(263 days)
The Medtronic ARES™ Antibiotic-Impregnated Catheters are intended 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 Medtronic ARES™ Antibiotic-Impregnated Catheters are manufactured using barium sulfate-filled silicone elastomer and are impregnated with clindamycin hydrochloride and rifampicin.
ARES Antibiotic-Impregnated Ventricular Catheter
The ARES ventricular catheter measures 23 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. Lengths are marked in 1 cm intervals starting from 3 cm to 15 cm from the catheter tip, thus enabling the surgeon to gauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 32 flow holes—four lines of eight holes spaced at 90° intervals around the catheter circumference. Components supplied with the ARES Ventricular Catheter include a pre-loaded stainless steel stylet and a Right Angle Clip, which is included to facilitate placement and use of the ventricular catheter.
ARES Antibiotic-Impregnated Peritoneal Catheter
The ARES peritoneal catheter measures 120 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. There are no length markers or wall slits on the catheter, and the tip is open ended. The catheter may be trimmed to the proper length.
This 510(k) summary describes the Medtronic ARES™ Antibiotic-Impregnated Catheters and their substantial equivalence to the BACTISEAL® Catheter. The submission primarily relies on non-clinical performance and biocompatibility data, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements pertaining to clinical studies, AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (ARES™) |
|---|---|---|
| Performance Testing | Meet requirements outlined in ISO 7197: Neurosurgical implants - Sterile, single use hydrocephalus shunts and components and ASTM 647-94 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | Successfully tested to meet the applicable requirements outlined in ISO 7197 and ASTM 647-94. Additionally, non-clinical tests were conducted for specific characteristics. |
| Sterilization Testing | Sterility assurance level (SAL) of 10-6 according to ISO 17665: Sterilization of health care products - Moist heat. | Validated using the Half Cycle method as outlined in ISO 17665 to a sterility assurance level (SAL) of 10-6. |
| Pyrogen Testing | Conform to FDA standards concerning pyrogen levels for devices in contact with cerebrospinal fluid, meeting a 2.15 EU/device specification. | Meets a 2.15 EU/device specification utilizing the Kinetic-Chromogenic LAL method. |
| Biocompatibility Testing (General) | Considered an implant device with tissue/bone contact and permanent contact duration of greater than 30 days, tested in accordance with ISO 10993-1:2009 and FDA Blue Book Memo, G95-1. | A series of tests were conducted to demonstrate biocompatibility with the following specific results: |
| Cytotoxicity | No biological reactivity. | No biological reactivity (Grade 0) observed at 48 hours post exposure to the test article extract. (Conclusion: Non-cytotoxic) |
| Sensitization | No reaction at challenge following induction phase. | Extracts elicited no reaction at the challenge (0% sensitization), following an induction phase. (Conclusion: Non-sensitizing) |
| Intracutaneous Irritation/Reactivity | Test article extract sites not significantly greater biological reaction than control. | Test article extract sites did not show a significantly greater biological reaction than the sites injected with the control article extract. (Conclusion: Non-irritant) |
| Acute Systemic Toxicity | Test article extracts not significantly greater biological reaction than control. | Test article extracts did not induce a significantly greater biological reaction than the control extracts. (Conclusion: Non-toxic (acute)) |
| Bacterial Reverse Mutation Study (Non-antibiotic impregnated catheter) | Non-mutagenic. | DMSO and saline test article extracts were considered to be non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 and to Escherichia coli tester strain WP2uvrA. (Conclusion: Non-genotoxic) |
| Bacterial Reverse Mutation Assay (Mock-impregnated catheter) | Non-mutagenic. | DMSO and saline test article extracts were considered to be non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 and to Escherichia coli tester strain WP2uvrA. (Conclusion: Non-genotoxic) |
| In Vitro Mouse Lymphoma Assay | Mutant frequencies and cloning efficiencies within limits for negative response. | Mutant frequencies and cloning efficiencies of preparations treated with test article were within the limits defined for a negative response. (Conclusion: Non-genotoxic) |
