ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Device Facts
| Record ID | K260226 |
|---|---|
| Device Name | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) |
| Applicant | Amptron Medical, Inc. |
| Product Code | BZK · Anesthesiology |
| Decision Date | Sep 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1850 |
| Device Class | Class 2 |
Indications for Use
ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period. ElintMAX is a non-invasive monitor that graphically displays changes in lung volume over time and presents estimated values for: - Tidal Volume - Respiratory Rate - Minute Ventilation - Inspiration-to-Expiration Time Ratio (I:E Ratio) - Rapid Shallow Breathing Index (RSBI) ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status.
Device Story
Non-invasive respiratory monitor; uses surface mechanomyography (sMMG) sensor placed over clothing on thoracoabdominal muscles to capture diaphragm activity; converts muscle activity to electrical signals; processes signals to estimate Tidal Volume, Respiratory Rate, Minute Ventilation, I:E Ratio, and RSBI; displays data on LCD interface; operated by healthcare professionals in hospital settings; provides supportive respiratory status data to supplement clinical judgment; does not detect apnea; intended for non-critical care environments.
Clinical Evidence
Clinical validation included 40 adult subjects (BMI 16.5-45.2 kg/m²) compared against a calibrated TSI Model 4040 flowmeter and Wright/Haloscale Respirometer. Results: Tidal Volume (mean bias +4.09 mL, Pearson 0.9782, MAE 41.01 mL); Minute Ventilation (mean bias -0.048 L/min, Pearson 0.938, MAE 0.542 L/min). Supplemental study (n=20) validated Respiratory Rate against CAPNOSTAT 5 capnography (correlation ~0.987, mean bias -0.18 breaths/min, 100% within ±3 breaths/min).
Technological Characteristics
Non-invasive sMMG sensing; external sensor placement over clothing; LCD touch screen interface; medical grade external power supply; software-based signal processing; non-sterile, single-patient use sensor; biocompatibility per ISO 10993-1; electrical safety per ANSI AAMI ES60601-1; EMC per IEC 60601-1-2.
Indications for Use
Indicated for spontaneously breathing adult patients in healthcare facilities who are hemodynamically stable and not under active procedural or post-anesthesia sedation. Contraindicated for intensive care, critical care, or immediate post-anesthesia recovery settings.
Regulatory Classification
Identification
A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
Predicate Devices
- ExSpiron 1Xi (K173181)
Reference Devices
Submission Summary (Full Text)
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September 16, 2026
Amptron Medical, Inc.
Nirav Patel
President
2231 Faraday Ave.,
Suite 130
Carlsbad, California 92008
Re: K260226
Trade/Device Name: ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Regulation Number: 21 CFR 868.1850
Regulation Name: Monitoring Spirometer
Regulatory Class: Class II
Product Code: BZK, BZQ
Dated: August 16, 2026
Received: August 17, 2026
Dear Nirav Patel:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260226 - Nirav Patel
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K260226 - Nirav Patel
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binoy J.
Mathews -S
Digitally signed by Binoy J.
Mathews -S
Date: 2026.09.16 21:31:39
-04'00'
For
James J. Lee, Ph.D.
Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K260226
Device Name
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
Indications for Use (Describe)
ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period.
ElintMAX is a non-invasive monitor that graphically displays changes in lung volume over time and presents estimated values for:
- Tidal Volume
- Respiratory Rate
- Minute Ventilation
- Inspiration-to-Expiration Time Ratio (I:E Ratio)
- Rapid Shallow Breathing Index (RSBI)
ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
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"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."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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# 510(k) Summary
# K260226
(as required by 21 CFR 807.92)
# I. SUBMITTER
Amptron Medical Inc.
