REMI
Device Facts
| Record ID | K203827 |
|---|---|
| Device Name | REMI |
| Applicant | Epitel, Inc. |
| Product Code | OMC · Neurology |
| Decision Date | Mar 29, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software. REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment. Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
Device Story
REMI system captures, amplifies, and transmits EEG signals; utilizes Epilog disposable sensors (single-channel, wearable, primary coin cell powered) attached to patient scalp via conductive hydrogel sticker; transmits data wirelessly to REMI-Tablet running REMI-Mobile application; tablet relays data via encrypted WiFi to REMI-Cloud; cloud platform processes data for viewing on third-party software (Persyst). Used in professional healthcare facilities by trained medical professionals. Provides physiological signal monitoring without diagnostic recommendations. Benefits include remote neurological review capabilities.
Clinical Evidence
No clinical data.
Technological Characteristics
System comprises disposable EEG sensors, mobile tablet, and cloud storage. Sensors: 2 passive gold electrodes with conductive hydrogel sticker; 27x27x7mm; primary coin cell powered. Connectivity: Bluetooth 2.4 GHz (sensor to tablet), WiFi (tablet to cloud). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26. Biocompatibility: ISO 10993-5:2009, ISO 10993-10:2010.
Indications for Use
Indicated for adult and pediatric patients (6+) in healthcare settings requiring near real-time or remote EEG monitoring. Contraindications not specified.
Regulatory Classification
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Predicate Devices
- Ceribell Instant EEG Headband (K171459)
- Ceribell Pocket EEG Device (K170363)
- AE-120A EEG Head Set (K183529)
Reference Devices
- Life Sensor Cardiac Monitor (K191331)
Submission Summary (Full Text)
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March 29, 2021
Epitel, Inc. % John Pappan RA Consultant / Project Management LeanRAQA 12602 North Summerwind Drive Marana, Arizona 85658
Re: K203827
Trade/Device Name: REMI Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: December 24, 2020 Received: December 29, 2020
Dear John Pappan:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (08) 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 mediation-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,
Jay R. Gupta -S
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K203827
Device Name REMI
#### Indications for Use (Describe)
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REM-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing and reviewing of EEG on third-party software.
REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
Type of Use (*Select one or both, as applicable*)
| <div> <b> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </b> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary
# 5.1 Applicant/Submitter
| Company Name | : Epitel, Inc. |
|------------------------|------------------|
| Phone Number | : 801-497-6297 |
| Company Street Address | : 124 S. 400 E. |
| City | : Salt Lake City |
| State | : UT |
| Country | : USA |
| Zip Code | : 84111 |
# 5.2 Contact Person
| Full Name | : Mark Lehmkuhle |
|-----------|------------------------|
| Job Title | : CEO/CTO |
| Phone | : 801-497-6297 |
| Email | : lehmkuhle@epitel.com |
## 5.3 Correspondent Information
| Full Name | : John Pappan |
|-----------|--------------------------------------|
| Job Title | : RA Consultant / Project Management |
| Phone | : 718-964-3406 |
| Email | : johnp@leanraqa.com |
## 5.4 Date of Preparation
Date of Preparation
: 02/23/2021
# 5.5 Device Information
#### Table - 5.1 Device information
| Trade Name | REMI |
|----------------------|------------------------|
| Common or Usual Name | Electroencephalograph. |
| Classfication Name | 21 CFR 882.1400 |
| Regulatory Class | 2 |
| Product Code | OMC, GXY |
## 5.6 Predicate Device(s)
Table - 5.2 Predicate Device(s)
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| Predicate Type | 510(k) Number | Name Of Device | Name Of Manufacturer |
|------------------|---------------|-------------------------------|---------------------------|
| Predicate Device | K171459 | Ceribell Instant EEG Headband | Ceribell, Inc. |
| Predicate Device | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. |
| Predicate Device | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation |
| Reference Device | K191331 | Life Sensor Cardiac Monitor | BraveHeart Wireless, Inc. |
## 5.7 Device Description
REMI amplifies the electroencephalogram (EEG) from a patient's scalp. After amplification, the EEG are sent to the REMI-Tablet running the REMI-Mobile Application. REMI-Mobile combines the EEG from four Epilog Sensors and patient information and relays the data to a cloud server running Persyst software. The EEG data is accessible through the Persyst Mobile interface. REMI is designed for use with adult and pediatric patients (6+). The user interface for the REMI-Tablet is an 10" LCD touchscreen display.
