MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER

K110560 · Medtronic Neurosurgery · JXG · Nov 18, 2011 · Neurology

Device Facts

• Record ID: K110560
• Device Name: MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

ARES Antibiotic-Impregnated Catheters are implantable medical devices used in hydrocephalus treatment to drain cerebrospinal fluid (CSF). Manufactured from barium sulfate-filled silicone elastomer, the catheters are impregnated with clindamycin hydrochloride and rifampicin to provide antimicrobial activity. The ventricular catheter features numerical length markers and 32 flow holes to facilitate placement; the peritoneal catheter is open-ended and trimmable. Used by neurosurgeons in clinical settings, the device functions as a passive component of a shunt system. The antimicrobial impregnation is designed to reduce the risk of shunt-related infections. The device is supplied sterile for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including ISO 7197 and ASTM 647-94 performance standards, sterilization validation (ISO 17665), pyrogen testing (ANSI/AAMI/ST72), and comprehensive biocompatibility testing (ISO 10993). Comparative bench studies demonstrated equivalent drug release kinetics and antimicrobial activity (zones of inhibition) over 38 days compared to the predicate.

Technological Characteristics

Materials: Barium sulfate-filled silicone elastomer. Active agents: 0.054% rifampicin, 0.150% clindamycin hydrochloride. Dimensions: Ventricular (23cm length, 0.050" ID x 0.100" OD), Peritoneal (120cm length, 0.050" ID x 0.100" OD). Sterilization: Moist heat (ISO 17665). Standards: ISO 7197, ASTM 647-94, ISO 10993.

Indications for Use

Indicated for patients requiring treatment of hydrocephalus via a shunt system for cerebrospinal fluid (CSF) drainage.

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® Catheter (K003322)

Submission Summary (Full Text)

