The Bactiseal EVD Catheter and Bactiseal Clear EVD Catheter sets are 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.

Device Description

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set 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. 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. 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 barium sulfate for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

AI/ML Overview

The provided document, K233448, is an FDA 510(k) clearance letter for the Integra LifeSciences Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set. Based on the content of this letter, the device in question is a physical medical device (catheter) and not an AI/software device.

Therefore, the request for information related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics (such as multi-reader multi-case studies, ground truth establishment for training/test sets, sample sizes for image data, and expert adjudication), is not applicable to this document.

The document describes the changes made to an existing device (Bactiseal EVD Catheter Sets) as:

Labeling changes: Updating MRI labeling to state MR Safe and administrative updates/harmonized symbols.
New supplier for clindamycin hydrochloride: The antimicrobial impregnated into the catheter.

The studies mentioned are non-clinical (bench testing and engineering analysis) to demonstrate equivalence to the predicate device despite these changes.

Here's a summary of the relevant "acceptance criteria" and "study that proves the device meets the acceptance criteria" as described in the document for this non-AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance/Conclusion
Drug Equivalency	Drug Equivalency Testing per USP standards and USP Monograph for clindamycin hydrochloride	Pass
Drug Effectiveness	Drug Effectiveness Testing per USP <81> and internal test method	Pass
Sterilization	Sterilization equivalency assessment (comparing predicate to proposed device with new supplier clindamycin hydrochloride)	Deemed acceptable
Shelf Life	Assessment for changes in shelf life due to proposed modifications	No changes
Biocompatibility	Assessment (due to new clindamycin supplier)	No new issues; additional testing not necessary
Overall Equivalence	Comparison to predicate device	Substantially equivalent

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of units tested, but it refers to "production equivalent devices" for performance testing.
Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This pertains to an AI/software device requiring human expert annotation/ground truth. For this catheter, the "ground truth" is adherence to established industry standards (USP) and internal test methods for drug performance and other material characteristics.

4. Adjudication Method for the Test Set:

Not applicable. This pertains to clinical data review for AI/software devices. Testing was based on established laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, not applicable. This type of study is for evaluating observer performance with and without AI assistance for clinical interpretations. The current device is a physical catheter, not an AI diagnostic tool.

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

No, not applicable. This applies to AI/software performance.

7. The Type of Ground Truth Used:

For drug equivalency and effectiveness: USP standards and monograph, internal test methods.
For biocompatibility: Assessment against known materials and established literature/standards.
For physical characteristics: Engineering analysis and comparison to predicate device specifications.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no "training set" or need for ground truth establishment in this context.

Summary

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

December 19, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

Re: K233448

Trade/Device Name: Bactiseal EVD Catheter Sets, Bactiseal Clear EVD Catheter Set Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: October 19, 2023 Received: October 20, 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.

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).

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

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 OS 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).

Sincerely,

Adam D. Digitally signed by Pierce -S Pierce -> 18:01:40 -05'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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

and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

Submission Number (if known)

K233448

Device Name

Bactiseal EVD Catheter Sets;

Bactiseal Clear EVD Catheter Set

Indications for Use (Describe)

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."

{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	(609) 627-9053
Primary Contact	Amanda Erwin
Date Summary Prepared	October 27, 2023
807.92(a) (2) Name of Device
Trade or Proprietary Name	Bactiseal EVD Catheter SetsBactiseal Clear EVD Catheter Set
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 Set: K021653Bactiseal EVD Catheter Set and Bactiseal Clear EVD CatheterSet: K090348

807.92(a) (4) Device Description

807.92(a) (5) Indications for Use

The Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set are 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 Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set 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:an update will be made	The catheter, LUER-LOK connector and cap

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

		to state that the catheter,LUER-LOK connectorand cap and anchoringclip are MR Safe.		and anchoring clip areMR Safe devices andlabeling has beenupdated to reflect thisinformation.
	●	Administrative updatesand updates toharmonized symbolsper ISO 15223-1.		●	Administrative updatesand compliance withthe latest standard.
Bactiseal Catheter SiliconeTubing	●	Integra is proposing anew supplier forclindamycinhydrochloride. Theclindamycinhydrochloride isimpregnated into theBactiseal CatheterSilicone Tubing.	●	Integra has made thedecision to change thesupplier for theclindamycinhydrochloride. Testinghas been executed toconfirm that theclindamycinhydrochloride from thenew supplier isconsidered equivalentto the clindamycinhydrochloride from thecurrent source based onmaterial specificationand drug efficacyrequirements. Thistesting verified that thenew source does notraise any questions ofsafety and effectivenessand supports that thenew source isequivalent to theclindamycinhydrochloride used inthe predicate devices asit has the samecharacterizations basedon identity,formulation,concentration of theantimicrobial agent,method of applicationto the device,mechanism of drugrelease and continues tomeet the same drugspecifications. A

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

		Assessment wasperformed whichdetermined that theintroduction of the newsupplier forclindamycinhydrochloride does notintroduce any newissues related tobiocompatibility andadditional testing wouldnot 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. All testing was performed on production equivalent devices.

Performance Bench Test Results
Test	Conclusion
Drug Equivalency Testing per USP standards and USPMonograph for clindamycin hydrochloride	Pass
Drug Effectiveness Testing per USP <81> and internaltest method.	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.

Clinical Studies

No clinical studies were required as appropriate verification of the subject device 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 EVD Catheter Sets and Bactiseal Clear EVD Catheter Set do not raise any new questions of safety and effectiveness, and is therefore, substantially equivalent to the predicate Bactiseal EVD Catheter Sets and Bactiseal Clear EVD Catheter Set.

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).