(265 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on standard electrical impedance tomography principles and performance metrics.
No
The device provides information for assessment of regional air content and is described as an "adjunctive tool" in its intended use, rather than directly treating or mitigating a condition.
Yes
The device "provides information of local impedance variation within a cross-section of a patient's thorax" and "supports the user's assessment of variations in regional air content within a cross section of a patient's lungs." This information is used by a clinician to assess a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it uses "several electrodes (usually between 16 and 32) placed around the patient's thorax" and is a "Ventilatory electrical impedance tomograph," indicating it includes hardware components beyond just software.
Based on the provided information, the ENLIGHT 2100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- ENLIGHT 2100 Function: The ENLIGHT 2100 is a non-invasive device that uses electrical impedance tomography to assess regional impedance variation within a patient's thorax. It directly interacts with the patient's body and does not analyze specimens taken from the body.
Therefore, the ENLIGHT 2100 falls under the category of a non-invasive medical device used for monitoring and assessment, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 - 134cm.
ENLIGHT 2100 does not measure regional ventilation of the lungs.
Product codes
OEB
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 cycles, 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
Thorax / Lungs
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)
Bench testing was performed with similar results between the subject device (ENLIGHT 2100) and the predicate device (ENLIGHT 1810). Key results are presented in a table comparing performance characteristics:
- Signal to Noise Ratio (SNR): ENLIGHT 2100: (50dB - 95dB), ENLIGHT 1810: (50dB - 85dB). ENLIGHT 2100 has slightly better performance in SNR.
- Voltage Accuracy: ENLIGHT 2100: (80% - 100%), ENLIGHT 1810: (85% - 100%).
- Drift: Both devices' Allan Variance converges to zero (below 100pV2), indicating similar long-term stability.
- Reciprocity Accuracy: ENLIGHT 2100: (95% - 100%), ENLIGHT 1810: (96% - 100%).
- Amplitude response: ENLIGHT 2100: (90% - 104%), ENLIGHT 1810: (94% - 106%).
- Position error: Both devices: Smaller than 4% of the radius.
- Ringing: Both devices: Smaller than 0.6.
- Resolution: Both devices: Smaller than 0.42.
- Percentage error of Plethysmogram: Both devices: Below 5%.
Overall, performance is similar, with ENLIGHT 2100 showing slightly better SNR.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include:
- Signal to Noise Ratio (SNR)
- Voltage Accuracy
- Drift (Allan Variance)
- Reciprocity Accuracy
- Amplitude response
- Position error
- Ringing
- Resolution
- Percentage error of Plethysmogram
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.
Timpel – ENLIGHT 1810 – DEN170072
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.
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January 6, 2022
Timpel S.A. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K211135
Trade/Device Name: Enlight 2100 Regulation Number: 21 CFR 868.1505 Regulation Name: Ventilatory Electrical Impedance Tomograph Regulatory Class: Class II Product Code: OEB Dated: December 6, 2021 Received: December 8, 2021
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,
Brandon Blakely, Ph.D. Assistant 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K21135
Device Name
Enlight 2100
Indications for Use (Describe)
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 - 134cm.
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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FORM FDA 3881 (6/20)
Page 1 of 1
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| Date Prepared: | 6-Jan-22 |
|---|---|
| Sponsor: | TIMPEL S.A. |
| Rua Simão Álvares, 356 Cj. 41/42 | |
| Pinheiros, São Paulo/SP - Brazil | |
| T - +55-113088-0305 | |
| E - Rafael.holzhacker@timpelmedical.com | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| 131 Bay Point Dr NE | |
| St. Petersburg, FL 33704 | |
| Proprietary or Trade Name: | ENLIGHT 2100 US |
| Regulation Number: | |
| Regulation Name: | |
| Product code: | 21 CFR 868.1505 |
| Ventilatory electrical impedance tomograph | |
| QEB | |
| Predicate Device: | Timpel – ENLIGHT 1810 – DEN170072 |
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 cycles, and which are linearly related to Variations in Regional Air Content within the lung.
