(280 days)
No
The summary describes a device that performs standard respiratory gas and pulse oximetry measurements and calculations based on these measurements. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
Explanation: The device is described as a "non-invasive, multi-parameter respiratory monitoring device" that provides measurements and calculated indices to assess a patient's respiratory status. Its intended use states it is "not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange" and "not intended to replace arterial blood gas sampling for treatment purposes." This indicates it is a diagnostic/monitoring tool, not a device that directly administers therapy or performs a therapeutic function.
Yes
Explanation: The device provides "respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices" to "assess a patient's respiratory status." While it states it is "not intended to be used as the sole basis for making diagnosis," it is explicitly designed to collect and provide data that contributes to a medical assessment, which is a key characteristic of a diagnostic device.
No
The device description explicitly mentions physical components like a mouthpiece, tubing system, pulse oximetry probe, and nose clip, indicating it is a hardware device with integrated software.
Based on the provided information, the MediPines Gas Exchange Monitor (GEM) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- GEM's Function: The GEM measures respiratory gases (oxygen and carbon dioxide) directly from the patient's breath, as well as SpO2 and pulse rate through a finger sensor. These are measurements taken from the patient, not on a sample taken from the patient.
- Lack of Sample Analysis: The device description focuses on the measurement of gases in the breath and physiological parameters, not on the analysis of biological samples.
Therefore, the MediPines Gas Exchange Monitor (GEM) falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.
At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor.
The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents.
The MediPines Gas Exchange Monitor (GEM) is not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for treatment purposes.
Product codes
CCK, CCL, BZL, DQA
Device Description
The Gas Exchange Monitor (GEM) is a non-invasive multi-parameter respiratory monitoring system that uses at-rest spot check breath samples to provide respiratory measurements of oxygen (PO₂, ETO₂) and carbon dioxide (PCO₂, ETCO₂) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices to assess a patient's respiratory status.
The device utilizes a single patient use disposable mouthpiece attached to the monitor via a tubing system and an attached pulse oximetry probe. A nose clip is used during the measurement session and real-time tracing of breath samples are displayed on the device screen and may be exported as PDF and image files.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient Mouthpiece (side stream gas measurement)
Nose clip
Patient finger sensor (SpO2 measurement)
Indicated Patient Age Range
eighteen (18) years and older
Intended User / Care Setting
qualified medical personnel in professional healthcare facilities
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
Controlled hypoxia test results were obtained in human adult volunteers to validate the accuracy of the pulse oximeter module with specified Adult Soft Tip Finger Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry.
Clinical studies were conducted on consenting adults to assess the operation of the ck measurement sessions and the calculation of specified indices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Compliance Testing: The device was tested to current applicable standards for medical device electrical safety and electromagnetic compatibility as well as particular standards for pulse oximetry and respiratoring. Environmental and mechanical shock and vibration testing was performed. Standards utilized include IEC 60601-1, IEC 60601-1-2, ISO 80601-2-55, ISO 80601-2-61, ISO 10993, ISO 14971, and IEC 62304. The device met acceptance criteria for compliance.
- Risk Management: Risk and hazard analysis was performed to ISO 14971. The device met acceptance criteria for residual risks.
- Software Verification and Validation: Software was developed in accordance with FDA guidelines for MODERATE level of concern devices. The software lifecycle process met IEC 62304 with software safety class B. Software was verified to requirements and validated to meet intended uses.
- Pulse Rate and Respiration Rate Testing: Evaluated for pulse rate accuracy per ISO 80601-2-61 and FDA guidance, and respiration rate per ISO 80601-2-55. The device met acceptance criteria for pulse rate accuracy; effects of high respiration rate were noted in device labeling.
- Biocompatibility: The single patient use disposable mouthpiece assembly was evaluated per ISO-10993-1, ISO-10993-5 and ISO-10993-10 (Cytotoxicity, Intracutaneous irritation, Guinea pig maximization sensitization). Device patient contact materials met acceptance criteria. The pulse oximeter sensor is a cleared device with biocompatibility evaluated by its manufacturer.
Clinical Performance Testing:
- Clinical testing was performed under an approved protocol with subject informed consent.
- Study Type: Controlled hypoxia test.
- Sample Size: Not specified beyond "human adult volunteers" and "consenting adults".
- Key Results: Clinical test results support device accuracy claims for the specified saturation range. Studies conducted on consenting adults assessed the operation of spot-check measurement sessions and the calculation of specified indices.
Conclusions: The MediPines Gas Exchange Monitor (GEM) is equivalent to the predicate device as supported by compliance, laboratory, and risk management and system level software evaluations. The results of all tests demonstrate substantial equivalence.
