(165 days)
ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
The ENLIGHT 2100 is a ventilatory electrical impedance tomograph that also provides respiratory parameters based on spirometric monitoring. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting. The device provides information on impedance variation from a cross-section of a patient's thorax as an adjunctive tool to support the user's assessment of variations in regional air content. It does not measure regional ventilation of the lungs. The device relies on a primary predicate (ENLIGHT 2100 - K211135) for its Electrical Impedance Tomography (EIT) data and a secondary predicate (Philips NM3 Respiratory Profile Monitor with VentAssist – K103578) for its spirometric monitoring capabilities. The data provided focuses on non-clinical/bench testing to demonstrate substantial equivalence to these predicates.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ENLIGHT 2100 are based on its performance characteristics in comparison to its predicate devices for both EIT parameters and spirometric parameters. The study conducted was non-clinical bench testing.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Subject Device's "Performance Characteristics") | Reported Device Performance (from Subject Device's "Performance Characteristics" and "Explanation of Differences") |
|---|---|---|
| EIT Parameters | ||
| Distribution Ratios | Range: 0 – 100% | Anterior, Posterior, Left, Right Distribution Ratio: Uncertainty of +/- 10 p.p. (Same as primary predicate). The explanation states the predicate didn't present the numeric parameter, but because the hardware and EIT algorithm are the same, the performance is equivalent. |
| Tidal Variation Z (TVz) | Range: 20% to 500% | Tidal Impedance Variation (TVz): Uncertainty of +/- 10% of reading. (Same as primary predicate). Calculates and displays: a) maximum impedance variation for the respiratory cycle in which the reference is positioned, b) the maximum impedance variation for the respiratory cycle in which the cursor is positioned, and c) the relationship between the maximum impedance variation of these two timepoints. |
| Tidal Variation Rate | Adult: 5 to 50 bpm, Pediatric: 10 to 140 bpm | Tidal Variation Rate: ±2.0 bpm if ≤ 60 bpm, ±5.0 bpm if > 60 bpm. (Same as primary predicate). The device calculates and displays the Tidal Variation Rate, considering the last minute (number of oscillations identified in the last minute). |
| Spirometric Parameters | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Tidal Volume | Range: 40 to 2500 ml | Accuracy: Max Error is less than or equal to 11.71mL, Max Relative Error is less than or equal to 4.97%. Comparison to NM3: Absolute accuracy related to NM3 is less than 6.27mL, and relative accuracy related to NM3 is less than 4.33%. |
| Respiratory Rate | Range: 5 to 150 breath/min | Accuracy: Max Error is less than or equal to 0.70 bpm. Comparison to NM3: Absolute accuracy related to NM3 is less than 0.39 bpm. |
| Positive End Expiratory Pressure (PEEP) | Range: 1.0 - 50.0 cmH2O | Accuracy: Max Error is less than or equal to 1.0cmH2O, Max Relative Error is less than or equal to 2.47%. Comparison to NM3: Absolute accuracy related to NM3 is less than 0.73 cmH2O. |
| Peak Inspiratory Pressure (PIP) | Range: 1.0-120.0 cmH2O | Accuracy: Max Error is less than or equal to 0.44 cmH2O. Comparison to NM3: Relative accuracy related to NM3 is less than 4.88%. |
| Resistance | Range: 5 - 40 cmH2O/L/s | Accuracy: Bias: 0 cmH2O/L/s, Std Dev: 3 cmH2O/L/s. Comparison to NM3: Absolute mean accuracy related to NM3 is less than 6 cmH2O/L/s. |
| Compliance | Range: 3 - 80 ml/cmH2O | Accuracy: Bias: -1 mL/cmH2O, Std. Dev: 5 mL/cmH20. Comparison to NM3: Absolute mean accuracy related to NM3 is less than 6.97 mL/cmH2O. |
| Plateau Pressure | Range: 10.0-90.0 cmH2O | Accuracy: Bias: 0.1 cmH2O, Std Dev: 1.1 cmH2O. Comparison to NM3: Absolute mean accuracy related to NM3 is less than 1.47 cmH2O. |
The "Explanation of Differences" column in the provided tables typically serves as the primary source for the reported device performance and the proof that it meets the acceptance criteria (i.e., demonstrating substantial equivalence to the predicates based on the non-clinical testing). For the EIT parameters, the performance is reported as "Same" as the predicate, with the rationale that the hardware and EIT algorithm are identical. For the spirometric parameters, specific accuracy metrics are provided for the subject device and its accuracy relative to the secondary predicate (NM3).
