What is the regulatory pathway for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

Q: Who is the manufacturer of MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

Medipines Corporation filed the 510(k) submission for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly (K180902).

Q: What is the FDA product code for MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly?

CCK. It is classified under 21 CFR 868.1400 as a Class 2 device in the Anesthesiology panel.

K180902 · Medipines Corporation · CCK · Jan 11, 2019 · Anesthesiology

Device Facts

Record ID	K180902
Device Name	MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
Applicant	Medipines Corporation
Product Code	CCK · Anesthesiology
Decision Date	Jan 11, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1400
Device Class	Class 2

Intended 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 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.

Device Story

Non-invasive multi-parameter respiratory monitor; inputs include breath samples via disposable mouthpiece/nose clip and pulse oximetry via finger sensor. Device uses NDIR for CO2 and galvanic cell for O2 sensing; pulse oximetry uses two-wavelength measurement. Operates as spot-check device (approx. 2-minute sessions) in professional healthcare facilities; operated by qualified medical personnel. Displays real-time breath tracings and calculated pulmonary indices (e.g., O2 deficit, Carrico Index, Respiratory Quotient). Output used by clinicians as adjunct to clinical assessment; not for diagnosis or treatment decisions; does not replace arterial blood gas sampling. No alarms. Benefits include rapid assessment of respiratory status.

Clinical Evidence

Clinical testing included controlled hypoxia studies in human adult volunteers to validate pulse oximeter accuracy against co-oximetry (SaO2). Additional clinical studies on consenting adults assessed operation of spot-check measurement sessions and calculation of respiratory indices. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-55, and ISO 80601-2-61.

Technological Characteristics

Multi-parameter monitor; NDIR sensor for CO2; galvanic cell for O2; two-wavelength pulse oximetry. PC-based touchscreen interface; embedded microcontroller. Dimensions: 267x216x108 mm; Weight: 1.7 kg. Mains/battery powered. Type BF electrical protection. IPX1 moisture protection. Software class B (moderate level of concern).

Indications for Use

Indicated for conscious, cooperative adults (18+ years) in professional healthcare facilities. Used for spot-check respiratory gas (O2, CO2), respiration rate, SpO2, and pulse rate monitoring. Contraindicated for use with supplemental oxygen or other respiratory gases/agents.

Regulatory Classification

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.

Predicate Devices

Capnostream20 (K094012)

Reference Devices

Metaphor Metabolic Monitor (K093080)

Related Devices

K981114 — MICROCAP · Oridion Medical , Ltd. · Jun 25, 1998
K992455 — NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES · Nihon Kohden America, Inc. · Jan 7, 2000
K160582 — WiCap · Athena Gtx · Sep 2, 2016
K964305 — NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES · Nihon Kohden America, Inc. · Feb 19, 1997
K170820 — Capnograph and Oximeter · Cmi Health, Inc. · Jul 18, 2018

Submission Summary (Full Text)

