CODMAN BACTISEAL EVD CATHETER SET

K021653 · Codman & Shurtleff, Inc. · JXG · Jul 29, 2002 · Neurology

Device Facts

• Record ID: K021653
• Device Name: CODMAN BACTISEAL EVD CATHETER SET
• Applicant: Codman & Shurtleff, Inc.
• Product Code: JXG · Neurology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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.

Device Story

Codman BACTISEAL™ EVD Catheter Set provides ventricular access for CSF drainage; used to reduce intracranial pressure and CSF volume. Device consists of radiopaque silicone rubber catheter impregnated with rifampicin and clindamycin hydrochloride to resist gram-positive organism colonization. Used in clinical settings by physicians for external ventricular drainage. Output is physical drainage of CSF; assists in managing intracranial pressure. Benefits include reduced risk of catheter-related colonization/infection while facilitating fluid management.

Clinical Evidence

Safety and effectiveness supported by bench testing, in vitro testing, biocompatibility studies per ISO 10993-Part 1, and clinical data. Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Radiopaque silicone rubber catheter; impregnated with rifampicin and clindamycin hydrochloride for antimicrobial properties. Dimensions compatible with standard external ventricular drainage systems. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring ventricular access for CSF drainage to reduce intracranial pressure and CSF volume. Compatible with dimensionally appropriate drainage devices.

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

• Codman BACTISEAL™ Catheters
• Codman External Drainage Ventricular Catheter Set
• Cook Inc. SPECTRUM® Ventricular Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 2 9 2002

## ATTACHMENT A

# K 021653

# 510(k) Summary Codman BACTISEAL™ EVD Catheter Sets

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

#### Contact Person

Kathy Wunder Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

Codman BACTISEAL™ EVD Catheter Sets Proprietary Name: Common Name: Ventricular catheters Classification Name: Catheter, Ventricular

### Device Classification

Ventricular Catheters are Class II devices per 21 CFR § 882.4100 (84 JXG).

### Statement of Substantial Equivalence

Codman BACTISEAL™ EVD Catheter Sets are substantially equivalent to Codman BACTISEAL™ Catheters, Codman External Drainage Ventricular Catheter Set and Cook Inc. SPECTRUM® Ventricular Catheter, based on the subject device's similarity to the predicate devices in intended use, materials, design, and dimensions.

#### Indications for Use

The 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.

{1}------------------------------------------------

## Physical Description

্

Codman BACTISEAL™ EVD Catheter Sets are manufactured from radiopaque silicone rubber which is then impregnated with rifampicin and clindamycin hydrochloride in order to render the device resistant to colonization of most gram positive organisms.

### Device Testing

Safety of this device to predicate products relied on extensive performance and in vitro testing, biocompatibility studies in accordance with ISO10993-Part 1, and clinical data. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

{2}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

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

Re: K021653

Trade/Device Name: Codman BACTISEAL™ EVD 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: May 17, 2002 Received: May 20, 2002

Dear Ms. Wunder:

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.

{3}------------------------------------------------

Page 2 - Ms. Kathy Wunder

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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), 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,

Mark N Milla

ia 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

{4}------------------------------------------------

510(k) Number (if known) Device Name

02165 TM EVD Codman BACTISE Catheter Set

Indications For Use:

The 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.

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

Mark N Milkman

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

510(k) Number _

Prescription Use A (Per 21 CFR §801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)