VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM

K071640 · Cook, Inc. · NHC · Jul 12, 2007 · Neurology

Device Facts

• Record ID: K071640
• Device Name: VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
• Applicant: Cook, Inc.
• Product Code: NHC · Neurology
• Decision Date: Jul 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume. The device is supplied sterile and is intended for one-time use.

Device Story

The Spectrum® VentriClear™ II is a silicone ventricular drainage catheter (2.8 mm/9 Fr, 33 cm length) featuring 16 sideports and numbered markings. The catheter is impregnated with minocycline and rifampin to provide antimicrobial properties. It is used by clinicians to access the brain's ventricular cavity for short-term external drainage of cerebrospinal fluid. The device is supplied sterile for one-time use. It functions as a passive drainage conduit to manage intracranial pressure. Clinical benefit is derived from the reduction of intracranial pressure and fluid volume in patients requiring neurosurgical drainage.

Clinical Evidence

Bench testing only. Testing included HPLC, tensile strength, liquid leakage, burst pressure, biocompatibility, and gravity flow rate testing to ensure design reliability and performance.

Technological Characteristics

Silicone catheter, 2.8 mm (9 Fr) diameter, 33 cm length, 16 sideports. Impregnated with minocycline and rifampin. Sterile, single-use. Passive drainage mechanism.

Indications for Use

Indicated for patients requiring short-term external ventricular drainage to relieve elevated intracranial pressure or fluid volume.

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

• Cook Spectrum® Ventricular Drainage Catheter Set (K011812)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification: Device Modification Spectrum® VentriClear™ II Ventricular Drainage Catheter Cook Incorporated June 14, 2007

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Ko71640

#### 510(k) Summary

#### Submitted By:

# JUL 1 2 2007

Theodore Heise, Ph.D., RAC Vice President Regulatory Scientific Affairs Cook Incorporated 750 Daniels Way (PO Box 489) Bloomington, IN 47404 (47402) 812-339-2235 June 14, 2007

#### Device:

Trade Name:

Proposed Classification:

Cook Incorporated Spectrum® VentriClear™ II Ventricular Drainage Catheter Set Catheter, Ventricular (Containing Antibiotic or Antimicrobial Agents) NHC (21 CFR \$882.4100)

#### Indications for Use

The Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume. The device is supplied sterile and is intended for one-time use.

#### Predicate Devices:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to the predicate Cook Spectrum® Ventricular Drainage Catheter Set.

#### Device Description:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set includes a silicone 2.8 mm (9 Fr.) ventricular catheter available in a 33 cm length with numbered markings and 16 sideports. VentriClear™ II is impregnated with minocycline and rifampin. This device is supplied sterile and is intended for one-time use.

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### Substantial Equivalence:

The Spectrum® VentriClear™ II Ventricular Drainage Catheter Set is similar to the Cook Incorporated Spectrum® Ventricular Drainage Catheter Set (D.C. # K011812). The similar indications for use, principles of operation, technological characteristics, and performance testing results of VentriClear™ II as compared to the predicate device support a determination of substantial equivalence.

## Test Data:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set was subjected to the following tests to assure reliable design and performance under the specified testing parameters.

- 1. HPLC testing
- 2. Tensile testing
- Liquid leakage testing 3.
- 4. Burst pressure testing
- న. Biocompatibility
- Gravity flow rate testing 6.

The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a ventricular catheter.

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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 eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 2 2007

Cooke Incorporated % Theodore Heise, Ph.D., RAC VP, Regulatory Scientific Affairs 750 Daniels Way Bloomington, Indiana 47404

Re: K071640

Trade/Device Name: Spectrum® VentriClear™ II Ventricular Drainage Catheter Set Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular catheter Regulatory Class: II Product Code: NHC Dated: June 14, 2007 Received: June 15, 2007

Dear Dr. Heise:

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 - Theodore Heise, Ph.D., RAC

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]. 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 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson
Director

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification: Device Modification Spectrum® VentriClear™ II Ventricular Drainage Catheter Cook Incorporated June 14, 2007

Indications for Use

Kot 164

510(k) Number (if known):

Device Name:

Spectrum® VentriClear™ II Ventricular Drainage Catheter Set.

Indications for Use:

Intended for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.

(Division Sign-Off)

(Division Sign-of-General, Restorative, Division of of of other and Neurological

510(k) Number K671640

Prescription Use XX (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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