2231 Faraday Avenue, Suite 130
Carlsbad, CA 92009
Contact Person: Nirav Patel, President
Phone: 442-325-1006
Date Prepared: September 16, 2026
# II. DEVICE
Trade name: ElintMAX
Common Name: Respiratory Monitor
Classification Name: Monitoring Spirometer (21 CFR 868.1850)
Regulatory Class: Class II
Product Code: BZK, BZQ
# III. PREDICATE DEVICE
Predicate Device (K173181):
Trade Name: ExSpiron 1Xi,
Common Name: Respiratory Monitor
Classification Name: Monitoring Spirometer (21 CFR 868.1850)
Regulatory Class: Class II
Product Code: BZK, BZQ
Reference Device (K091853):
Trade Name: nSpire Wright/Haloscale Respirometer,
Common Name: Respiratory Monitor
Classification Name: Monitoring Spirometer (21 CFR 868.1850)
Regulatory Class: Class II
Product Code: BZK
# IV. DEVICE DESCRIPTION
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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ElintMAX is a non-invasive respiratory monitoring system composed of a Display Monitor, Patient Sensor, Sensor Cable, and Cart. The Patient Sensor non-invasively measures thoracoabdominal muscle activity and converts it into an electrical signal that reflects the activity function of the diaphragm. The sensor is positioned externally over the patient's clothing and secured using adjustable straps, ensuring stable placement. It connects to the monitor via a detachable cable, allowing flexibility in setup and disconnection. The Patient Sensor is supplied non-sterile and intended for single-patient use in a hospital setting. The system is intended for prescription use only.
## V. INDICATIONS FOR USE
ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation.
ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period.
ElintMAX is a non-invasive monitor that graphically displays changes in lung volume over time and presents estimated values for:
- Tidal Volume
- Respiratory Rate
- Minute Ventilation
- Inspiration-to-Expiration Time Ratio (I:E Ratio)
- Rapid Shallow Breathing Index (RSBI)
ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status.
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device demonstrates substantial equivalence to the referenced predicate device through several key technological and safety attributes. The following comparative analysis highlights the Indications for Use and principal technological attributes of the subject device in relation to the predicate device.
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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# **COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE**
| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
| --- | --- | --- | --- | --- |
| **Trade Name** | ElintMAX | ExSpiron 1Xi | Wright/Haloscale Respirometer | |
| **Common Name** | Respiratory Monitor | Respiratory Monitor | Respiratory Monitor | |
| **510(K) Number** | K260226 | K173181 | K091853 | |
| **Regulation Classification (Product Code)** | 21 CFR 868.1850 (BZK) 21 CFR 868.2375 (BZQ) | 21 CFR 868.1850 (BZK) 21 CFR 868.2375 (BZQ) | 21 CFR 868.1850 (BZK) | Same regulation classification and product codes |
| **Intended Use** | ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period. ElintMAX is a non-invasive monitor that | ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age. ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: • Minute Ventilation (MV) • Tidal volume (TV) | The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and postoperative recovery. It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit, or in spontaneously breathing or mechanically ventilated patients. | The subject monitor is intended for the same clinical use as the predicate device. Both are designed for deployment by qualified healthcare professionals in hospital settings. Minor textual differences between the devices do not reflect a change in intended use. These variations correspond to minor technical distinctions and do not impact the intended purpose, user population, or conditions of use. |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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| | graphically displays changes in lung volume over time and presents • Tidal Volume • Respiratory Rate • Minute Ventilation • Inspiration-to-Expiration Time Ratio (I:E Ratio) • Rapid Shallow Breathing Index (RSBI) ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status. | • Respiratory rate (RR) ExSpiron 1Xi measurements are used as an adjunct to other clinical information. | | |
| --- | --- | --- | --- | --- |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
| --- | --- | --- | --- | --- |
| **Measurement Modality** | Surface mechanomyography (sMMG) | Thoracic bioimpedance | Turbine flow measurement | sMMG uses a different, but scientifically supported, non-invasive technique to capture equivalent respiratory data. |
| **Sensor Placement** | Over clothing on the thoracoabdominal muscles | Skin-surface electrodes on the chest | In line with the airway via the mouthpiece | Substantial equivalence of differences in sensor placement addressed through performance testing. |
| **Invasiveness** | Non-invasive, no skin or airway contact | Non-invasive | Non-invasive (requires breath interface) | Similar |
