(311 days)
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
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.
The provided text focuses on the 510(k) summary for the Spry Health Loop System, comparing it to a predicate device. It briefly mentions clinical studies but does not provide detailed acceptance criteria or study results in the format requested. Therefore, the answers will be based on the limited information available and will highlight what is missing.
Here's an attempt to answer based on the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria and their corresponding reported device performance values are mostly stated in comparison to the predicate device or standards. The document identifies acceptance criteria through compliance with ISO standards and FDA guidelines.
| Parameter | Acceptance Criteria (from predicate/standards) | Reported Device Performance (Loop System) |
|---|---|---|
| Respiration Rate | 3 RPM ARMS | 3 RPM ARMS |
| SpO2 | 2% ARMS (predicate) | 3% ARMS, no motion |
| Heart Rate (HR) | 3 BPM ARMS, no motion | 3 BPM ARMS, no motion |
| Respiration Rate Range | 4 - 70 RPM (predicate) | 4 - 40 RPM |
| SpO2 Range | 70 - 100% | 70 - 100% |
| Heart Rate Range | 25 - 240 BPM (predicate) | 25 - 250 BPM |
| 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 |
Note: For SpO2, the Loop System's 3% ARMS performance compared to the predicate's 2% ARMS is stated to still comply with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters (2013). The document rationalizes the reduced respiration rate range as "not clinically differentiating in a retrospective monitoring context" and the SpO2 accuracy as still complying with relevant standards and guidance.
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size:
- Respiration Rate Study: 12 healthy adult subjects
- Pulse Oximetry Study: 12 healthy adult subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective clinical studies conducted specifically for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth. It refers to:
- "Gold standard monitoring procedure" for respiration rate.
- "Gold standard, arterial blood gas analysis" for pulse oximetry.
It does not mention human expert interpretation as the ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method as the ground truth was established using "gold standard" medical procedures (e.g., arterial blood gas analysis) rather than expert consensus on subjective interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned. The device measures physiological parameters automatically; it does not appear to be an AI-assisted diagnostic tool that would involve human readers improving their performance. The purpose is "passive, intermittent data collection" for remote review by a clinician, implying the data is presented to the clinician, but the study described is about the accuracy of the device's measurements themselves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical studies described appear to be standalone performance assessments of the device's ability to accurately measure physiological parameters (SpO2, HR, RR) against a "gold standard." The device collects data "when no motion is detected," and the data is then processed by internal algorithms to derive the measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Respiration Rate: "gold standard monitoring procedure" (details not provided).
- SpO2: "gold standard, arterial blood gas analysis" (a direct physiological measurement).
8. The sample size for the training set
The document does not mention details about a training set since this is a 510(k) submission primarily focused on demonstrating substantial equivalence and performance of a measurement device, not an AI/ML model that typically requires a distinct training and test set. While the device uses "data processing algorithms," there is no explicit mention of an "AI/ML training set" in the context of this document.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" and its ground truth establishment are not discussed in this 510(k) summary.
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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.
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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
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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, Inc235 Alma StPalo Alto, CA 94301Tel: (650) 352-3429 |
| Primary Communicant | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140 |
| Device Common Name: | OximeterBreathing Frequency Monitor |
| Device Classification Number: | 21 CFR 870.270021 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: | OximeterBreathing Frequency Monitor |
| Predicate Device Premarket Notification #: | K181956 |
| Predicate Device Classification: | 21 CFR 870.2700: Oximeter21 CFR 868.2375: Breathing FrequencyMonitor |
| 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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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 DeviceMasimo MightySat RxFingertip PulseOximeterK181956 | Application DeviceSpry Health, Inc.Loop System | Impact onSubstantial Equivalence | |
|---|---|---|---|
| Intended Use Issues | |||
