The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

Device Description

The DeltaScan Patch is a single use EEG electrode Patch, used exclusively with the DeltaScan Monitor. The DeltaScan Patch is used with the DeltaScan Monitor to enable the acquisition of EEG signals. The DeltaScan Monitor provides signal analysis technology intended for use as an adjunct to clinical judgment.

The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.

AI/ML Overview

The provided text describes the DeltaScan Patch, a cutaneous electrode intended to record EEG signals in conjunction with the DeltaScan Monitor. However, the document primarily focuses on the substantial equivalence argument to a predicate device (Covidien BIS Sensors, K143506) and the safety testing (biocompatibility, electrical safety, mechanical testing, and shelf-life).

Crucially, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch. Therefore, it does not contain information about acceptance criteria for device performance in terms of signal capture quality or diagnostic accuracy, nor does it describe a study proving the device meets such criteria. The "performance data" section primarily refers to safety and functional verification, not clinical performance for its primary intended use of recording EEG signals (beyond "it transfers the electrical signals as intended").

Given this limitation in the input, I cannot populate all sections of your requested table and study description definitively. I will outline what can be inferred from the provided text, and explicitly state where information is missing due to the nature of the FDA submission for this device.

Acceptance Criteria and Reported Device Performance

As noted, the document explicitly states that "No dedicated clinical study is needed to validate the device performance" for recording EEG signals. The performance data provided relates to safety, materials, and mechanical integrity.

Acceptance Criteria (from provided text)	Reported Device Performance (from provided text)
Biocompatibility: Meet ISO 10993-1:2018 requirements for a surface contacting device (<24 hours each day)	All parts of the DeltaScan Patch R2 with REF 009.000.B that are directly in contact with the patient's skin have passed the acceptance criteria defined per ISO 10993-1:2018 requirements.
Electrical Safety: Not Applicable (not Medical Electrical Equipment per EN ISO 60601-1)	The DeltaScan Patch is not considered Medical Electrical Equipment as defined by the EN ISO 60601-1. Its use does not depend on essential performance according to EN ISO 60601-1.
Software V&V: Not Applicable (does not contain software)	N/A
Mechanical Testing (Labels): Legible, durable, compliant, compatible with packaging	The labels on the packaging were tested to verify be legible, durable, compliant with regulations, and compatible with the packaging.
Mechanical Testing (Packaging): Compatible with labeling, can be shipped without damage	The packaging was tested to verify to be compatible with the labeling, and can be shipped without damage.
Shelf Life: 9 months	The stated shelf life of 9 months is mainly based on the degradation of the two frontal electrodes. This is verified and documented in the Verification Report based on accelerated aging. (Real time aging in progress, may show longer shelf life in future.)
Electrical Signal Transfer: Transfers electrical signals as intended	The Verification Report provides sufficient proof that it transfers the electrical signals as intended. (This is a functional claim, but no specific performance metrics or studies are described for how well or with what fidelity it transfers EEG signals, beyond the implication that it works sufficiently for its intended use in conjunction with the DeltaScan Monitor, which presumably has its own performance validation). The report concludes that it "shows that it performs as intended, is safe and effective for its intended use, and provides similar safety and effectiveness results to the predicate device."

Study Details (Based on the provided text)

Since the document states "No dedicated clinical study is needed to validate the device performance" for the DeltaScan Patch itself, the following sections will reflect the lack of such clinical performance study data in this submission. The "studies" mentioned are largely engineering verification and validation for safety and functional aspects.

