BAERVELT PARS PLANA GLAUCOMA IMPLANT

K955455 · Pharmacia Iovision, Inc. · KYF · Feb 18, 1997 · Ophthalmic

Device Facts

• Record ID: K955455
• Device Name: BAERVELT PARS PLANA GLAUCOMA IMPLANT
• Applicant: Pharmacia Iovision, Inc.
• Product Code: KYF · Ophthalmic
• Decision Date: Feb 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3920
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.

Device Story

Non-valved artificial drainage device; shunts aqueous humor via silicone tube to episcleral plate; implanted in equatorial regions of globe. Device features silicone plate with 13 mm convex radius; barium-impregnated for radiopacity (CT, MRI, plain film). Includes silicone tube with elbow attachment for posterior chamber insertion; flange with fixation holes for scleral attachment. Used by ophthalmic surgeons in surgical setting to manage intraocular pressure in refractory glaucoma patients; provides alternative drainage pathway to reduce pressure; prevents vision loss.

Clinical Evidence

No clinical data provided; substantial equivalence based on design comparison and surgical performance similarity to predicate.

Technological Characteristics

Medical grade silicone construction; barium-impregnated for radiopacity; 13 mm convex radius plate; non-valved drainage mechanism; includes silicone tube with elbow connector.

Indications for Use

Indicated for patients with medically uncontrollable glaucoma and poor surgical prognosis.

Regulatory Classification

Identification

An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) “Aqueous Shunts—510(k) Submissions.”

Predicate Devices

• Baerveldt Glaucoma Implant

Submission Summary (Full Text)

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K955455

# PREMARKET NOTIFICATION [510(k)] SUMMARY

FEB 18 1997

This summary of information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990).

**Date Summary Prepared:** November 10, 1995

**Distributor:** Pharmacia Inc.
P.O. Box 16529
Columbus, OH 43216

**Manufacturer:** Pharmacia Iovision
34 Mauchly
Irvine, CA 92718

**Telephone/Fax:** [phone]; Fax [phone]

**Company Contact Person:** Shelley Beadle, Manager, Regulatory Affairs

**Device Name:** Baerveldt Pars Plana Glaucoma Implant

**Common Name:** Glaucoma Implant

**Classification:** Class III - 86 KYF, Ophthalmic Panel

**Substantial Equivalence:** Baerveldt Glaucoma Implant currently manufactured by Pharmacia Iovision.

**Intended Use:** The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.

**General Description:** The Baerveldt Pars Plana Glaucoma Implant is a non-valved, artificial drainage device that shunts aqueous via a tube to an episcleral plate over the equatorial regions of the globe. It is constructed entirely of medical grade silicone with an episcleral plate. The implant is molded to conform to the curvature of the glove with a 13 mm convex radius. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI, and plain skull films. A silicone tube connected to an "elbow" for insertion into the posterior chamber is attached to the anterior surface of the plate. The proximal portion of the plate has a flange with two large fixation holes for scleral attachment.

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## Device Comparison

The Baerveldt Pars Plana Glaucoma Implant is substantially equivalent to the Baerveldt Glaucoma Implant. Both share identical plates (BG 102-350 and BG 101-350, respectively) and differ only in that the pars plana device has a silicone "elbow" to facilitate placement of the tube in the posterior chamber.

## Comparison Data

Surgical performance of the both devices indicate that both perform comparably.

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