TRUFILL PVA PARTICLES

K965174 · Cordis Neurovascular, Inc. · HCG · Mar 21, 1997 · Neurology

Device Facts

• Record ID: K965174
• Device Name: TRUFILL PVA PARTICLES
• Applicant: Cordis Neurovascular, Inc.
• Product Code: HCG · Neurology
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable.

Device Story

TruFill PVA Particles; artificial embolization device. Used for vascular occlusion in neurovascular systems; indicated for arteriovenous malformations and neoplastic lesions requiring presurgical devascularization. Delivered endovascularly by physicians to block blood flow to target lesions. Benefits include reduced blood supply to malformations/tumors prior to surgical intervention.

Clinical Evidence

No clinical data; biocompatibility testing successfully performed.

Technological Characteristics

Poly vinyl alcohol (PVA) particles; artificial embolization device; Class III; 84HCG; CFR 882.5950.

Indications for Use

Indicated for vascular occlusion of neurovascular blood vessels; specifically for endovascular management of arteriovenous malformations and neoplastic lesions requiring presurgical devascularization.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• TruFill PVA Particles (K951314)
• Contour PVA (K944354)

Submission Summary (Full Text)

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03/19/97 19:21 3058248610
MAR 21 1997
K965174
PREMARKET NOTIFICATION 510 (K)
Cordis Endovascular Systems, Inc.
Trufill PVA Particles
Modification - September 13, 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Provisions

Common or Usual Name: Artificial Embolization Device
Proprietary Name: TruFill™ PVA Particles

## II. Name of Predicate Devices

TruFill PVA Particles manufactured by Cordis Endovascular Systems, Inc (CES) 510(k) No. K951314, concurred on 8/8/95

Contour PVA manufactured by Interventional Therapeutics Corporation 510 (k) No. K944354, concurred 12/13/94

## III. Classification

Class III, Artificial Embolization Device, 84HCG, CFR 882.5950

## IV. Performance Standards

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable.

## VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the TruFill PVA Particles.

## VII. Summary of Substantial Equivalence

The TruFill PVA are similar in their basic design, construction, indication for use and performance characteristics to other commercially available poly vinyl alcohol particles.