| Mouse Peripheral Blood Micronucleus Study | No induction of micronuclei. | The test article extracts did not induce micronuclei in mice. (Conclusion: Non-genotoxic) |
| Implantation - 13 week brain and subcutaneous implant & Sub-Chronic / Chronic Toxicity | No systemic signs of toxicity and no local adverse event. | The test article does not appear to demonstrate any systemic signs of toxicity when implanted in the brain and subcutaneous tissue of New Zealand White rabbits for a period of 13 weeks. (Conclusion: No local adverse event, Non-toxic (sub-chronic)) |
| Comparative Performance (Predicate Device) | ||
| Drug release kinetics | Demonstration that antibiotics release kinetics over a 38-day period is the same for ARES and BACTISEAL. | Antibiotic release kinetics measured over a 38-day period demonstrated the same as BACTISEAL antibiotic release rates. |
| Zone of Inhibition Testing | Demonstration of antimicrobial activity for at least 31 days with statistically equivalent zones of inhibition for ARES and BACTISEAL. | Antimicrobial activity demonstrated for at least 31 days. Measured ZOIs statistically equivalent to those of BACTISEAL. |
| Catheter Crush Resistance | ARES catheter mean value must not be significantly lower than control group (BACTISEAL) mean using a two-sample t-test at 95% confidence. | Pass |
| Drug Content | Clindamycin: 0.150 ± 45%; Rifampicin: 0.054 ± 60%. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily details non-clinical (bench and in-vitro/in-vivo animal) tests. Therefore, the concept of a "test set" in the context of clinical data or AI performance (which would typically involve patient cases) is not directly applicable.
- Bench tests: No specific sample sizes are provided within the summary for tests like performance testing or sterilization testing, although these would involve multiple units for validation.
- Biocompatibility tests: Sample sizes are implicit in the descriptions of animal studies (e.g., "All animals increased in weight" implies multiple animals were used, but specific numbers are not given for each test). The studies used Salmonella typhimurium and Escherichia coli tester strains, mice, and New Zealand White rabbits.
- Data Provenance: The data originates from internal testing conducted by Medtronic as part of their 510(k) submission. It's prospective in the sense that these tests were conducted specifically to support this submission. The origin is implied to be within controlled laboratory settings, likely in the US, given the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This submission relies on objective, measurable physical, chemical, and biological endpoints from non-clinical tests (bench, in-vitro, and in-vivo animal studies) rather than human expert interpretation of clinical data or images. Therefore, no experts were used to establish "ground truth" in the clinical AI sense.
4. Adjudication Method for the Test Set
Not Applicable. Since no human expert evaluation or clinical data interpretation was involved for establishing a "ground truth" or test set, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This submission is for a physical medical device (antibiotic-impregnated catheter) and does not involve AI algorithms or human reading of medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This submission is for a physical medical device and does not involve an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" or reference standards used are established scientific and regulatory standards and validated test methodologies. These include:
- Engineering Standards: ISO 7197, ASTM 647-94 for performance.
- Sterilization Standards: ISO 17665.
- Pyrogen Standards: ANSI/AAMI/ST72.
- Biocompatibility Standards: ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and FDA Blue Book Memo, G95-1.
- Quantitative Measurements: Drug release kinetics (mg/day), Zone of Inhibition (mm), Drug content (weight %), mechanical strength (crush resistance).
- Biological Endpoints: Cytotoxicity (cellular response), Sensitization (immune response), Irritation (tissue reaction), Systemic Toxicity (organism-wide effects), Genotoxicity (DNA damage), Implantation responses (local tissue reaction in vivo).
Comparisons were also made directly against the predicate device (BACTISEAL® Catheter) for key performance characteristics to demonstrate "sameness."
8. The Sample Size for the Training Set
Not Applicable. This submission is for a physical medical device and does not involve AI algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI algorithm, there is no training set or ground truth for one.
