Certas Plus Programmable Valves

K223330 · Integra Lifesciences Production Corporation · JXG · Feb 1, 2023 · Neurology

Device Facts

• Record ID: K223330
• Device Name: Certas Plus Programmable Valves
• Applicant: Integra Lifesciences Production Corporation
• Product Code: JXG · Neurology
• Decision Date: Feb 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Device Story

Implantable, sterile, single-use valve for hydrocephalus management; diverts cerebrospinal fluid (CSF) from brain ventricles to another body cavity to relieve intracranial pressure. Features eight programmable performance settings for pressure and drainage. Settings adjusted preoperatively or noninvasively post-implantation using magnetic Certas Tool Kits. Used by neurosurgeons in clinical settings. Benefits patients by providing adjustable, constant pressure regulation to manage CSF accumulation. Device modifications include material changes (Polyethersulfone to Polysulfone; Nylon to Polysulfone) and minor dimensional/tolerance adjustments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including accelerated aging (ASTM F1980), functional testing (ISO 7197, ASTM F647), MRI compatibility (ISO/TS 10974), X-ray testing (ASTM F640), and comprehensive biocompatibility testing (ISO 10993 series, USP 42-NF 37).

Technological Characteristics

Implantable valve; materials include Polysulfone (PSU); magnetic adjustment mechanism; MR conditional. Standards: ASTM F1980 (aging), ISO 7197/ASTM F647 (functional), ISO/TS 10974 (MRI), ASTM F640 (X-ray), ISO 10993 (biocompatibility).

Indications for Use

Indicated for patients with hydrocephalus requiring management of intraventricular pressure and CSF drainage.

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

• Certas Plus Programmable Valves (K152152)
• Certas Plus Programmable Valves (K182265)

Reference Devices

• Certas Plus Programmable Valves (K143111)

Submission Summary (Full Text)

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

February 1, 2023

Integra LifeSciences Production Corporation Amanda Erwin Manager, Regulatory Affairs 11 Cabot Boulevard Mansfield, Massachusetts 02048

Re: K223330

Trade/Device Name: Certas Plus Programmable Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: October 31, 2022 Received: November 3, 2022

Dear Amanda Erwin:

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 (OS) 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 includes the name "Adam D. Pierce -S" on two lines. The signature also includes the date "2023.02.01" and the time "11:59:50-05'00'".

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) K223330

Device Name Certas Plus Programmable Valves

Indications for Use (Describe)

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

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

| <div> <object data="checkbox_checked.svg" height="20" type="image/svg+xml" width="20"> </object> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <object data="checkbox_unchecked.svg" height="20" type="image/svg+xml" width="20"> </object> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 807.92(a) (1) Submitter Information | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name and Address | Integra LifeSciences Production Corporation<br>11 Cabot Boulevard<br>Mansfield, MA 02048<br><br>On behalf of:<br>Integra LifeSciences Switzerland SARL<br>Floor 2, Rue Girardet 29<br>Le Locle, Neuchatel CH-2400<br>Switzerland |
| Telephone number | [phone] |
| Primary Contact | Amanda Erwin |
| Date Summary Prepared | February 1, 2023 |
| 807.92(a) (2) Name of Device | |
| Trade or Proprietary Name | Certas Plus Programmable Valves |
| Common Name | Central Nervous System Fluid Shunt and Components |
| Classification Name | Central Nervous System Fluid Shunt and Components<br>(21 CFR 882.5550) |
| Device Class | II |
| Product Code | JXG |
| 807.92(a) (3) Predicate Information | |
| Predicate Device | Certas Plus Programmable Valves: K152152 and K182265<br><br>Certas Plus Programmable Valves: K143111 (reference device) |
| 807.92(a) (4) Device Description | |

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The Certas Plus Programmable Valves are implantable, sterile, single use devices that provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. Hydrocephalus is a condition caused by excessive accumulation of CSF in the ventricles of the brain due to a disturbance of CSF secretion, flow, or absorption, which causes a rise in intracranial pressure (ICP). To relieve ICP, CSF can be diverted through a shunting device, such as a Certas Plus Programmable Valve, to another body cavity where it is subsequently absorbed. The Certas Plus Programmable Valves can be set to eight different performance settings for intraventricular pressure and drainage of CSF. The performance settings of the valves can be set preoperatively and can also be noninvasively changed postimplantation by using the Certas Tool Kits. The Certas Tool Kits employ magnetic force to select one of eight settings.

