(447 days)
The Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.
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.
The provided text describes a medical device, the Baerveldt Pars Plana Glaucoma Implant, its intended use, and its general description. It also mentions a comparison to a predicate device, the Baerveldt Glaucoma Implant, noting their identical plates and a minor difference in a silicone "elbow" for the pars plana device. The document states that surgical performance of both devices indicates they perform comparably.
However, the provided text does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in your prompt (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set sample size).
Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported performance, or to answer the subsequent questions about study details, as this information is entirely absent from the provided input. The document is a "PREMARKET NOTIFICATION [510(k)] SUMMARY" from 1997, which typically focuses on demonstrating substantial equivalence rather than presenting detailed clinical study results against specific performance criteria in the format you're requesting.
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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 16529Columbus, OH 43216 |
| Manufacturer: | Pharmacia Iovision34 MauchlyIrvine, 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.
§ 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.”