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510(k) SUMMARY Medtronic ARES™ Antibiotic Impregnated Catheters K110560
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Name | Medtronic Neurosurgery |
| Address | 125 Cremona DriveGoleta, CA 93117-5503USA |
| Phone number | 805-571-8400 |
| Fax number | 805-571-8480 |
| EstablishmentRegistration Number | 2021898 |
| Name of contactperson | Jeffrey Henderson |
| Date prepared | November 17, 2011 |
| Name of device | |
| Trade or proprietaryname | Medtronic ARES™ Antibiotic-Impregnated Catheter |
| Common or usualname | Hydrocephalus Catheter |
| Classification name | Shunt, Central Nervous System and Components |
| Classification | Class II |
| Panel | Neurological |
| Regulation | 21 CFR §882.5550 |
| Product Code(s) | JXG |
| Legally marketed device(s)to which equivalence isclaimed | Johnson & Johnson (Codman & Shurtleff)BACTISEAL® Catheter (K003322) |
| Reason for 510(k)submission | New device |
| Device description | The Medtronic ARES™ Antibiotic-Impregnated Catheters aremanufactured using barium sulfate-filled silicone elastomerand are impregnated with clindamycin hydrochloride andrifampicin.ARES Antibiotic-Impregnated Ventricular CatheterThe ARES ventricular catheter measures 23 cm in length,0.13 cm in inner diameter, and 0.25 cm in outer diameter.Lengths are marked in 1 cm intervals starting from 3 cm to 15cm from the catheter tip, thus enabling the surgeon to gaugethe depth of penetration of the catheter into the lateralventricle. The proximal end of the catheter has 32 flowholes—four lines of eight holes spaced at 90° intervals |
| around the catheter circumference. Components suppliedwith the ARES Ventricular Catheter include a pre-loadedstainless steel stylet and a Right Angle Clip, which is includedto facilitate placement and use of the ventricular catheter.ARES Antibiotic-Impregnated Peritoneal CatheterThe ARES peritoneal catheter measures 120 cm in length,0.13 cm in inner diameter, and 0.25 cm in outer diameter.There are no length markers or wall slits on the catheter, andthe tip is open ended. The catheter may be trimmed to theproper length. | |
| Intended use of the device | The Medtronic ARES™ Antibiotic-Impregnated Catheters areintended for use in the treatment of hydrocephalus as acomponent of a shunt system when draining or shunting ofcerebrospinal fluid (CSF) is indicated. |
| Indications for use | The Medtronic ARES™ Antibiotic-Impregnated Catheters areintended for use in the treatment of hydrocephalus as acomponent of a shunt system when draining or shunting ofcerebrospinal fluid (CSF) is indicated. |
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Summary of the technological characteristics of the device compared to the predicate device
The Medtronic ARES™ Antibiotic-Impregnated catheter is substantially equivalent in device description, function, principle of operation, and basic composition to the BACTISEAL® predicate device. The ARES and BACTISEAL devices characteristics are summarized below.
| Characteristic | New Device [MedtronicAREST™ Antibiotic-Impregnated Catheters] | Predicate [BACTISEAL®Catheter, K003322] |
|---|---|---|
| Catheter Body Material | BaSO4 filled silicone elastomer | BaSO4 filled silicone elastomer |
| Drugs Formulation | 0.054 weight % rifampicin0.150 weight % clindamycinhydrochloride | 0.054 weight % rifampicin0.150 weight % clindamycinhydrochloride |
| Catheter Body Dimensions | Ventricular: 0.050" ID x 0.100"ODPeritoneal: 0.050" ID x 0.100"OD | Ventricular: 0.055" ID x 0.106"OD or 0.050" ID x 0.100" ODPeritoneal: 0.039" ID x 0.0866"OD or 0.050" ID x 0.100" OD |
| Catheter Length | Ventricular: 23 cmPeritoneal: 120 cm | Ventricular: 14, 15, or 23 cmPeritoneal: 120 cm |
| Length Markers | Ventricular: numerical lengthmarkersPeritoneal: None | Ventricular: 1 dot at 10 cm & 2dots at 15 cmPeritoneal: None |
| Tip Configuration | Ventricular: Bullet shape with 32inlet holes (4 rows of 8 holes)Peritoneal: Open end, no slits | Ventricular: Bullet shape with 24inlet holes (3 rows of 8 holes)Peritoneal: Open end, no slits |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary
The ARES™ Antibiotic-Impregnated Catheters have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate devices. Results of the non-clinical testing support the conclusion of substantial equivalence to the ARES™ Antibiotic-Impregnated Catheters to the predicate devices.