### 807.92(a) (5) Indications for Use

The Certas Plus Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

807.92(a) (6) Technological Characteristics Compared to Predicate

The proposed Certas Plus Programmable Valves have intended use, sterility, design principles and fundamental operation as the predicate valves. The proposed minor change in technological characteristics for the valves consists of a material change and minor dimensional and tolerance changes for various components. The changes do not raise any new questions of safety and/or effectiveness.

| Component Affected | Proposed Modification | Rationale |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Various Internal<br>Components | Replacement of<br>Polyethersulfone<br>(PES) with<br>Polysulfone (PSU) in<br>Certas Plus<br>Programmable<br>Valves for various<br>internal components. | Polyethersulfone will<br>no longer be available<br>for Integra to<br>manufacture the<br>impacted internal<br>components with. |
| | Replacement of<br>Nylon with | Nylon will no longer<br>be used to |
| | Polysulfone (PSU) in<br>Certas Plus<br>programmable Valve<br>Needle Guard internal<br>component. | manufacture the<br>impacted Certas Plus<br>Programmable Valve<br>Inline Valve Needle<br>Guard internal<br>component with. |
| | Minor dimensional<br>and tolerance changes<br>to internal<br>components. A<br>design feature in the<br>Small and Right<br>Angle Needle Guards<br>will also be removed. | The minor<br>dimensional and<br>tolerance changes to<br>the internal<br>components have<br>been made to<br>accommodate the<br>material changes. The<br>removal of the design<br>feature in the Small<br>and Right Angle<br>Needle Guards was<br>done to remove a<br>design feature that<br>was never utilized. |
| Labeling | Updates made to<br>reflect the proposed<br>material changes, as<br>well as administrative<br>updates and<br>corrections. | Update labelling with<br>new material and<br>administrative<br>updates and corrected<br>information. |
| | Inclusion of a Patient<br>Implant Card and a<br>Patient Information<br>Leaflet | A Patient Implant<br>Card and Patient<br>Information Leaflet is<br>included as the<br>devices are MR<br>conditional implants. |
| 807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed | | |

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The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.

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| Performance Bench Test Results | |
|------------------------------------------------------------|------------|
| Test | Conclusion |
| Accelerated Aging for Shelf Life Testing per<br>ASTM F1980 | Pass |
| Functional Testing per ISO 7197 | Pass |
| Functional Testing per ASTM F647 | Pass |
| MRI Testing per ISO/TS 10974 | Pass |
| X-Ray Testing per ASTM F640 | Pass |

| Biocompatibility Testing Results | |
|------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Test | Conclusion |
| MTS Cytotoxicity per ISO 10993-5 | Pass |
| Guinea Pig Maximization Sensitization Study per<br>ISO 10993-10 | Pass |
| Intracutaneous Irritation Study in Rabbits per ISO<br>10993-10 | Pass |
| Acute Systemic Toxicity Study in mice per ISO<br>10993-11 | Pass |
| Rabbit Pyrogen Study per United States<br>Pharmacopeia 42 – NF 37 | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1<br>and 4 weeks per ISO 10993-6 | Pass |
| Systemic Toxicity and Local Effects Study in<br>Rabbits following Subcutaneous Implantation 13<br>weeks per ISO 10993-6 and ISO 10993-11 | Pass |
| Bacterial Reverse Mutation Study per ISO 10993-3<br>and ISO/TR 10993-33 | Pass |
| In Vitro Mouse Lymphoma Study per ISO 10993-3<br>and ISO/TR 10993-33 | Pass |
| Hemolysis on Extract Study per ISO 10993-4 and<br>ASTM F756 | Pass |

There are no changes in sterility as a result of the proposed material changes and minor dimensional and tolerance changes; a sterilization equivalency assessment was performed comparing the proposed device to the predicate device and deemed acceptable.

No clinical studies were required as appropriate verification and validation of the subject device was achieved based on the comparison to the predicate device and from the results of testing.

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## 807.92(b) (3) Conclusion

Based upon the intended use, design, comparison to the predicate device, and testing performed, Integra LifeSciences believes that the proposed modifications to the Certas Plus Programmable Valves do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Certas Plus Programmable Valves.