Principle of Operation:
Electrical impedance tomography (EIT) is a technique in which the electrical properties of tissues are estimated from surface electrode voltage measurements and used to provide information on Local Impedance Variation (LIV) within a cross section of a patient's thorax. Considerable electrical impedivity variations are imposed on lung tissue by variations in the lung's air content.
There is a linear relationship between the variations in air content and the percentage change in lung tissue impedance. This is a characteristic of lung tissue due to the properties of alveoli walls. This linear relationship is explored in Electrical Impedance Tomography, supporting its use as a tool to support the user's assessment of the variations in regional air content within a cross section of a patient's lungs.
The electrode voltage measurement can be made at high rates as 50 times / second, making it possible to display Local Impedance Variations with a high temporal resolution, almost continuously.
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 information in order to
4
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.
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, besides the patient population.
Patient Population - The intended Patient Population for ENLIGHT 2100 are adult and pediatric patients, whose thorax perimeter is within the range of 37.5 - 134 cm. ENLIGHT 2100 is indicated for mechanically ventilated patients, so the patient is usually sedated, and the application of the electrode belt is performed in uncooperative patients, regardless being adult or pediatric patients. There are no differences in the algorithm or software between different sizes of electrode belt, only the reconstruction meshes are different, but with the same performance.
Environment of Use - There is no difference in the environment of use.
Technological Characteristics - The Operating Principle is the same for ENLIGHT 2100 and ENLIGHT 1810. The hardware system was redesigned, reducing the module volume with improved hardware lavout. The digital part of the hardware was redesigned and the analog hardware (driven shields and common mode circuits of acquisition channels) have the same wellproven topology and only layout was improved.
The enclosure also includes the pneumotachograph OEM Module (the same part number used in ENLIGHT 1810) and DC-DC power supplies, that were previously presented within other mechanical enclosures - Hub and power supply enclosure, respectively.
Improvements on power dissipation were implemented, reducing static consumption of operational amplifiers by reducing the voltage of power supplies without compromising performance. ENLIGHT 1810 OEM AC-DC power supply was replaced by a lower power version OEM module of same manufacturer, as the power consumption of ENLIGHT 2100 US is lower than its predecessor. There is no battery in ENLIGHT 2100 US.
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Non-clinical testing
Biocompatibility – There is no difference in the patient contact between the proposed device and the predicate.
Bench testing - We have performed the following performance tests, with similar results between the 2 devices.
Substantial Equivalence Conclusion
Data presented indicated that there is substantial equivalence between ENLIGHT 2100 and ENLIGHT 1810.
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| Explanation of Differences | |||
|---|---|---|---|
| Attributes | Subject | ||
| ENLIGHT 2100 | Predicate | ||
| ENLIGHT 1810 | |||
| 510(k) | DEN170072 | ||
| Product Classification | |||
| CFR | 868.1505 - QEB | 868.1505 - QEB | Similar |
| Indications for Use | ENLIGHT 1810 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. | 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 | |||
| patients in a hospital setting, whose thorax | |||
| perimeter is within the range of 78-122 cm. | Inclusion of new sizes of accessories and | ||
| software modifications to expand the patient | |||
| range. | |||
| Patient Population | Pediatric patients, whose thorax perimeter is | ||
| within the range of 37.5 -134 cm. | Adult patients, whose thorax perimeter is | ||
| within the range of 78-122 cm. | Inclusion of pediatric patients. | ||
| Patient type | Mechanically ventilated patients | Mechanically ventilated patients | No differences. |
| Prescriptive | Yes | Yes | 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 | Declared on Instructions for use | Declared on 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. | ||
