(90 days)
Not Found
No
The device description and performance studies focus on the physical properties, antimicrobial treatment, and radiopacity of the catheters, with no mention of AI or ML.
Yes
The device is used in the treatment of hydrocephalus to drain cerebrospinal fluid (CSF), directly addressing a medical condition.
No
The device is a component of a shunt system used to treat hydrocephalus by draining cerebrospinal fluid, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components made of silicone, barium sulfate, and tantalum, which are implanted in the patient. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat hydrocephalus by draining cerebrospinal fluid (CSF) as part of a shunt system. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical catheter designed to be implanted in the body to divert fluid. It contains antimicrobials and radiopaque materials to aid in its function and placement within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a therapeutic device for fluid management within the body.
The performance studies mentioned (MRI safety, drug equivalency, drug effectiveness) are relevant to the safety and function of an implanted medical device, not to the performance of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JXG, HCA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, peritoneal cavity
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)
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: MRI Safety Testing per ASTM F2052, ASTM F2213, ASTM F2182 and ASTM FF2119. Conclusion: Pass.
Test: Drug Equivalency Testing per USP standards and USP Monograph for Clindamycin Hydrochloride. Conclusion: Pass.
Test: Drug Effectiveness Testing per USP and internal test methods. 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.
Bactiseal Catheters: K172022, Bactiseal Barium Striped Catheters: K031123, Bactiseal Endoscopic Ventricular Catheter: K110751
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
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.
1
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,
2
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
3
Indications for Use
Submission Number (if known)
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 Corporation |
| 11 Cabot Boulevard | |
| Mansfield, 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 Catheters |
| Bactiseal Barium Striped Catheters | |
| Bactiseal Endoscopic Ventricular Catheter | |
| Common Name | Hydrocephalus Shunt System |
| Hydrocephalus 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: K172022 |
| Bactiseal Barium Striped Catheters: K031123 | |
| Bactiseal Endoscopic Ventricular Catheter: K110751 |
807.92(a) (4) 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.
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.
5
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 Endoscopic | ||
| Ventricular Catheter: Updated | ||
| MR labeling from MR Safe to | ||
| MR Conditional | Bactiseal Endoscopic | |
| Ventricular Catheter: | ||
| the labeling is being | ||
| updated for consistency | ||
| with other Bactiseal | ||
| catheters that contain | ||
| tantalum. | ||
| Bactiseal Barium Striped | ||
| Catheters: MR Conditional | ||
| labeling claim added and | ||
| clarification that this claim only | ||
| applies to the catheters and right | ||
| angle adapter | Bactiseal Barium | |
| Striped Catheters: The | ||
| labeling is being | ||
| updated for consistency | ||
| with other Bactiseal | ||
| catheters that contain | ||
| tantalum. | ||
| The catheters are | ||
| packaged with | ||
| accessories, including a | ||
| stylet. Since the stylet is | ||
| only used during the | ||
| catheter implant | ||
| 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. | ||
| Bactiseal Catheters: Updated | ||
| MR labeling to clarify that only | ||
| the catheters and right angle | ||
| adapter are MR Conditional | Bactiseal Catheters: | |
| The catheters are | ||
| packaged with | ||
| accessories, including a | ||
| stylet. Since the stylet is | ||
| only used during the | ||
| catheter 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 |
6
7
| 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 USP | |
| Monograph for Clindamycin Hydrochloride | Pass |
| Drug Effectiveness Testing per USP and internal | |
| test 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.
8
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.