The Bactiseal Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

Device Description

The Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter include a ventricular and/or distal (peritoneal) drainage catheter that are used as part of a CSF shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system, which is then implanted in the patient's brain. The ventricular catheter diverts the excessive CSF from the ventricles of the brain through the valve. After passing through the valve, the excessive CSF is drained through the distal (peritoneal) drainage catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Bactiseal silicone catheters have been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have tantalum "dots" incorporated onto the silicone tubing to aid in positioning of the catheter. The Bactiseal Catheters and Bactiseal Endoscopic Ventricular Catheter are made of radiopaque silicone tubing, and the Bactiseal Barium Striped Catheters are made of clear silicone tubing with radiopaque striping. The Bactiseal Endoscopic Ventricular Catheter has a slit in the tip of the ventricular catheter in order for the catheter to be placed with the use of an endoscope.

AI/ML Overview

This document is a 510(k) summary for modifications made to existing Bactiseal Catheters, Bactiseal Barium Striped Catheters, and Bactiseal Endoscopic Ventricular Catheters. The modifications primarily involve updates to MRI labeling and a change in the supplier of clindamycin hydrochloride.

Therefore, the submission focuses on demonstrating that these modifications do not introduce new questions of safety or effectiveness, rather than proving the initial efficacy of an entirely new device. This means that a conventional study with specific acceptance criteria, test sets, expert adjudication, and detailed ground truth establishment as typically seen for entirely new AI/CADe devices, is not applicable in this context. The document relies on bench testing and an equivalency assessment to the predicate devices.

Here's a breakdown of the requested information based on the provided text, with significant portions noted as "Not applicable" due to the nature of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
MRI Safety Testing (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119)	Device meets established MRI safety standards for MR Conditional.	Pass
Drug Equivalency Testing (USP standards, USP Monograph for Clindamycin Hydrochloride)	Clindamycin hydrochloride from new supplier is equivalent to current supplier in identity, formulation, concentration, application method, and drug release.	Pass
Drug Effectiveness Testing (USP<81> and internal test methods)	Device continues to demonstrate the intended antimicrobial effectiveness.	Pass
Sterilization Equivalency Assessment	Sterilization process remains effective with the new clindamycin hydrochloride supplier.	Acceptable
Biocompatibility Assessment	New clindamycin hydrochloride supplier does not introduce new biocompatibility issues.	Determined no new issues

Explanation of Implied Acceptance Criteria: The document states that the testing "utilized well-established methods, including those from FDA consensus standards." For a "Pass" result in such tests, the device must meet the specific criteria outlined in those standards. For drug equivalency and effectiveness, the stated goal is to confirm the new supplier's clindamycin hydrochloride is "equivalent" and "continues to meet the same drug specifications" and efficacy. The biocompatibility assessment "determined that the introduction of the new supplier for clindamycin hydrochloride does not introduce any new issues."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document indicates "All testing was performed on production equivalent devices," but the number of devices or units tested for each benchmark is not provided.
Data Provenance: Not applicable in the context of clinical data. The tests are benchtop performance tests. The specific labs or countries where these bench tests were conducted are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring expert-established ground truth.

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

Not applicable. This submission concerns bench testing and equivalency assessment of device modifications, not clinical performance requiring adjudication.

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

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

Not applicable in the conventional sense. The "ground truth" for the bench tests would be the established scientific and engineering principles, and the specifications of the predicate device/original drug, against which the modified device's performance is compared. For example, the ground truth for MRI safety is defined by the ASTM standards.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device, and no training set is mentioned or implied for its development or evaluation.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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January 17, 2024

Image /page/0/Picture/1 description: The image contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name is "U.S. Food & Drug Administration".

Integra LifeSciences Production Corporation Jocelyn Raposo Director, Regulatory Affairs 11 Cabot Boulevard Mansfield, Massachusetts 02048

Re: K233445

Trade/Device Name: Bactiseal Catheters Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG, HCA Dated: October 19, 2023 Received: October 19, 2023

Dear Jocelyn Raposo:

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.

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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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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.

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-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).

Sincerelv.

Adam D. Digitally signed by Digitally signed by Date: 2024.01.17 Pierce -S 16:07:40 -05'00'

Adam D. Pierce. Ph.D. Assistant Director DHT5A: Division of Neurosurgical,

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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

Submission Number (if known)

K233445

Device Name

Bactiseal Catheters;

Bactiseal Barium Striped Catheters;

Bactiseal Endoscopic Ventricular Catheter

Indications for Use (Describe)

The Bactiseal Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid (CSF) is indicated.

