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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MediPines Gas Exchange Monitor (GEM), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific accuracy criteria for CO2 and O2 measurements, and SpO2/Pulse rate.

Parameter	Acceptance Criteria	Reported Device Performance
CO2 Measurement	± 2 mmHg from 0 - 38 mmHg (at ATPS) ± 5% of actual from 39 - 76 mmHg (at ATPS) ± 8% of actual from 77 - 99 mmHg (at ATPS)	Met current gas monitoring standard accuracy requirements. This performance matches the acceptance criteria explicitly stated.
O2 Measurement	< ± 1% (at ATPS)	The text states "Subject device includes galvanic O2 measurement (as does reference Metaphor device)" and lists this as the performance, implying it met its specified accuracy.
SpO2 Accuracy	± 3% Arms between 70 – 99% ( < 70% is undefined)	Equivalent functionality. The clinical study results supported device accuracy claims for the specified saturation range. This matches the acceptance criteria explicitly stated.
Pulse Rate Accuracy	± 3 BPM	Equivalent functionality. "The device met acceptance criteria for pulse rate accuracy – effects of high respiration rate were noted in device labeling." This matches the acceptance criteria explicitly stated.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Controlled hypoxia test results were obtained in human adult volunteers" for SpO2 accuracy.

Sample Size: Not explicitly stated.
Data Provenance: Prospective, controlled clinical study in human adult volunteers. The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. However, the ground truth for SpO2 was determined by "arterial oxygen saturation (SaO2) as determined by co-oximetry," which suggests a reliance on a gold-standard laboratory method rather than expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable as the ground truth for physiological parameters (like SaO2 via co-oximetry) is often established by a direct measurement method rather than expert interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physiological monitor, and its accuracy is assessed against reference standards rather than human reader performance.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the described tests for CO2, O2, SpO2, and Pulse Rate accuracy are all standalone performance evaluations of the device's ability to measure these parameters against a reference/ground truth. The clinical studies were conducted to "assess the operation" and support "accuracy claims" of the device itself.

7. Type of Ground Truth Used

Ground Truth Type:
- SpO2: Arterial oxygen saturation (SaO2) as determined by co-oximetry (considered a gold standard for blood gas measurement).
- CO2, O2, Pulse Rate: Not explicitly stated, but typically these are validated against highly accurate reference gas analyzers or calibrated physiological simulators. The document refers to "test levels" for standards (ISO 80601-2-55 for respiratory gas monitors and ISO 80601-2-61 for pulse oximeters), implying a reliance on established reference methods and simulators.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document describes verification and validation for software (IEC 62304) and hardware performance testing. This is a medical device that makes direct measurements, not a machine learning or AI-driven diagnostic system that typically requires a 'training set' in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no mention of a training set for a machine-learning algorithm. The device's functionality is based on established physical principles of gas analysis (Non-dispersive Infrared for CO2, galvanic cell for O2) and pulse oximetry (two-wavelength pulse measurement).

Summary

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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

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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

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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.

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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		Exhibit 4
	MediPines Corporation		Document Title	K180902/S001 510(k) Summary
OriginatorMediPines	Change Order-	Document Number		Rev	Page1 of 8
(a) (1) Submitted by:		MediPines Corporation22845 Savi Ranch Pkwy, Suite EYorba Linda, CA 92887Phone: (949) 398-4670	510(k) Summary in accordance with 21 CFR 807.92
Contact Person:		Steve Lee, Presidentsteve@medipines.com
Date of Preparation:		December 7, 2018
(2) Proprietary or Trade Name:		Gas Exchange Monitor (GEM)
Common/Usual Name(s):		1) Carbon dioxide monitor2) Oxygen monitor3) Pulse oximeter
Classification Name(s):		1) 21CFR 868.1400 (Carbon Dioxide Gas Analyzer)Product Code: CCK2) 21CFR 868.1720 (Oxygen gas analyzer)Product Code: CCL3) 21CFR 870.2700 (Oximeter)Product Code: DQA4) 21CFR 870.1730 (Oxygen Uptake Computer)Product Code: BZL
(3) Predicate device(s):		K-NumberK094012	ModelCapnostream20		ManufacturerOridion Capnography, Inc.(now Medtronic)
Reference device(s):		K093080	Metaphor Metabolic Monitor		TreyMed, Inc.

(4) Device Description

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Exhibit 4
MediPines Corporation	Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	Change Order-	Document Number	Rev	Page2 of 8

(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.

