CipherOx CRI M1
Device Facts
| Record ID | K173929 |
|---|---|
| Device Name | CipherOx CRI M1 |
| Applicant | Flashback Technologies, Inc. |
| Product Code | PPW · Cardiovascular |
| Decision Date | Jul 24, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2200 |
| Device Class | Class 2 |
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. 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.
Device Story
CipherOx CRI M1 is a portable, battery-powered, non-invasive monitor for SpO2, pulse rate, and Compensatory Reserve Index (CRI). It uses a finger-clip pulse oximetry sensor (Nonin 8000AA) to capture photoplethysmograph (PPG) signals. The device integrates a Nonin OEM III module to convert analog signals into digital data. The CRI algorithm processes these PPG waveforms by comparing them to a reference model to trend intravascular volume changes. Used by qualified medical providers in hospital and pre-hospital settings, the device displays real-time metrics on a 2.4" TFT color screen. The output serves as an adjunct to traditional hemodynamic measures, assisting clinicians in assessing a patient's response to hypovolemia. The device is intended for stable, supine adults without cardiovascular disease.
Clinical Evidence
Bench testing only. The device relies on the identical CRI algorithm and hardware parameters (bandpass, sample rate) as the predicate (DEN160020). Verification testing confirmed compliance with AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12, and ISO 80601-2-61. SpO2 accuracy was validated for the integrated Nonin OEM III module.
Technological Characteristics
Transmissive pulse oximetry using 660 nm and 910 nm LEDs. Integrated Nonin OEM III module for signal processing. 2.4" TFT color display. Powered by 1.5V AAA batteries. Type BF applied part. Complies with AAMI/ANSI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-12, and ISO 80601-2-61. Biocompatible surface-contact materials (Nonin 8000AA sensor).
Indications for Use
Indicated for continuous noninvasive monitoring of SpO2, pulse rate, and Compensatory Reserve Index (CRI) in adults (19-36 years old) in supine, non-motion conditions without cardiovascular disease. For patients with finger thickness 0.3"-1" in hospital/pre-hospital settings. Contraindicated for infants/neonates, MR environments, explosive atmospheres, and trauma patients.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- CipherOx CRI Tablet (DEN160020)
Reference Devices
- Nonin 8000AA (K080255)
Submission Summary (Full Text)
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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);
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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
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# 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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# K173929
#### 510(k) Summary Page 1 of 7 23-Jul-18
| Company: | Flashback Technologies, Inc.<br>80 Health Park Drive, Suite 20<br>Louisville, CO 80027 |
|----------------------------|--------------------------------------------------------------------------------------------|
| Official Contact: | Dr. Greg Grudic, CO-Founder, CO-President, CTO<br>Phone: 720-204-2575 |
| Proprietary or Trade Name: | CipherOx CRITM M1 |
| Common/Usual Name: | Adjunctive cardiovascular status indicator |
| Classification Name: | 21 CFR 870.2200<br>Procode – PPW<br>Adjunctive cardiovascular status indicator<br>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:
- 1. 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.
- 3. 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.
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#### 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<br>"CipherOx CRI M1" | Predicate<br>"CipherOx CRI Tablet"<br>DEN160020 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CipherOx CRI M1 is indicated for<br>continuous noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate (measured<br>by an SpO2 sensor), and the<br>Compensatory Reserve Index (CRI),<br>which trends changes in intravascular<br>volume relative to the individual patient's<br>response to hypovolemia. | The CipherOx CRI Tablet is indicated for<br>continuous noninvasive monitoring of<br>functional oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate (measured<br>by an SpO2 sensor), and the Compensatory<br>Reserve Index (CRI), which trends changes<br>in intravascular volume relative to the<br>individual<br>patient's response to hypovolemia. |
| | For patients with a finger thickness of 0.3"<br>to 1" in hospital and pre-hospital settings.<br><br>CRI trends with changes in intravascular<br>volume relative to the individual patient's<br>response to hypovolemia, and should only<br>be used by qualified medical providers as | For patients with a finger thickness of 0.3"<br>to 1" in hospital and pre-hospital settings.<br><br>CRI trends with changes in<br>intravascular volume relative to the<br>individual patient's response to<br>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<br>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<br>IEC 60601-1-2<br>IEC 60601-1-12<br>ISO 80601-2-61 | ES 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-1-12<br>ISO 80601-2-61 |
| Biocompatibility | Surface contact<br>Skin<br>Limited duration (<24 hours) | Surface contact<br>Skin<br>Limited duration (<24 hours) |
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# 510(k) Summary Page 3 of 7
23-Jul-18
# Substantial Equivalence Discussion
Indications –
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#### 510(k) Summary Page 4 of 7 23-Jul-18
The CipherOx CRI M 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.
# Patient Population -
The patient population is identical - adults (19-36 years old)
#### Environment of Use -
The environment of use for use is identical - hospital and pre-hospital settings
#### Prescriptive -
The "CipherOx CRI M1" and "CipherOx CRI Tablet" are prescriptive.
#### Design and Technology -
The "CipherOx CRI M1" and "CipherOx CRI Tablet" have equivalent technological and design features. They both calculate SpO2 and pulse by use of the same technology – the ratio of red and infrared signals of light propagated through the tissue between light sources and detector. Both devices use Photoplethysmography (PPG) signals of red and infrared light through tissue to calculate SpO2 and pulse rate. Both device use PPG signals to calculate the Compensatory Reserve Index.
#### Performance Specifications -
The "CipherOx CRI M1" and "CipherOx CRI Tablet" have equivalent specifications.