2. Sample size used for the test set and data provenance
The document explicitly states that "Bench Testing - We have performance tests to check the automatic calculation of the parameters shown at the Trend Screen." and lists "Non-clinical testing" and "Bench Test" as the method. Therefore, the data provenance is bench test data. No information is provided regarding the specific sample size (e.g., number of test points, simulated cases, or repetitions) used for this bench testing. The data does not specify the country of origin, but given the sponsor's location (Brazil) and the nature of bench testing, it would likely be laboratory/engineering data. It is inherently prospective as it involves controlled testing to confirm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The study described is non-clinical bench testing. It involves evaluating the device's numerical calculations and performance against specified ranges and accuracy criteria, likely using simulated physiological signals or validated reference equipment. Therefore, no human experts were used to establish ground truth in the way they would be for image interpretation or diagnosis. The ground truth for this type of testing is established by the specifications of the signals generated or the reference standards of the testing equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Given that this was a non-clinical bench study focused on numerical calculation accuracy and signal acquisition performance, no human adjudication method was employed. The "ground truth" was inherently defined by the test setup and reference measurements, not by human interpretation or consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. The device (ENLIGHT 2100) functions as a sensor and data display unit for physiological parameters, not an AI-assisted diagnostic tool that would directly assist human readers in interpreting complex medical images or data where a reader study would be applicable. The document describes it as an "adjunctive tool to other clinical information," implying it provides data for clinicians to interpret, but not in a way that necessitates an AI-assistance reader study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone (algorithm only) performance evaluation was implicitly done through the bench testing. The document states, "We have performance tests to check the automatic calculation of the parameters shown at the Trend Screen." This testing evaluates the device's ability to accurately measure and calculate the specified EIT and spirometric parameters within defined ranges and accuracies, independent of human interaction or interpretation beyond setting up the test and recording results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this non-clinical bench testing was established through engineered inputs/simulations and/or comparisons to a validated reference standard. For example, for spirometric parameters like Tidal Volume or Respiratory Rate, the system would be fed precisely controlled and measured airflow/pressure signals, and the device's output would be compared to the known input values of these signals. For EIT parameters, the ground truth would similarly come from controlled electrical impedance variations generated under laboratory conditions.
8. The sample size for the training set
The document describes non-clinical bench testing for the purpose of demonstrating substantial equivalence. It does not mention any machine learning or AI components that would require a separate training set. Therefore, information regarding a training set sample size is not applicable or provided in this context. The device's algorithms are likely based on established physiological and electrical impedance principles, not trained on a large dataset of patient measurements requiring specific "training set" ground truth establishment.
9. How the ground truth for the training set was established
As there is no mention of a training set or machine learning/AI model training, the question of how its ground truth was established is not applicable based on the provided information.
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March 7, 2023
Timpel S.A. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K222897
Trade/Device Name: Enlight 2100 Regulation Number: 21 CFR 868.1505 Regulation Name: Ventilatory Electrical Impedance Tomograph Regulatory Class: Class II Product Code: QEB, BZK Dated: February 6, 2023 Received: February 6, 2023
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,
Ethan L. Nyberg -S
for James Lee Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia 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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Indications for Use
510(k) Number (if known)
K22897
Device Name
Enlight 2100
Indications for Use (Describe)
ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | |
|---|---|
| Date Prepared: | 6-Mar-23 |
| Sponsor: | TIMPEL S.A.Rua Simão Álvares, 356 Cj. 41/42Pinheiros, São Paulo/SP - BrazilT - +55-113088-0305Rafael Holzhacker - CEO |
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | ENLIGHT 2100 |
| Regulation Number: | 868.1505 |
| Regulation Name: | Ventilatory electrical impedance tomograph |
| Product code: | QEB |
| Secondary Product Code: | BZK |
| Regulation Number: | 868.1850 |
| Regulation Name: | Spirometer, Monitoring (W/Wo Alarm) |
| Primary Predicate: | Primary Predicate - ENLIGHT 2100 - K211135 |
| Regulation Number: | 868.1505 |
| Regulation Name: | Ventilatory electrical impedance tomograph |
| Product code: | QEB |
| Secondary Predicate: | Philips NM3 Respiratory Profile Monitor with VentAssist – K10357 8 |
| Regulation Number: | 868.1850 |
| Regulation Name: | Spirometer, Monitoring (W/Wo Alarm) |
| Product Code: | BZK |
510(k) Summary
Device Description:
ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
Principle of Operation:
Electrical impedance tomography (ET) provides information on Local Impedance Variation (LIV) within a cross section of a patient's thorax.
