(264 days)
The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.
The provided document is a 510(k) clearance letter from the FDA for a medical device (Codman Libertís™ EVD Catheter). It describes the device, its intended use, a comparison to a predicate device, and summaries of nonclinical testing.
However, the question asks for details related to acceptance criteria and studies that prove a device meets acceptance criteria, specifically those typically associated with AI/software medical devices. This document does not describe an AI/software medical device; it describes a physical medical device (a catheter for draining CSF). Therefore, much of the information requested in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) study," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of device and are not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, and sterilization validation, which are standard for physical medical devices.
Here's an attempt to answer the applicable parts of your request based on the provided text, and explicitly state where information is not available or not applicable.
Description of Acceptance Criteria and Proving Device Meets Criteria
The Codman Libertís™ EVD Catheter is a physical medical device. Its acceptance criteria are primarily demonstrated through a battery of nonclinical performance bench tests, biocompatibility testing, and sterilization validation, to show that it is substantially equivalent to a legally marketed predicate device. The performance criteria are generally considered a "Pass" or "Fail" based on established standards and internal methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria values but rather states a "Pass" or "Fail" for each test. The acceptance criterion for each test is implicitly that the device performs as expected according to the specified standard or internal method.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Evaluation of Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 | Meets specifications of ASTM F647 and ISO 7197 for EVD catheters. | Pass |
| Evaluation of Aged Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 (T = 12 months) | Meets specifications of ASTM F647 and ISO 7197 for EVD catheters after 12 months simulated aging. | Pass |
| Functional/Mechanical Performance of Codman Libertís EVD Catheters | Meets predefined functional and mechanical performance specifications. | Pass |
| Functional/Mechanical Performance of Aged Codman Libertís EVD Catheters (T = 12 months) | Meets predefined functional and mechanical performance specifications after 12 months simulated aging. | Pass |
| MRI Compatibility Assessment of Codman Libertís EVD Catheters per ASTM F2503 | Meets specifications of ASTM F2503 for MRI compatibility (Note: Catheter is MR Conditional, Trocar and Stylet are MR-Unsafe, as noted in labeling). | Pass |
| Antimicrobial Efficacy of Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use | Demonstrates sufficient Zone of Inhibition against specified bacteria after 28 days of simulated use to show antimicrobial efficacy. | Pass |
| Antimicrobial Efficacy of Aged Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use (T = 12 months) | Demonstrates sufficient Zone of Inhibition after 12 months simulated aging and 28 days of simulated use. | Pass |
| Antibiotic Content Testing of Codman Libertís EVD Catheters | Contains the specified levels of antibiotics (rifampicin and clindamycin hydrochloride). | Pass |
| Residual Solvents Testing of Codman Libertís EVD Catheters | Levels of residual solvents are within acceptable limits. | Pass |
| Libertís EVD Catheters with Bactiseal® and Endexo® Technology – Summative Usability Study | Meets user-related safety and effectiveness requirements, indicating the device can be used safely and effectively by its intended users. | Pass |
| Product Shelf Life Testing per ASTM F1980 and ISO 11607-1 | Maintains integrity and performance over its stated shelf life (12 months) as per ASTM F1980 and ISO 11607-1. | Pass |
| Biocompatibility Testing per ISO 10993-1 | Demonstrates biocompatibility in accordance with ISO 10993-1 for medical devices in contact with the body. | Pass |
| Sterilization Validation (Electron Beam) | Achieves a sterility assurance level (SAL) of 10-6. | Pass |
2. Sample size used for the test set and the data provenance
The document states, "All testing was performed on production equivalent devices." However, it does not specify the sample size for any of the individual bench tests.
Data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the traditional sense for these bench tests, which are conducted in a laboratory setting to evaluate physical properties and performance characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of medical device (physical catheter). "Ground truth" in this context would refer to established engineering standards, material specifications, and validated test methods, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
This concept is not applicable to this type of medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers (e.g., radiologists) to resolve disagreements in interpretation, which is not relevant for bench testing of a physical device.
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 MRMC comparative effectiveness study was done, as this is a physical medical device (catheter), not an AI/software device. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable since the device is a physical catheter, not a software algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests of this physical device consists of:
- Established industry standards (e.g., ASTM F647, ISO 7197, ASTM F2503, ISO 10993-1, ASTM F1980, ISO 11607-1).
- Internal predefined functional and mechanical specifications.
- Validated laboratory methods for chemical content, antimicrobial efficacy (Zone of Inhibition), and sterility assurance (SAL 10-6).
- Usability requirements for the Summative Usability Study.
8. The sample size for the training set
This concept is not applicable as this is a physical medical device, not an AI/software device that would involve a "training set."
