(210 days)
Unknown
The description mentions a "CRI™ algorithm" that compares extracted waveforms to a "reference model" to trend intravascular volume. While this could potentially involve ML, the summary does not explicitly state the use of AI, ML, or provide details about training or test sets, which are common indicators of ML use in medical devices.
No
The device is described as a non-invasive, continuous, and multi-parameter monitor that displays physiological parameters (SpO2, HR, and CRI). Its intended use is for continuous monitoring and to assess a patient's hemodynamic status, not to treat or prevent a disease or condition.
Yes
Explanation: The device is indicated for "continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate... and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia." It assesses a patient's hemodynamic status and is used by medical providers as an adjunct to traditional hemodynamic measures, which are all diagnostic activities.
No
The device description explicitly states that the CipherOx CRI™ M1 incorporates a "Nonin pulse ox sensor" and an "M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™." These are hardware components, making it a hardware and software medical device, not software-only.
Based on the provided information, the CipherOx™ CRI MI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- CipherOx™ CRI MI Function: The CipherOx™ CRI MI is a non-invasive device that measures physiological parameters (SpO2, pulse rate, and CRI) directly from the patient's finger using photoplethysmography. It does not analyze specimens derived from the body.
- Intended Use: The intended use is for continuous monitoring of physiological parameters to assess a patient's hemodynamic status, not for the examination of in vitro specimens.
Therefore, the CipherOx™ CRI MI falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.
For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings.
CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.
Product codes
PPW
Device Description
The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability.
The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status.
The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI.
The CipherOx CRI™ M1 incorporates:
-
- CRI™ algorithm
- Nonin pulse ox sensor (8000AA K080255) 2.
- a. The 8000AA is an off-the-shelf finger clip sensor. It is designed to be used with the Nonin OEM III pulse oximetry module integrated in the M1 User Interface Module.
-
- M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.
- a. It contains a color display, processor, and the Nonin OEM III internal pulse oximeter module.
- i. Nonin designed the OEM III specifically for integration into devices such as the M1. The OEM III converts analog signals from the attached finger sensor into a stream of digital data that provides heart rate, SpO2, and PPG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmograph (PPG) waveform
Anatomical Site
Digits
Indicated Patient Age Range
adults (19-36 years old)
Intended User / Care Setting
qualified medical providers / hospital and pre-hospital settings
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)
Non-clinical performance testing (Bench): Bench tests were performed and found that the CipherOx CRI M1 met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes Verification Testing and compliance testing to AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12, and IEC 80601-2-61. The results demonstrate that the devices perform as intended, are substantially equivalent to the performance of the predicate and in accordance with applicable standards.
Biocompatibility / Materials: The patient contacting materials are part of the Nonin 8000AA sensor, which has been cleared as part of K080255. The sensor used with the CipherOx CRI™ M1 is identical to the cleared device.
Clinical Testing: The clinical study determining the SpO2 accuracy for the Nonin OEM III was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2200 Adjunctive cardiovascular status indicator.
(a)
Identification. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
e.g., age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
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July 24, 2018
Flashback Technologies, Inc. Paul Dryden Consultant 80 Health Park Drive, Suite 20 Louisville, Colorado 80027
Re: K173929
Trade/Device Name: CipherOx CRI M1 Regulation Number: 21 CFR 870.2200 Regulation Name: Adjunctive Cardiovascular Status Indicator Regulatory Class: Class II Product Code: PPW Dated: June 20, 2018 Received: June 21, 2018
Dear Paul Dryden:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Shawn W. Forrest -A for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173929
Device Name
CipherOx™ CRI M1
Indications for Use (Describe)
The CipherOx™ CRI MI is indicated for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor),and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.
For patients with a finger thickness of 0.3'' to 1'' in hospital and pre-hospital settings.
CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K173929
510(k) Summary Page 1 of 7 23-Jul-18
| Company: | Flashback Technologies, Inc.
80 Health Park Drive, Suite 20
Louisville, CO 80027 |
|----------------------------|--------------------------------------------------------------------------------------------|
| Official Contact: | Dr. Greg Grudic, CO-Founder, CO-President, CTO
Phone: 720-204-2575 |
| Proprietary or Trade Name: | CipherOx CRITM M1 |
| Common/Usual Name: | Adjunctive cardiovascular status indicator |
| Classification Name: | 21 CFR 870.2200
Procode – PPW
Adjunctive cardiovascular status indicator
Class II |
| Predicate Device: | DEN160020- Flashback Technologies – CipherOx CRITM Table |
Device Description:
The CipherOx CRI™ M1 is a modification of the predicate device, the CipherOx CRI Tablet (DEN160020). The M1 is a smaller version of the Tablet that is designed for increased portability.
The CipherOx CRITM M1 is a non-invasive, continuous, and multi-parameter monitor that displays SpO2, HR, and the Compensatory Reserve Index (CRI). CRITM is a physiologic parameter that trends changes in intravascular volume, which help to assess a patient's hemodynamic status.