Indications for Use:
ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs.
ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring.
It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm.
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ENLIGHT 2100 does not measure regional ventilation of the lungs.
Patient Population:
Mechanically ventilated adult and pediatric patients whose thorax perimeter is within the range of 37.5 -134 cm.
Environments of use: Hospital setting.
Substantial Equivalence Discussion
Indications - There are no differences in the indication for use.
Patient Population - There is no difference in the patient population.
Environment of Use - There is no difference in the environment of use.
Technological Characteristics - There are no technological characteristic differences between either the Enlight 2100 or NM3 and the technology is the same as the NM3 cleared under K103578 which is a pneumotach with flow sensor.
Parameters - The subject device provides numerical calculation from data already present in the secondary predicate device, to complement the Trends Screen. Numerical data will be used as reference for trend analysis, in other words, to compare different moments during the continuous monitoring of the same patient.
There are no standard values or expectations related to the parameters shown, as well as clinical significance for the absolute values. Variations of the same parameter shall be used as adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax.
Non-clinical testing
Biocompatibility - There is no difference in the patient contact or materials between the proposed device and the predicates.
Human Factors - There are no changes in the primary functions of the device or risk control measures that require new human factors validation.
Bench Testing - We have performance tests to check the automatic calculation of the parameters shown at the Trend Screen.
The following non-clinical testing was performed to support substantial equivalence. Details of the test results are provided in the tables below.
- · EIT Parameters
- 0 Distribution ratios
- o TVz Tidal Variation Z
- TVR Tidal Variation Rate O
- Airway Ventilation Parameters ●
- Airway Ventilation Parameters ●
- Alveolar Parameters ●
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- Ventilation Parameters for adult / pediatric flow sensor ●
- Compliance O
- Resistance O
- Plateau Pressure O
- Auto PEEP O
- Driving Pressure O
For NM3, K103578, as a secondary predicate device
Indications -ENLIGHT 2100 will provide only a subset of the spirometric monitoring for pediatric and adult patients, to complement it as an adjunctive tool to support the user's assessment of variations in regional air content.
Patient Population - The intended Patient Population for ENLIGHT 2100 are adult and pediativ patients, whose thorax perimeter is within the range of 37.5 – 134 cm and neonates above 29 days. The intended patient population for ENLIGHT 2100 is not the same as NM3, but it's included in the range of intended patient population of the predicate device.
Environment of Use - There is no difference in the environment of use.
Technological Characteristics - The technology is the same as the NM3 cleared under K103578 which is a pneumotach with flow sensor.
Standards - We referenced the following FDA recognized standards.
- [Rec. Number 19-4] AAMI ANSI ES 60601-1: 2005 / (R)2012 and A1:2012 Medical electrical . equipment - Part 1: General requirements for basic safety and essential performance
- [Rec. Number 19-1] IEC 60601-1-2 ed. 4: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Substantial Equivalence Conclusion
The data presented supports the substantial equivalence between the subject device ENLIGHT 2100, ENLIGHT 2100 cleared under K211135 and NM3 (spirometric measurements subset), cleared under K103578.