{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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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 2) Oxygen monitor 3) Pulse oximeter | | | | | | Classification Name(s): | | 1) 21CFR 868.1400 (Carbon Dioxide Gas Analyzer) Product Code: CCK 2) 21CFR 868.1720 (Oxygen gas analyzer) Product Code: CCL 3) 21CFR 870.2700 (Oximeter) Product Code: DQA 4) 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 (<5 minute) spot-check sessions; continuous for short duration | Continuous | Subject device use as spot- check device device is within the scope of the predicate device | | Supplemental gases | Not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents | Use with supplemental gases | Use without supplemental gases is within the scope of the predicate device and consistent with spot-check use | | Sterility | Non-sterile mouthpiece and reusable SpO2 sensor | Non-sterile airway adapter and reusable SpO2 sensor | Equivalent function | | Control System | User interface via PC-based touch screen display. Embedded microcontroller interfaces with gas sensors and pulse oximeter module to obtain measurement data for host | Internal embedded microprocessor | Equivalent functionality | | Control Keys | Power Button Touchscreen Display with Virtual keyboard | Monitor Power ON/OFF Event Button Patient Admit/ Discharge Pump Off Temporary Alarm Silence Control Knob | Equivalent functionality | {7}------------------------------------------------ | Exhibit 4 | | | | | |-------------------------|---------------|-----------------------------------------------|-----|----------------| | MediPines Corporation | | Document Title K180902/S001 510(k) Summary | | | | Originator MediPines | Change Order- | Document Number | Rev | Page 5 of 8 | | Product/Feature | Gas Exchange Monitor (GEM) (Proposed Device) | Capnostream 20 Capnograph/Pulse Oximeter | Remark | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Measurement principle - SpO2 | Two wavelength pulse measurement to obtain functional oxygen saturation | Two wavelength pulse measurement to obtain functional oxygen saturation | Same measurement principles | | Measurement method - CO2 | Sidestream gas sample: Non- dispersive Infrared (NDIR) for CO2 gas | Sidestream gas sample: Non- dispersive Infrared (NDIR) for CO2 gas | Same measurement principles | | Measurement method - Oxygen | Sidestream gas sample: galvanic cell for Oxygen sensor | (no galvanic O2 gas measurement) | Subject device includes galvanic O2 measurement (as does reference Metaphor device) | | CO2 measurement range | 0 - 100 mmHg (0 - 13%) | 0-99 mmHg (0-13%) | Equivalent ranges | | CO2 measurement accuracy | ± 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) | ± 2 mmHg from 0 - 38 mmHg 39-99 mmHg ± (5% of reading + 0.08% for every 1 mmHg above 38mmHg) | Equivalent ranges, subject device meets current gas monitoring standard accuracy requirements | | O2 measurement range | 0 – 800 mmHg (0 - 100%) | N/A | Subject device includes galvanic O2 measurement (as does reference Metaphor device) | | O2 measurement accuracy | < ± 1% (at ATPS) | N/A | Subject device includes galvanic O2 measurement (as does reference Metaphor device) | | SpO2 measurement range | 0 – 99 % | 1-100% | Equivalent ranges | | Pulse rate measurement 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 digits Motion: ± 5 digits | Equivalent functionality | {8}------------------------------------------------ | MediPines Corporation | Document Title K180902/S001 510(k) Summary | Exhibit 4 | | | |-------------------------|-----------------------------------------------|-----------------|-----|----------------| | Originator MediPines | Change Order- | Document Number | Rev | Page 6 of 8 | | Product/Feature | Gas Exchange Monitor (GEM) | Capnostream 20 Capnograph/Pulse | Remark | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | (Proposed Device) | Oximeter | | | Displayed Parameters | Measured/ Displayed: CO2 Waveform 02 Waveform Continuous partial pressure of O2 Continuous partial pressure of CO2 End Tidal O2 (PETO2) End Tidal CO2 (PETCO2) Oxygen Saturation (SpO2) Pulse Rate (PR) Respiratory Rate (RR) Pressure of Inspired O2 (PIO2) Pulse Plethysmograph Barometric Pressure Calculated Indices: Estimated Arterial 02 (gPaO2) O2 Deficit (Alveolar-arterial O2 difference) Arterial/alveolar oxygen exchange ratio (gPaO2/PAO2) Carrico Index ratio (gPaO2/FiO2) Respiratory Quotient (RQ) | CO2 Waveform ET CO2- End Tidal CO2 FiCO2- Fraction of Inspired CO2 RR- Respiratory Rate SpO2- Oxygen Hemoglobin Saturation PI- Perfusion Index PR- Pulse Rate Calculated Indices: IPI- Integrated Pulmonary Index Oxygen Desaturation Index (ODI) Apnea per hour (A/hr) | Equivalent functionality for the pulse oximeter and capnograph values. The MediPines Gas Exchange Monitor (GEM) and predicate device provide additional calculated numerical indices of pulmonary status based upon mathematical relationships between measured parameters. Differences in pulmonary indices reported for the devices are accounted for by labeling which describes the indices 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, some dimensional differences | | Weight | Monitor Weight: 1.7 kg (3.7 lbs) | Monitor Weight: 3.5 kg (7.7 lbs) | Equivalent functionality, some difference in weight | | Power | Mains connected device, internal battery | Mains connected device, internal battery | Equivalent functionality | | Electrical Protection Class | Type BF | Type BF defibrillation proof | Equivalent functionality, defib not claimed for spot check device | | Moisture Protection Class | 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 ● {9}------------------------------------------------ | Exhibit 4 | | | | | | |--------------------------------|---------------|------------------------------------------------------|-----|---------------|--| | MediPines Corporation | | Document Title 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.