The CRI™ algorithm trends intravascular volume using non-invasive arterial pulsatile waveform signals by continuously comparing extracted waveforms to a reference model. CipherOx™ CRI system operates on the photoplethysmograph (PPG) waveform used in pulse oximetry to estimate CRI.
The CipherOx CRI™ M1 incorporates:
-
- CRI™ algorithm
- Nonin pulse ox sensor (8000AA K080255) 2.
- a. The 8000AA is an off-the-shelf finger clip sensor. It is designed to be used with the Nonin OEM III pulse oximetry module integrated in the M1 User Interface Module.
-
- M1 User Interface module which is a small, portable, battery powered unit that displays heart rate. SpO2, and CRI™.
- a. It contains a color display, processor, and the Nonin OEM III internal pulse oximeter module.
- i. Nonin designed the OEM III specifically for integration into devices such as the M1. The OEM III converts analog signals from the attached finger sensor into a stream of digital data that provides heart rate, SpO2, and PPG.
4
510(k) Summary Page 2 of 7 23-Jul-18
Indications for Use:
The CipherOx™ CRI M1is indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient's response to hypovolemia.
For patients with a finger thickness of 0.3" to 1" in hospital and pre-hospital settings.
CRI trends with changes in intravascular volume relative to the individual patient's response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures. CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.
Patient Population:
Based upon the validation studies - supine adults (19-36 years old) under non-motion conditions excluding patients with cardiovascular diseases.
Environment of Use:
Hospital and pre-hospital settings. a
Contraindications:
The contraindications of the CipherOx™ CRI M1
- Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients.
- This device is not defibrillation proof per IEC 60601-1. ●
Predicate Device Comparison
Table 1 - Comparison to the Predicate
| CHARACTERISTICS | Subject Device
"CipherOx CRI M1" | Predicate
"CipherOx CRI Tablet"
DEN160020 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CipherOx CRI M1 is indicated for
continuous noninvasive monitoring of
functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate (measured
by an SpO2 sensor), and the
Compensatory Reserve Index (CRI),
which trends changes in intravascular
volume relative to the individual patient's
response to hypovolemia. | The CipherOx CRI Tablet is indicated for
continuous noninvasive monitoring of
functional oxygen saturation of arterial
hemoglobin (SpO2), pulse rate (measured
by an SpO2 sensor), and the Compensatory
Reserve Index (CRI), which trends changes
in intravascular volume relative to the
individual
patient's response to hypovolemia. |
| | For patients with a finger thickness of 0.3"
to 1" in hospital and pre-hospital settings.
CRI trends with changes in intravascular
volume relative to the individual patient's
response to hypovolemia, and should only
be used by qualified medical providers as | For patients with a finger thickness of 0.3"
to 1" in hospital and pre-hospital settings.
CRI trends with changes in
intravascular volume relative to the
individual patient's response to
hypovolemia. and should only be used by |
| Type of use | Continuous | Continuous |
| Motion | Non-motion | Non-motion |
| Patient Population | adults (19-36 years old) | adults (19-36 years old) |
| Perfusion | Well | Well |
| Environment of Use | Hospital and prehospital settings | Hospital and prehospital settings |
| Technology | Transmissive | Transmissive |
| Batteries | 1.5V AAA batteries | 3400Wh Lithium Ion Battery |
| Characteristics | | |
| SpO2 Display Range | 0% to 100% SpO2 | 0% to 100% SpO2 |
| Pulse rate declared accuracy range | 18-321 BPM | 18-321 BPM |
| Compensatory Reserve Index | 0-1.0 numeric with graph | 0-1.0 numeric with graph |
| Accuracy | | |
| SpO2 | $\pm$ 2 digits | $\pm$ 2 digits |
| Pulse rate | 18-300 $\pm$ 3 digits | 20-250 $\pm$ 3 digits |
| Display | | |
| LCD | Daylight readable TFT-color, 2.4" | Multi-pixel 3 digits |
| Pulse strength indicator | None | None |
| Data Displayed | SpO2, pulse rate, CRI, trend (CRI) | SpO2, pulse rate, CRI, trend (CRI) |
| Application site | Digits | Digits |
| Data output | Front panel easy-to-read display (LCD) | Front panel easy-to-read display (LCD) |
| Operation mode | Continuous | Continuous |
| LED wavelengths (multiple) | 660 and 910 nm | 660 and 910 nm |
| Compensatory Reserve Index | | |
| Hardware | Nonin OEM III internal pulse oximeter module, Nonin 8000AA sensor microcontroller based | Nonin 9560 Pulse Oximeter with integrated sensor
Tablet |
| Software | Flashback CRI algorithm | Flashback CRI algorithm |
| Physical | | |
| Degree of protection against electric shock | Type BF - applied part | Type BF - applied part |
| Functional and safety testing | ES 60601-1
IEC 60601-1-2
IEC 60601-1-12
ISO 80601-2-61 | ES 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-1-12
ISO 80601-2-61 |
| Biocompatibility | Surface contact
Skin
Limited duration (