The user interface for Epilog Sensors is a single button kevpad overmolded in each Sensor, REMI-Tablet power is through A/C adapter as well as limited onboard rechargeable battery. Epilog Sensor power is through a single-use primary coin cell. Using its wireless link, the Epilog Sensors can exchange EEG data and commands with the REMI-Mobile application running on the REMI-Tablet.
REMI has three major components:
1) Epilog-D disposable EEG sensors,
2) REMI-Mobile - mobile OS application designed to run on a medical-grade tablet, acquire EEG data transmitted from Epilog devices along with user-entered patient and device information, and then transmit the EEG data and patient/device information via wireless encrypted WiFi to.
3) REMI-Cloud – A HIPAA-compliant cloud storage and data processing platform where data is processed into a format that a FDA-cleared (K171184) EEG reviewing software called Persyst can use, which will allow remote neurological review.
#### 5.8 Intended Use/Indications for Use
The REMI Platform is intended to be used in healthcare settings where near real-time and/or remote EEG is warranted. REMI consists of Epilog disposable Sensors - a single patient, disposable, wearable sensor intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for up to 48 hours. The REMI-Mobile software and REMI-Tablet are intended to receive and transmit data from four Epilog Sensors to secure cloud storage for subsequent viewing of EEG on third-party software.
REMI does not make any diagnosis or recommendations and is intended only as a physiological signal monitor. Epilog Sensors are intended for use by trained medical professionals in a professional healthcare facility environment.
Epilog Sensors are intended for use with adult and pediatric patients (6+). (Rx only).
#### 5.9 Comparison of Technological Characteristics with Predicate
REMI is substantially equivalent to the Ceribell Pocket EEG device combined with Ceribell Instant EEG Headband and Nihon Kohden AE-120A EEG headset based on the Comparison Summary in the substantial equivalence discussion.
Epilog Sensors use a one-piece conductive "sticker" that includes a conductive hydrogel converted with an adhesive similar to the BraveHeart Wireless Life Sensor Cardiac Monitor. While the BraveHeart sensor amplifies the electrocardiogram from the chest and REMI amplifies the electroencephalogram from the scalp, both devices are wearable sensors intended to record biopotentials that are similar in frequency and amplitude to justify comparison.
Epitel is of the opinion that the individual and combined system differences do not change the safety and effectiveness of this device with respect to the proposed pathway. Nor do the risks vary significantly from the predicate devices, and similar reference devices on the market; what risks do exist are similar and mitigated
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through user centric design and a risk management based approach to design controls.
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#### Table - 5.3 Comparison Summary
| Attributes | Subject Device<br>REMI | Predicate Device(s)*<br>Ceribell Pocket EEG Device<br>(K170363)<br>Ceribell Instant EEG Headband<br>(K171459)<br>*Both K170363 and K171459<br>together is substantially equivalent<br>to REMI | Predicate Device<br>Nihon Kohden<br>AE-120A EEG Head Set<br>(K183529) | Reference Device<br>BraveHeart Wireless<br>Life Sensor Cardiac Monitor<br>(K191331) | Comments |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Regulation | Class II per 21 CFR 882.1400<br>Electroencephalograph (Head Set)<br>Class II per 21 CFR 882.1320 (for<br>electrodes within headset) | Class II per 21 CFR 882.1400<br>Electroencephalograph (EEG<br>Device) Class II per 21 CFR<br>882.1320 (Instant EEG Headband -<br>cutaneous electrodes) | Class II per 21 CFR 882.1400<br>Electroencephalograph (Head<br>Set) Class II per 21 CFR<br>882.1320 (for electrodes within<br>headset) | Class II per 21 CFR 870.2910<br>Radiofrequency physiological signal<br>transmitter and receiver | Same Classification<br>Regulation to<br>Ceribell<br>Pocket EEG Device<br>and<br>Nihon Kohden AE-<br>120A<br>EEG Head Set |
| Product Code(s) | OMC and GXY | OMC and GXY | OMC | DRG, DRT, DRX | Same Product Codes<br>to<br>Ceribell Pocket<br>EEG<br>Device and Nihon<br>Kohden<br>AE-120A EEG<br>Head Set |