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| Attributes | Subject | Primary Predicate | Explanation of Differences |
|---|---|---|---|
| ENLIGHT 2100 – K232897 | ENLIGHT 2100 - K211135 | ||
| Indications for Use | ENLIGHT 2100 is a non-invasive, radiation freemedical device that provides information fromimpedance variation from a cross-section of apatient's thorax. This information is presented tothe clinician user as an adjunctive tool to otherclinical information in order to support the user'sassessment of variations in regional air contentwithin a cross section of a patient's lungs.ENLIGHT 2100 also provides respiratoryparameters based on spirometric monitoring.It is intended for mechanically ventilated adult andpediatric patients in a hospital setting, whose thoraxperimeter is within the range of 37.5 - 134cm.ENLIGHT 2100 does not measure regional | ENLIGHT 2100 is a non-invasive, non-radiationmedical device that provides information of localimpedance variation within a cross-section of apatient's thorax. This information is presented to theclinician user as an adjunctive tool to other clinicalinformation in order to support the user'sassessment of variations in regional air contentwithin a cross section of a patient's lungs.It is intended for mechanically ventilated adult andpediatric patients in a hospital setting, whose thoraxperimeter is within the range of 37.5 -134 cm.ENLIGHT 2100 does not measure regionalventilation of the lungs. | The change in the Indications forUse is related only to the inclusionof respiratory parameters, which areequivalent to the other predicateclaimed. |
| ventilation of the lungs. | |||
| Patient Population | Adult and Pediatric patients, whose thoraxperimeter is within the range of 37.5 -134 cm. | Adult and Pediatric patients, whose thoraxperimeter is within the range of 37.5 -134 cm. | No differences. |
| Patient type | Mechanically ventilated patients | Mechanically ventilated patients | No differences. |
| Principle ofOperation | Electrical Impedance Tomography based on voltagemeasures to estimate local impedance variationwithin a cross-section of a patient's thorax. | Electrical Impedance Tomography based on voltagemeasures to estimate local impedance variationwithin a cross-section of a patient's thorax. | No differences. |
| Contraindications | No changes, presented in Instructions for use | No changes, presented in Instructions for use | No differences. |
| Environment of Use | Hospital Setting | Hospital Setting | No differences. |
| Duration of Use | Up to 30 days, with Addere Change each 48 hours. | Up to 30 days, with Addere Change each 48 hours. | No differences. |
| Operating System | Update of the version of Linux OS and OpenSource Software for the Processing and InterfaceModule (PIM) | The PIM software runs on top of a Linux OS, usingJAVA. | The differences do not impact thesoftware structure. There are nodifferences to the end user. |
| Table 1 - Comparison - Subject vs. Primary Predicate - EIT Data | |
|---|---|
| ----------------------------------------------------------------- | -- |
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| Attributes | Subject | Primary Predicate | Explanation of Differences |
|---|---|---|---|
| ENLIGHT 2100 – K232897 | ENLIGHT 2100 - K211135 | ||
| Features | |||
| Accessories /Available Sizes | Electrode Belt sizes – 11 sizesAddere sizes - 11 sizesShaper No 2Reference Cable (Single size) | Electrode Belt sizes – 11 sizesAddere sizes - 11 sizesShaper No 2Reference Cable (Single size) | No differences. |
| Patient Contact perISO 10993-1 | Surface contact, Intact skinProlonged duration (Up to 30 days) | Surface contact, Intact skinProlonged duration (Up to 30 days) | No differences. |
| Trends Screen | Data from the device is presented to the user ingraphic format and with possibility to compare twomoments (reference and cursor) to assist the user inthe patient assessment. | Data from the device is presented to the user ingraphic format and with possibility to compare twomoments (reference and cursor) to assist the user inthe patient assessment. | Numerical data are automations ofcalculations that could be donemanually using the predicate device. |
| Trends ScreenDistribution Ratios | Graphic Information for Global and Regional(Anterior / Posterior / Right / Left) Plethysmograms,with numerical indications of tidal variations (Δ) forthe period indicated by the reference and cursor lines(defined by the user), color coded. | Graphic Information for Global and Regional(Anterior / Posterior / Right / Left) Plethysmograms,with numerical indications of tidal variations (Δ) forthe period indicated by the reference and cursor lines(defined by the user), color coded. | Calculates and displays theRelationship between the amplitude ofthe regional plethysmograms(Anterior / Posterior / Right / Left)and the amplitude of the globalplethysmogram, in percentage. |
