(175 days)
Not Found
No
The summary describes a device for reading the pressure of a valve and does not mention any AI/ML terms or capabilities.
No
The device is described as an "Electronic Reading Instrument" intended to "locate and read the operating pressure of a Polaris valve before and after implantation". It functions as a diagnostic or monitoring tool for a pre-existing therapeutic device (the Polaris valve), rather than providing therapy itself. The predicate device is also a "POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM," which is the therapeutic device being adjusted or monitored by this instrument.
Yes
The device "locates and reads the operating pressure of a Polaris valve before and after implantation," which is a measurement of a physiological parameter to inform treatment or monitoring, classifying it as a diagnostic device.
No
The device description explicitly states it is an "electronic reading instrument" and mentions "electrical safety test" and "EMC safety test," indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "locate and read the operating pressure of a Polaris valve." This is a measurement of a physical parameter of an implanted medical device, not an analysis of a biological sample from the human body.
- Device Description: The description reinforces that it "non-invasively locate[s] and read[s] the operating pressure of a Polaris® valve." Again, this is about interacting with and reading data from a medical device, not analyzing biological material.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts with an implanted valve.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance testing included design verification tests, software tests, electrical safety test, EMC safety test, simulated use test, use life test and transit test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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).
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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)
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)
| ☑ 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 |
| ORSAY, 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 XUE |
| Consultant | |
| z.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 |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------------------------------- |
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. |
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.