| Attributes | Subject Device<br>REMI | Predicate Device(s)*<br>Ceribell Pocket EEG Device<br>(K170363)<br>Ceribell Instant EEG Headband<br>(K171459)<br>*Both K170363 and K171459<br>together is substantially equivalent<br>to REMI | Predicate Device<br>Nihon Kohden<br>AE-120A EEG Head Set<br>(K183529) | Reference Device<br>BraveHeart Wireless<br>Life Sensor Cardiac Monitor<br>(K191331) | Comments |
| Indications for Use | The REMI Platform is intended to be<br>used in healthcare settings where<br>near real-time and/or remote EEG is<br>warranted. REMI consists of Epilog<br>disposable Sensors - a single use.<br>single patient, disposable, wearable<br>sensor intended to amplify, capture.<br>and wirelessly transmit a single<br>channel of electrical activity of the<br>brain for up to 48 hours. The REMI-<br>Mobile software and REMI-Tablet<br>are intended to receive and transmit<br>data from four Epilog Sensors to<br>secure cloud storage for subsequent<br>viewing and reviewing of EEG on<br>third-party software.<br>REMI does not make any diagnosis<br>or recommendations and is intended<br>only as a physiological signal<br>monitor. Epilog Sensors are intended<br>medical<br>for use by by<br>trained<br>professionals in a professional<br>healthcare facility environment.<br>Epilog Sensors are intended for use<br>with adult and pediatric patients<br>(6+). (Rx only). | The Ceribell Pocket EEG<br>(K170363) Device is intended to<br>record and store EEG signals, and to<br>present the EEG signals in visual and<br>audible formats in real time. The<br>visual and audible signals assist<br>trained medical staff to make<br>neurological diagnoses. The Pocket<br>EEG Device does not provide any<br>diagnostic conclusion about the<br>subject's condition and does not<br>provide any automated alerts of an<br>adverse clinical event. The Pocket<br>EEG Device is intended to be used in<br>a professional healthcare facility<br>environment. (Rx only)<br>The Ceribell Instant EEG Headband<br>(K171459) is an<br>electroencephalogram (EEG)<br>electrode array intended for<br>single patient use in the recording of<br>EEGs in patients of 6 years and<br>older. The Instant EEG Headband is<br>intended for prescription use in the<br>home, healthcare facility or clinical<br>research environment. (Rx Only). | The AE-120A EEG Head<br>Set is intended to amplify,<br>capture, and wirelessly transmit<br>electrical activity of the brain for<br>review by a trained medical<br>professional using the previously<br>cleared and validated Nihon<br>Kohden electroencephalograph<br>systems (EEG-1200A series and<br>EEG-9100) to assist in the<br>diagnosis of neurological<br>disorders. The AE-120A EEG<br>Head Set and its associated EEG<br>Software do not provide any<br>diagnostic conclusion or<br>automated alerts of an adverse<br>clinical event about a patient's<br>condition. The device is intended<br>for use by trained medical<br>professionals in a medical facility<br>such as a physician's office,<br>laboratory, or clinic. The device<br>is intended for use on adults (ages<br>18 and above). (Rx Only). | The Life Sensor Cardiac Monitor<br>(CM) is a wireless monitoring system<br>intended for use by healthcare<br>professionals for monitoring of<br>physiological data within healthcare<br>settings. This includes heart rate and<br>electrocardiography (ECG).<br>Data is transmitted wirelessly<br>from Life Sensor Electrode<br>to an application on iOS device where<br>it is displayed for review by<br>healthcare professionals. The device<br>is intended for use on general care<br>patients 18 years or older and by<br>prescription only. The device is<br>contraindicated for use on critical<br>care patients, patients with active<br>implantable medical devices such as<br>pacemakers, implanted cardioverter<br>defibrillator (ICD), and left<br>ventricular<br>assist devices (LVAD); for use in<br>magnetic resonance (MR)<br>environments; for use during surgical<br>procedures when electro-surgical<br>equipment is optional. The<br>Life Sensor Cardiac Monitor does<br>not detect or diagnose medical<br>conditions. | No significant<br>difference in<br>Indications for Use<br>to<br>Ceribell Pocket<br>EEG<br>Device and Nihon<br>Kohden<br>AE-120A EEG<br>Head Set |
