The Codman Hakim Precision Fixed Pressure Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

Device Description

The Codman Hakim® Precision Fixed Pressure and 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 Hakim Precision Valve or Hakim Programmable Valve, to another body cavity where it is a subsequently absorbed. Both the Codman Hakim Precision Fixed Pressure and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Hakim Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman Hakim Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman Hakim Programmable Valves can be adjusted to 18 different opening pressure settings.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Hakim Programmable Valves and Hakim Precision Fixed Pressure Valves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance against specific targets.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment are not applicable or not explicitly stated in the provided document. The submission is for minor changes (material and dimensional) to an existing device, and relies on bench testing and an equivalency assessment.

Here's a breakdown of the information that can be extracted and a clear indication of what is not available from the given FDA letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for the device's clinical performance. Instead, it demonstrates that the device passed a series of performance and biocompatibility tests, indicating compliance with established standards. The acceptance criteria for the tests are implied by the "Pass" outcome, meaning they met the requirements of the specified standards (e.g., ISO 7197, ASTM F1980).

Test	Acceptance Criteria (Implied by standard)	Reported Device Performance
Product Shelf Life Testing per ASTM F1980	Met requirements of ASTM F1980	Pass
Functional Testing per ISO 7197	Met requirements of ISO 7197	Pass
Functional Testing per ASTM F647	Met requirements of ASTM F647	Pass
MRI Spatial Gradient Testing per ASTM F2052	Met requirements of ASTM F2052	Pass
X-Ray Testing per ASTM F640	Met requirements of ASTM F640	Pass
MTT and MTS Cytotoxicity Studies per ISO 10993-5	Met requirements of ISO 10993-5	Pass
Guinea Pig Maximization Sensitization Studies per ISO 10993-10	Met requirements of ISO 10993-10	Pass
Intracutaneous Irritation Studies in Rabbits per ISO 10993-10	Met requirements of ISO 10993-10	Pass
Acute Systemic Toxicity Study in Mice per ISO 10993-11	Met requirements of ISO 10993-11	Pass
Rabbit Pyrogen Studies per USP 42 – NF 37	Met requirements of USP 42 – NF 37	Pass
Subcutaneous Implantation Studies in Rabbits, 1 Week and 4 Weeks per ISO 10993-6	Met requirements of ISO 10993-6	Pass
Systemic Toxicity and Local Effects Study in Rabbits Following Subcutaneous Implantation, 13 Weeks per ISO 10993-6 and ISO 10993-11	Met requirements of ISO 10993-6 and ISO 10993-11	Pass
Bacterial Reverse Mutation Studies per ISO 10993-3 and ISO/TR 10993-33	Met requirements of ISO 10993-3 and ISO/TR 10993-33	Pass
In Vitro Mouse Lymphoma Studies per ISO 10993-3 and ISO/TR 10993-33	Met requirements of ISO 10993-3 and ISO/TR 10993-33	Pass
Hemolysis on Extract Studies per ISO 10993-4 and ASTM F756	Met requirements of ISO 10993-4 and ASTM F756	Pass

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for each individual test. The document states "All testing was performed on production equivalent devices," implying a sufficient number of units to conduct the referenced tests, but the exact count is not given.
Data Provenance: Not explicitly stated (e.g., country of origin). The testing is described as "performance bench test results" and "biocompatibility testing results," indicating lab-based testing rather than patient data. These appear to be prospective tests conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This submission does not involve clinical studies requiring expert ground truth for a test set. The tests are bench and biocompatibility studies against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As there are no clinical trials or interpretations of complex data like medical images by multiple experts, no adjudication method is cited.

5. 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. An MRMC study was not conducted and is not relevant to this device submission, which involves physical CSF shunting devices, not AI-assisted reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed is the compliance with the specified international and national standards (e.g., ISO 7197, ASTM F1980, ISO 10993 series, USP). The "Pass" outcome indicates the device met the objective criteria defined within these standards.