Sample size used for the test set and the data provenance:
- Biocompatibility: Not specified for the number of samples, but "all parts of the DeltaScan Patch R2" were tested.
- Mechanical Testing (Labels & Packaging): Not specified.
- Shelf Life: Not specified for the number of patches or test duration, but based on accelerated aging.
- Electrical Signal Transfer ("Verification Report"): Not specified.
- Data Provenance: The studies appear to be internal verification and validation studies conducted by the manufacturer (Prolira B.V.). No information on country of origin of data or retrospective/prospective nature is given beyond the type of studies (e.g., accelerated aging).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical performance study with expert ground truth data is described for the DeltaScan Patch itself. The "ground truth" for the verification activities would be established by industry standards (e.g., ISO 10993-1) and internal engineering specifications.
Adjudication method for the test set:
- Not applicable as no clinical performance study requiring expert adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. The DeltaScan Patch is an EEG electrode, not an AI-powered diagnostic device, and thus this type of study is not relevant to its primary submission. The document explicitly states "No dedicated clinical study is needed to validate the device performance" and that the patch does not contain software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The DeltaScan Patch is a hardware component (an electrode); it is not an algorithm. Its function is to acquire signals for a separate device (DeltaScan Monitor, K222680).
The type of ground truth used:
- For Biocompatibility: Established by adherence to ISO 10993-1:2018 standards and their defined acceptance criteria.
- For Mechanical Testing (Labels & Packaging): Established by internal specifications for legibility, durability, compliance, and shipping integrity.
- For Shelf Life: Established by accelerated aging protocols and internal specifications for electrode degradation.
- For Electrical Signal Transfer: Established by internal verification that the patch "transfers the electrical signals as intended." Specific metrics or objective "ground truth" (e.g., comparison to a gold-standard EEG recording) for signal fidelity are not detailed in this summary.
The sample size for the training set:
- Not applicable. The DeltaScan Patch is a hardware device; it does not involve machine learning algorithms requiring a training set.
How the ground truth for the training set was established:
- Not applicable (no training set as it's a hardware device).

Summary

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February 2, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Prolira B.V. % Dr. Paul Manberg Corolla Clin/Reg Consulting 481 Spindrift Trail #696 Corolla, North Carolina 27927

Re: K222671

Trade/Device Name: DeltaScan Patch Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 25, 2022 Received: September 6, 2022

Dear Paul Manberg:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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).

Sincerelv.

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222671

Device Name DeltaScan Patch

Indications for Use (Describe)

The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.

The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

Please refer to the Instructions for Use and the Instructions for Use on the Primary packaging of the DeltaScan Patch for more information.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.

SUBMITTER l.

Prolira BV Padualaan 8 Utrecht, The Netherlands NL-3584 CH Phone Number: +31 6 47762936 Email: r.vanmerkerk@prolira.com

Contact Person: Rutger van Merkerk Date Prepared: August 25, 2022, date updated 05-Jan-2023

II. DEVICE

Name of Device: DeltaScan Patch Common or Usual Name: DeltaScan Patch Classification Name: Cutaneous electrode (21 CFR 882.1320). Regulatory Class: II Product Code: GXY

III. PREDICATE DEVICE

Name	Manufacturer	510(k) #
Covidien BIS Sensors (BIS Quatro Sensor, BISExtend, BIS Pediatric Sensor, BIS Bilateral Sensor)	COVIDIEN	K143506

IV. DEVICE DESCRIPTION

The DeltaScan Patch is used to collect EEG signals from two electrode locations see Figure 5-1 DeltaScan Patch Electrode Locations.

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Image /page/4/Figure/2 description: The image shows a diagram of the human head with various points labeled, likely representing electrodes for an EEG. Key points such as 'Fpz (ref)', 'Fp2', and 'Pz' are highlighted with arrows pointing to their respective locations on the head. Other points like 'F1', 'F3', 'F4', 'F8', 'A1', 'T3', 'C3', 'C4', 'T4', 'A2', 'P3', 'P4', 'TS', 'T6', '01', and '02' are also labeled, indicating a comprehensive mapping of the head's surface.