| Indications for Use | The Masimo MightySat RxFingertip Pulse Oximeter isintended for hospitals,hospital-type facilities, homeenvironments, and transport.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of functionaloxygen saturation of arterialhemoglobin (SpO2) and pulserate (PR) for adult andpediatric patients duringboth no motion and motionconditions, and for patientswho are well or poorlyperfused.The Masimo MightySat RxFingertip Pulse Oximeter isindicated for the noninvasivespot checking of respirationrate (RRp) for adult patients. | The Loop System is intended foradult patients in the homeenvironment for passive, non-invasive, intermittent datacollection of physiologicalparameters that will later betransmitted to a web server forremote review by a clinician.The Loop System measures andrecords:• arterial oxygen saturation(SpO2)• heart rate (HR)• respiration rate (RR)All of these measurements aremade when no motion isdetected by the System.The Loop System device does notprovide physiological alarms. | The application Loop SystemIndications for Use includes asubset of the patients and useconditions cleared in thepredicate device. The LoopSystem and the predicate areintended for adults in a homeenvironment when the wearersare not moving.Since the application device isintended for a subset of theapplication conditions of thepredicated device, no newtypes of safety or efficacyquestions are raised.Both devices provide SpO2, HR,and RR.Neither device is intended forcontinuous vital signmonitoring. |
| Product CodeRegulation Description | DQA - OximeterBZQ -Breathing FrequencyMonitor | DQA - OximeterBZQ -Breathing FrequencyMonitor | Arterial Oxygen saturation andderived HR and RR capabilitiesall fall under the same productcodes for both devices. |
| Patient Population | HR & SpO2 - Adults,pediatricsRespiratory Rate - AdultsNon-critical care | Adult patients for all parametersNon-critical care | The application deviceintended cohort is a subset ofthe predicate's; no new typesof safety or efficacy questionsare raised. |
| Predicate DeviceMasimo MightySat RxFingertip PulseOximeterK181956 | Application DeviceSpry Health, Inc.Loop System | Impact onSubstantial Equivalence | |
| Use Environment | hospitals, hospital-typefacilities, homeenvironments, and transport. | home environment | The application device useenvironment is a subset of thepredicate's; no new types ofsafety or efficacy questions areraised. |
| Prescribed? | Prescription use only | Prescription use only | Identical |
| Parameter SamplingFrequency | Spot check parameters asdesired by users. Notdesigned for continuouswearing. | Designed for nearly continuousmeasuring and recording ofphysiological data when thepatient is not in motion | Difference in samplingfrequency does not raise newsafety or efficacy questions |
| Technology associated with each parameter | |||
| Respiration RateFundamental ScientificTechnology | Respiration rate (RR)measured by analyzing cyclicvariations in thephotoplethysmogram. Thediodes are mounted in thedevice such that they are incontact with the skin. | Same | Technologically equivalent |
| Respiration Rate Range | 4 - 70 respirations perminute (RPM) | 4 - 40 RPM | Application device has a lowerupper limit than predicate.Specific RPMs that are >40 arenot clinically differentiating in aretrospective monitoringcontext |
| Respiration RateAccuracy | 3 RPM ARMS | 3 RPM ARMS | A clinical study demonstratedthat the Loop System couldaccurately monitor respirationrate as well as the predicate,within the sensor range |
| Arterial hemoglobinoxygen saturation (SpO2)Fundamental ScientificTechnology | SpO2 measured by analyzingreflectance of certain LEDfrequencies in aphotoplethysmogram design.The diodes are mounted inthe device such that they arein contact with the skin. | Same | Technologically equivalent |
| Predicate DeviceMasimo MightySat RxFingertip PulseOximeterK181956 | Application DeviceSpry Health, Inc.Loop System | Impact onSubstantial 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 FDAGuidance for Pulse Oximeters(2013) |
| Heart Rate (HR)Fundamental ScientificTechnology | HR measured by analyzingcyclic variations inreflectance of certain LEDfrequencies in aphotoplethysmogram design.The diodes are mounted inthe device such that they arein contact with the skin. | Same | Technologically equivalent |
| Heart Rate Range | 25 - 240 beats per minute(BPM) | 25 - 250 beats per minute (BPM) | Clinically equivalent. Bothcomply with ISO 80601-2-61 |
| Heart Rate Accuracy | 3 BPM ARMS, no motion | 3 BPM ARMS, no motion | Clinically equivalent. Bothcomply with ISO 80601-2-61 |
| Standards Compliance | IEC 60601-1IEC 60601-1-2IEC 60601-1-11ISO 80601-2-61ISO 10993-1 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-1-6ISO 80601-2-61ISO 10993-1 | Both devices meet latestguidelines for safety andefficacy |
| Design | |||
| User Interface | Finger clamp | Wrist band | Both devices are worn toprovide device access toperipheral arteries. Differencein particular user interface doesnot raise new questions ofsafety or efficacy. |
| Predicate DeviceMasimo MightySat RxFingertip PulseOximeterK181956 | Application DeviceSpry Health, Inc.Loop System | Impact onSubstantial Equivalence | |
| Wearing location andfrequency | For intermittent wearing, aka"spot checking"Image: Person using fingertip pulse oximeter | Continuous wearing, nearlycontinuous recording of all data.Image: Spry Health Loop System on wrist | Difference in wearing locationon the body and frequencydoes not raise new questions ofsafety or efficacy. Bothlocations allow for monitoringperipheral arteries. |
| Display | OLED color display of HR andSpO2 when device wornImage: Masimo MightySat Rx Fingertip Pulse Oximeter display | LED color display of HR and SpO2on demandImage: 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 assmartphones | Wireless (cellular connection) viacharging station to Spry Server. | Both devices are designed totransmit their data to alternatedevices or sites. |
| Type of protection | Unknown | Type BF - Applied Part per IEC60601-1 | Application device meets latestguidelines for electrical safety |
| Patient contractingmaterials | Plastic | Plastic | Similar |
| Biocompatibility | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Identical |
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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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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.
§ 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).