K Number
K955455
Device Name
BAERVELT PARS PLANA GLAUCOMA IMPLANT
Date Cleared
1997-02-18

(447 days)

Product Code
Regulation Number
886.3920
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.
Device 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.
More Information

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Not Found

No
The device description and other sections focus on the physical construction and function of a passive implant, with no mention of AI/ML capabilities or data processing beyond basic imaging for identification.

Yes
The device is used to treat medically uncontrollable glaucoma by shunting aqueous humor, which directly addresses a pathological condition.

No
The device is an artificial drainage implant used to treat glaucoma, not to diagnose it. It is a therapeutic device.

No

The device description clearly states it is a physical implant constructed of medical grade silicone with an episcleral plate and tube, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to treat glaucoma by surgically implanting a device to drain aqueous humor. This is a therapeutic intervention performed on a patient's body.
  • Device Description: The device is a physical implant made of silicone, designed to be surgically placed within the eye.
  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.

This device is a surgical implant used in vivo (within the living body) for treatment, not for analyzing samples in vitro.

N/A

Intended Use / Indications for Use

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

Product codes

KYF

Device 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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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

Key Metrics

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Predicate Device(s)

Baerveldt Glaucoma Implant

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 886.3920 Aqueous shunt.

(a)
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.(b)
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.”

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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:(614) 761-4511; Fax (614) 764-8125
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.