Figure 5-1 DeltaScan Patch Electrode Locations

The 1st electrode is placed on or close . to Pz (on the crown of the head)
. a second electrode on or close to Fp2 (above the patient's right eyebrow
0 a third (Reference) electrode on or close to Fpz (above the nose on the forehead)

Pz, Fp2 and Fpz refer to defined EEG electrode locations in the standard 10/20 EEG setup

Image /page/4/Figure/8 description: This image shows a diagram of a flexible EEG sensor patch. The patch has an adhesive foam for adherence to the skin on the forehead. There are two hydrogel anchors for improved adherence to the head and for stability. The patch has a butterfly shape to realize a one-size-fits-all design for different head sizes.

For a depiction of the main components, see Figure 5-2 below:

In designing the DeltaScan Patch, the International 10-20 System was used as a basis for electrode placement. Two recording electrodes are placed on the Fp2 and Pz locations, while the reference electrode is placed at the Fpz location, see Figure 5-1 DeltaScan Patch Electrode

Figure 5-2 Product overview

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Locations above. The electrodes are individually packaged and pre-gelled. The DeltaScan Monitor should only be used in combination with a DeltaScan Patch, see Figure 5-3.

Image /page/5/Picture/3 description: The image shows a diagram of a medical device called PROLIRA DELTASCAN. The device consists of a head-mounted sensor array connected by a cable to a control unit. The head-mounted sensor array is positioned on the head, and the control unit has a display screen and buttons. The device is likely used for brain monitoring or diagnostics.

Figure 5-3: Artist impression of the DeltaScan Monitor used with a DeltaScan Patch

V. INDICATIONS FOR USE

The DeltaScan Patch is applied directly to the patient's skin to record EEG signals.

The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design.

Please refer to the Instructions for Use and the Instructions for Use on the Primary packaging of the DeltaScan Patch for more information.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Like the predicate, the DeltaScan Patch is applied directly to the patient's skin to enable recordings of EEG signals.
The BIS Sensor with submission number K143506 is suggested as the most appropriate predicate device.

A technology comparison is provided in Table 5-1 below.

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Table 5-1 technology comparison
BIS Sensor	DeltaScan Patch
Intended Use
Electrode, Cutaneous Electrode	Electrode, Cutaneous Electrode
Indications for Use
Electrode that is applied directly to a patient's skinto record EEG signals.	The DeltaScan Patch is an electrode that is applieddirectly to a patient's skin to record EEG signals.The DeltaScan Patch is intended to be used in
Note: used in conjunction with Covidien BISMonitors.	combination with the DeltaScan Monitor (K222680)through a proprietary connector design.Please refer to the Instructions for Use on thePrimary packaging of the DeltaScan Patch and theInstructions for Use of the DeltaScan Monitor formore information.
LIMITATIONS	LIMITATIONS
For prescription use only.	For prescription use only.
Single use	Single use
Only to be used with the BIS Monitor	Only to be used with the DeltaScan Monitor
Refers to the labeling for a more complete list of	Refers to the labeling for a more complete list of
Warnings, Precautions and Contraindications.	Warnings, Precautions and Contraindications.
Primary EEG Feature/Electrode position
It is a low impedance, single patient use, disposableelectrode sensor	It is a low impedance, single patient use, disposableelectrode sensor
The "zipprep" design is constructed using flexibletine disks placed in pockets on a polyethylenebasepad. A polyurethane foam disk and hydrogel isplaced over the tines. The basepad has a medicalgrade pressure sensitive adhesive for adhering tothe skin. A mylar substrate with conductive silver /silver chloride ink circuit is adhered to the otherside of the base pad. The flexible tines, surroundedby hydrogel, are used to part the outermost layer ofskin. While the flexible tines part the skin, hydrogelflows around the tines and forms a conductivebridge with the skin. The silver / silver chloridecircuit provides signal continuity from eachelectrode (gel/tine/foam) to the monitor. Apolyester insulation is used to restrict electricalcontact to the electrode area.	EquivalentThe DeltaScan Patch electrode buildup (see Figure5-2) consists of:- a polyurethane foam sponge with conductivewet EEG gel and tines to reduce impedance- a carrier (substrate) of flexible PET foil(Melinex)- a medical grade adhesive foam around theelectrodes for adherence to the skin- the conductive silver tracks and silver /silverchloride electrodes provide signal continuityfrom the electrode (gel, foam, tine) to themonitor- isolation layer covering the silver ink tracks ofthe printed electrodes is used to restrictelectrical contact to the electrode area- hydrogel anchors for improved adherence tothe head and for stability- the reinforced connector is a dedicatedmechanism to interface with the Monitor.
BIS Sensor	DeltaScan Patch
	Equivalent
The body of the sensor houses three (3) electrodes	The body of the sensor houses two (2) electrodes
which are placed on the forehead, and a fourth	which are placed on the forehead, and a third
electrode placed over the temple area.	electrode at the area on the crown of the head (Pz
	location).
Software
N/A	N/A
Device Output
	Equivalent
The sensor collects EEG signals and these are used	The sensor collects EEG signals and these are used
to calculate the Bispectral Index (BIS) value by the	to calculate the DeltaScan Output by the DeltaScan
BIS Monitor.	Monitor.