| **Patient Contact** | No direct skin contact | Contact with skin electrodes | Contact with exhaled air | Substantial equivalence of differences in patient contact addressed through biocompatibility |
| **Primary Measurements** | Tidal Volume, Minute Volume, Respiratory Rate, | Tidal Volume, Minute Volume, Respiratory Rate | Tidal Volume, Minute Volume | Similar |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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| **Accuracy** | Tidal Volume: RMS percentage accuracy 8.43%; MAE: 41.01 mL. Minute Volume: RMS percentage accuracy 8.98%; MAE: 0.542 L/min. Respiratory Rate: ±3 breaths/min MAE = 0.60 breaths/min. | Tidal Volume: RMS percentage accuracy 12% Minute Volume: RMS percentage accuracy 11.9% Respiratory Rate: 4.2% | Tidal Volume: ±3% for minute volumes >5 L/min and ±4% for minute volumes >4 L/min; | ElintMAX demonstrated acceptable performance for Tidal Volume, Minute Volume, and Respiratory Rate. |
| --- | --- | --- | --- | --- |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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| Characteristic | Subject Device | Predicate Device | Reference Device | Comparison |
| --- | --- | --- | --- | --- |
| **Derived Measurements** | IE Ratio, RSBI | None | None | RSBI is calculated from the ElintMAX respiratory rate and tidal volume measurements (RR/VT). K030722 was used as a reference device because it provides cleared precedent for RSBI as a calculated respiratory monitoring parameter. I:E ratio is calculated from inspiratory and expiratory time intervals identified from the ElintMAX sMMG respiratory waveform (Ti/Te). K030722 was used as a reference device because it provides cleared precedent for display of I:E ratio as a respiratory monitoring parameter. |
| **Display Method** | Liquid Crystal Display (LCD) Interface | Liquid Crystal Display (LCD) Interface | Analog Dial | Similar |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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| **User Controls** | Touch Screen | Touch Screen | Mechanical Buttons | Similar |
| --- | --- | --- | --- | --- |
| **Use Environment** | Healthcare facilities (not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period) | Healthcare facilities (such as postoperative care and critical care units.) | Healthcare facilities (intensive care patients, during anaesthesia and post operative recovery) | Comparable use environment |
| **Alarms** | - Vt High - Vt Low - RSBI High - MV High - MV Low - RR High - RR Low - No Breath Detected | - TV High - TV Low - MV High - MV Low - RR High - RR Low - No Breath Detected - Period | Not Applicable | |
| **Power Source** | Medical Grade External Power Supply | Internal Power Supply | Manual (no power source) | Comparable power source |
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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## VII. PERFORMANCE DATA
The submitted performance data supports the determination of substantial equivalence between the subject and predicate devices.
### Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the ElintMAX System in accordance with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012, & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1: 2005 +A1: 2012 +A2: 2020 AAMI ES 60601-1: 2005 +A1:2012 +A2: 2021
(Medical electrical equipment – Part 1: General requirements for safety of Medical electrical equipment – General requirements for basic safety and essential performance)
- IEC 60601-1-2: Ed. 4.1: 2020 and CISPR 11: 2010:
(General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)
- Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, August 14, 2013.
- ANSI C63.27-2021 — American National Standard for Evaluation of Wireless Coexistence.
The EMC evaluation was performed consistent with FDA's guidance "Electromagnetic Compatibility (EMC) of Medical Devices" (June 6, 2022). Immunity to nearby RF wireless communications equipment was verified through proximity-field testing per IEC 60601-1-2
### Software Verification and Validation Test
Software verification and validation were performed and documented in accordance with FDA's guidance - *Content of Premarket Submissions for Device Software Functions*.
The device's software has been classified as requiring Basic Documentation Level, given that, a failure or latent flaw of the device software function(s) would not present a hazardous situation with probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures.
### Cybersecurity Verification and Validation Test
Cybersecurity risk management and testing were performed and documented in accordance with FDA's guidance, *Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions*. Cybersecurity activities included evaluation of potential cybersecurity risks and implementation and verification of appropriate security controls to support the confidentiality, integrity, and availability of the device and its data. Cybersecurity verification and validation demonstrated that the implemented controls adequately mitigate identified cybersecurity risks and support the safe and effective operation of the device.