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Performance Testing | Performance testing wasperformed according to ISO7197: Neurosurgical implants -Sterile, single use hydrocephalusshunts and components andASTM 647-94 Standard Practicefor Evaluating and SpecifyingImplantable Shunt Assemblies forNeurosurgical Application | The ARES Antibiotic-Impregnated Catheters havebeen designed and successfullytested to meet the applicablerequirements outlined in ISO7197 and ASTM 647-94 |
| Sterilization Testing | Sterilization testing wasperformed according to ISO17665: Sterilization of healthcare products - Moist heat | Sterilization of ARESTMAntibiotic-ImpregnatedCatheters is validated usingthe Half Cycle method asoutlined in ISO 17665 to asterility assurance level (SAL)of 10-6. |
| Pyrogen Testing | Pyrogen testing was performedaccording to ANSI/AAMI/ST72Bacterial endotoxins - Testmethodologies, routine monitoringand alternatives to batch testing | ARES Antibiotic-ImpregnatedCatheters conform to FDAstandards concerning pyrogenlevels for devices in contactwith cerebrospinal fluid.Utilizing the Kinetic-Chromogenic LAL method, theproduct meets a 2.15EU/device specification. |
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Biocompatibility Test Summary
For purposes of biocompatibility testing, the Medtronic ARES™ Antibiotic-Impregnated Catheters are considered an implant device with tissue/bone contact and permanent contact duration of greater than 30 days. The selection of biocompatibility testing for Medtronic ARES™ Antibiotic-Impregnated Catheters was based on this categorization of the device, and in accordance with ISO 10993-1:2009-Biological evaluation of medical devices-Part 1: Evaluation and the FDA Blue Book Memo, G95-1, Use of the International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
| Test System | Study Results | Conclusion |
|---|---|---|
| Cytotoxicity - MEM Elution(ISO 10993-5) | No biological reactivity (Grade 0) was observed at 48hours post exposure to the test article extract. | Non-cytotoxic |
| Sensitization - KligmanMaximization(ISO 10993-10) | The extracts of the test article elicited no reaction at thechallenge (0% sensitization), following an inductionphase. | Non-sensitizing |
| IntracutaneousIrritation/Reactivity -Intracutaneous Injection(ISO 10993-10) | All animals increased in weight and none exhibitedover signs of toxicity at any observation point. The testarticle extract sites did not show a significantly greaterbiological reaction than the sites injected with thecontrol article extract. | Non-irritant |
| Acute Systemic Toxicity -Systemic Injection(ISO 10993-11) | All animals increased in weight and none exhibitedovert signs of toxicity at any observation point. Thetest article extracts did not induce a significantly greaterbiological reaction than the control extracts. | Non-toxic(acute) |
| Bacterial ReverseMutation Study - Non-antibiotic impregnatedcatheter(ISO 10993-3) | DMSO and saline test article extracts were consideredto be non-mutagenic to Salmonella typhimurium testerstrains TA98, TA100, TA1535, and TA1537 and toEscherichia coli tester strain WP2uvrA. | Non-genotoxic |
| Bacterial ReverseMutation Assay - Extracts- Mock-impregnatedcatheter(ISO 10993-3) | DMSO and saline test article extracts were consideredto be non-mutagenic to Salmonella typhimurium testerstrains TA98, TA100, TA1535, and TA1537 and toEscherichia coli tester strain WP2uvrA. | Non-genotoxic |
| In Vitro Mouse LymphomaAssay with ExtendedTreatment(ISO 10993-3) | The mutant frequencies and cloning efficiencies ofpreparations treated with test article were within thelimits defined for a negative response. | Non-genotoxic |
| Mouse Peripheral BloodMicronucleus Study(ISO 10993-3) | The test article extracts did not induce micronuclei inmice. | Non-genotoxic |
