Codman® BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiseal Shunt System is 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 Description

The CODMAN® BACTISEAL® Catheter Set and CODMAN® BACTISEAL® EVD Catheter Set are radiopaque catheters packaged with components to facilitate placement and use of the catheters. 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.

AI/ML Overview

The provided text from K102589 does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a typical AI/software device would.

This 510(k) submission, K102589, is for a series of physical medical devices (catheters) that are part of shunt systems. The primary purpose of this particular submission is to request a reduction in the frequency of pyrogen testing, not to demonstrate new performance characteristics of the device itself. The document explicitly states:

"The subject of this change is not related to a change to the devices but rather a reduction in the frequency of pyrogen testing; therefore, the technological characteristics of the proposed device are exactly the same as the predicated devices."

And under "Performance Data":

"Control of endotoxin testing has been demonstrated through design and manufacturing controls as demonstrated by the process risk analysis. There were no changes to the device."

Therefore, I cannot provide the requested information for acceptance criteria and a study to prove the device meets acceptance criteria, as this information is not present in the given document. The document describes a regulatory change related to testing frequency for an existing device, not a performance study for a novel device or AI component.

Summary

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K102589

510(k) Summary .

ﺔ

JAN 1 4 2011

A. Submitter Information
Submitter's name:	Codman & Shurtleff, Inc.
Address:	325 Paramount Drive
	Raynham, MA 02767
Telephone:	508-880-8349
Fax:	508-828-2777
Contact Person:	Sharon McDermott
Date of Submission:	September 8, 2010
B. Trade/Device Name:	CODMAN® BACTISEAL EVD Catheter Set (82-1745 - Ventricular Catheter Component)
	CODMAN® HAKIM® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System (82-3072 - Ventricular and Distal Catheter Components)
	CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System (82-3073 - Ventricular Catheter Component)
	CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiseal Shunt System (82- 3074 - Distal Catheter Component)
Common Name:	Ventricular catheter, peritoneal catheter
Classification Name:	Central Nervous System Fluid Shunt and Components
Regulatory Class:	Class II per 21 CFR § 882.5550
Product Code:	JXG
C. Predicate Device:	CODMAN® BACTISEAL® Catheter Set (K003322) CODMAN® BACTISEAL® EVD Catheter Set (K021653)
D. Device Description:	The CODMAN® BACTISEAL® Catheter Set and CODMAN® BACTISEAL® EVD Catheter Set are radiopaque catheters packaged with components to facilitate placement and use of the catheters. 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.
E. Intended Use:	Codman® BACTISEAL® EVD Catheter Set is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid

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(CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

F. Summary of technological characteristics of the proposed to the predicate device.

The subject of this change is not related to a change to the devices but rather a reduction in the frequency of pyrogen testing; therefore, the technological characteristics of the proposed device are exactly the same as the predicated devices.

G. Performance Data

Control of endotoxin testing has been demonstrated through design and manufacturing controls as demonstrated by the process risk analysis. There were no changes to the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, with three curved lines forming the body and head. The symbol is positioned to the right of the text, which is arranged in a circular fashion around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Codman & Shurtleff, Inc. c/o Ms. Sharon McDermott Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767

JAN 1 4 2011

Re: K102589

Trade/Device Name: CODMAN® BACTISEAL EVD Catheter Set (82-1745 - Ventricular Catheter Component)

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System (82-3072 - Ventricular and Distal Catheter Components)

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System (82-3073 - Ventricular Catheter Component) CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiseal Shunt System (82- 3074 - Distal Catheter Component)

Regulation Number: 21 CFR 882.5550

Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: December 15, 2010 Received: December 16, 2010

Dear Ms. McDermott:

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.

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Page 2-Ms. Sharon McDermott

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.

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" (2) CFR 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 vours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear. Nose. Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K102589

Device Name: CODMAN® BACTISEAL EVD Catheter Set (82-1745 - Ventricular Catheter Component)

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter and Distal Catheter Kit with Bactiseal Shunt System (82-3072 - Ventricular and Distal Catheter Components)

CODMAN® HAKIM® BACTISEAL® Ventricular Catheter with Bactiseal Shunt System (82-3073 - Ventricular Catheter Component)

CODMAN® HAKIM® BACTISEAL® Distal Catheter Kit with Bactiseal Shunt System (82- 3074 - Distal Catheter Component)

Indications For Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)Concurrence of CDRH, Offices of Original Distinct Distinct Car,

Nose and Throat Devices

510(k) Number K102589

Regulation Number and Section

§ 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).