(311 days)
Not Found
No
The description mentions "filtering technology" and "data processing algorithms" but does not explicitly state or imply the use of AI or ML. The performance studies and key metrics are standard for physiological monitoring devices and do not suggest AI/ML components.
No.
The device is intended for passive, intermittent data collection for remote review by a clinician and does not provide physiological alarms or therapy.
Yes
Explanation: The device measures and records physiological parameters (SpO2, HR, RR) for remote review by a clinician, which are used to assess a patient's health status. While it doesn't provide alarms or immediate diagnoses, the collection and transmission of these data for clinical review constitute a diagnostic purpose.
No
The device description explicitly mentions hardware components like the "Loop Band" with embedded LEDs, photodiodes, and an accelerometer, as well as a "Loop Charging Station." While software is involved in data processing and transmission, the system relies on physical hardware for data acquisition.
Based on the provided information, the Loop System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Loop System Function: The Loop System collects physiological data (SpO2, HR, RR) directly from the patient's wrist using non-invasive methods (photoplethysmography). This data collection happens on the body, not from a specimen taken from the body.
- Intended Use: The intended use is for passive, intermittent data collection of physiological parameters for remote review by a clinician. This is a monitoring function, not a diagnostic test performed on a biological sample.
Therefore, the Loop System 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 Loop System is intended for adult patients in the home environment for passive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
The Loop System measures and records:
- · arterial oxygen saturation (SpO2)
- · heart rate (HR)
- · respiration rate (RR)
All of these measurements are made when no motion is detected by the System.
The Loop System device does not provide physiological alarms
Product codes
DOA, BZQ
Device Description
The Loop System is a prescription-only medical device indicated for use by adult patients in the home environment for passive, non-invasive, intermittent data collection of resting (i.e., no motion) physiological parameters. The data is derived from reflectance-based photoplethysmogram (PPG) signals from the patient's wrist, collected by Light Emitting Diodes
(LEDs) of varying wavelengths and photodiodes sensitive to said wavelengths embedded in the Loop Band. An accelerometer incorporated in the Loop Band determines when the patient is at rest by constantly monitoring the activity level of the patient. The data is recorded during those resting periods. Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server.
Patients wear the Loop Band on their wrist for periods of up to 24 hours. Patients will then have to charge the Loop Band with a Loop Charging Station provided to them as part of the Loop System. During charging, the data is uploaded to the Spry Server.
The Loop band can independently analyze and display resting heart rate and arterial oxygen saturation (SpO2). The data must be downloaded and analyzed by the Spry Server to determine respiration rate.
All physiological measurements collected by the Loop System are reported on a comma separated value (CSV) file as a time-stamped series. The CSV can then be remotely accessed through a web interface for review and analysis by a clinician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflectance-based photoplethysmogram (PPG) signals
Anatomical Site
Patient's wrist
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Clinician for remote review, home environment
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)
Two clinical studies were conducted to demonstrate the performance of the Loop System.
One clinical study investigated the accuracy of respiration rate monitoring in 12 healthy adult subjects with a range of skin types and respiratory rates. The Loop System accuracy was shown to be equivalent to a gold standard monitoring procedure.
Another clinical study investigated the accuracy of the pulse oximetry monitoring in 12 healthy adult subjects with a range of skin types. The Loop System accuracy was compared to the gold standard, arterial blood gas analysis.
This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and in accordance with the FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013). The Loop System was found to be in compliance with both documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 3% ARMS, no motion
Heart Rate Accuracy: 3 BPM ARMS, no motion
Respiration Rate Accuracy: 3 RPM ARMS
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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March 29, 2019
Spry Health, Inc. % Craig Coombs Consultant Coombs Medical Device Consulting, Inc. 1193 Sherman St. Alameda, CA 94501
Re: K181352
Trade/Device Name: Loop System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DOA, BZQ Dated: March 4, 2019 Received: March 5, 2019
Dear Craig Coombs:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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 -S 2019.03.29 10:28:03 -04'00'
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) K181352
Device Name Loop System
Indications for Use (Describe)
The Loop System is intended for adult patients in the home environment for passive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
The Loop System measures and records:
- · arterial oxygen saturation (SpO2)
- · heart rate (HR)
- · respiration rate (RR)
All of these measurements are made when no motion is detected by the System.