| Attributes | Subject | ||
| ENLIGHT 2100 | Predicate | ||
| ENLIGHT 1810 | Explanation of Differences | ||
| Useful life | ENLIGHT 2100 has 7 years of useful life. | ENLIGHT 1810 has 7 years of useful life. | No differences. |
| Shelf life | Addere has 2 year of shelf life. | ||
| Electrode Belt has 1 year of shelf life. | Addere has 1 year of shelf life. | ||
| Electrode Belt has 1 year of shelf life. | There is no change of shelf life for the | ||
| Electrode Belts, but new validation test data | |||
| with real-time aged samples increased Addere | |||
| shelf life from 1 to 2 years. | |||
| Non-sterile | There are no sterile components or accessories. | There are no sterile components or accessories. | No differences. |
| Cleaning methods | Cleaning and disinfection prescribed only for | ||
| the device. | |||
| Accessories are single patient use. | Cleaning and disinfection prescribed only for | ||
| the device. | |||
| Accessories are single patient use. | No differences. | ||
| Features | |||
| Available sizes | Electrode Belt sizes P0, P1, P2, 4S, 5S, XXS, | ||
| XS, S, M, L, XL | |||
| Addere sizes P0, P1, P2, 4S, 5S, XXS, XS, S, | |||
| M, L, XL | Electrode Belt sizes XS, S, M, L | ||
| Addere sizes XS, S, M, L | New Electrode Belts and Addere sizes | ||
| included to expand the patient range. | |||
| Shaper No 2 | |||
| Reference Cable (Single size) | Shaper No 2 | ||
| Reference Cable (Single size) | |||
| Shape | Monitor-like device, transportable | Monitor-like device, mobile, with incorporated | |
| cart | Device size is smaller to facilitate the shipping | ||
| logistics and device handling inside the | |||
| hospital. | |||
| 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. | ||
| Attributes | Subject | ||
| ENLIGHT 2100 | Predicate | ||
| ENLIGHT 1810 | Explanation of Differences | ||
| Performance Characteristics – Bench Test with Electrode Belt size S | |||
| Signal to Noise Ratio | |||
| (SNR) | (50dB - 95dB) | (50dB - 85dB) | SNR and Drift are both parameters that reflect |
| the precision of data acquisition. SNR | |||
| indicates the system noise in data acquisition. | |||
| Voltage Accuracy | (80% - 100%) | (85% - 100%) | indicates the system noise in data acquisition. |
| Drift | Allan Variance converges to zero (below | ||
| 100pV2) | Allan Variance converges to zero (below | ||
| 100pV2) | Drift indicates a long-term stability in data | ||
| acquisition. | |||
| ENLIGHT 2100 has slight better performance | |||
| considering the Signal to Noise Ratio when | |||
| compared to ENLIGHT 1810. The drift of | |||
| both devices is similar, as Allan Variance of | |||
| both devices converge to less than 100pV2, | |||
| which is a negligible value when considering | |||
| the background noise measured by SNR. | |||
| ENLIGHT computes normalized difference | |||
| voltages from the acquired voltages to | |||
| generate local impedance variation images and | |||
| not on the absolute voltages itself. The | |||
| subtraction of a reference voltage reduces the | |||
| effect of hardware imperfections related to | |||
| bias and the normalization by a reference | |||
| voltage reduces the effect of imperfections | |||
| related to gain. Voltage Accuracy and | |||
| Reciprocity Accuracy reflect those | |||
| imperfections even though attenuated by the | |||
| imaging algorithm. | |||
| Voltage Accuracy and Reciprocity Accuracy | |||
| of ENLIGHT 2100 are similar to ENLIGHT | |||
| 1810, but as indicated above, the imaging | |||
| Reciprocity Accuracy | (95% - 100%) | (96% - 100%) | quality is not reflected by these parameters |
| Attributes | Subject | ||
| ENLIGHT 2100 | Predicate | ||
| ENLIGHT 1810 | Explanation of Differences | ||
| Amplitude response | (90% - 104%) | (94% - 106%) | ENLIGHT 2100 US Infant and ENLIGHT |
| 1810 have similar performance in all | |||
| Position error | Smaller than 4% of the radius | Smaller than 4% of the radius | parameters related to imaging quality with no |
| Ringing | Smaller than 0.6 | Smaller than 0.6 | significant differences |
| Resolution | Smaller than 0.42 | Smaller than 0.42 | |
| Percentage error of | |||
| Plethysmogram | Below 5% | Below 5% | ENLIGHT 2100 and ENLIGHT 1810 have |
| similar performance with error below 5%. |
Table 5.1 – Comparison – Subject vs. Predicate
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510(k) Summary Page 6 of 7
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