| Trends ScreenTidal Variation Z | The device automates the calculation that could bedone by the user. It calculates the maximumimpedance variation for the respiratory cycle in whichthe reference is positioned, and also calculates themaximum impedance variation for the respiratorycycle in which the cursor is positioned. These valuesare called "Tidal Impedance Variation". | In the plethysmogram, the user can see the value of thetidal impedance variation by positioning the referenceand cursor lines in the maximum and the minimumvalue of a certain respiration cycle at a first moment(t1). (Δ1 in blue, in the example above). By selectingthe maximum and the minimum values in a differentcycle (t2), it is possible to manually calculate the ratioof the Tidal Impedance Variation between those 2moments (Δ1 assessed in t2 divided by Δ1 assessed int1). | It calculates and displays the a)maximum impedance variation for therespiratory cycle in which thereference is positioned, b) themaximum impedance variation for therespiratory cycle in which the cursor ispositioned, and c) the relationshipbetween the maximum impedancevariation of these two timepoints. |
| Trends ScreenTidal Variation Rate | The device calculates the Tidal Variation Rate,considering number of oscillations that were identifiedin the last minute.This data is presented in the Numerical Area (table)and in graphical form in the trends screen. | In the global plethysmogram, the user can count howmany oscillations of the plethysmogram he observeswithin the time period between the reference andcursor lines, and calculate how many oscillations perminute occurred. | The device calculates and displays theTidal Variation Rate, considering thelast minute. |
| Attributes | SubjectENLIGHT 2100 – K232897 | Primary PredicateENLIGHT 2100 - K211135 | Explanation of Differences |
| Performance Characteristics - Non-clinical / Bench Test | |||
| Distribution Ratios | Range: 0 – 100%Uncertainty of +/- 10 p.p. for Anterior, Posterior, Leftand Right distribution ratio. | Same | The predicate didn't present thenumeric parameter, but as thehardware is the same and the EITalgorithm is the same, theperformance is equivalent for thischaracteristic. |
| Tidal Variation Z(TVz) | Range: 20% to 500%Uncertainty of +/- 10% of reading. | Same | |
| Tidal Variation Rate | Adult: 5 to 50 bpm, Pediatric: 10 to 140 bpm±2.0 bpm if ≤ 60 bpm, ±5.0 bpm if > 60 bpm | Same |
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| Attributes | SubjectENLIGHT 2100 | Secondary PredicateNM3 | Explanation of Differences |
|---|---|---|---|
| 510(k) | K222897 | K103578 | |
| Product ClassificationCFR | 868.1850 - BZK | 868.1850 - BZK | Different product codes. Addingproduct code of the reference. |
| Indications for Use | ENLIGHT 2100 is a non-invasive, radiation freemedical device that provides information fromimpedance variation from a cross-section of apatient's thorax. This information is presented to theclinician user as an adjunctive tool to other clinicalinformation in order to support the user's assessmentof variations in regional air content within a crosssection of a patient's lungs.ENLIGHT 2100 also provides respiratoryparameters based on spirometric monitoring.It is intended for mechanically ventilated adult andpediatric patients in a hospital setting, whose thoraxperimeter is within the range of 37.5 - 134cm.ENLIGHT 2100 does not measure regionalventilation of the lungs. | The intended use of the Philips NM3 RespiratoryProfile Monitor, Model 7900, is to provide:Cardiac output monitoring via the method of partialrebreathing in adult patients receiving mechanicalventilation during general anesthesia and in theintensive care unit (ICU);Spirometric, and carbon dioxide monitoring inneonatal, pediatric and adult patients duringgeneral anesthesia and in the intensive care unit(ICU) and the emergency department (ED). Separatecombination CO2/flow sensors are provided foradult, pediatric and neonatal use.Continuous, non-invasive monitoring of functionalarterial oxygen saturation and pulse rate in neonatal,pediatric and adult patients during both no motionand motion conditions and for patients who are wellor poorly perfused during general anesthesia and inthe intensive care unit (ICU) and the emergencydepartment (ED). | ENLIGHT 2100 provides someparameters provided by NM3, somost of the Indications for Use aredifferent.ENLIGHT 2100 will provide onlya subset of the spirometricmonitoring for pediatric and adultpatients, to complement it as anadjunctive tool to support theuser's assessment of variations inregional air content. |
| Patient Population | Adult and Pediatric patients, whose thorax perimeteris within the range of 37.5 -134 cm. | Adult, pediatric and neonatal patients | Does not include neonatalpatients. |
| Patient type | Mechanically ventilated patients | Mechanically ventilated patients | No differences. |
Table 2: Comparison of Subject vs. Secondary Predicate – Ventilatory Data
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| Attributes | SubjectENLIGHT 2100 | Secondary PredicateNM3 | Explanation of Differences |
|---|---|---|---|