The Loop System device does not provide physiological 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)
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Section 5: 510(k) Summary
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | Spry Health, Inc |
| 235 Alma St | |
| Palo Alto, CA 94301 | |
| Tel: (650) 352-3429 | |
| Primary Communicant | Craig Coombs |
| Coombs Medical Device Consulting | |
| 1193 Sherman Street | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Device Common Name: | Oximeter |
| Breathing Frequency Monitor | |
| Device Classification Number: | 21 CFR 870.2700 |
| 21 CFR 868.2375 | |
| Device Classification & | |
| Product Code: | Class 2, |
| DQA & BZQ | |
| Device Proprietary Name: | Loop System |
Predicate Device Information:
| Predicate Device: | MightySat RX Fingertip Pulse Oximeter |
|---|---|
| Predicate Device Manufacturer: | Masimo |
| Predicate Device Common Name: | Oximeter |
| Breathing Frequency Monitor | |
| Predicate Device Premarket Notification #: | K181956 |
| Predicate Device Classification: | 21 CFR 870.2700: Oximeter |
| 21 CFR 868.2375: Breathing Frequency | |
| Monitor | |
| Predicate Device Class & Product Code: | Class 2, DQA & BZQ |
B. Date Summary Prepared
13 March 2019
C. Description of Device
The Loop System is a prescription-only medical device indicated for use by adult patients in the home environment for passive, non-invasive, intermittent data collection of resting (i.e., no motion) physiological parameters. The data is derived from reflectance-based photoplethysmogram (PPG) signals from the patient's wrist, collected by Light Emitting Diodes
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Image /page/4/Picture/1 description: The image shows the logo for Spry. The logo consists of three concentric circles, with the outermost circle being blue, the middle circle being a lighter shade of green, and the innermost circle being a darker shade of green. Below the circles, the word "spry" is written in lowercase letters.
(LEDs) of varying wavelengths and photodiodes sensitive to said wavelengths embedded in the Loop Band. An accelerometer incorporated in the Loop Band determines when the patient is at rest by constantly monitoring the activity level of the patient. The data is recorded during those resting periods. Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server.
Patients wear the Loop Band on their wrist for periods of up to 24 hours. Patients will then have to charge the Loop Band with a Loop Charging Station provided to them as part of the Loop System. During charging, the data is uploaded to the Spry Server.
The Loop band can independently analyze and display resting heart rate and arterial oxygen saturation (SpO2). The data must be downloaded and analyzed by the Spry Server to determine respiration rate.
All physiological measurements collected by the Loop System are reported on a comma separated value (CSV) file as a time-stamped series. The CSV can then be remotely accessed through a web interface for review and analysis by a clinician.
D. Indications for Use
The Loop System is intended for adult patients in the home environment for passive, noninvasive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician.
The Loop System measures and records:
- arterial oxygen saturation (SpO2)
- · heart rate (HR)
- · respiration rate (RR)
All of these measurements are made when no motion is detected by the System.
The Loop System device does not provide physiological alarms
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Image /page/5/Picture/1 description: The image shows a logo for a company called "spry". The logo consists of three concentric circles, with the outermost circle being blue, the middle circle being a lighter shade of blue, and the innermost circle being green. The word "spry" is written in a sans-serif font below the circles.
E. Comparison to Predicate Device
The application Spry Health Loop System is substantially equivalent to the Masimo MightySat Rx Fingertip Pulse Oximeter (K181956). The devices have a similar Indications for Use, features, technology and accuracy.
| | Predicate Device
Masimo MightySat Rx
Fingertip Pulse
Oximeter
K181956 | Application Device
Spry Health, Inc.
Loop System | Impact on
Substantial Equivalence |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use Issues | | | |
| Indications for Use | The Masimo MightySat Rx
Fingertip Pulse Oximeter is
intended for hospitals,
hospital-type facilities, home
environments, and transport.
The Masimo MightySat Rx
Fingertip Pulse Oximeter is
indicated for the noninvasive
spot checking of functional
oxygen saturation of arterial
hemoglobin (SpO2) and pulse
rate (PR) for adult and
pediatric patients during
both no motion and motion
conditions, and for patients
who are well or poorly
perfused.
The Masimo MightySat Rx
Fingertip Pulse Oximeter is
indicated for the noninvasive
spot checking of respiration
rate (RRp) for adult patients. | The Loop System is intended for
adult patients in the home
environment for passive, non-
invasive, intermittent data
collection of physiological
parameters that will later be
transmitted to a web server for
remote review by a clinician.
The Loop System measures and
records:
• arterial oxygen saturation
(SpO2)
• heart rate (HR)
• respiration rate (RR)
All of these measurements are
made when no motion is
detected by the System.
