(165 days)
Not Found
No
The summary describes a device that uses electrical impedance tomography and spirometric monitoring to provide physiological parameters and regional impedance variation information. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The analysis focuses on standard physiological measurements and impedance variations, not on learned patterns or predictions.
No
Explanation: The device is described as providing information to support a clinician's assessment and respiratory parameters, and it functions as an electrical impedance tomograph to assess regional impedance variations. It acts as an adjunctive tool for diagnostic information rather than directly treating or curing a medical condition.
No
The device provides information as an "adjunctive tool to other clinical information" and explicitly states it does "not measure regional ventilation of the lungs," indicating it supports, rather than definitively establishes, a diagnosis.
No
The device description explicitly states it uses "several electrodes (usually between 16 and 32) placed around the patient's thorax" to perform electrical impedance tomography. This indicates the device includes hardware components beyond just software.
Based on the provided information, the ENLIGHT 2100 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., outside of the body to provide information about a person's health.
- The ENLIGHT 2100 is a non-invasive device. It uses electrodes placed on the patient's thorax to measure electrical impedance variations within the body. It does not analyze any samples taken from the patient.
- Its intended use is to provide information from the patient's thorax. The device directly interacts with the patient's body to gather data.
Therefore, the ENLIGHT 2100 falls under the category of a medical device that provides physiological information through non-invasive means, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QEB, BZK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electrical Impedance Tomography
Anatomical Site
patient's thorax / lung
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Clinician user in a hospital setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing, specifically bench testing, was performed to support substantial equivalence. This included performance tests to check the automatic calculation of parameters shown at the Trend Screen. The device automates calculations for Distribution ratios, Tidal Variation Z, and Tidal Variation Rate. Accuracy ranges are provided for these parameters, as well as for Tidal Volume, Respiratory Rate, PEEP, Peak Inspiratory Pressure, Resistance, Compliance, and Plateau Pressure, comparing the subject device's performance to the secondary predicate (NM3). The key result is that the data supports substantial equivalence between the subject device and the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Distribution Ratios: Range: 0 – 100%, Uncertainty of +/- 10 p.p. for Anterior, Posterior, Left and Right distribution ratio.
- Tidal Variation Z (TVz): Range: 20% to 500%, Uncertainty of +/- 10% of reading.
- Tidal Variation Rate: Adult: 5 to 50 bpm, Pediatric: 10 to 140 bpm, +/- 2.0 bpm if 60 bpm.
- Tidal Volume: Range: 40 to 2500 ml, Accuracy: Max Error is less or equal to 11.71mL, Max Relative Error is less of equal to 4.97%.
- Respiratory Rate: Range: 5 to 150 breath/min, Accuracy: Max Error is less or equal to 0.70 bpm.
- Positive End Expiratory Pressure (PEEP): Range: 1.0 - 50.0 cmH2O, Accuracy: Max Error is less or equal to 1.0cmH2O, Max Relative Error is less of equal to 2.47%.
- Peak Inspiratory Pressure: Range: 1.0-120.0 cmH2O, Accuracy: Max Error is less or equal to 0.44 cmH2O.
- Resistance: Range: 5 - 40 cmH2O/L/s, Accuracy: Bias:0 cmH2O/L/s, Std Dev: 3 cmH2O/L/s.
- Compliance: Range: 3 - 80 ml/cmH2O, Accuracy: Bias: -1 mL/cmH2O, Std. Dev: 5 mL/cmH20.
- Plateau Pressure: Range: 10.0-90.0 cmH2O, Accuracy: Bias: 0.1 cmH2O, Std Dev:1.1 cmH2O.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
1
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
2
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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3
| 510(k) Summary | |
|---|---|
| Date Prepared: | 6-Mar-23 |
| Sponsor: | TIMPEL S.A. |
| Rua Simão Álvares, 356 Cj. 41/42 | |
| Pinheiros, São Paulo/SP - Brazil | |
| T - +55-113088-0305 | |
| Rafael Holzhacker - CEO | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, 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.
