(112 days)
No
The device description and performance studies focus on mechanical and material properties of an implantable valve, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implantable device that manages hydrocephalus by providing constant intraventricular pressure and drainage of cerebral spinal fluid, which are therapeutic actions.
No
The device description states that the Codman Hakim systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus. This describes a therapeutic function (managing a condition by diverting fluid and regulating pressure), not a diagnostic one.
No
The device description explicitly states that the devices are "implantable, sterile, single use devices" and describes their physical function in diverting CSF. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as an "implantable device" for the "management of hydrocephalus" by draining cerebral spinal fluid. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description reinforces that it's an "implantable, sterile, single use device" that "provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF)". This is a physical device implanted to manage a medical condition.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any testing of samples or diagnostic purposes.
Therefore, the Codman Hakim Precision Fixed Pressure and Programmable Valve Systems are therapeutic medical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 Valve Systems are implantable devices that provide constant intraventricular pressure and drainage of cerebral spinal fluid (CSF) for the management of hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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:
- 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:
- MTT and MTS Cytotoxicity Studies per ISO 10993-5: Pass
- Guinea Pig Maximization Sensitization Studies per ISO 10993-10: Pass
- Intracutaneous Irritation Studies in Rabbits per ISO 10993-10: Pass
- Acute Systemic Toxicity Study in Mice per ISO 10993-11: Pass
- Rabbit Pyrogen Studies per United States Pharmacopeia (USP 42 – NF 37): Pass
- Subcutaneous Implantation Studies in Rabbits, 1 Week and 4 Weeks per 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: 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 and ASTM 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.
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.
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.
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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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 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.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
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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 Boulevard |
| Mansfield, 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 Valves |
| Hakim 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: |
| K172022 | |
| The following reference device is used in this submission: | |
| Codman Certas Plus Programmable Valve: K143111, | |
| K182265 | |
| 807.92(a) (4) 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
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 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 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 Internal | ||
| Components | • Replacement of | |
| Polyethersulfone | ||
| (PES) with | ||
| Polysulfone (PSU) in | ||
| Hakim Precision | ||
| Fixed Pressure | ||
| Valves and Hakim | ||
| Programmable Valves | Polyethersulfone will no | |
| longer be available for | ||
| Integra to manufacture the | ||
| impacted internal | ||
| components with. Nylon will | ||
| no longer be available to | ||
| manufacture the impacted | ||
| Hakim Programmable | ||
| Labeling | for various internal | |
| components. Minor | ||
| dimensional and | ||
| tolerance changes to | ||
| internal components | ||
| will also be made to | ||
| the internal | ||
| components to | ||
| accommodate the | ||
| material change. | ||
| Replacement of | ||
| Nylon with | ||
| Polysulfone (PSU) in | ||
| Hakim programmable | ||
| Valve internal | ||
| component. Minor | ||
| dimensional changes | ||
| will be made to | ||
| accommodate the | ||
| material change. Updates made to | ||
| reflect the proposed | ||
| material change, as | ||
| well as administrative | ||
| updates and | ||
| corrections. Inclusion of Patient | ||
| Implant Cards and | ||
| Patient Information | ||
| Leaflet The labelling for | ||
| Hakim Programmable | ||
| Valves has also been | ||
| updated to comply | ||
| with Regulation (EU) | ||
| 2017/745. | Valves Needle Guard | |
| internal component with. | ||
| The minor dimensional and | ||
| tolerance changes to the | ||
| internal components have | ||
| been made to accommodate | ||
| the material change or | ||
| standardize component | ||
| design across Integra's | ||
| hydrocephalus valve | ||
| portfolio. | ||
| Update labelling with | ||
| current information. Patient Implant Cards | ||
| and Patient | ||
| Information Leaflets | ||
| are included as the | ||
| devices are MR | ||
| conditional implants. To comply with | ||
| Regulation (EU) | ||
| 2017/745. | ||
| 807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed |
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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 ISO | |
| 10993-5 | Pass |
| Guinea Pig Maximization Sensitization Studies per | |
| ISO 10993-10 | Pass |
| Intracutaneous Irritation Studies in Rabbits per ISO | |
| 10993-10 | Pass |
| Acute Systemic Toxicity Study in Mice per ISO | |
| 10993-11 | Pass |
| Rabbit Pyrogen Studies per United States | |
| Pharmacopeia (USP 42 – NF 37) | Pass |
| Subcutaneous Implantation Studies in Rabbits, 1 | |
| Week and 4 Weeks per 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 | 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 and | |
| ASTM 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.
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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.