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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 Drive<br>Goleta, CA 93117-5503<br>USA |
| Phone number | 805-571-8400 |
| Fax number | 805-571-8480 |
| Establishment<br>Registration Number | 2021898 |
| Name of contact<br>person | Jeffrey Henderson |
| Date prepared | November 17, 2011 |
| Name of device | |
| Trade or proprietary<br>name | Medtronic ARES™ Antibiotic-Impregnated Catheter |
| Common or usual<br>name | 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)<br>to which equivalence is<br>claimed | Johnson & Johnson (Codman & Shurtleff)<br>BACTISEAL® Catheter (K003322) |
| Reason for 510(k)<br>submission | New device |
| Device description | The Medtronic ARES™ Antibiotic-Impregnated Catheters are<br>manufactured using barium sulfate-filled silicone elastomer<br>and are impregnated with clindamycin hydrochloride and<br>rifampicin.<br><br>ARES Antibiotic-Impregnated Ventricular Catheter<br>The ARES ventricular catheter measures 23 cm in length,<br>0.13 cm in inner diameter, and 0.25 cm in outer diameter.<br>Lengths are marked in 1 cm intervals starting from 3 cm to 15<br>cm from the catheter tip, thus enabling the surgeon to gauge<br>the depth of penetration of the catheter into the lateral<br>ventricle. The proximal end of the catheter has 32 flow<br>holes—four lines of eight holes spaced at 90° intervals |
| | around the catheter circumference. Components supplied<br>with the ARES Ventricular Catheter include a pre-loaded<br>stainless steel stylet and a Right Angle Clip, which is included<br>to facilitate placement and use of the ventricular catheter.<br>ARES Antibiotic-Impregnated Peritoneal Catheter<br>The ARES peritoneal catheter measures 120 cm in length,<br>0.13 cm in inner diameter, and 0.25 cm in outer diameter.<br>There are no length markers or wall slits on the catheter, and<br>the tip is open ended. The catheter may be trimmed to the<br>proper length. |
| Intended use of the device | The Medtronic ARES™ Antibiotic-Impregnated Catheters are<br>intended for use in the treatment of hydrocephalus as a<br>component of a shunt system when draining or shunting of<br>cerebrospinal fluid (CSF) is indicated. |
| Indications for use | The Medtronic ARES™ Antibiotic-Impregnated Catheters are<br>intended for use in the treatment of hydrocephalus as a<br>component of a shunt system when draining or shunting of<br>cerebrospinal 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 [Medtronic<br>AREST™ Antibiotic-<br>Impregnated Catheters] | Predicate [BACTISEAL®<br>Catheter, K003322] |
|--------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Catheter Body Material | BaSO4 filled silicone elastomer | BaSO4 filled silicone elastomer |
| Drugs Formulation | 0.054 weight % rifampicin<br>0.150 weight % clindamycin<br>hydrochloride | 0.054 weight % rifampicin<br>0.150 weight % clindamycin<br>hydrochloride |
| Catheter Body Dimensions | Ventricular: 0.050" ID x 0.100"<br>OD<br>Peritoneal: 0.050" ID x 0.100"<br>OD | Ventricular: 0.055" ID x 0.106"<br>OD or 0.050" ID x 0.100" OD<br>Peritoneal: 0.039" ID x 0.0866"<br>OD or 0.050" ID x 0.100" OD |
| Catheter Length | Ventricular: 23 cm<br>Peritoneal: 120 cm | Ventricular: 14, 15, or 23 cm<br>Peritoneal: 120 cm |
| Length Markers | Ventricular: numerical length<br>markers<br>Peritoneal: None | Ventricular: 1 dot at 10 cm & 2<br>dots at 15 cm<br>Peritoneal: None |
| Tip Configuration | Ventricular: Bullet shape with 32<br>inlet holes (4 rows of 8 holes)<br>Peritoneal: Open end, no slits | Ventricular: Bullet shape with 24<br>inlet holes (3 rows of 8 holes)<br>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 was<br>performed according to ISO<br>7197: Neurosurgical implants -<br>Sterile, single use hydrocephalus<br>shunts and components and<br>ASTM 647-94 Standard Practice<br>for Evaluating and Specifying<br>Implantable Shunt Assemblies for<br>Neurosurgical Application | The ARES Antibiotic-<br>Impregnated Catheters have<br>been designed and successfully<br>tested to meet the applicable<br>requirements outlined in ISO<br>7197 and ASTM 647-94 |
| Sterilization Testing | Sterilization testing was<br>performed according to ISO<br>17665: Sterilization of health<br>care products - Moist heat | Sterilization of ARESTM<br>Antibiotic-Impregnated<br>Catheters is validated using<br>the Half Cycle method as<br>outlined in ISO 17665 to a<br>sterility assurance level (SAL)<br>of 10-6. |
| Pyrogen Testing | Pyrogen testing was performed<br>according to ANSI/AAMI/ST72<br>Bacterial endotoxins - Test<br>methodologies, routine monitoring<br>and alternatives to batch testing | ARES Antibiotic-Impregnated<br>Catheters conform to FDA<br>standards concerning pyrogen<br>levels for devices in contact<br>with cerebrospinal fluid.<br>Utilizing the Kinetic-<br>Chromogenic LAL method, the<br>product meets a 2.15<br>EU/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<br>(ISO 10993-5) | No biological reactivity (Grade 0) was observed at 48<br>hours post exposure to the test article extract. | Non-cytotoxic |
| Sensitization - Kligman<br>Maximization<br>(ISO 10993-10) | The extracts of the test article elicited no reaction at the<br>challenge (0% sensitization), following an induction<br>phase. | Non-sensitizing |
| Intracutaneous<br>Irritation/Reactivity -<br>Intracutaneous Injection<br>(ISO 10993-10) | All animals increased in weight and none exhibited<br>over signs of toxicity at any observation point. The test<br>article extract sites did not show a significantly greater<br>biological reaction than the sites injected with the<br>control article extract. | Non-irritant |
| Acute Systemic Toxicity -<br>Systemic Injection<br>(ISO 10993-11) | All animals increased in weight and none exhibited<br>overt signs of toxicity at any observation point. The<br>test article extracts did not induce a significantly greater<br>biological reaction than the control extracts. | Non-toxic<br>(acute) |
| Bacterial Reverse<br>Mutation Study - Non-<br>antibiotic impregnated<br>catheter<br>(ISO 10993-3) | DMSO and saline test article extracts were considered<br>to be non-mutagenic to Salmonella typhimurium tester<br>strains TA98, TA100, TA1535, and TA1537 and to<br>Escherichia coli tester strain WP2uvrA. | Non-genotoxic |
| Bacterial Reverse<br>Mutation Assay - Extracts<br>- Mock-impregnated<br>catheter<br>(ISO 10993-3) | DMSO and saline test article extracts were considered<br>to be non-mutagenic to Salmonella typhimurium tester<br>strains TA98, TA100, TA1535, and TA1537 and to<br>Escherichia coli tester strain WP2uvrA. | Non-genotoxic |
| In Vitro Mouse Lymphoma<br>Assay with Extended<br>Treatment<br>(ISO 10993-3) | The mutant frequencies and cloning efficiencies of<br>preparations treated with test article were within the<br>limits defined for a negative response. | Non-genotoxic |
| Mouse Peripheral Blood<br>Micronucleus Study<br>(ISO 10993-3) | The test article extracts did not induce micronuclei in<br>mice. | Non-genotoxic |
| Implantation - 13 week<br>brain and subcutaneous<br>implant<br>(ISO 10993-6)<br>&<br>Sub-Chronic / Chronic<br>Toxicity<br>(ISO 10993-11) | The test article does not appear to demonstrate any<br>systemic signs of toxicity when implanted in the brain<br>and subcutaneous tissue of New Zealand White rabbits<br>for a period of 13 weeks. | No local<br>adverse event<br>Non-toxic (sub-<br>chronic) |

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# K110560

| Comparative Performance Information Summary | | | |
|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Requirement | ARES | BACTISEAL |
| Drug release kinetics | Demonstration of<br>antibiotics release<br>kinetics over a 38<br>day period is the<br>same for<br>ARES and<br>BACTISEAL | Antibiotics release<br>kinetics measured over<br>a 38 day period<br>Antibiotic release rates<br>demonstrated the same<br>as BACTISEAL<br>antibiotic release rates | Antibiotics release<br>kinetics measured<br>over a 38 day period<br>Antibiotic release rates<br>demonstrated the<br>same as ARES<br>antibiotic release rates |
| Zone of Inhibition Testing | Demonstration of<br>antimicrobial activity<br>for at least 31 days<br>has statistically<br>equivalent zones of<br>inhibition for<br>ARES and<br>BACTISEAL | Antimicrobial activity<br>demonstrated for at<br>least 31 days<br>Measured ZOIs<br>statistically equivalent<br>to those of BACTISEAL | Antimicrobial activity<br>demonstrated for at<br>least 31 days<br>Measured ZOIs<br>statically equivalent to<br>those of ARES |
| Catheter Crush<br>Resistance | ARES catheter<br>mean value must<br>not be significantly<br>lower than control<br>group (BACTISEAL)<br>mean using a two<br>sample t-test at 95%<br>confidence | Pass | Pass |
| Drug Content | Clindamycin: 0.150<br>± 45%<br>Rifampicin: 0.054 ±<br>60% | Pass | Pass |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL 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 [phone] or [phone] 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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K110560

4. 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