4
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 ●
5
- 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 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 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 - 134cm. | |||
| ENLIGHT 2100 does not measure regional | 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 | |||
| information in order to support the user's | |||
| assessment of variations in regional air content | |||
| within a cross section of a patient's lungs. | |||
| 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. | The change in the Indications for | ||
| Use is related only to the inclusion | |||
| of respiratory parameters, which are | |||
| equivalent to the other predicate | |||
| claimed. | |||
| ventilation of the lungs. | |||
| Patient Population | Adult and Pediatric patients, whose thorax | ||
| perimeter is within the range of 37.5 -134 cm. | Adult and Pediatric patients, whose thorax | ||
| perimeter is within the range of 37.5 -134 cm. | No differences. | ||
| Patient type | Mechanically ventilated patients | Mechanically ventilated patients | No differences. |
| Principle of | |||
| Operation | Electrical Impedance Tomography based on voltage | ||
| measures to estimate local impedance variation | |||
| within a cross-section of a patient's thorax. | Electrical Impedance Tomography based on voltage | ||
| measures to estimate local impedance variation | |||
| within 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 Open | ||
| Source Software for the Processing and Interface | |||
| Module (PIM) | The PIM software runs on top of a Linux OS, using | ||
| JAVA. | The differences do not impact the | ||
| software structure. There are no | |||
| differences 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 sizes | ||
| Addere sizes - 11 sizes | |||
| Shaper No 2 | |||
| Reference Cable (Single size) | Electrode Belt sizes – 11 sizes | ||
| Addere sizes - 11 sizes | |||
| Shaper No 2 | |||
| Reference Cable (Single size) | No differences. | ||
| Patient Contact per | |||
| ISO 10993-1 | Surface contact, Intact skin | ||
| Prolonged duration (Up to 30 days) | Surface contact, Intact skin | ||
| Prolonged duration (Up to 30 days) | No differences. | ||
| Trends Screen | Data from the device is presented to the user in | ||
| graphic format and with possibility to compare two | |||
| moments (reference and cursor) to assist the user in | |||
| the patient assessment. | Data from the device is presented to the user in | ||
| graphic format and with possibility to compare two | |||
| moments (reference and cursor) to assist the user in | |||
| the patient assessment. | Numerical data are automations of | ||
| calculations that could be done | |||
| manually using the predicate device. | |||
| Trends Screen | |||
| Distribution Ratios | Graphic Information for Global and Regional | ||
| (Anterior / Posterior / Right / Left) Plethysmograms, | |||
| with numerical indications of tidal variations (Δ) for | |||
| the 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) for | |||
| the period indicated by the reference and cursor lines | |||
| (defined by the user), color coded. | Calculates and displays the | ||
| Relationship between the amplitude of | |||
| the regional plethysmograms | |||
| (Anterior / Posterior / Right / Left) | |||
| and the amplitude of the global | |||
| plethysmogram, in percentage. | |||
| Trends Screen | |||
| Tidal Variation Z | The device automates the calculation that could be | ||
| done by the user. It calculates the maximum | |||
| impedance variation for the respiratory cycle in which | |||
| the reference is positioned, and also calculates the | |||
| maximum impedance variation for the respiratory | |||
| cycle in which the cursor is positioned. These values | |||
| are called "Tidal Impedance Variation". | In the plethysmogram, the user can see the value of the | ||
| tidal impedance variation by positioning the reference | |||
| and cursor lines in the maximum and the minimum | |||
| value of a certain respiration cycle at a first moment | |||
| (t1). (Δ1 in blue, in the example above). By selecting | |||
| the maximum and the minimum values in a different | |||
| cycle (t2), it is possible to manually calculate the ratio | |||
| of the Tidal Impedance Variation between those 2 | |||
| moments (Δ1 assessed in t2 divided by Δ1 assessed in | |||
| t1). | It calculates and displays the 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. | |||
| Trends Screen | |||
| Tidal Variation Rate | The device calculates the Tidal Variation Rate, | ||
| considering number of oscillations that were identified | |||
| in 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 how | ||
| many oscillations of the plethysmogram he observes | |||
| within the time period between the reference and | |||
| cursor lines, and calculate how many oscillations per | |||
| minute occurred. | The device calculates and displays the | ||
| Tidal Variation Rate, considering the | |||
| last minute. | |||
| Attributes | Subject | ||
| ENLIGHT 2100 – K232897 | Primary Predicate | ||
| ENLIGHT 2100 - K211135 | Explanation of Differences | ||
| Performance Characteristics - Non-clinical / Bench Test | |||
| Distribution Ratios | Range: 0 – 100% | ||
| Uncertainty of +/- 10 p.p. for Anterior, Posterior, Left | |||
| and Right distribution ratio. | Same | The predicate didn't present the | |
| numeric parameter, but as the | |||
| hardware is the same and the EIT | |||
| algorithm is the same, the | |||
| performance is equivalent for this | |||
| characteristic. | |||
| 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 |
8
9
| Attributes | Subject
ENLIGHT 2100 | Secondary Predicate
NM3 | Explanation of Differences |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K222897 | K103578 | |
| Product Classification
CFR | 868.1850 - BZK | 868.1850 - BZK | Different product codes. Adding
product code of the reference. |
| Indications for Use | 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 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 - 134cm.
