CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER

K955265 · Cordis Corp. · JXG · Dec 20, 1996 · Neurology

Device Facts

• Record ID: K955265
• Device Name: CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER
• Applicant: Cordis Corp.
• Product Code: JXG · Neurology
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.

Device Story

Kit facilitates intracranial cyst drainage; includes ventricular catheter with modified distal tip, sharp-ended stylet, and blunt-ended stylet. Procedure: stereotactic localization of cyst entry; blunt-ended stylet inserted into catheter to approach cyst wall; exchange for sharp-ended stylet; stylet locked into catheter tip; assembly advanced to puncture cyst wall; catheter advanced into cyst lumen; stylet withdrawn; catheter remains for drainage. Used in neurosurgical settings by physicians. Benefits: enables access to thick-walled or mobile cysts otherwise difficult to penetrate.

Clinical Evidence

No clinical data; bench testing only. Radiopacity validation data provided.

Technological Characteristics

Catheter manufactured from silicone elastomer with barium sulfate for radiopacity. Kit includes sharp-ended and blunt-ended stylets. Mechanical assembly with locking mechanism at distal catheter tip. No software or electronic components.

Indications for Use

Indicated for puncturing and draining thick-walled or mobile intracranial cysts in patients requiring cyst drainage via ventricular catheter placement.

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

• Elekta Blacklund Needle (Preamendments)
• Cordis Ventricular Catheter Stylet (Preamendments)
• Cordis Ventricular Catheter Introducer (Orbis-Sigma Valve (K913636))
• Cordis Ventricular Catheter with Enlarged Holes (K914995)

Submission Summary (Full Text)

{0}

K955265 00-00004

# SECTION 2 - SUMMARY AND CERTIFICATION

DEC 20 1996

## Summary of Safety and Effectiveness
## Cordis Cyst Puncture Catheter Kit

(Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act)

### I. General Information:

#### Cordis Sharp-ended Stylet

Classification Name: Microsurgical instrument
Common/Usual Name: Puncture Cannula
Trade/Proprietary Name: Cordis Sharp-ended Stylet

#### Cordis Blunt-ended Stylet

Classification Name: Shunt implantation instrument
Common/Usual Name: Stylet
Trade/Proprietary Name: Cordis Blunt-ended Stylet

#### Cordis Cyst Puncture Catheter

Classification Name: Ventricular Catheter
Common/Unusual Name: Catheter
Trade/Proprietary Name: Cordis Cyst Puncture Catheter

#### Applicant's Name and Address:

Cordis Corporation
14201 NW 60th Avenue
Miami, FL 33014

### II. Name of predicate device(s):

| Component | Predicate Device |
| --- | --- |
| Sharp-ended stylet: | Elekta Blacklund Needle (Preamendments). |
| Blunt-ended stylet: | Cordis Ventricular Catheter Stylet (Preamendments).
Cordis Ventricular Catheter Introducer (Orbis-Sigma Valve (K913636)). |
| Cyst Puncture Catheter: | Cordis Ventricular Catheter with Enlarged Holes (K914995). |

{1}

00-00005

## III. Classification:

When used alone as a cyst puncture needle, the Cordis Cyst Puncture Stylet is a Microsurgical Instrument (Class I - 21 CFR 882.4525). Neurosurgical shunt system instruments are Class I (21 CFR 882.4545). Ventricular Catheters are Class II (21 CFR 882.4100).

## IV. Performance Standards:

No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description:

The Cordis Cyst Puncture Catheter Kit is intended to facilitate puncturing thick-walled or mobile intracranial cysts, allowing insertion of a ventricular catheter for cyst drainage.

## VI. Summary of Substantial Equivalence¹:

**Indications for use:** The Cordis Cyst Puncture Catheter Kit is used to puncture and drain thick-walled or mobile intracranial cysts.

**System Description:** The Cordis Cyst Puncture Catheter kit consists of a ventricular catheter with enlarged holes whose distal tip has been modified. The modification allows the sharp-ended stylet to be inserted through and locked into the distal tip. This facilitates cyst puncture. The kit also includes sharp- and blunt-ended stylets to facilitate catheter placement. The catheter is manufactured from silicone elastomer made radiopaque with barium sulfate (see Section 5 for Biocompatibility Assessment and Appendix III for Radiopacity Validation Data).

Standard stereotactic techniques are used to localize the cyst entry point. The blunt-ended stylet, included in the kit, inserted into the catheter to approach the cyst wall. After contacting the cyst wall, the blunt-ended stylet is exchanged for the sharp-ended stylet. The sharp-ended stylet is pushed through the small hole in the distal catheter tip until the flange is seated against the molded shelf of the catheter. The stylet/catheter assembly is then advanced until the sharp-ended stylet punctures the cyst wall. The ventricular catheter can

¹Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patient infringement litigation. As the Commissioner of the FDA has indicated, “...a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or classification. This determination is not intended to have any bearing whatever on resolution of patent infringement suits.” 42 Fed. Reg. 42,520 et seq. (1977).

{2}

00-00006

then be advanced into the lumen of the cyst. The stylet is then withdrawn, leaving the catheter in place to drain the cyst.

The indications for the Cordis Sharp- and Blunt-ended Stylets and Cyst Puncture Catheter are similar to those for the predicate devices.

## Design, Materials, Manufacturing Methods and Specifications:

The design, materials, manufacturing methods and specifications of the components of the Cordis Cyst Puncture Catheter Kit are similar to those of the predicate devices and do not raise any new issues relating to safety and effectiveness for their intended use. Thus, Cordis considers the Cordis Cyst Puncture Catheter Kit to be equivalent to predicate devices.