### Alarm Verification and Validation Test
Alarm testing were conducted on the ElintMAX System in accordance with the following
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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standards:
IEC 60601-1-8: (Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.)
## Performance Testing - Bench
Nonclinical performance testing was conducted to verify that the ElintMAX Respiratory Monitor meets its applicable design and performance specifications.
In addition, controlled bench testing was performed under predefined adult respiratory conditions, with repeated measurements across specified respiratory parameter settings and breathing patterns to verify that ElintMAX measurements met the applicable parameter-specific performance specifications.
Additional nonclinical testing included Cart verification, labeling verification, Sensor Cable testing, continuous-use reliability testing, and respiratory waveform comparison. The results of these evaluations demonstrated that ElintMAX met the applicable predefined acceptance criteria and design requirements and, together with the other verification and validation evidence provided in the submission, support the performance of the device for its intended use and the substantial-equivalence determination.
A biological evaluation of ElintMAX was conducted in accordance with ISO 10993-1:2018 and FDA's guidance "Use of International Standard ISO 10993-1" (September 2023). The Patient Sensor is applied over the patient's clothing, and no component of the system is intended to contact the patient's body directly. Based on this contact categorization, the evaluation identified no biological endpoints applicable to the device.
## Performance Testing – Clinical
Clinical performance testing was conducted to evaluate the accuracy and reliability of the ElintMAX Respiratory Monitor for tidal volume (VT), minute ventilation (MV), respiratory rate (RR), rapid shallow breathing index (RSBI), and inspiration-to-expiration (I:E) ratio. The primary clinical validation study, included 40 adult subjects. The study population included male and female subjects across a broad range of body habitus, with BMI ranging from 16.5 to 45.2 kg/m². ElintMAX measurements were evaluated against an independent respiratory measurement system incorporating a calibrated TSI Model 4040 flowmeter and against a Wright/Haloscale Respirometer as a clinical comparator. The TSI-based system served as the quantitative reference for evaluation of VT and MV accuracy, while the Wright/Haloscale comparison provided supportive clinical-comparator evidence.
Performance was characterized using descriptive statistics, relative-error analysis, regression and correlation analyses, Bland-Altman analysis, and error metrics including mean absolute error, root mean square error, and mean absolute percentage error. For VT, ElintMAX demonstrated a mean bias of +4.09 mL, Pearson correlation of 0.9782, MAE 41.01 mL relative to the TSI reference. For MV, the mean bias was -0.048 L/min, Pearson correlation of 0.938, MAE 0.542 L/min relative to the TSI reference.
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
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The additional derived parameters I:E ratio and RSBI were also clinically validated. For I:E ratio, the final analysis demonstrated a mean bias of +0.0159, Pearson correlation of 0.9124, and limits of agreement of -0.3812 to +0.4130; For RSBI, the mean bias was -0.0584 breaths/min/L, Pearson correlation was 0.9709, and limits of agreement were -9.0882 to +8.9714 breaths/min/L;
Respiratory rate was further evaluated in a supplemental clinical validation study using CAPNOSTAT 5 capnography with clinician-reviewed reference respiratory rates. Performance testing was conducted on 20 human subjects. ElintMAX respiratory rate measurements were compared against manually scored end-tidal CO₂ (etCO₂) obtained using the FDA-cleared capnograph, which served as the reference standard for respiratory rate. Testing included normal breathing, positional change, coughing, rapid shallow breathing, and slow breathing. The pooled analysis demonstrated agreement with the reference, including correlation of approximately 0.987, mean bias of approximately -0.18 breaths/min, and 100% of measurements meeting the predefined ±3 breaths/min acceptance criterion.
Collectively, the clinical performance testing demonstrated that the ElintMAX Respiratory Monitor provides measurements of VT, MV, RR, I:E ratio, and RSBI across the evaluated adult population that are substantially equivalent to the predicate device.
### VIII. CONCLUSIONS
The passing results of performance testing, along with a comparative analysis of technological characteristics and Indications for Use, support the determination that the subject device is shown to be substantially equivalent to a legally marketed predicate device, Expiron 1Xi (K173181).
ElintMAX Respiratory Monitor
Amptron Medical, Inc.
