The Electronic Reading Instrument is intended to locate and read the operating pressure of a Polaris valve. It is specifically designed to be combined with the Locator from a compatible Polaris Adjustment Kit (PAK2).

Device Description

The Polaris® valve electronic reading instrument (PAK3-ERI) is intended to non-invasively locate and read the operating pressure of a Polaris® valve before and after implantation in the treatment of hydrocephalus. It should be inserted into the PAK2-LI locator tool (identical to the locator tool part as in the predicate device cleared via K141227) in order to read the valve's pressure position.

AI/ML Overview

The provided text describes a 510(k) submission for the "Polaris Valve Electronic Reading Instrument." However, it does not include detailed information regarding the acceptance criteria of a study that proves the device meets specific performance metrics. Instead, it focuses on the equivalence to a predicate device and summarizes non-clinical testing.

Therefore, many of the requested items cannot be directly extracted from the provided text. I will provide what can be inferred or stated from the document, and indicate where information is not provided.

Device Description:
The Polaris Valve Electronic Reading Instrument (PAK3-ERI) is intended to non-invasively locate and read the operating pressure of a Polaris® valve, particularly when combined with the Locator from a compatible Polaris® Adjustment Kit (PAK2). It uses an indicator light to measure the valve's magnetic field and display the valve pressure position.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in this document. The document states that "Performance testing included design verification tests, software tests, electrical safety test, EMC safety test, simulated use test, use life test and transit test," but it does not specify the acceptance criteria for these tests nor the reported numerical performance of the device against those criteria. This is typically found in a separate detailed test report.

2. Sample Size Used for the Test Set and Data Provenance

Not provided regarding performance testing. For the "simulated use test" and "use life test," the sample size of valves or test subjects is not specified. The data provenance (country of origin, retrospective/prospective) for these tests is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for this type of device. This device is an "Electronic Reading Instrument" that reads the physical operating pressure of a valve. The "ground truth" for its function would likely be established by comparing its readings to known, precisely set pressures of the valves, not by human expert interpretation of images or clinical data. Therefore, expert consensus in the typical sense (e.g., radiologists interpreting images) is not relevant for establishing ground truth for the device's primary function.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods like "2+1" or "3+1" are typically used when there is subjective interpretation involved, such as in image reading or clinical diagnosis. For an instrument that reads a physical property (valve pressure), the "ground truth" would be objective measurements or pre-set values, not subject to adjudication by multiple human observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, not performed and not applicable. An MRMC study is relevant for AI/imaging devices where human readers interpret medical images. This device is an electronic reading instrument for a physical valve, not an image analysis or diagnostic aid requiring human interpretation of complex medical imagery. The document states a comparison to a predicate device (PAK2-RI vs. PAK3-ERI), but this is a technical equivalence comparison, not an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Likely yes, as this is an instrument. The device's primary function is to read the operating pressure. Performance tests (e.g., accuracy of pressure reading) would inherently be "standalone" in this context, meaning the instrument's reading accuracy would be assessed against a known standard. However, the specific details or results of these standalone tests are not provided. The text mentions "simulated use test," which would evaluate the device's function directly.

7. The Type of Ground Truth Used

Inferred to be objective physical measurements/settings. For an instrument designed to "read the operating pressure of a Polaris valve," the ground truth would be the actual, precisely known operating pressure of the test valves, established by a calibrated reference method or by setting the valves to known pressures. This is based on the device's function as a measurement tool.

8. The Sample Size for the Training Set

Not applicable to this type of device/submission. This is an electronic measurement instrument, not an AI/machine learning device that requires a "training set" in the typical sense (e.g., for image recognition or predictive models). The "software tests" mentioned would refer to verification and validation of the embedded software's functionality, not training data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable to this type of device/submission. As there's no "training set" for an AI algorithm, the concept of establishing ground truth for it does not apply here.

Summary

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February 2, 2023

Sophysa Zheng Xue Consultant 05 Rue Guy Moquet Orsay, Essonne 91400 France

Re: K222422

Trade/Device Name: Polaris Valve Electronic Reading Instrument Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: December 30, 2022 Received: December 30, 2022

Dear Zheng Xue:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2023.02.02, and the time is 15:22:38 -05'00'.

Adam D. Pierce, Ph.D. 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) K222422

Device Name

Polaris Valve Electronic Reading Instrument

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
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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

1. Sponsor Information

Applicant Name:	Sophysa SA
Address:	5 Rue Guy MoquetORSAY, FRANCE, 91400
Phone and Fax Number:	+33 (0)1 69 35 35 00 (phone)+33 (0)1 69 35 36 90 (fax)
Contact Person:	Zheng XUEConsultantz.xuecazenave@sophysa.fr
Date Prepared:	February 23, 2023

2. Device Name and Classification

Trade/Proprietary Name:	Polaris Valve Electronic Reading Instrument
Common Name:	Accessory to Hydrocephalus shunt system
510(k) Submitter:	Sophysa
Device Class:	Class II
Product code:	JXG
Regulation:	21 CFR 882.5550

Predicate Device 3.

Predicate:	POLARIS® PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS® ADJUSTABLE VALVE WITH SIPHONX (Sophysa SA), K141227, Product code: JXG
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Device Description 4.

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న. Intended Use

The Electronic Reading Instrument is intended to locate and read the operating pressure of a Polaris® valve.

It is specifically designed to be combined with the Locator from a compatible Polaris® Adjustment Kit (PAK2).

6. Summary of Equivalence to Predicate Device

The Polaris® valve electronic reading instrument (PAK3-ERI) is substantially equivalent to the Polaris® pressure reading instrument (PAK2-RI) in the bundled submission of K141227 as listed in Table 5-1.

Table 5-1: Predicate Devices Comparison: PAK2-RI vs. PAK3-ERI
Item	Polaris® pressure reading instrument in the bundled submission of K141227 (predicate device)	The Polaris® valve electronic reading instrument (subject device)
INTENDED USES AND DEVICE DESIGN
Intended Use	designed for reading the operating pressure of a Polaris®valve	designed for reading the operating pressure of a Polaris®valve.
Indications for use	Same as above	Same
Prescription use	Prescription use only	Same
Operating Principle	After that the locator identifies the valves axis, the PAK2-RI is inserted in the locator. PAK2-RI incorporates an indicator that aligns with the valve's magnetic field to display the valve pressure position.	Similar, After that the locator identifies the valves axis, the PAK3-ERI is inserted in the locator. PAK3-ERI incorporates an indicator light that measures the valve's magnetic field and display the valve pressure position.
Energy type	Mechanical, not battery operated	Battery operated
Location/indication feedback	Location: No location feedback; the user is required to manually palpate to determine the valve location	Location: display screen with a Ball to aid the localization of valve's magnetic center.Indication: display a light indicator to the valve pressure

			Table 5-1: Predicate Devices Comparison: PAK2-RI vs. PAK3-ERI

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Item	Polaris® pressure reading instrument in the bundled submission of K141227 (predicate device)	The Polaris® valve electronic reading instrument (subject device)
	Indication: display a mechanical indicator to the valve pressure position on the locator tool (PAK2-LI)	position on the locator tool (PAK2-LI)
Materials – not patient contacting	No patient contact.	No patient contact
	ABS	ABS, PBT, Polycarbonate
Software	No	Yes
Sterilization	NA, non-sterile	NA, non-sterile

7. Summary of Non-clinical testing

Performance testing included design verification tests, software tests, electrical safety test,

EMC safety test, simulated use test, use life test and transit test.

8. Statement of Substantial Equivalence

The information summarized above demonstrates that the Polaris® valve electronic reading instrument is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).