(160 days)
No
The device description and performance studies focus on the material properties, drug release, physical dimensions, and compatibility with existing shunt systems. There is no mention of any computational analysis, data processing, or learning algorithms.
Yes
The device is impregnated with clindamycin hydrochloride and rifampicin, designed to be released over time, which has a therapeutic effect.
No
This device is described as a catheter used for cerebrospinal fluid shunting, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components made of barium sulfate fillcone elastomer, stainless steel, and potentially a deflector, which are implanted into the body. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cerebrospinal fluid (CSF) shunting." This is a surgical procedure performed in vivo (within the body) to drain excess CSF.
- Device Description: The device is a catheter designed to be implanted in the body. It is made of materials suitable for implantation and is impregnated with drugs for release within the body.
- Anatomical Site: The anatomical site is "cerebrospinal fluid (CSF)," which is within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
This device is clearly designed for implantation and use within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.
The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.
Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.
The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.
The XABO Catheters are designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System. Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
A toxicological risk assessment evaluated the risk of chronic toxicity, and developmental and reproductive toxicity to patients associated with exposure to the extractable compounds to adult, pediatric an dneonatal patients.
Intended User / Care Setting
Prescription Use
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 testing:
Testing was conducted in accordance with ISO 7197 (2006). Testing results confirm that the XABO Catheters meet performance specifications.
Zone of Inhibition, Drug Content, Drug Release Kinetic and Crush Resistance Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics.
MRI Safety Testing according to ASTM F2213, ASTM F2182 and ASTM FF2119 demonstrated that the deflector is MR Conditional in 3-Tesla Magnetic Resonance Imaging systems per ASTM F2503.
All testing was performed on the worst-case final finished device.
Biocompatibility testing:
A biocompatibility evaluation was condance with ISO 1099-1 and "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. Biocompatibility testing included Cytotoxicity, Sensitization/Reactivity, Genotoxicity, Implantation, Acute Systemic Toxicity, Sub- Chronic, Hemolysis, and Pyrogenicity. Chronic systemic toxicity and carcinogenicity endpoints have been addressed by a chemical characterization (extractable and leachable studies).
A toxicological risk assessment evaluated the risk of chronic toxicity, and developmental and reproductive toxicity to patients associated with exposure to the extractable compounds to adult, pediatric an dneonatal patients.
The XABO Catheters and deflector are considered an implant device of permanent duration (>30 days). While the stylet is classified as indirect contact in the area of tissue/bone intended for less than 1 hour duration.
Conclusion:
Results of all testing confirm that the XABO Catheters as a component of a scepticism criteria for the specified shelf life, conform to applicable standard ISO 7179, and are equivalent in function to the predicate device, the Medtronic ARES Antibiotic-Impregnated Catheters.
Results of the conducted comparative performance testing confirm that the performance characteristics for both devices, the XABO Catheters and Medtronic ARES Antibiotic-Impregnated Catheters, are substantial equivalent.
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.
K192266/K190174/K161853/K141687/K110206/K030698/K011030
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 16, 2024
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 ADMINISTRATION" in blue text.
Aesculap Inc. Kathy Racosky Technical Manager II 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K242003
Trade/Device Name: XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO 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: November 15, 2024 Received: November 15, 2024
Dear Kathy Racosky:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 10:37:07 -05'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, 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
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
Indications for Use (Describe)
The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.
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) #: K242003 | 510(k) Summary | Prepared on: 2024-11-15 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Aesculap Inc. | |
| Applicant Address | 3773 Corporate Parkway Center Valley PA 18034 United States | |
| Applicant Contact Telephone | 610-984-7402 | |
| Applicant Contact | Kathy Racosky | |
| Applicant Contact Email | kathy.racosky@bbraunusa.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter | |
| Set | ||
| Common Name | Central nervous system fluid shunt and components | |
| Classification Name | Shunt, Central Nervous System And Components | |
| Regulation Number | 882.5550 | |
| Product Code(s) | JXG | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K110560 | Medtronic ARES Antibiotic- Impregnated Catheters | JXG |
| K011030/K020728/ K | Aesculap Miethke Shunt System | JXG |
| Device Description Summary | 21 CFR 807.92(a)(4) |
5
The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.
The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.
Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.
The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.
The XABO Catheters are designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System. Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).
Intended Use/Indications for Use
The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.
Indications for Use Comparison
The indications for use is the same as the reference device.
Technological Comparison
As established in this submission, the XABO Catheters are antibiotic-impregnated catheters offered in similar dimensions, lengths, marker lengths and tip configurations that are substantially equivalent to the predicate and reference device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, function, principles of operation, intended use, material composition, and range of sizes.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
Performance bench testing:
Testing was conducted in accordance with ISO 7197 (2006). Testing results confirm that the XABO Catheters meet performance specifications.
Zone of Inhibition, Druq Content, Druq Release Kinetic and Crush Resistance Comparison testing of the XABO Catheters and the predicate device show that they have the same characteristics.
MRI Safety Testing according to ASTM F2213, ASTM F2182 and ASTM FF2119 demonstrated that the deflector is MR Conditional in 3-Tesla Magnetic Resonance Imaging systems per ASTM F2503.
All testing was performed on the worst-case final finished device.
Biocompatibility testing:
A biocompatibility evaluation was condance with ISO 1099-1 and "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. Biocompatibility testing included Cytotoxicity, Sensitization/Reactivity, Genotoxicity, Implantation, Acute Systemic Toxicity, Sub- Chronic, Hemolysis, and Pyrogenicity. Chronic systemic toxicity and carcinogenicity endpoints have been addressed by a chemical characterization (extractable and leachable studies).
A toxicological risk assessment evaluated the risk of chronic toxicity, and developmental and reproductive toxicity to patients associated with exposure to the extractable compounds to adult, pediatric an dneonatal patients.
The XABO Catheters and deflector are considered an implant device of permanent duration (>30 days). While the stylet is classified as indirect contact in the area of tissue/bone intended for less than 1 hour duration.
Conclusion:
Results of all testing confirm that the XABO Catheters as a component of a sceptance criteria for the specified shelf life, conform to applicable standard ISO 7179, and are equivalent in function to the predicate device, the Medtronic ARES Antibiotic-Impregnated Catheters.
Results of the conducted comparative performance testing confirm that the performance characteristics for both devices, the XABO Catheters and Medtronic ARES Antibiotic-Impregnated Catheters, are substantial equivalent.