9. How the ground truth for the training set was established
This concept is not applicable for the same reason as above.
FDA 510(k) Clearance Letter - Codman Libertís™ EVD Catheter
Page 1
August 6, 2025
Integra LifeSciences Production Corporation
Kali Sacco
Manager, Regulatory Affairs
11 Cabot Boulevard
Mansfield, Massachusetts 02048
Re: K243552
Trade/Device Name: Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Regulation Number: 21 CFR 882.5550
Regulation Name: Central nervous system fluid shunt and components
Regulatory Class: Class II
Product Code: JXG
Dated: November 15, 2024
Received: July 7, 2025
Dear Kali Sacco:
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 (the 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 available 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.
August 6, 2025
Integra LifeSciences Production Corporation
Kali Sacco
Manager, Regulatory Affairs
11 Cabot Boulevard
Mansfield, Massachusetts 02048
Re: K243552
Trade/Device Name: Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Regulation Number: 21 CFR 882.5550
Regulation Name: Central nervous system fluid shunt and components
Regulatory Class: Class II
Product Code: JXG
Dated: November 15, 2024
Received: July 7, 2025
Dear Kali Sacco:
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 (the 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 available 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.
Page 2
K243552 - Kali Sacco
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
K243552 - Kali Sacco
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243552 - Kali Sacco
assistance/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,
Yen-chih Lin -S Digitally signed by Yen-chih Lin -S Date: 2025.08.06 16:51:02 -04'00'
For
Adam 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
K243552 - Kali Sacco
assistance/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,
Yen-chih Lin -S Digitally signed by Yen-chih Lin -S Date: 2025.08.06 16:51:02 -04'00'
For
Adam 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
Page 4
Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Submission Number (if known)
K243552
Device Name
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761);
Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Indications for Use (Describe)
The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
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."
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243552
Device Name
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761);
Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
Indications for Use (Describe)
The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
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."
Page 5
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
Page 1 of 4
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 Corporation11 Cabot BoulevardMansfield, MA 02048 |
|---|---|
| Telephone number | (680) 910-4999 |
| Primary Contact | Kali Sacco |
| Date Summary Prepared | August 6, 2025 |
807.92(a) (2) Name of Device
| Trade or Proprietary Name | Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology |
|---|---|
| Common Name | Ventricular Catheters |
| 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 | Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set (K233448) |
|---|
807.92(a) (4) Device Description
The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.
807.92(a) (5) Indications for Use
The Codman® LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
807.92(a) (6) Technological Characteristics Compared to Predicate
The proposed LibertísTM EVD Catheters have the same intended use and functionality as the predicate devices. The proposed changes to the design, materials, and sterility do not raise different questions of safety and/or effectiveness.
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
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 Corporation11 Cabot BoulevardMansfield, MA 02048 |
|---|---|
| Telephone number | (680) 910-4999 |
| Primary Contact | Kali Sacco |
| Date Summary Prepared | August 6, 2025 |
807.92(a) (2) Name of Device
| Trade or Proprietary Name | Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology |
|---|---|
| Common Name | Ventricular Catheters |
| 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 | Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set (K233448) |
|---|
807.92(a) (4) Device Description
The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.
807.92(a) (5) Indications for Use
The Codman® LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.
807.92(a) (6) Technological Characteristics Compared to Predicate
The proposed LibertísTM EVD Catheters have the same intended use and functionality as the predicate devices. The proposed changes to the design, materials, and sterility do not raise different questions of safety and/or effectiveness.