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

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Exhibit 4
MediPines Corporation	Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	Change Order-Document Number Rev Page3 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/PulseOximeter
Manufacturer	MediPines Corporation	Oridion Medical Ltd. (nowMedtronic)
Model Number(s)	GEM Model B	20
510(k) Number	K180902	K094012

Comparison of Technological Features to Predicate Device

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Exhibit 4
MediPines Corporation		Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	Change Order-	Document Number	Rev	Page4 of 8

Product/Feature	Gas Exchange Monitor (GEM)	Capnostream 20 Capnograph/PulseOximeter	Remark
IntendedUse/Application	(Proposed Device)Multi-parameter monitor includingcapnography, oximetry;Respiratory gas measurements ofoxygen (PO₂, ETO₂) and carbondioxide (PCO2, ETCO2) frombreathing, respiration rate (RR),Functional oxygen saturation ofarterial hemoglobin (SpO₂) and pulserate;Calculated pulmonary indices;intended to be used in conjunctionwith additional methods of assessingclinical signs and symptoms	Combined capnograph/pulseoximeter monitor;Monitoring of carbon dioxideconcentration of the expired andinspired breath and respiration rate;Functional oxygen saturation ofarterial hemoglobin (SpO2) and pulserate;integrated pulmonary index (IPI)displays a single value thatrepresents the patient's pulmonaryparameters. The IPI is an adjunct to,and is not intended to replace, vitalsign monitoring.	Subject device use asrespiratory gas monitor andpulse oximeter within claims ofthe predicate device;Measurement of Oxygen in thesubject device
Intended PatientPopulation	Adults eighteen (18) years and older,spontaneously breathing	Neonatal, pediatric, and adultpopulations;User manual describes spontaneousbreathing and ventilated cases	Subject device intended use forspontaneously breathingadults is within the claims ofthe predicate device
IntendedEnvironment of Care	Professional healthcare facilities only	Hospitals, hospital-type facilities, andintra-hospital transport and homeenvironments	Use of subject device inprofessional environments iswithin the scope of thepredicate device
Patient Applicationsites	Patient Mouthpiece (side stream gasmeasurement)Nose clipPatient finger sensor (SpO2measurement)	Patient Airway (side stream gasmeasurement)Patient digit (SpO2 measurement)	Addition of nose clip in subjectdevice does not changeintended use for respiratorygas measurement
Alarms	No alarms	Visual and auditory alarms	Use as a non-alarming device iswithin the scope of thepredicate device andconsistent with spot-check use
Duration ofoperation	Short (<5 minute) spot-checksessions; continuous for shortduration	Continuous	Subject device use as spot-check device device is withinthe scope of the predicatedevice
Supplemental gases	Not to be utilized simultaneouslywith supplemental Oxygen nor withother respiratory gases or agents	Use with supplemental gases	Use without supplementalgases is within the scope of thepredicate device andconsistent with spot-check use
Sterility	Non-sterile mouthpiece and reusableSpO2 sensor	Non-sterile airway adapter andreusable SpO2 sensor	Equivalent function
Control System	User interface via PC-based touchscreen display. Embeddedmicrocontroller interfaces with gassensors and pulse oximeter moduleto obtain measurement data for host	Internal embedded microprocessor	Equivalent functionality
Control Keys	Power ButtonTouchscreen Display withVirtual keyboard	Monitor Power ON/OFFEvent ButtonPatient Admit/ DischargePump OffTemporary Alarm SilenceControl Knob	Equivalent functionality

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Exhibit 4
MediPines Corporation		Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	Change Order-	Document Number	Rev	Page5 of 8

