(214 days)
Not Found
No
The device description details a purely mechanical implant for draining fluid. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
Yes
The device is intended to reduce intraocular pressure, which is a physiological parameter, in patients with glaucoma, which is a disease.
No
The device is an implant designed to reduce intraocular pressure, which is a treatment for glaucoma, not a diagnostic tool used to identify or analyze a condition.
No
The device description clearly describes a physical, implantable medical device made of stainless steel, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ex-Press™ Miniature Glaucoma Implant is a surgical implant designed to be placed inside the eye to drain fluid and reduce intraocular pressure. It does not analyze samples taken from the body.
- Intended Use: The intended use is to reduce intraocular pressure in patients with glaucoma, which is a direct treatment/management of a condition within the body, not an in vitro diagnostic test.
The description clearly indicates it's an implantable medical device used for surgical intervention.
N/A
Intended Use / Indications for Use
The Ex-PRESS™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
Product codes (comma separated list FDA assigned to the subject device)
KYF
Device Description
The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt needle shaped penetrating tip at one end and a flat, angled flange at the opposite (distal) end. The device is 2.96mm in length and 0.4mm in diameter. The device consists of a tube whose purpose is to capture aqueous fluid from the anterior chamber of the eve and transport the fluid to the distal end and out of the device from which the fluid then moves into a conjunctival bleb. There are three transverse reserve openings near the proximal end of the device to serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the device serves as a reservoir and prevents intrusion into the eye. The spur along the bottom of the device prevents extrusion of the device and serves as an anchor. The material of the device is a medical grade stainless steel composition similar in characteristics to other medical implant devices for different indications for use. The device has a stainless steel wire embedded in the tube transverse to the shaft. The purpose of the wire is to restrict the flow passing through the tube. The device drains aqueous humor from the anterior chamber to relieve excessive intraocular pressure associated with glaucoma. The devices available are the R-30 and R-50 versions that represent different flow characteristics created by different wire diameters welded inside the device. The higher the R- number, the lower the resistance of the device to flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chamber of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical study was a prospective, open-label, multi-center study conducted at 14 international sites in 8 countries outside of the United States. There were 113 open-angle glaucoma patients enrolled into 3 protocols: [1] Failed medical therapy or laser trabeculoplasty, {2} Failed medical therapy or laser trabeculoplasty patients who underwent a combined Ex-PRESS™ implantation and cataract surgery and, [3] Failed filtering surgery (trabeculectomy).
The safety and effectiveness evaluation was done on a total of 113 patients implanted with the R-30 and R-50, 58 consecutive patients completed a one-year follow-up (defined as Per-Protocol cohort). The cumulative probability of success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year (Kaplan-Meier survival curve) was 77%, where success was defined as an IOP reduction greater than 20% from baseline with or without medications (overall success). The cumulative probability of success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year (Kaplan-Meier survival curve) was 83%, where success was defined as an IOP less than 21 mmHg with or without medications (overall success).
The overall success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year was 80.4% (weighted mean), where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. The overall success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year was 75.9%, where overall success was defined as an IOP
§ 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.”
0
K012852
510(k) Summary
SUBMITTER:
Submitted on behalf of:
Company Name: Address:
Phone: Fax:
CONTACT PERSON:
Optonol, Ltd. Communication Center Neve Ilan 90850 Israel (972) 2 5349666 (972) 2 5349660
Richard E. Lippman, O.D., F.A.A.O. Official Representative and Correspondent C.L. McIntosh, Inc. 12300 Twinbrook Parkway Suite 230 Rockville, MD 20852
DATE SUMMARY PREPARED:
February, 2002
TRADE NAME: COMMON NAME: Ex-PRESS™ Miniature Glaucoma Implant Eye valve implant
SUBSTANTIALLY EQUIVALENT TO:
The Ex-PRESS™ Miniature Glaucoma Implant is a drainage device for the anterior chamber of the eye to relieve intraocular pressure in patients with glaucoma from failed medical therapy and failed prior surgical intervention. The device is substantially equivalent to the Ahmed Glaucoma Valve (K980657), the OptiMed Glaucoma Shunt (K903462) and the Baerveldt Glaucoma Shunt (K905129 and K955455).
DESCRIPTION of the DEVICE:
The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt needle shaped penetrating tip at one end and a flat, angled flange at the opposite (distal) end. The device is 2.96mm in length and 0.4mm in diameter. The device consists of a tube whose purpose is to capture aqueous fluid from the anterior chamber of the eve and transport the fluid to the distal end and out of the device from which the fluid then moves into a conjunctival bleb. There are three transverse reserve openings near the proximal end of the device to serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the device serves as
1
a reservoir and prevents intrusion into the eye. The spur along the bottom of the device prevents extrusion of the device and serves as an anchor. The material of the device is a medical grade stainless steel composition similar in characteristics to other medical implant devices for different indications for use. The device has a stainless steel wire embedded in the tube transverse to the shaft. The purpose of the wire is to restrict the flow passing through the tube.
The device drains aqueous humor from the anterior chamber to relieve excessive intraocular pressure associated with glaucoma. The devices available are the R-30 and R-50 versions that represent different flow characteristics created by different wire diameters welded inside the device. The higher the R- number, the lower the resistance of the device to flow.
INDICATIONS FOR USE:
The Ex-PRESS™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
PARAMETERS AVAILABLE:
The Ex-PRESS™ Miniature Glaucoma Implant is available in the following models: R-30 and R-50.
PRECLINICAL INFORMATION
A battery of preclinical tests including biocompatibility evaluations of intramuscular implantation in rabbits, cytotoxicity tests, animal ocular implantations for safety and tolerance, and an LAL Endotoxicity Test were conducted. In each of these tests the results indicate that the device is nontoxic and the tests indicate that no additional questions of safety are raised.
Physical evaluations including dimensional and surface quality tests, pressure/flow characteristics and structural integrity laboratory bench tests were conducted and determined as acceptable for this device as required in the FDA Guidance: Aqueous Shunts- 510(k) Submissions, November 16. 1998.
CLINICAL TESTING
The clinical study was a prospective, open-label, multi-center study conducted at 14 international sites in 8 countries outside of the United States. There were 113 open-angle glaucoma patients enrolled into 3 protocols: [1] Failed medical therapy or laser trabeculoplasty, {2} Failed medical therapy or laser trabeculoplasty patients who underwent a combined Ex-PRESS™ implantation and cataract surgery and, [3] Failed filtering surgery (trabeculectomy).
The studies were conducted in accordance with the Helsinki Declarations for protection of human subjects and the applicable laws and regulations in each country. Study sites were monitored and managed by Optonol Ltd.
2
There was a 1-year follow-up period with intermediate scheduled examinations that included tonometry, gonioscopy, and slit-lamp examination.
The safety and effectiveness evaluation was done on a total of 113 patients implanted with the R-30 and R-50, 58 consecutive patients completed a one-year follow-up (defined as Per-Protocol cohort).
The cumulative probability of success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year (Kaplan-Meier survival curve) was 77%, where success was defined as an IOP reduction greater than 20% from baseline with or without medications (overall success). The cumulative probability of success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year (Kaplan-Meier survival curve) was 83%, where success was defined as an IOP less than 21 mmHg with or without medications (overall success).
The overall success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year was 80.4% (weighted mean), where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. The overall success for the Per Protocol cohort (R-30 and R-50, n=58) at 1 year was 75.9%, where overall success was defined as an IOP