| Principle of Operation | ENLIGHT 2100 already includes the FloTrakpneumotachograph internally and the flow sensor asan accessory. ENLIGHT 2100 uses a fixed orificeflow sensor, in which the pressure drop isproportional to the square of the flow. | The NM3 monitor comprises the cleared Mercurymodule and the Capnostat 5 sensor. The NM3monitor uses fixed orifice flow sensors forspirometric monitoring, in which the pressure drop isproportional to the square of the flow. | Both devices use sensors with thesame principle of operation forflow measurement. |
| The flow sensor is available for pediatric / adultrange. The flow sensor was cleared in the K963380. | |||
| Contraindications | Declared on Instructions for use | Declared on Instructions for use | Similar as applicable |
| Environment of Use | Hospital Setting | Hospital Setting | No differences. |
| Duration of Use | Up to 30 days, with Addere Change each 48 hours. | Not declared. | ENLIGHT 2100 will not changeits duration of use. |
| Features | |||
| Patient Contact perISO 10993-1 | Externally Communicating Tissue | Externally Communicating Tissue | No differences. |
| Prolonged duration (Up to 30 days) | Prolonged duration (Up to 30 days) | ||
| Parameters on trendscreen | The Trend screen displays a table of numericparameters and two user-selectable trend graphs.In the graphic, data is updated once every minute.Users can adjust the time frame to shorter or longerperiods by pressing the Zoom buttons directly on thegraphs.In the table, numeric parameters are presented forthe lines positioned in the graphic (reference - REFand cursor - CUR) by the user, with a time stamp. | The TREND screen displays two user-selectablenumeric parameters and three user-selectable trendgraphs.The time periods are: 1 minute average for the 1 hourtrend, 2 minute average for the 2 hour trend, 4 minutesfor the 4 hour trend, 8 minutes for the 8 hour trend, 12minutes for the 12 hour trend and 24 minutes for the 24hour trend. | Similar |
| Attributes | SubjectENLIGHT 2100 | Secondary PredicateNM3 | Explanation of Differences |
| Performance Characteristics - Non-clinical / Bench Test | |||
| Tidal Volume | Range: 40 to 2500 mlAccuracy: Max Error is less or equal to 11.71mL,Max Relative Error is less of equal to 4.97% | The absolute accuracy of ENLIGHT 2100 related toNM3 is less than 6.27mL and the relative accuracy ofENLIGHT related to NM3 is less than 4.33% | Considering the accuracy resultsof the comparison for TidalVolume, Respiratory Rate, PEEP ,PIP, Plateau Pressure, Resistanceand Compliance, subject andpredicate are substantiallyequivalent.ENLIGHT 2100 providesventilation data to support theuser's interpretation of EIT trendsdata. The clinical user may referto the ventilator and patientmonitoring device as that trenddata is more accurate. |
| Respiratory Rate | Range: 5 to 150 breath/minAccuracy: Max Error is less or equal to 0.70 bpm | The absolute accuracy of ENLIGHT 2100 related toNM3 is less than 0.39 bpm. | |
| Positive EndExpiratory Pressure(PEEP) | Range: 1.0 - 50.0 cmH2OAccuracy: Max Error is less or equal to 1.0cmH2O,Max Relative Error is less of equal to 2.47%. | The absolute accuracy of ENLIGHT 2100 related toNM3 is less than 0.73 cmH2O. | |
| Peak InspiratoryPressure | Range: 1.0-120.0 cmH2OAccuracy: Max Error is less or equal to 0.44 cmH2O | The relative accuracy of ENLIGHT 2100 related toNM3 is less than 4.88%. | |
| Resistance | Range: 5 - 40 cmH2O/L/sAccuracy: Bias:0 cmH2O/L/s, Std Dev: 3cmH2O/L/s | The absolute mean accuracy of ENLIGHT 2100 relatedto NM3 is less than 6 cmH2O/L/s. | |
| Compliance | Range: 3 - 80 ml/cmH2OAccuracy: Bias: -1 mL/cmH2O, Std. Dev: 5mL/cmH20 | The absolute mean accuracy of ENLIGHT 2100 relatedto NM3 is less than 6.97 mL/cmH2O. | |
| Plateau Pressure | Range: 10.0-90.0 cmH2OAccuracy: Bias: 0.1 cmH2O, Std Dev:1.1 cmH2O | The absolute mean accuracy of ENLIGHT 2100 relatedto NM3 is less than 1.47 cmH2O. |
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§ 868.1505 Ventilatory electrical impedance tomograph.
(a)
Identification. A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Characterization of device parameters, including signal-to-noise ratio, voltage accuracy, drift, reciprocity accuracy, amplitude response, position error, and ringing;
(ii) Real time evaluation of local impedance variation;
(iii) Plethysmogram accuracy testing; and
(iv) Use life testing of reusable components.
(3) Performance data must validate reprocessing instructions for any reusable components of the device.
(4) Performance data must demonstrate the electrical, thermal, and mechanical safety and the electromagnetic compatibility of the device.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Labeling must include the following:
(i) Guidance for interpretation of the images generated;
(ii) A warning that the device should be removed before use of a defibrillator, or defibrillator interaction information based on defibrillator performance testing with the device;
(iii) A use life for any reusable components; and
(iv) Instructions for reprocessing any reusable components.