The Loop System device does not
provide physiological alarms. | The application Loop System
Indications for Use includes a
subset of the patients and use
conditions cleared in the
predicate device. The Loop
System and the predicate are
intended for adults in a home
environment when the wearers
are not moving.
Since the application device is
intended for a subset of the
application conditions of the
predicated device, no new
types of safety or efficacy
questions are raised.
Both devices provide SpO2, HR,
and RR.
Neither device is intended for
continuous vital sign
monitoring. |
| Product Code
Regulation Description | DQA - Oximeter
BZQ -Breathing Frequency
Monitor | DQA - Oximeter
BZQ -Breathing Frequency
Monitor | Arterial Oxygen saturation and
derived HR and RR capabilities
all fall under the same product
codes for both devices. |
| Patient Population | HR & SpO2 - Adults,
pediatrics
Respiratory Rate - Adults
Non-critical care | Adult patients for all parameters
Non-critical care | The application device
intended cohort is a subset of
the predicate's; no new types
of safety or efficacy questions
are raised. |
| | Predicate Device
Masimo MightySat Rx
Fingertip Pulse
Oximeter
K181956 | Application Device
Spry Health, Inc.
Loop System | Impact on
Substantial Equivalence |
| Use Environment | hospitals, hospital-type
facilities, home
environments, and transport. | home environment | The application device use
environment is a subset of the
predicate's; no new types of
safety or efficacy questions are
raised. |
| Prescribed? | Prescription use only | Prescription use only | Identical |
| Parameter Sampling
Frequency | Spot check parameters as
desired by users. Not
designed for continuous
wearing. | Designed for nearly continuous
measuring and recording of
physiological data when the
patient is not in motion | Difference in sampling
frequency does not raise new
safety or efficacy questions |
| Technology associated with each parameter | | | |
| Respiration Rate
Fundamental Scientific
Technology | Respiration rate (RR)
measured by analyzing cyclic
variations in the
photoplethysmogram. The
diodes are mounted in the
device such that they are in
contact with the skin. | Same | Technologically equivalent |
| Respiration Rate Range | 4 - 70 respirations per
minute (RPM) | 4 - 40 RPM | Application device has a lower
upper limit than predicate.
Specific RPMs that are >40 are
not clinically differentiating in a
retrospective monitoring
context |
| Respiration Rate
Accuracy | 3 RPM ARMS | 3 RPM ARMS | A clinical study demonstrated
that the Loop System could
accurately monitor respiration
rate as well as the predicate,
within the sensor range |
| Arterial hemoglobin
oxygen saturation (SpO2)
Fundamental Scientific
Technology | SpO2 measured by analyzing
reflectance of certain LED
frequencies in a
photoplethysmogram design.
The diodes are mounted in
the device such that they are
in contact with the skin. | Same | Technologically equivalent |
| | Predicate Device
Masimo MightySat Rx
Fingertip Pulse
Oximeter
K181956 | Application Device
Spry Health, Inc.
Loop System | Impact on
Substantial Equivalence |
| SpO2 Range | 70 – 100% | 70 – 100% | Identical |
| Sp02 Accuracy | 2% ARMS, no motion | 3% ARMS, no motion | Both comply with ISO 80601-2-
61 as well as with FDA
Guidance for Pulse Oximeters
(2013) |
| Heart Rate (HR)
Fundamental Scientific
Technology | HR measured by analyzing
cyclic variations in
reflectance of certain LED
frequencies in a
photoplethysmogram design.
The diodes are mounted in
the device such that they are
in contact with the skin. | Same | Technologically equivalent |
| Heart Rate Range | 25 - 240 beats per minute
(BPM) | 25 - 250 beats per minute (BPM) | Clinically equivalent. Both
comply with ISO 80601-2-61 |
| Heart Rate Accuracy | 3 BPM ARMS, no motion | 3 BPM ARMS, no motion | Clinically equivalent. Both
comply with ISO 80601-2-61 |
| Standards Compliance | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
ISO 80601-2-61
ISO 10993-1 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-1-6
ISO 80601-2-61
ISO 10993-1 | Both devices meet latest
guidelines for safety and
efficacy |
| Design | | | |
| User Interface | Finger clamp | Wrist band | Both devices are worn to
provide device access to
peripheral arteries. Difference
in particular user interface does
not raise new questions of
safety or efficacy. |
| | Predicate Device
Masimo MightySat Rx
Fingertip Pulse
Oximeter
K181956 | Application Device
Spry Health, Inc.