8. The sample size for the training set

Not Applicable. This refers to a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

October 14, 2022

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

Re: K221840

Trade/Device Name: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: July 18, 2022 Received: July 18, 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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221840

Device Name Hakim Precision Fixed Pressure Valves Hakim Programmable Valves

Indications for Use (Describe)

The Codman Hakim Programmable Valves Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Hakim® Precision Fixed Pressure Valves and Hakim® Programmable Valves

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	Integra LifeSciences Production Corporation
Address	11 Cabot BoulevardMansfield, MA 02048
Telephone number	(609) 627-9053
Primary Contact	Amanda Erwin
Date Summary Prepared	June 23, 2022
807.92(a) (2) Name of Device
Trade or Proprietary Name	Hakim Precision ValvesHakim Programmable Valves
Common Name	Central Nervous System Fluid Shunt and Components
Classification Name	Central Nervous System Fluid Shunt and Components(21 CFR 882.5550)
Device Class	II
Product Code	JXG
807.92(a) (3) Predicate Information
Predicate Device	Hakim Precision Valves and Hakim Programmable Valves:K172022The following reference device is used in this submission:Codman Certas Plus Programmable Valve: K143111,K182265
807.92(a) (4) Device Description

{4}------------------------------------------------

Hakim® Precision Fixed Pressure Valves and Hakim® Programmable Valves

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 Hakim Precision Valve or Hakim Programmable Valve, to another body cavity where it is a subsequently absorbed. Both the Codman Hakim Precision Fixed Pressure and Programmable Valves are pressure regulating valves which maintain intraventricular pressure at a constant level. The Hakim Precision valves are fixed pressure valves and are available in 5 different opening pressure ranges. The Codman Hakim Programmable Valves, not having fixed pressures, permit non-invasive adjustment of the valve opening pressure. The Codman Hakim Programmable Valves can be adjusted to 18 different opening pressure settings.

807.92(a) (5) Indications for Use

The Codman Hakim Programmable Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.

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

The proposed Hakim Precision Valves and Hakim Programmable Valves have the same 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 InternalComponents	• Replacement ofPolyethersulfone(PES) withPolysulfone (PSU) inHakim PrecisionFixed PressureValves and HakimProgrammable Valves	Polyethersulfone will nolonger be available forIntegra to manufacture theimpacted internalcomponents with. Nylon willno longer be available tomanufacture the impactedHakim Programmable
Labeling	for various internalcomponents. Minordimensional andtolerance changes tointernal componentswill also be made tothe internalcomponents toaccommodate thematerial change.Replacement ofNylon withPolysulfone (PSU) inHakim programmableValve internalcomponent. Minordimensional changeswill be made toaccommodate thematerial change. Updates made toreflect the proposedmaterial change, aswell as administrativeupdates andcorrections. Inclusion of PatientImplant Cards andPatient InformationLeaflet The labelling forHakim ProgrammableValves has also beenupdated to complywith Regulation (EU)2017/745.	Valves Needle Guardinternal component with.The minor dimensional andtolerance changes to theinternal components havebeen made to accommodatethe material change orstandardize componentdesign across Integra'shydrocephalus valveportfolio.Update labelling withcurrent information. Patient Implant Cardsand PatientInformation Leafletsare included as thedevices are MRconditional implants. To comply withRegulation (EU)2017/745.
807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed

{5}------------------------------------------------

Hakim® Precision Fixed Pressure Valves and Hakim® Programmable Valves

{6}------------------------------------------------

Hakim® Precision Fixed Pressure Valves and Hakim® Programmable Valves

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.

Performance Bench Test Results
Test	Conclusion
Product Shelf Life Testing per ASTM F1980	Pass
Functional Testing per ISO 7197	Pass
Functional Testing per ASTM F647	Pass
MRI Spatial Gradient Testing per ASTM F2052	Pass
X-Ray Testing per ASTM F640	Pass

Biocompatibility Testing Results
Test	Conclusion
MTT and MTS Cytotoxicity Studies per ISO10993-5	Pass
Guinea Pig Maximization Sensitization Studies perISO 10993-10	Pass
Intracutaneous Irritation Studies in Rabbits per ISO10993-10	Pass
Acute Systemic Toxicity Study in Mice per ISO10993-11	Pass
Rabbit Pyrogen Studies per United StatesPharmacopeia (USP 42 – NF 37)	Pass
Subcutaneous Implantation Studies in Rabbits, 1Week and 4 Weeks per ISO 10993-6	Pass
Systemic Toxicity and Local Effects Study inRabbits Following Subcutaneous Implantation, 13Weeks per ISO 10993-6 and ISO 10993-11	Pass
Bacterial Reverse Mutation Studies per ISO 10993-3 and ISO/TR 10993-33	Pass
In Vitro Mouse Lymphoma Studies per ISO 10993-3 and ISO/TR 10993-33	Pass
Hemolysis on Extract Studies per ISO 10993-4 andASTM F756	Pass

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

{7}------------------------------------------------

Hakim® Precision Fixed Pressure Valves and Hakim® Programmable Valves

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

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 Hakim Precision Valves and Hakim Programmable Valves do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Hakim Precision Valves and Hakim Programmable Valves.

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).