#### Compliance with standards -
The "CipherOx CRI M1" complies with AAMI/ANSVES60601-1, IEC 60601-1-2, IEC 60601-1-12, and ISO 80601-2-61. The predicate complied with these plus IEC 60601-1-11.
#### Non-clinical performance testing
#### Bench -
We have performed bench tests 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 the following:
- . Verification Testing
- Testing for compliance to AAMI/ANSI/ES 60601-1 ●
- Testing for compliance to IEC 60601-1-2
- Testing for compliance to IEC 60601-1-12
- Testing for compliance to IEC 80601-2-61
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#### 510(k) Summary Page 5 of 7 23-Jul-18
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. The sensor has been cleared as part of K080255. The Nonin 8000AA 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.
#### Differences -
Differences are primarily related to the predicate "CipherOx CRI Tablet" used a discreet SpO2 monitor (Nonin 9560) that communicated via wireless to a tablet where compensatory reserve data was calculated and displayed. The tablet also mirrored data from the Nonin 9560. The "CipherOx CRI M1" connects directly to a sensor and contains hardware and software for calculating HR, SpO2 and compensatory reserve index. The SpO2 calculations are performed by the Nonin OEM III board. The OEM III board has been demonstrated by UL to function in the CipherOx CRI M1 and has previously been FDA cleared as part of multiple medical devices.
Other differences relate to the battery and range of detected beats per minute which do not alter the function or raise concerns of safety.
We maintain these differences do not raise different questions of safety or effectiveness when compared to the predicate device for the proposed indications for use.
#### Special Controls
These devices have Special Controls requirements we have reviewed the Special controls which include.
| Control | Evidence |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 1. Software description, verification and validation based on<br>comprehensive hazard analysis must be provided including: | |
| | |
| a. Full characterization of technical parameters of the software,<br>including any proprietary algorithm(s); | Software Description |
| | |
| b. Description of the expected impact of all applicable sensor<br>acquisition hardware characteristics on performance and any<br>associated hardware specifications; | Software Description |
| | |
| | |
| c. Specification of acceptable incoming sensor data quality<br>control measures; | Software Description |
| | |
| d. Mitigation of impact of user error or failure of any<br>subsystem components (signal detection and analysis, data<br>display, and storage) on accuracy of patient reports; | Software Description |
| | |
| | |
| 23-Jul-18 | |
| 2. Scientific justification for the validity of the status indicator<br>algorithm(s) must be provided. Verification of algorithm<br>calculations and validation testing of the algorithm using a data<br>set separate from the training data must demonstrate the<br>validity of modeling; | The CRI algorithm is identical to<br>that in DEN160020. Critical aspects<br>of hardware such as bandpass,<br>sample rate are identical. |
| 3. Usability assessment must be provided to demonstrate that<br>risk of misinterpretation of the status indicator is appropriately<br>mitigated; | Usability assessment provided. |
| 4. Clinical data must be provided in support of the intended use<br>and include the following: | |
| a. Output measure(s) must be compared to an acceptable<br>reference method to demonstrate that the output measure(s)<br>represent(s) the predictive measure(s) that<br>the device provides in an accurate and reproducible manner; | The CRI algorithm is identical to<br>that in DEN160020. Critical aspects<br>of hardware such as bandpass,<br>sample rate are identical. |
| b. The data set must be representative of the intended use<br>population for the device. Any selection criteria or limitations<br>of the samples must be fully described and<br>justified; | The CRI algorithm is identical to<br>that in DEN160020. Critical aspects<br>of hardware such as bandpass,<br>sample rate are identical. |
| c. Agreement of the measure(s) with the reference measure(s)<br>must be assessed across the full measurement range; | The CRI algorithm is identical to<br>that in DEN160020. Critical aspects<br>of hardware such as bandpass,<br>sample rate are identical. |
| d. Data must be provided within the clinical validation study or<br>using equivalent datasets to demonstrate the consistency of the<br>output and be representative of the range of data sources and<br>data quality likely to be encountered in the intended use<br>population and relevant use conditions in the intended use<br>environment; | The CRI algorithm is identical to<br>that in DEN160020. Critical aspects<br>of hardware such as bandpass,<br>sample rate are identical. |
| 5. Device labeling must include the following: | |
| a. The type of sensor data used, including specification of<br>compatible sensors for data acquisition; | User manual includes this warning |
| b. A description of what the device measures and outputs to the<br>user; | User manual includes this<br>information |
| c. Warnings identifying sensor reading acquisition factors that<br>may impact measurement results; | User manual includes this<br>information |
| d. Guidance for interpretation of the measurements, including<br>warning(s) specifying adjunctive use of the measurements; | User manual includes this<br>information |
| e. Key assumptions made in the calculation and determination<br>of measurements; | User manual includes this<br>information |
| f. The measurement performance of the device for all presented<br>parameters, with appropriate confidence intervals, and the<br>supporting evidence for this performance; and | User manual includes this<br>information |
| g. A detailed description of the patients studied in the clinical<br>validation (e.g., age, gender, race/ethnicity, clinical stability) as<br>well as procedural details of the clinical study | User manual includes this<br>information |
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# 510(k) Summary Page 6 of 7
23-Jul-18
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#### 510(k) Summary Page 7 of 7 23-Jul-18
## Substantial Equivalence Conclusion -
The "CipherOx CRI M1" is substantially equivalent to the predicate in: indications for use, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. The differences do not raise different questions of safety or effectiveness when compared to the predicate device for the proposed indications for use.
