(60 days)
Not Found
No
The device description focuses on the physical components, antimicrobial treatment, and function of a catheter for draining cerebrospinal fluid. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to reduce intracranial pressure and CSF volume, which are therapeutic interventions. Additionally, the catheter is impregnated with antimicrobials to reduce bacterial colonization, further supporting its therapeutic function.
No
The device is described as a catheter used for draining cerebrospinal fluid to reduce intracranial pressure and CSF volume, not for diagnosing conditions.
No
The device description clearly indicates it is a physical catheter and associated accessories, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to gain access to the ventricles of the brain for draining cerebrospinal fluid (CSF) and other fluids to reduce intracranial pressure and CSF volume. This is a therapeutic and diagnostic procedure performed directly on the patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The device is a catheter designed for insertion into the brain. While it interacts with CSF, it's for drainage and pressure management, not for analyzing the CSF itself to diagnose a condition. The mention of antimicrobial properties is related to preventing infection during the procedure, not for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on the properties of the fluid. The focus is on the physical act of draining fluid.
In summary, the Bactiseal EVD Catheter is a medical device used for a surgical/therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Test Results
Test: Drug Equivalency Testing per USP standards and USP Monograph for clindamycin hydrochloride; Conclusion: Pass
Test: Drug Effectiveness Testing per USP and internal test method.; Conclusion: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
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)
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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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 Corporation |
| 11 Cabot Boulevard | |
| Mansfield, 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 Sets |
| Bactiseal 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: K021653 |
| Bactiseal EVD Catheter Set and Bactiseal Clear EVD Catheter | |
| 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: | |
| an update will be made | The catheter, LUER-LOK connector and cap |
5
| | | to state that the catheter,
LUER-LOK connector
and cap and anchoring
clip are MR Safe. | | and anchoring clip are
MR Safe devices and
labeling has been
updated to reflect this
information. | |
|---------------------------------------|---|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | ● | 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 source based on
material specification
and drug efficacy
requirements. This
testing 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 | |
6
| | | 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. All testing was performed on production equivalent devices.
| Performance Bench Test Results | |
|---|---|
| Test | Conclusion |
| Drug Equivalency Testing per USP standards and USP | |
| Monograph for clindamycin hydrochloride | Pass |
| Drug Effectiveness Testing per USP and internal | |
| 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.