CODMAN BACTISEAL BARIUM STRIPED CATHETERS

K031123 · Codman & Shurtleff, Inc. · HCA · May 14, 2003 · Neurology

Device Facts

• Record ID: K031123
• Device Name: CODMAN BACTISEAL BARIUM STRIPED CATHETERS
• Applicant: Codman & Shurtleff, Inc.
• Product Code: HCA · Neurology
• Decision Date: May 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Codman BACTISEAL™ Barium Striped 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

Codman BACTISEAL™ Barium Striped Catheters are silicone catheters used in hydrocephalus treatment to drain or shunt cerebrospinal fluid (CSF). The device is manufactured from barium-striped silicone impregnated with Clindamycin Hydrochloride and Rifampicin. These antimicrobial agents are incorporated into the catheter material to reduce the colonization of gram-positive bacteria on the tubing surface. The device functions as a passive component within a larger shunt system. It is intended for clinical use by neurosurgeons during surgical procedures for hydrocephalus management. The device provides a conduit for CSF flow, helping to manage intracranial pressure. No active electronic components, software, or algorithms are involved in the device's operation.

Clinical Evidence

Bench testing only. In vitro studies demonstrated the device's ability to reduce colonization of gram-positive bacteria on the tubing surface compared to non-impregnated catheters. No clinical trial data was required or provided for this 510(k) submission.

Technological Characteristics

Materials: Barium-striped silicone impregnated with Clindamycin Hydrochloride and Rifampicin. Sensing/Actuation: Passive fluid conduit. Energy Source: None. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

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

Regulatory Classification

Identification

A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

Predicate Devices

• Codman BACTISEAL™ Catheters
• Uni-Shunt Catheters with Elliptical Reservoir
• CODMAN HAKIM™ Shunt Systems

Submission Summary (Full Text)

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MAY 1 4 2003

# EXHIBIT A

# KO3/123

# 510(k) Summary Codman BACTISEAL™ Barium Striped Catheters

## Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person

Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

| Proprietary Name: | Codman BACTISEAL™ Barium Striped Catheters |
|----------------------|---------------------------------------------------|
| Common Name: | Hydrocephalus catheters |
| Classification Name: | Central Nervous System Fluid Shunt and Components |

#### Device Classification

Class II per 21 CFR & 882.5550 - Central nervous system fluid shunt and components (84 JXG)

## Statement of Substantial Equivalence

Codman BACTISEAL™ Barium Striped Catheters are substantially equivalent to Codman BACTISEAL™ Catheters, Uni-Shunt Catheters with Elliptical Reservoir. CODMAN HAKIM™ Shunt Systems based on the subject device's similarity to the predicate devices in intended use, materials, design, and dimensions.

#### Indications for Use

Codman BACTISEAL™ Barium Striped 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.

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### Physical Description

Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.

#### Device Testing

Substantial equivalence for this device was based upon performance testing and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, represented by simple lines, facing to the right.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 4 2003

Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K031123

Trade/Device Name: Codman BACTISEAL™ Barium Striped Catheters Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular catheter Regulatory Class: II Product Code: HCA Dated: April 7, 2003 Received: April 14, 2003

Dear Ms. Dolan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Elizabeth Dolan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

(d Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K 031123

Device Name:

Codman BACTISEAL™ Barium Striped Catheters

Indications For Use:

Codman BACTISEAL™ Barium Striped 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.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR §801.109)

OR

Over-the-Counter Use

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031123