Product/Feature	Gas Exchange Monitor (GEM)(Proposed Device)	Capnostream 20 Capnograph/PulseOximeter	Remark
Measurementprinciple - SpO2	Two wavelength pulse measurementto obtain functional oxygensaturation	Two wavelength pulse measurementto obtain functional oxygensaturation	Same measurement principles
Measurementmethod - CO2	Sidestream gas sample: Non-dispersive Infrared (NDIR) for CO2 gas	Sidestream gas sample: Non-dispersive Infrared (NDIR) for CO2gas	Same measurement principles
Measurementmethod - Oxygen	Sidestream gas sample: galvanic cellfor Oxygen sensor	(no galvanic O2 gas measurement)	Subject device includesgalvanic O2 measurement (asdoes reference Metaphordevice)
CO2 measurementrange	0 - 100 mmHg(0 - 13%)	0-99 mmHg(0-13%)	Equivalent ranges
CO2 measurementaccuracy	± 2 mmHg from 0 - 38 mmHg (atATPS)± 5% of actual from 39 - 76 mmHg (atATPS)± 8% of actual from 77 - 99 mmHg (atATPS)	± 2 mmHg from 0 - 38 mmHg39-99 mmHg ± (5% of reading +0.08% for every 1 mmHg above38mmHg)	Equivalent ranges, subjectdevice meets current gasmonitoring standard accuracyrequirements
O2 measurementrange	0 – 800 mmHg(0 - 100%)	N/A	Subject device includesgalvanic O2 measurement (asdoes reference Metaphordevice)
O2 measurementaccuracy	< ± 1% (at ATPS)	N/A	Subject device includesgalvanic O2 measurement (asdoes reference Metaphordevice)
SpO2measurement range	0 – 99 %	1-100%	Equivalent ranges
Pulse ratemeasurement range	30 - 254 BPM	25-240 BPM	Equivalent ranges
SpO2 accuracy	± 3% Arms between 70 – 99%< 70% is undefined	70% to 100% ± 2 digits< 70% is undefined	Equivalent functionality
Pulse rate accuracy	± 3 BPM	No motion: ± 3 digitsMotion: ± 5 digits	Equivalent functionality

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MediPines Corporation	Document TitleK180902/S001 510(k) Summary	Exhibit 4
OriginatorMediPines	Change Order-	Document Number	Rev	Page6 of 8

Product/Feature	Gas Exchange Monitor (GEM)	Capnostream 20 Capnograph/Pulse	Remark
	(Proposed Device)	Oximeter
DisplayedParameters	Measured/ Displayed:CO2 Waveform02 WaveformContinuous partial pressure of O2Continuous partial pressure of CO2End Tidal O2 (PETO2)End Tidal CO2 (PETCO2)Oxygen Saturation (SpO2)Pulse Rate (PR)Respiratory Rate (RR)Pressure of Inspired O2 (PIO2)Pulse PlethysmographBarometric PressureCalculated Indices:Estimated Arterial 02 (gPaO2)O2 Deficit (Alveolar-arterial O2difference)Arterial/alveolar oxygenexchange ratio (gPaO2/PAO2)Carrico Index ratio (gPaO2/FiO2)Respiratory Quotient (RQ)	CO2 WaveformET CO2- End Tidal CO2FiCO2- Fraction of Inspired CO2RR- Respiratory RateSpO2- Oxygen HemoglobinSaturationPI- Perfusion IndexPR- Pulse RateCalculated Indices:IPI- Integrated Pulmonary IndexOxygen Desaturation Index (ODI)Apnea per hour (A/hr)	Equivalent functionality for thepulse oximeter andcapnograph values.The MediPines Gas ExchangeMonitor (GEM) and predicatedevice provide additionalcalculated numerical indices ofpulmonary status based uponmathematical relationshipsbetween measuredparameters. Differences inpulmonary indices reported forthe devices are accounted forby labeling which describes theindices and the calculations
Dimensions	Monitor Dimensions:(W x H x D): 267 x 216 x 108 mm	Monitor Dimensions(W x H x D): 220 x 167 x 192	Equivalent functionality, somedimensional differences
Weight	Monitor Weight:1.7 kg (3.7 lbs)	Monitor Weight:3.5 kg (7.7 lbs)	Equivalent functionality, somedifference in weight
Power	Mains connected device, internalbattery	Mains connected device, internalbattery	Equivalent functionality
Electrical ProtectionClass	Type BF	Type BF defibrillation proof	Equivalent functionality, defibnot claimed for spot checkdevice
Moisture ProtectionClass	IPX1	IPX1	Equivalent functionality

In summary, the MediPines Gas Exchange Monitor (GEM) utilizes equivalent technology and has similar technical specifications as the predicate device and the reference device, the Capnostream 20 and TreyMed Metaphor Monitor, respectively.

(b) (1) Non-Clinical Tests Submitted

Compliance Testing

The MediPines Gas Exchange Monitor (GEM) 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 with test levels for professional (non-mobile) use. The following standards were utilized in compliance testing:

IEC 60601-1 Electrical safety ●
IEC 60601-1-2 EMC ●
ISO 80601-2-55 Performance of respiratory gas monitors ●
ISO 80601-2-61 Performance of pulse oximeters ●

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Exhibit 4
MediPines Corporation		Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	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.

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Exhibit 4
MediPines Corporation	Document TitleK180902/S001 510(k) Summary
OriginatorMediPines	Change Order-	Document Number	Rev	Page8 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.

Regulation Number and Section

§ 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).