Loop System | Impact on
Substantial Equivalence |
| Wearing location and
frequency | For intermittent wearing, aka
"spot checking"
Image: Person using fingertip pulse oximeter | Continuous wearing, nearly
continuous recording of all data.
Image: Spry Health Loop System on wrist | Difference in wearing location
on the body and frequency
does not raise new questions of
safety or efficacy. Both
locations allow for monitoring
peripheral arteries. |
| Display | OLED color display of HR and
SpO2 when device worn
Image: Masimo MightySat Rx Fingertip Pulse Oximeter display | LED color display of HR and SpO2
on demand
Image: Spry Health Loop System display | Similar |
| Power source | 2 AA batteries | Internal rechargeable batteries | Both battery-powered |
| Data Communication | Wireless (Bluetooth pairing)
with mobile devices such as
smartphones | Wireless (cellular connection) via
charging station to Spry Server. | Both devices are designed to
transmit their data to alternate
devices or sites. |
| Type of protection | Unknown | Type BF - Applied Part per IEC
60601-1 | Application device meets latest
guidelines for electrical safety |
| Patient contracting
materials | Plastic | Plastic | Similar |
| Biocompatibility | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Identical |
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Image /page/6/Picture/0 description: The image shows the logo for Spry. The logo consists of a circular design with multiple concentric rings in shades of blue and green. Below the circular design, the word "spry" is written in lowercase letters.
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Image /page/7/Picture/0 description: The image shows the logo for Spry. The logo consists of a circular design with three concentric rings in shades of blue and green. Below the circular design, the word "spry" is written in lowercase letters.
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Image /page/8/Picture/0 description: The image shows the logo for Spry. The logo consists of three concentric circles, with the outermost circle being blue and the innermost circle being green. Below the circles, the word "spry" is written in lowercase letters.
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Image /page/9/Picture/1 description: The image shows the logo for Spry. The logo consists of three concentric circles, with the outermost circle being blue, the middle circle being a lighter shade of blue, and the innermost circle being green. Below the circles, the word "spry" is written in lowercase letters.
F. Summary of Supporting Data
Spry Health has conducted extensive testing to ensure that the Loop System met design specifications, functions as intended, and conforms to internationally recognized standards and FDA Guidelines.
Bench Testing
All test results demonstrate the performance of Spry Health Loop System met the requirements of its pre-defined acceptance criteria and intended use. The results of the bench (non-clinical) testing demonstrate that the Loop System is as safe and effective as the predicate device.
Bench testing demonstrated the accuracy of the heart rate monitoring with the Loop System. This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and in accordance with the FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013). The Loop System was found to be in compliance with both documents.
Additionally, transit testing and one-year shelf life testing was conducted.
Electrical Safety and Electromagnetic Compatibility Testing
Electrical safety testing was conducted in accordance with: IEC 60601-1:2005+AM1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014: Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Disturbances - Requirements and tests
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 60601-1-6:2013 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
The Spry Health Loop System passed all electrical safety and EMC testing.
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with ISO 10993-1:2009/AC:2010, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and FDA's guidance documents, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a rick management process" issued June 16, 2016. This testing demonstrates that the materials in the Loop Band will not cause an adverse biocompatibility reaction when used as intended.
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Image /page/10/Picture/1 description: The image shows the logo for Spry. The logo consists of three concentric circles, with the outermost circle being blue, the middle circle being a lighter shade of blue, and the innermost circle being green. Below the circles, the word "spry" is written in lowercase letters.
Clinical Studies
Two clinical studies were conducted to demonstrate the performance of the Loop System.
One clinical study investigated the accuracy of respiration rate monitoring in 12 healthy adult subjects with a range of skin types and respiratory rates. The Loop System accuracy was shown to be equivalent to a gold standard monitoring procedure.
Another clinical study investigated the accuracy of the pulse oximetry monitoring in 12 healthy adult subjects with a range of skin types. The Loop System accuracy was compared to the gold standard, arterial blood gas analysis.
This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment -Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and in accordance with the FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013). The Loop System was found to be in compliance with both documents.
G. Conclusion
Spry Health concludes that the application Spry Health Loop System is substantially equivalent to the Masimo MightySat Rx Fingertip Pulse Oximeter (K181956). The devices have a similar Indications for Use, features, technology and accuracy in monitoring respiration rate, heart rate and pulse oximetry saturation.