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
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MediPines Corporation Timothy Marcum Product Engineer 155 N. Riverview Drive Anaheim Hill, California 92808
Re: K180902
Trade/Device Name: MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK, CCL, BZL, DQA Dated: December 7, 2018 Received: December 18, 2018
Dear Timothy Marcum:
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 mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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.
Todd D. Courtney -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180902
Device Name
MediPines Gas Exchange Monitor (GEM)
Indications for Use (Describe)
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO-) and carbon dioxide (PCO-, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO-), pulse rate (PR), and a range of other calculated indices.
At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor.
The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents.
The MediPines Gas Exchange Monitor (GEM) is not intended to be used as for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for diagnosis or treatment purposes.
| 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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3
| Exhibit 4 | ||||||
|---|---|---|---|---|---|---|
| MediPines Corporation | Document Title | K180902/S001 510(k) Summary | ||||
| Originator | ||||||
| MediPines | Change Order- | Document Number | Rev | Page | ||
| 1 of 8 | ||||||
| (a) (1) Submitted by: | MediPines Corporation | |||||
| 22845 Savi Ranch Pkwy, Suite E | ||||||
| Yorba Linda, CA 92887 | ||||||
| Phone: (949) 398-4670 | 510(k) Summary in accordance with 21 CFR 807.92 | |||||
| Contact Person: | Steve Lee, President | |||||
| steve@medipines.com | ||||||
| Date of Preparation: | December 7, 2018 | |||||
| (2) Proprietary or Trade Name: | Gas Exchange Monitor (GEM) | |||||
| Common/Usual Name(s): | 1) Carbon dioxide monitor |
- Oxygen monitor
- Pulse oximeter | | | |
| | Classification Name(s): | | 1) 21CFR 868.1400 (Carbon Dioxide Gas Analyzer)
Product Code: CCK - 21CFR 868.1720 (Oxygen gas analyzer)
Product Code: CCL - 21CFR 870.2700 (Oximeter)
Product Code: DQA - 21CFR 870.1730 (Oxygen Uptake Computer)
Product Code: BZL | | | |
| | (3) Predicate device(s): | | K-Number
K094012 | Model
Capnostream20 | | Manufacturer
Oridion Capnography, Inc.
(now Medtronic) |
| | Reference device(s): | | K093080 | Metaphor Metabolic Monitor | | TreyMed, Inc. |
(4) Device Description
The Gas Exchange Monitor (GEM) is a non-invasive multi-parameter respiratory monitoring system that uses at-rest spot check breath samples to provide respiratory measurements of oxygen (PO₂, ETO₂) and carbon dioxide (PCO₂, ETCO₂) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices to assess a patient's respiratory status.
4
| Exhibit 4 | ||||
|---|---|---|---|---|
| MediPines Corporation | Document Title | |||
| K180902/S001 510(k) Summary | ||||
| Originator | ||||
| MediPines | Change Order- | Document Number | Rev | Page |
| 2 of 8 |
The device utilizes a single patient use disposable mouthpiece attached to the monitor via a tubing system and an attached pulse oximetry probe. A nose clip is used during the measurement session and real-time tracing of breath samples are displayed on the device screen and may be exported as PDF and image files.
(5) Intended Use
As described above, the intended use of the device combines respiratory gas monitor and pulse oximeter functionality and is intended for non-invasive measurement of expired and inspired breathing gases and respiration rate, and for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Indices calculated from the breathing gas and pulse oximeter measurements may be used for assessment of patient respiratory status.
Indications for Use:
The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCQ2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpOz), and a range of other calculated indices.
At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor.
The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents.
The MediPines Gas Exchange Monitor (GEM) is not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for treatment purposes.
Discussion of Differences in Indications to the Predicate Devices
The submitted device and referenced predicate device have the following differences in their indication statements:
- The specified patient population for the MediPines Gas Exchange Monitor (GEM), adults at least 18 years of age, is o within the scope of claims of the predicate device, which specify adult through neonatal.
- . The MediPines Gas Exchange Monitor (GEM) specifies use in spontaneously breathing patients not simultaneously using supplemental Oxygen nor with other respiratory gases or agents. The predicate device may be used for spontaneously breathing or ventilated patients receiving supplemental Oxygen or other respiratory gases or agents. The claims for the subject device are within the scope of the predicate device.
- The MediPines Gas Exchange Monitor (GEM) intended uses for respiratory gas, SpO2, and pulse rate measurements are similar to the predicate device. The physiological parameters directly measured by the MediPines Gas Exchange Monitor (GEM) include Carbon Dioxide and Oxygen by side stream gas measurement including respiration rate (RR) and functional saturation of arterial hemoglobin (SpO2) and pulse rate (PR) by pulse oximetry.