| Attributes | Subject Device<br>REMI | Predicate Device(s)*<br>Ceribell Pocket EEG Device<br>(K170363)<br>Ceribell Instant EEG Headband<br>(K171459)<br>*Both K170363 and K171459<br>together is substantially equivalent<br>to REMI | Predicate Device<br>Nihon Kohden<br>AE-120A EEG Head Set<br>(K183529) | Reference Device<br>BraveHeart Wireless<br>Life Sensor Cardiac Monitor<br>(K191331) | Comments |
| Physiological Signal<br>Acquired | EEG | EEG | EEG | ECG | Same Physiological<br>Signal Acquired<br>to Ceribell Pocket<br>EEG Device and<br>Nihon Kohden<br>AE-120A EEG<br>Head Set |
| Type of patient<br>contact | Contacts patient scalp | Contacts patient scalp | Contacts patient scalp | Contacts patient chest over the heart | Same type of patient<br>contact to<br>Ceribell Pocket EEG<br>and<br>Nihon Kohden AE-<br>120A EEG<br>Head Set |
| Electrodes | 2 passive gold electrodes<br>using a conductive hydrogel<br>sticker | 10 passive Ag/AgCl<br>electrodes | 10 passive Ag/AgCl<br>electrodes | 2 passive electrodes using a<br>conductive hydrogel sticker | No significant<br>difference in<br>Electrodes to<br>BraveHeart<br>Wireless Life<br>Sensor Cardiac<br>Monitor |
| Attributes | Subject Device<br>REMI | Predicate Device(s)*<br>Ceribell Pocket EEG Device<br>(K170363)<br>Ceribell Instant EEG Headband<br>(K171459)<br>*Both K170363 and K171459<br>together is substantially equivalent<br>to REMI | Predicate Device<br>Nihon Kohden<br>AE-120A EEG Head Set<br>(K183529) | Reference Device<br>BraveHeart Wireless<br>Life Sensor Cardiac Monitor<br>(K191331) | Comments |
| Type of Use | Epilog Disposable is single<br>use,<br>non-sterile, disposable | Electrodes: Single use, nonsterile,<br>disposable.<br>EEG Device:<br>Ceribell Pocket EEG Device<br>is<br>reusable and non-patient<br>contacting.<br>Ceribell Instant EEG<br>headband is<br>single use, patient contacting<br>and<br>disposable. | Electrodes: Single use, non-<br>sterile.<br>disposable<br>EEG Device: AE-120A EEG<br>Head set is reusable and<br>nonpatient<br>contacting. Belts are patient<br>contacting and reusable (they can<br>be cleaned & disinfected but<br>are recommended for single<br>patient use) | Electrodes: Single use, non-sterile,<br>disposable. The Life Sensor Module<br>automatically performs all the<br>processing functions related<br>to capturing the required<br>physiological data from the body and<br>performs encrypted, bi-directional<br>communication to the Life Sensor<br>Application, using Bluetooth Low<br>Energy (BLE), when in range of the<br>Life Sensor Application installed on a<br>paired iOS device. | No significant<br>difference in<br>Type of Use to all<br>predicates |
| Channel | Up to 10 | 8 | 8 | 1 | No significant<br>difference in<br>EEG Channels to<br>Ceribell<br>Pocket EEG Device<br>and<br>Nihon Kohden AE-<br>120A<br>EEG Head Set |
| Montage | 10/20 system - Epilog-Disposable<br>can be placed anywhere in the 10/20<br>system where each channel<br>represents a bipolar derivation<br>approximation of the 10/20 system | 10/20 System - Ceribell Pocket EEG<br>Device and Ceribell Instant EEG<br>Headband approximates a 10/20<br>montage | 10/20 System - AE-120A<br>EEG Head Set approximates the<br>10/20 montage but may<br>deviate slightly depending<br>on the patient's head shape | Not Applicable | No significant<br>difference in<br>Montage to Ceribell<br>Pocket<br>EEG Device and<br>Nihon Kohden AE-<br>120A EEG<br>Head Set |
| Attributes | Subject Device<br>REMI | Predicate Device(s)*<br>Ceribell Pocket EEG Device<br>(K170363)<br>Ceribell Instant EEG Headband<br>(K171459)<br>*Both K170363 and K171459<br>together is substantially equivalent<br>to REMI | Predicate Device<br>Nihon Kohden<br>AE-120A EEG Head Set<br>(K183529) | Reference Device<br>BraveHeart Wireless<br>Life Sensor Cardiac Monitor<br>(K191331) | Comments |
| Electrical Safety &<br>EMC | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-26 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-26<br>IEC 62133 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-26 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-27 | No significant<br>difference in<br>Electrical Safety &<br>EMC to predicates |
| Input Dynamic<br>Range | 1 mVp-p | Unknown | 1 mVp-p | Unknown | No significant<br>difference in<br>Dynamic Range to<br>Nihon Kohden AE-<br>120A EEG Head Set |
| Input Noise | 5 μVp-p…
