Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set

K233448 · Integra Lifesciences Production Corporation · JXG · Dec 19, 2023 · Neurology

Device Facts

• Record ID: K233448
• Device Name: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
• Applicant: Integra Lifesciences Production Corporation
• Product Code: JXG · Neurology
• Decision Date: Dec 19, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Ventricular catheter system; silicone tubing impregnated with rifampicin and clindamycin hydrochloride to reduce gram-positive bacterial colonization. Catheter placed in brain ventricles; CSF enters through inlet holes; drains into external drainage system. Includes barium sulfate for radiopacity; numerical depth markings; circumferential bands. Used in clinical settings (e.g., neurosurgery/ICU) by physicians to manage intracranial pressure. Output is physical drainage of CSF; enables pressure reduction and volume control. Modifications include updated MR Safe labeling and new supplier for clindamycin hydrochloride.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including drug equivalency per USP standards and drug effectiveness testing per USP <81> and internal methods.

Technological Characteristics

Silicone tubing impregnated with rifampicin and clindamycin hydrochloride; barium sulfate for radiopacity; ink-based depth markings/bands. MR Safe components (catheter, LUER-LOK connector, cap, anchoring clip). Sterilization process unchanged. Compliance with ISO 15223-1 for symbols.

Indications for Use

Indicated for patients requiring access to brain ventricles for CSF drainage to reduce intracranial pressure and CSF volume.

Regulatory Classification

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.

Predicate Devices

• Bactiseal EVD Catheter Set (K021653)
• Bactiseal EVD Catheter Set and Bactiseal Clear EVD Catheter Set (K090348)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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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)

K233448

Device Name

Bactiseal EVD Catheter Sets;

Bactiseal Clear EVD Catheter Set

Indications for Use (Describe)

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.

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 Corporation<br>11 Cabot Boulevard<br>Mansfield, MA 02048 |
| Telephone number | [phone] |
| Primary Contact | Amanda Erwin |
| Date Summary Prepared | October 27, 2023 |
| 807.92(a) (2) Name of Device | |
| Trade or Proprietary Name | Bactiseal EVD Catheter Sets<br>Bactiseal Clear EVD Catheter Set |
| Common Name | Ventricular Catheters |
| Classification Name | Central Nervous System Fluid Shunt and Components<br>(21 CFR 882.5550) |
| Device Class | II |
| Product Code | JXG |
| 807.92(a) (3) Predicate Information | |
| Predicate Device | Bactiseal EVD Catheter Set: K021653<br>Bactiseal EVD Catheter Set and Bactiseal Clear EVD Catheter<br>Set: K090348 |

#### 807.92(a) (4) 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.

#### 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:<br>an update will be made | The catheter, LUER-LOK connector and cap |

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| | | to state that the catheter,<br>LUER-LOK connector<br>and cap and anchoring<br>clip are MR Safe. | | and anchoring clip are<br>MR Safe devices and<br>labeling has been<br>updated to reflect this<br>information. | |
|---------------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | ● | Administrative updates<br>and updates to<br>harmonized symbols<br>per ISO 15223-1. | | ● | Administrative updates<br>and compliance with<br>the latest standard. |
| Bactiseal Catheter Silicone<br>Tubing | ● | Integra is proposing a<br>new supplier for<br>clindamycin<br>hydrochloride. The<br>clindamycin<br>hydrochloride is<br>impregnated into the<br>Bactiseal Catheter<br>Silicone Tubing. | ● | Integra has made the<br>decision to change the<br>supplier for the<br>clindamycin<br>hydrochloride. Testing<br>has been executed to<br>confirm that the<br>clindamycin<br>hydrochloride from the<br>new supplier is<br>considered equivalent<br>to the clindamycin<br>hydrochloride from the<br>current source based on<br>material specification<br>and drug efficacy<br>requirements. This<br>testing verified that the<br>new source does not<br>raise any questions of<br>safety and effectiveness<br>and supports that the<br>new source is<br>equivalent to the<br>clindamycin<br>hydrochloride used in<br>the predicate devices as<br>it has the same<br>characterizations based<br>on identity,<br>formulation,<br>concentration of the<br>antimicrobial agent,<br>method of application<br>to the device,<br>mechanism of drug<br>release and continues to<br>meet the same drug<br>specifications. A | |

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| | | Assessment was<br>performed which<br>determined that the<br>introduction of the new<br>supplier for<br>clindamycin<br>hydrochloride does not<br>introduce any new<br>issues related to<br>biocompatibility and<br>additional testing would<br>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. All testing was performed on production equivalent devices.

| Performance Bench Test Results | |
|-----------------------------------------------------------------------------------------------|------------|
| Test | Conclusion |
| Drug Equivalency Testing per USP standards and USP<br>Monograph for clindamycin hydrochloride | Pass |
| Drug Effectiveness Testing per USP <81> and internal<br>test 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.