- The predicate Capnostream 20 measures side stream Carbon Dioxide with respiration rate (RR) plus Sp2 o and pulse rate (PR).
- The reference Metaphor monitor device measures side stream Oxygen, Carbon Dioxide with respiration O rate (RR), and optionally Nitrous Oxide gas plus SpO2 and pulse rate (PR).
- . The measurement sites for the MediPines Gas Exchange Monitor (GEM) are equivalent to the predicate device: use of side stream gas measurement and a digit (finger for GEM) for pulse oximetry. The side stream measurement of patient breathing gas is equivalent in the subject and predicate device.
- . The MediPines Gas Exchange Monitor (GEM) utilizes a single patient use disposable mouthpiece for side stream breathing gas measurement placed in the patient's mouth and the predicate device utilize a disposable airway
5
| Exhibit 4 | |
|---|---|
| MediPines Corporation | Document Title |
| K180902/S001 510(k) Summary | |
| Originator | |
| MediPines | Change Order- |
| Document Number Rev Page | |
| 3 of 8 |
adapter for side stream breathing gas measurement which is typically placed in the patient's breathing circuit. The breathing gases obtained are equivalent, including both inspired and expired breath.
- . The MediPines Gas Exchange Monitor (GEM) specifies a reusable SpO2 sensor type which is applied on the patient's digit (finger sensor). The predicate Capnostream and reference Metaphor monitors make available a range of reusable finger sensors and other sensors, including disposable SpO2 sensors. The function and intended use for pulse oximetry is equivalent.
- . The MediPines Gas Exchange Monitor (GEM) is defined for short duration measurement sessions. The predicate Capnostream 20 is specified for continuous operation, and the referenced Metaphor is specified for spot check or continuous operation. The MediPines Gas Exchange Monitor (GEM) provides no alarms, which is consistent with the use as a spot check device for short duration use.
- . The MediPines Gas Exchange Monitor (GEM) and referenced Metaphor are specified for use in professional healthcare facilities. The Capnostream 20 defines both hospital use environments.
The differences in the wording of the subject and predications for use are not critical to the intended use of the device as a pulse oximeter sensor and do not affectiveness of the device when used as labeled for the following reasons:
- Slight differences in terminology for the measured parameters are equivalent, i.e. all claims are readily understandable as referring to the respective measurements (example: ETCO2 versus end tidal concentration).
- . The MediPines Gas Exchange Monitor (GEM) and the predicate device provide additional calculated numerical indices of pulmonary status based upon mathematical relationships between measured parameters. The Capnostream 20 provides an integrated pulmonary index (IPI) which is a numerical value of overall ventilatory status. Differences in pulmonary indices reported for the devices are accounted for by labeling which describes the indices and the calculations. Both the MediPines Gas Exchange Monitor (GEM) and referenced Metaphor Monitor provide calculated respiratory quotient (RQ).
The differences in the wording of subject and predications for use are within the scope of the predicate device for the intended use of the subject device as a pulse oximeter and respiratory gas monitor when used as labeled. In summary, the MediPines Gas Exchange Monitor (GEM) has equivalent intended use, or where different, claims which are within those of the predicate device and the reference device, the Capnostream 20 and Metaphor Monitor, respectively.
(6) Technological Characteristics
The MediPines Gas Exchange Monitor (GEM) is designed for the same application and intended use as the listed predicate device, using the same technological principles. Refer to the following comparison tables:
| Product/Feature | Gas Exchange Monitor (GEM)
(Proposed Device) | Capnostream 20 Capnograph/Pulse
Oximeter | Remark |
|-----------------|-------------------------------------------------|---------------------------------------------|--------|
| Manufacturer | MediPines Corporation | Oridion Medical Ltd. (now
Medtronic) | |
| Model Number(s) | GEM Model B | 20 | |
| 510(k) Number | K180902 | K094012 | |
Comparison of Technological Features to Predicate Device
6
| Exhibit 4 | |||||
|---|---|---|---|---|---|
| MediPines Corporation | Document Title | ||||
| K180902/S001 510(k) Summary | |||||
| Originator | |||||
| MediPines | Change Order- | Document Number | Rev | Page | |
| 4 of 8 |
| Product/Feature | Gas Exchange Monitor (GEM) | Capnostream 20 Capnograph/Pulse
Oximeter | Remark |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Application | (Proposed Device)
Multi-parameter monitor including
capnography, oximetry;
Respiratory gas measurements of
oxygen (PO₂, ETO₂) and carbon
dioxide (PCO2, ETCO2) from
breathing, respiration rate (RR),
Functional oxygen saturation of
arterial hemoglobin (SpO₂) and pulse
rate;
Calculated pulmonary indices;
intended to be used in conjunction
with additional methods of assessing