The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

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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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	(609) 627-9053
Primary Contact	Amanda Erwin
Date Summary Prepared	January 2, 2024
807.92(a) (2) Name of Device
Trade or Proprietary Name	Bactiseal CathetersBactiseal Barium Striped CathetersBactiseal Endoscopic Ventricular Catheter
Common Name	Hydrocephalus Shunt SystemHydrocephalus Catheters
Classification Name	Central Nervous System Fluid Shunt and Components(21 CFR 882.5550)Ventricular Catheter(21 CFR 882.4100)
Device Class	II
Product Code	JXG, HCA
807.92(a) (3) Predicate Information
Predicate Device	Bactiseal Catheters: K172022Bactiseal Barium Striped Catheters: K031123Bactiseal Endoscopic Ventricular Catheter: K110751

807.92(a) (4) Device Description

807.92(a) (5) Indications for Use

The Bactiseal Catheters and Bactiseal Barium Striped Catheters are indicated for use in the treatment of hydrocephalus as a component of a shunt system when draining of cerebrospinal fluid is indicated.

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The Bactiseal Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.

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

The proposed Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter have the same intended use, design, materials, sterility, and fundamental operation as the predicate devices. The proposed changes to labeling and the supplier of the clindamycin hydrochloride do not impact the technological characteristics of the devices. The changes do not raise any new questions of safety and/or effectiveness.

Component Affected	Proposed Modification	Rationale
Labeling	MRI labeling changes:	MRI labeling changes:
	Bactiseal EndoscopicVentricular Catheter: UpdatedMR labeling from MR Safe toMR Conditional	Bactiseal EndoscopicVentricular Catheter:the labeling is beingupdated for consistencywith other Bactisealcatheters that containtantalum.
	Bactiseal Barium StripedCatheters: MR Conditionallabeling claim added andclarification that this claim onlyapplies to the catheters and rightangle adapter	Bactiseal BariumStriped Catheters: Thelabeling is beingupdated for consistencywith other Bactisealcatheters that containtantalum.
		The catheters arepackaged withaccessories, including astylet. Since the stylet isonly used during thecatheter implantprocedure, it is notintended to go into anMR environment.Therefore, the labelingwill clarify that only thecatheter and right angleadapter are MRConditional.
	Bactiseal Catheters: UpdatedMR labeling to clarify that onlythe catheters and right angleadapter are MR Conditional	Bactiseal Catheters:The catheters arepackaged withaccessories, including astylet. Since the stylet isonly used during thecatheter implant

	Inclusion of a Patient Implant Card and a Patient Information Leaflet	procedure, it is not intended to go into an MR environment. Therefore, the labeling will clarify that only the catheter and right angle adapter are MR Conditional. A Patient Implant Card is required per FDA's current guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment , issued on October 10, 2023. The patient information leaflet is provided as it includes information essential for understanding the information included on the patient implant card and additional information on the device itself that cannot be provided directly on the patient implant card due to space availability.
	Made administrative updates and updates to harmonized symbols per ISO 15223-1.	Administrative updates and compliance with the latest standard.
Bactiseal Catheter Silicone Tubing	Integra is proposing a new supplier for clindamycin hydrochloride. The clindamycin hydrochloride is impregnated into the Bactiseal catheter silicone tubing.	Integra has made the decision to change the supplier for the clindamycin hydrochloride. Testing has been executed to confirm that the clindamycin hydrochloride from the new supplier is considered equivalent to the clindamycin hydrochloride from the current supplier based on material specification and drug efficacy. This testing

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verified that the new source

does not raise any questions of
safety and effectiveness and
supports that the new source is
equivalent to the clindamycin
hydrochloride used in the
predicate devices as it has the
same characterizations based on
identity, formulation,
concentration of the
antimicrobial agent, method of
application to the device,
mechanism of drug release and
continues to meet the same drug
specifications. A
Biocompatibility Assessment
was performed which
determined that the introduction
of the new supplier for
clindamycin hydrochloride does
not introduce any new issues
related to biocompatibility and
additional testing would not be
necessary.

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 well-established methods, including those from FDA consensus standards. All testing was performed on production equivalent devices.

Performance Bench Test Results
Test	Conclusion
MRI Safety Testing per ASTM F2052, ASTM F2213,ASTM F2182 and ASTM FF2119	Pass
Drug Equivalency Testing per USP standards and USPMonograph for Clindamycin Hydrochloride	Pass
Drug Effectiveness Testing per USP<81> and internaltest methods.	Pass

Sterilization/Cleaning

There are no changes in sterility as a result of the proposed changes. A sterilization equivalency assessment was performed comparing the predicate devices to the proposed device, using clindamycin hydrochloride from the new supplier, and the results were deemed acceptable.

Shelf Life

There are no changes in shelf life as a result of the proposed changes.

Animal Studies

No animal studies were required as appropriate verification of the subject devices was achieved based on the comparison to the predicate devices and from the results of the bench testing and engineering analysis.

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Clinical Studies

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

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 Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Bactiseal Catheters, Bactiseal Barium Striped Catheters and Bactiseal Endoscopic Ventricular Catheter.

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).