accuracy of the subject device
is within the range of the predicate and reference
devices. The PR measurement accuracy of the subject
device meets the requirements of ISO 80601-2-61, so
any minor differences do not raise new questions of
safety or effectiveness. |
| Atmospheric Pressure | 70 kPa - 106 kPa | 70 kPa - 106 kPa | 70 kPa – 106 kPa | Identical |
| Comparison Element | Subject Device
circul pro Ring | Predicate Device
Belun Ring BLR 100X | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
| Operating Temperature | 5°C - 40°C | 10°C - 38°C | 5°C - 40°C | Substantially Equivalent
The operating temperature of the subject device is
identical to the reference device, which is a wider
range than the predicate device. The subject device
met the requirements of IEC 60601-1, IEC 60601-1-
11, and ISO 80601-2-61. The difference in operating
temperature between the subject and predicate device
does not raise new questions of safety or
effectiveness. |
| Relative Humidity | 30% - 80%
(non-condensing) | ≤ 75% | 10% - 95% | Substantially Equivalent
The relative humidity of the subject device falls
within the range of the reference device. The subject
device met the requirements of IEC 60601-1, IEC
60601-1-11, and ISO 80601-2-61. The difference in
relative humidity between the subject and predicate
device does not raise new questions of safety or
effectiveness. |
| Storage Environment | -10°C - 50°C Temperature
15% - 95% Relative
Humidity (non-condensing)
70 kPa - 106 kPa
Atmospheric Pressure | -10°C - 60°C Temperature
10% - 95% Relative
Humidity
50 kPa - 106 kPa
Atmospheric Pressure | -25°C - 70°C | Substantially Equivalent
The storage environment conditions of the subject
device fall within the range of the subject and
reference devices and are expressed in the device
labeling.
The subject device met the requirements of IEC
60601-1, IEC 60601-1-11, and ISO 80601-2-61. The
difference in storage conditions between the subject
and predicate device does not raise new questions of
safety or effectiveness. |
| IP Classification | IP65 | IP22 | Not Reported | Substantially Equivalent
The subject device met the requirements of ISO
80601-2-61. The difference in ingress protection
between the subject and predicate device does not
raise new questions of safety or effectiveness. |
| Normal Service Life | 3 Years | 3 Years | Not Reported | Identical |
| Comparison Element | Subject Device
circul pro Ring | Predicate Device
Belun Ring BLR 100X | Reference Device
Oxiband (Checkme) O2
Pulse Oximeter | Comments |
| Contacting Materials | Stainless Steel, PC | TPE, PC | Not Reported | Substantially Equivalent
The subject device met the requirements of ISO
10993 testing for skin-contacting materials.
Therefore, the difference in contacting materials does
not raise new questions of safety or effectiveness. |
6
7
8
9
10
11
Performance Data 9.
Non-Clinical Testing
The proposed device was tested in accordance with both mandatory and voluntary standards, including:
- . ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- . EN 60601-1:2006+A1:2013 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
- IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: General ● requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-2+A1: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
The results of bench testing for pulse oximetry accuracy showed an acceptable accuracy of ± 3.5% SpO2 within a range of 70% - 100%. No claims are made for SpO2 accuracy under conditions of motion or low perfusion. The results of bench testing for pulse rate accuracy showed an acceptable accuracy of ± 2% or ± 2 bpm (30 bpm – 240 bpm). No claims are made for Pulse Rate accuracy under conditions of motion or low perfusion.
Software validation was performed per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The management of cybersecurity is in compliance with the FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Biocompatibility testing successfully met the requirements for the skin-contacting components of the circul pro Ring per applicable standards:
- ISO 10993-5:2009: Biological evaluation of medical devices Part 5: Tests for in ● vitro cytotoxicity
- ISO 1099-3-10:2010: Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
12
Clinical Testing
A clinical study was performed per clause 201.12.1 of ISO 80601-2-61:2017, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment. The study enrolled a total of twelve subjects, four of which had dark pigmentation (33.3%). In the study, the subjects' blood oxygen saturation was measured using the circul pro Ring and the values were then compared with arterial saturation values recorded by a Blood Oxygen, Electrolyte, and Metabolite Analyzer.
The primary endpoint of the study was the accuracy of the circul pro pulse blood oxygen saturation measurements as compared to the SaO2 measurements of the control device. The measurement error of the circul pro Ring in the range of 70% - 100% should be ≤ 3.5%. The secondary endpoints of the study were:
- . The accuracy of the pulse rate recorded by the circul pro Ring as compared to the heart rate measured by a control patient monitor (IntelliVue Patient Monitor MX500/MX550)
- . The overall device safety, operational stability, device defects, and incidence of adverse events (complications)
- Overall device safety -
- . Breaking of the connecting parts of the overall device system
- Parts loose and falling off during use, resulting in abnormal . operation
- Unable to return to normal when rebooting ●
- Other (with a description provided) .
- I Operational stability
- Unable to match the machine ●
- Poor contact during use ●
- Abnormal interruption occurring for reasons attributable to the ● machine during use
- Other (with a description provided) .
- I Device defects
- Device failures or defects (including the overall safety of the tested ● device, operational stability, and whether any failure of the tested device caused any injury to the subject) during the trial
- I Incidence of adverse events
- Where a medical oximeter is placed, the probe overheated and the . skin showed an allergic reaction
- Other (with a description provided) .
- Overall device safety -
The Accuracy Root Mean Square (ARMS) of the blood oxygen saturation measured by the circul pro Ring was 1.85%, within the range of