Page 6
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
Page 2 of 4
| Component Affected | Proposed Modification | Rationale |
|---|---|---|
| LibertísTM EVD Catheters | Addition of Endexo additive | A surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The Endexo technology modifies polymeric medical device surfaces to passively reduce the protein – biomaterial interactions which mediate thrombus formation and cellular adhesion. |
| The diameter of the catheter inlet hole on the smaller diameter catheter (821761) is larger than the predicate P/N 821745 and there are fewer inlet holes | To ensure the same performance specifications as the predicate by maintaining the same inlet hole opening surface area. | |
| Additional ventricular catheter markings | Addition of numerical markings and circumferential bands is part of continuous improvement in catheter usability | |
| Different material formulations in the ink markings | A different ink formulation was used to ensure adherence to the catheter. | |
| Catheter Anchoring Clip | Different material formulation | To accommodate the manufacturing processes |
| Increased thickness of the catheter anchoring clip | Continuous improvement for usability | |
| Trocar | Reduced diameter in the bending region | More bendable as part of continuous improvement |
| Reduced barb ridges to 4 compared to 6 on the predicate | Continuous improvement for usability to maintain consistency between the trocars used with each Libertís EVD Catheter (821761 and 821762) | |
| Stylet for 821761 | Decreased cross-section size of the stylet | The decrease in cross-section is required due to the smaller size of the catheter |
| Catheter and Stylet | Sterilization using electron-beam radiation | Radiation (electron beam) sterilization methods were chosen to reduce thermal degradation of the antibiotics. |
| Packaging of Catheter and Stylet | Change the catheter and stylet tray to PETG | PETG was selected for greater compatibility with electron beam sterilization |
| Change the sterile barrier for the proposed catheter and stylet to two sheets of nylon/LDPE (low density polyethylene) rather than Tyvek 1073B and polyester/polyolefin. | To facilitate packaging in a low pressure N2 atmosphere. | |
| Filling the pouch with low pressure N2 | To reduce oxidative degradation of the antibiotics | |
| Labeling | Device and package labels:• New device name• New reference number (SKU)• New description to identify contents of each pouch• Updated symbology for pouch containing Catheter and Stylet | To accurately reflect Libertís EVD Catheter |
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
| Component Affected | Proposed Modification | Rationale |
|---|---|---|
| LibertísTM EVD Catheters | Addition of Endexo additive | A surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The Endexo technology modifies polymeric medical device surfaces to passively reduce the protein – biomaterial interactions which mediate thrombus formation and cellular adhesion. |
| The diameter of the catheter inlet hole on the smaller diameter catheter (821761) is larger than the predicate P/N 821745 and there are fewer inlet holes | To ensure the same performance specifications as the predicate by maintaining the same inlet hole opening surface area. | |
| Additional ventricular catheter markings | Addition of numerical markings and circumferential bands is part of continuous improvement in catheter usability | |
| Different material formulations in the ink markings | A different ink formulation was used to ensure adherence to the catheter. | |
| Catheter Anchoring Clip | Different material formulation | To accommodate the manufacturing processes |
| Increased thickness of the catheter anchoring clip | Continuous improvement for usability | |
| Trocar | Reduced diameter in the bending region | More bendable as part of continuous improvement |
| Reduced barb ridges to 4 compared to 6 on the predicate | Continuous improvement for usability to maintain consistency between the trocars used with each Libertís EVD Catheter (821761 and 821762) | |
| Stylet for 821761 | Decreased cross-section size of the stylet | The decrease in cross-section is required due to the smaller size of the catheter |
| Catheter and Stylet | Sterilization using electron-beam radiation | Radiation (electron beam) sterilization methods were chosen to reduce thermal degradation of the antibiotics. |
| Packaging of Catheter and Stylet | Change the catheter and stylet tray to PETG | PETG was selected for greater compatibility with electron beam sterilization |
| Change the sterile barrier for the proposed catheter and stylet to two sheets of nylon/LDPE (low density polyethylene) rather than Tyvek 1073B and polyester/polyolefin. | To facilitate packaging in a low pressure N2 atmosphere. | |
| Filling the pouch with low pressure N2 | To reduce oxidative degradation of the antibiotics | |
| Labeling | Device and package labels:• New device name• New reference number (SKU)• New description to identify contents of each pouch• Updated symbology for pouch containing Catheter and Stylet | To accurately reflect Libertís EVD Catheter |
Page 7
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
Page 3 of 4
| to identify the sterilization method | |
|---|---|
| Instructions for Use | • Update Description to add information about Endexo and location of catheter marking and inlet holes• Revised How Supplied section to describe the two separate sterilized pouches and contents• Added symbol for sterilization method change |
| Added new sections: Intended Clinical Benefits, Intended User, Intended Patient Population, Disposal | |
| Added statement that the trocar and stylet provided to aid in the placement of the Codman Libertís EVD Catheter are MR-Unsafe |
807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed
The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized FDA recognized consensus standards and internal test methods. All testing was performed on production equivalent devices.
Performance Bench Test Results
| Test | Conclusion |
|---|---|
| Evaluation of Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 | Pass |
| Evaluation of Aged Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 (T = 12 months) | Pass |
| Functional/Mechanical Performance of Codman Libertís EVD Catheters | Pass |
| Functional/Mechanical Performance of Aged Codman Libertís EVD Catheters (T = 12 months) | Pass |
| MRI Compatibility Assessment of Codman Libertís EVD Catheters per ASTM F2503 | Pass |
| Antimicrobial Efficacy of Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use | Pass |
| Antimicrobial Efficacy of Aged Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use (T = 12 months) | Pass |
| Antibiotic Content Testing of Codman Libertís EVD Catheters | Pass |
| Residual Solvents Testing of Codman Libertís EVD Catheters | Pass |
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
| to identify the sterilization method | |
|---|---|
| Instructions for Use | • Update Description to add information about Endexo and location of catheter marking and inlet holes• Revised How Supplied section to describe the two separate sterilized pouches and contents• Added symbol for sterilization method change |
| Added new sections: Intended Clinical Benefits, Intended User, Intended Patient Population, Disposal | |
| Added statement that the trocar and stylet provided to aid in the placement of the Codman Libertís EVD Catheter are MR-Unsafe |
807.92(b) 1-2: Summary of Nonclinical and Clinical Testing Performed
The following performance testing has been conducted in support of the substantial equivalence determination. The testing utilized FDA recognized consensus standards and internal test methods. All testing was performed on production equivalent devices.