| Implantation - 13 weekbrain and subcutaneousimplant(ISO 10993-6)&Sub-Chronic / ChronicToxicity(ISO 10993-11) | The test article does not appear to demonstrate anysystemic signs of toxicity when implanted in the brainand subcutaneous tissue of New Zealand White rabbitsfor a period of 13 weeks. | No localadverse eventNon-toxic (sub-chronic) |
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K110560
| Comparative Performance Information Summary | |||
|---|---|---|---|
| Characteristic | Requirement | ARES | BACTISEAL |
| Drug release kinetics | Demonstration ofantibiotics releasekinetics over a 38day period is thesame forARES andBACTISEAL | Antibiotics releasekinetics measured overa 38 day periodAntibiotic release ratesdemonstrated the sameas BACTISEALantibiotic release rates | Antibiotics releasekinetics measuredover a 38 day periodAntibiotic release ratesdemonstrated thesame as ARESantibiotic release rates |
| Zone of Inhibition Testing | Demonstration ofantimicrobial activityfor at least 31 dayshas statisticallyequivalent zones ofinhibition forARES andBACTISEAL | Antimicrobial activitydemonstrated for atleast 31 daysMeasured ZOIsstatistically equivalentto those of BACTISEAL | Antimicrobial activitydemonstrated for atleast 31 daysMeasured ZOIsstatically equivalent tothose of ARES |
| Catheter CrushResistance | ARES cathetermean value mustnot be significantlylower than controlgroup (BACTISEAL)mean using a twosample t-test at 95%confidence | Pass | Pass |
| Drug Content | Clindamycin: 0.150± 45%Rifampicin: 0.054 ±60% | Pass | Pass |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |||
| No prospective clinical trials were conducted in support of this Traditional 510(k) |
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
Medtronic Neurosurgery considers the Medtronic ARES™ Antibiotic-Impregnated Catheters to be the "same" as the predicate BACTISEAL® catheters according to the definition of medical devices containing antimicrobial agents considered by FDA to be "the same" as described in FDA Draft Guidance for Industry and FDA Staff - Premarket Notification (510(k)) Submissions for Medical Devices that Include Antimicrobial Agents (issued July 19, 2007). The indications for use, function, implantation techniques, performance characteristics, and test standards for both devices are substantially equivalent. Medtronic Neurosurgery considers the Medtronic ARES™ Antibiotic-Impregnated Catheters to be substantially equivalent to the previously cleared Codman BACTISEAL® Catheters.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is positioned inside a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 8 2011
Medtronic, Inc. c/o Mr. Jeffrey Henderson Vice President, Quality and Regulations Affairs 125 Cremona Drive Goleta, CA 93117
Re: K110560
Trade/Device Name: Medtronic Ares™ Antibiotic-Impregnated Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: November 11, 2011 Received: November 14, 2011
Dear Mr. Henderson:
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 (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. 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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melvin R. Felder, MD
Malvina B. Eydelman, M)D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Indications for Use Statement
510(k) Number (if known):
To be determined
Device Name:
Indications for Use:
ARES™ Antibiotic-Impregnated The Medtronic Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF)
ARES™ Antibiotic-Impregnated Catheters
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
is indicated.
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number k//0560
§ 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).