Polaris Valve Electronic Reading Instrument

K222422 · Sophysa · JXG · Feb 2, 2023 · Neurology

Device Facts

• Record ID: K222422
• Device Name: Polaris Valve Electronic Reading Instrument
• Applicant: Sophysa
• Product Code: JXG · Neurology
• Decision Date: Feb 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2

Indications for 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).

Device Story

Electronic reading instrument (PAK3-ERI) used to non-invasively locate and read operating pressure of Polaris hydrocephalus valves; device inserted into compatible locator tool (PAK2-LI). Instrument measures valve's magnetic field; displays valve pressure position and provides visual feedback via screen and light indicator to aid localization of magnetic center. Used by clinicians in clinical settings. Replaces mechanical indicator of predicate with electronic display/light feedback. Benefits include improved accuracy and ease of valve localization and pressure reading.

Clinical Evidence

No clinical data. Performance testing included design verification, software tests, electrical safety, EMC safety, simulated use, use life, and transit testing.

Technological Characteristics

Battery-operated electronic instrument; non-patient contacting. Materials: ABS, PBT, Polycarbonate. Sensing principle: magnetic field measurement. Form factor: handheld, designed for insertion into PAK2-LI locator tool. Connectivity: standalone. Software: included for electronic display and localization feedback. Sterilization: non-sterile.

Indications for Use

Indicated for patients with hydrocephalus requiring non-invasive location and reading of the operating pressure of a Polaris valve, both before and after implantation. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• POLARIS® PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS® ADJUSTABLE VALVE WITH SIPHONX (K141227)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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).

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

| <span style="text-decoration: underline;">☑</span> Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------|
|-------------------------------------------------------------------------------------------------|-----------------------------------------------|

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 Moquet<br>ORSAY, FRANCE, 91400 |
| Phone and Fax Number: | [phone] (phone)<br>[phone] (fax) |
| Contact Person: | Zheng XUE<br>Consultant<br>[e-mail] |
| 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 |
|------------|---------------------------------------------------------------------------------------------------------------------------|
|------------|---------------------------------------------------------------------------------------------------------------------------|

#### Device Description 4.

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.

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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.<br><br>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.