ENLIGHT 2100 does not measure regional
ventilation of the lungs. | The intended use of the Philips NM3 Respiratory
Profile Monitor, Model 7900, is to provide:
Cardiac output monitoring via the method of partial
rebreathing in adult patients receiving mechanical
ventilation during general anesthesia and in the
intensive care unit (ICU);
Spirometric, and carbon dioxide monitoring in
neonatal, pediatric and adult patients during
general anesthesia and in the intensive care unit
(ICU) and the emergency department (ED). Separate
combination CO2/flow sensors are provided for
adult, pediatric and neonatal use.
Continuous, non-invasive monitoring of functional
arterial oxygen saturation and pulse rate in neonatal,
pediatric and adult patients during both no motion
and motion conditions and for patients who are well
or poorly perfused during general anesthesia and in
the intensive care unit (ICU) and the emergency
department (ED). | ENLIGHT 2100 provides some
parameters provided by NM3, so
most of the Indications for Use are
different.
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 | Adult and Pediatric patients, whose thorax perimeter
is within the range of 37.5 -134 cm. | Adult, pediatric and neonatal patients | Does not include neonatal
patients. |
| 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 | Subject
ENLIGHT 2100 | Secondary Predicate
NM3 | Explanation of Differences |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | ENLIGHT 2100 already includes the FloTrak
pneumotachograph internally and the flow sensor as
an accessory. ENLIGHT 2100 uses a fixed orifice
flow sensor, in which the pressure drop is
proportional to the square of the flow. | The NM3 monitor comprises the cleared Mercury
module and the Capnostat 5 sensor. The NM3
monitor uses fixed orifice flow sensors for
spirometric monitoring, in which the pressure drop is
proportional to the square of the flow. | Both devices use sensors with the
same principle of operation for
flow measurement. |
| | The flow sensor is available for pediatric / adult
range. 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 change
its duration of use. |
| Features | | | |
| Patient Contact per
ISO 10993-1 | Externally Communicating Tissue | Externally Communicating Tissue | No differences. |
| | Prolonged duration (Up to 30 days) | Prolonged duration (Up to 30 days) | |
| Parameters on trend
screen | The Trend screen displays a table of numeric
parameters and two user-selectable trend graphs.
In the graphic, data is updated once every minute.
Users can adjust the time frame to shorter or longer
periods by pressing the Zoom buttons directly on the
graphs.
In the table, numeric parameters are presented for
the lines positioned in the graphic (reference - REF
and cursor - CUR) by the user, with a time stamp. | The TREND screen displays two user-selectable
numeric parameters and three user-selectable trend
graphs.
The time periods are: 1 minute average for the 1 hour
trend, 2 minute average for the 2 hour trend, 4 minutes
for the 4 hour trend, 8 minutes for the 8 hour trend, 12
minutes for the 12 hour trend and 24 minutes for the 24
hour trend. | Similar |
| Attributes | Subject
ENLIGHT 2100 | Secondary Predicate
NM3 | Explanation of Differences |
| Performance Characteristics - Non-clinical / Bench Test | | | |
| Tidal Volume | Range: 40 to 2500 ml
Accuracy: 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 to
NM3 is less than 6.27mL and the relative accuracy of
ENLIGHT related to NM3 is less than 4.33% | Considering the accuracy results
of the comparison for Tidal
Volume, Respiratory Rate, PEEP ,
PIP, Plateau Pressure, Resistance
and Compliance, subject and
predicate are substantially
equivalent.
ENLIGHT 2100 provides
ventilation data to support the
user's interpretation of EIT trends
data. The clinical user may refer
to the ventilator and patient
monitoring device as that trend
data is more accurate. |
| Respiratory Rate | Range: 5 to 150 breath/min
Accuracy: Max Error is less or equal to 0.70 bpm | The absolute accuracy of ENLIGHT 2100 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 or equal to 1.0cmH2O,
Max Relative Error is less of equal to 2.47%. | The absolute accuracy of ENLIGHT 2100 related to
NM3 is less than 0.73 cmH2O. | |
| Peak Inspiratory
Pressure | Range: 1.0-120.0 cmH2O
Accuracy: Max Error is less or equal to 0.44 cmH2O | The relative accuracy of ENLIGHT 2100 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 | The absolute mean accuracy of ENLIGHT 2100 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 | The absolute mean accuracy of ENLIGHT 2100 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 | The absolute mean accuracy of ENLIGHT 2100 related
to NM3 is less than 1.47 cmH2O. | |
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