Performance Bench Test Results
| Test | Conclusion |
|---|---|
| Evaluation of Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 | Pass |
| Evaluation of Aged Codman Libertís EVD Catheters per ASTM F647 and ISO 7197 (T = 12 months) | Pass |
| Functional/Mechanical Performance of Codman Libertís EVD Catheters | Pass |
| Functional/Mechanical Performance of Aged Codman Libertís EVD Catheters (T = 12 months) | Pass |
| MRI Compatibility Assessment of Codman Libertís EVD Catheters per ASTM F2503 | Pass |
| Antimicrobial Efficacy of Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use | Pass |
| Antimicrobial Efficacy of Aged Codman Libertís EVD Catheters – Zone of Inhibition (ZOI) after 28 Days of Simulated Use (T = 12 months) | Pass |
| Antibiotic Content Testing of Codman Libertís EVD Catheters | Pass |
| Residual Solvents Testing of Codman Libertís EVD Catheters | Pass |
Page 8
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
Page 4 of 4
| Libertís EVD Catheters with Bactiseal® and Endexo® Technology – Summative Usability Study | Pass |
|---|---|
| Product Shelf Life Testing per ASTM F1980 and ISO 11607-1 | Pass |
Biocompatibility Testing Results
| Test | Conclusion |
|---|---|
| Biocompatibility Testing per ISO 10993-1 | Pass |
Sterilization/Cleaning
The proposed device (Codman LibertísTM EVD Catheter and stylet) is sterilized via electron beam radiation. A sterilization validation was performed and determined that the sterility assurance level achieved (SAL = 10-6) is equivalent to the sterility level achieved in the predicate device, which is sterilized via steam. There has been no change to the sterilization method (steam sterilized) or sterility assurance level (SAL = 10-6) for the LibertísTM EVD Catheter accessories (Trocar, Female LUER-LOKTM Connectors, Male LUER-LOK Cap, and Catheter Anchoring Clip) as compared to the predicate device.
Shelf Life
There are no changes in shelf life as a result of the proposed changes. The proposed device, Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology shelf life is 12 months which is the same as the predicate.
Animal Studies
No animal studies were required as appropriate verification and validation testing of the subject device was achieved based on the comparison to the predicate device and from the results of the bench testing.
Clinical Studies
No clinical studies were required as appropriate verification and validation testing of the subject device was achieved based on the comparison to the predicate device and from the results of the bench 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 Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology do not raise different questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set.
Integra LifeSciences-Traditional 510(k)
Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection
| Libertís EVD Catheters with Bactiseal® and Endexo® Technology – Summative Usability Study | Pass |
|---|---|
| Product Shelf Life Testing per ASTM F1980 and ISO 11607-1 | Pass |
Biocompatibility Testing Results
| Test | Conclusion |
|---|---|
| Biocompatibility Testing per ISO 10993-1 | Pass |
Sterilization/Cleaning
The proposed device (Codman LibertísTM EVD Catheter and stylet) is sterilized via electron beam radiation. A sterilization validation was performed and determined that the sterility assurance level achieved (SAL = 10-6) is equivalent to the sterility level achieved in the predicate device, which is sterilized via steam. There has been no change to the sterilization method (steam sterilized) or sterility assurance level (SAL = 10-6) for the LibertísTM EVD Catheter accessories (Trocar, Female LUER-LOKTM Connectors, Male LUER-LOK Cap, and Catheter Anchoring Clip) as compared to the predicate device.
Shelf Life
There are no changes in shelf life as a result of the proposed changes. The proposed device, Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology shelf life is 12 months which is the same as the predicate.
Animal Studies
No animal studies were required as appropriate verification and validation testing of the subject device was achieved based on the comparison to the predicate device and from the results of the bench testing.
Clinical Studies
No clinical studies were required as appropriate verification and validation testing of the subject device was achieved based on the comparison to the predicate device and from the results of the bench 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 Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology do not raise different questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set.
§ 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).