Tahle 5-1 te -1 ...

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the DeltaScan Patch was assessed in accordance with the FDA's guidance document titled, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 16, 2016.

The DeltaScan Patch is only worn by hospitalized adult patients (e.g., in the intensive care unit (ICU), cardiothoracic postoperative ward or geriatric traumatology ward) (see Figure 5-3) during a DeltaScan measurement². Such measurement potentially takes place once per 8 hours and has a duration of approx. 4 minutes (worst case 3x 10 minutes per 24 hours) and potentially on 3 to 5 consecutive days. Therefore, the DeltaScan Patch is a so called "surface contacting device" (contact with intact skin) with a limited duration (<24 hours each day).

As can been seen in Figure 5-2, the parts of the DeltaScan Patch that are in direct contact with the patient's skin during a measurement are the materials that construct the electrodes (the Sponge (Polyurethane foam), Adhesive Foam, Tines, Wet gel electrolyte, Hydrogel PROMEON 863B, Green isolation layer)).

All parts of the DeltaScan Patch R2 with REF 009.000.B that are directly in contact with the patient's skin have passed the acceptance criteria defined per ISO 10993-1:2018 requirements.

4 DeltaScan Monitor is Indicated for adults over 60 years of age.

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Electrical safety and electromagnetic compatibility (EMC)

In accordance with the EN ISO 60601-1, the use of the DeltaScan Patch does not depend on essential performance. The DeltaScan Patch is not considered Medical Electrical Equipment as defined by the EN ISO 60601-1.

Software verification and validation testing

N/A as the DeltaScan Patch does not contain software.

Mechanical testing

The labels on the packaging were tested to verify be legible, durable, compliant with regulations, and compatible with the packaging.
The packaging was tested to verify to be compatible with the labeling, and can be shipped without damage.

The 'Label and IfU review report' is provided in this 510(k) and the Shipping Validation Report DeltaScan Patch is provided in this 510(k).

Shelf life

The DeltaScan Patch has a stated shelf life of 9 months. These 9 months are mainly based on the degradation of the two frontal electrodes, being the most critical part for shelf life of the DeltaScan Patch. This is verified and documented in the Verification Report based on accelerated aging.

Real time aging is still in progress and may in future demonstrate a longer shelf life.

Clinical Studies

The Verification Report provides sufficient proof that it transfers the electrical signals as intended. No dedicated clinical study is needed to validate the device performance.

The data in the Verification Report for the DeltaScan Patch shows that it performs as intended, is safe and effective for its intended use, and provides similar safety and effectiveness results to the predicate device.

VIII. CONCLUSION

Based on the intended use, technological characteristics, and performance data provided in this premarket notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).