clinical signs and symptoms | Combined capnograph/pulse
oximeter monitor;
Monitoring of carbon dioxide
concentration of the expired and
inspired breath and respiration rate;
Functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse
rate;
integrated pulmonary index (IPI)
displays a single value that
represents the patient's pulmonary
parameters. The IPI is an adjunct to,
and is not intended to replace, vital
sign monitoring. | Subject device use as
respiratory gas monitor and
pulse oximeter within claims of
the predicate device;
Measurement of Oxygen in the
subject device |
| Intended Patient
Population | Adults eighteen (18) years and older,
spontaneously breathing | Neonatal, pediatric, and adult
populations;
User manual describes spontaneous
breathing and ventilated cases | Subject device intended use for
spontaneously breathing
adults is within the claims of
the predicate device |
| Intended
Environment of Care | Professional healthcare facilities only | Hospitals, hospital-type facilities, and
intra-hospital transport and home
environments | Use of subject device in
professional environments is
within the scope of the
predicate device |
| Patient Application
sites | Patient Mouthpiece (side stream gas
measurement)
Nose clip
Patient finger sensor (SpO2
measurement) | Patient Airway (side stream gas
measurement)
Patient digit (SpO2 measurement) | Addition of nose clip in subject
device does not change
intended use for respiratory
gas measurement |
| Alarms | No alarms | Visual and auditory alarms | Use as a non-alarming device is
within the scope of the
predicate device and
consistent with spot-check use |
| Duration of
operation | Short (K180902/S001 510(k) Summary | | | |
| Originator
MediPines | Change Order- | Document Number | Rev | Page | |
| | | | | 7 of 8 | |
- ISO 10993 Biological testing of medical devices
- ISO 14971 Risk Evaluation ●
- IEC 62304 Software validation and software lifecycle process ●
The device met acceptance criteria for compliance to the standards.
Risk Management
Risk and hazard analysis of the MediPines Gas Exchange Monitor (GEM) was performed to the following standard:
- Application of risk management to medical devices per ISO 14971 ●
The device met acceptance criteria for residual risks.
Software Verification and Validation
The MediPines Gas Exchange Monitor (GEM) software was developed in accordance with FDA guidelines for MODERATE level of concern devices. The software lifecycle process was evaluated to meet:
- Medical device software lifecycle process per IEC 62304 with software safety class B (equivalent to MODERATE level ● of concern).
The device software was verified to requirements and validated to meet the specified intended use(s).
Pulse Rate and Respiration Rate Testing
Test MediPines Gas Exchange Monitor (GEM) was evaluated for pulse rate accuracy per the following standards and guidance:
- Pulse simulator testing of pulse rate per ISO 80601-2-61 and the FDA pulse oximeter guidance
- Respiration testing of testing of respiration rate per ISO 80601-2-55 ●
The device met acceptance criteria for pulse rate accuracy – effects of high respiration rate were noted in device labeling.
Biocompatibility
The single patient use disposable mouthpiece assembly was evaluated for biocompatibility. The tests were performed to the following standards and included the listed tests:
- Biocompatibility testing per ISO-10993-1, ISO-10993-5 and ISO-10993-10
- Cytotoxicity test - MEM elution assay using L-929 mouse fibroblast cells
- Intracutaneous irritation test ●
- . Guinea pig maximization sensitization test
Device patient contact materials met the acceptance criteria for biocompatibility.
The pulse oximeter sensor is a cleared device, with biocompatibility evaluated by the respective manufacturer.
In summary, the device met test criteria for standards conformance to the applicable standards, pulse and respiration rate accuracy, and biocompatibility. Residual risks met criteria for acceptability for the intended use.
(2) Clinical Tests Submitted
Clinical testing was performed under an approved protocol with subject informed consent. Controlled hypoxia test results were obtained in human adult volunteers to validate the accuracy of the pulse oximeter module with specified Adult Soft Tip Finger Sensor versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
10
| Exhibit 4 | ||||
|---|---|---|---|---|
| MediPines Corporation | Document Title | |||
| K180902/S001 510(k) Summary | ||||
| Originator | ||||
| MediPines | Change Order- | Document Number | Rev | Page |
| 8 of 8 |
Clinical studies were conducted on consenting adults to assess the operation of the ck measurement sessions and the calculation of specified indices.
(3) Conclusions from Tests
As described in (b)(1) and (b)(2) above, the MediPines Gas Exchange Monitor (GEM) is equivalent to the predicate device as supported by compliance, laboratory, and cisk management and system level software evaluations as described above.
The results of all tests demonstrate that the MediPines Gas Exchange Monitor (GEM) is substantially equivalent to the referenced predicate device.