(104 days)
No
The device description and performance studies focus on a mechanical valve system for glaucoma management, with no mention of AI or ML technologies.
Yes
This device is a therapeutic device because its intended use is for the management of refractory glaucomas, which involves treating a medical condition. The device description also highlights its function in reducing excessive intraocular pressure.
No
Explanation: The device description clearly states it is an "ophthalmic implant" designed to "reduce excessive intraocular pressure by venting aqueous out of the anterior chamber." This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an ophthalmic implant consisting of physical components (silicone drainage tube, polypropylene valve body, silicone membrane valve system). It is a hardware device, 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 Description: The Ahmed™ Glaucoma Valve is an implantable ophthalmic device. It is surgically placed in the eye to manage intraocular pressure.
- Intended Use: The intended use is to manage refractory glaucomas by surgically venting aqueous humor from the anterior chamber. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a medical device used for surgical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ahmed™ Glaucoma Valve is indicated for the management of refractory glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.
Product codes (comma separated list FDA assigned to the subject device)
86 KYF
Device Description
The Ahmed™ Glaucoma Valve Bi-plate is a modification of an already approved device called the Ahmed™ Glaucoma Valve (AGV™) Ref. 510 (k) 925636 dated November 12, 1993. The Ahmed™ Glaucoma Valve (AGV™) is an ophthalmic implant for use in intractable Glaucoma. The device features a specially engineered, one way silicone membrane valve system designed to prevent collapse of the anterior chamber (AC) due to hypotony (abnormally low intraocular pressure) and to reduce excessive intraocular pressure by venting aqueous out of the anterior chamber through this control one way valve. The AGV™ implant consists of a silicone drainage tube, a polypropylene valve body to house the valve membrane, and to protect it from occlusion due to fibrosis. All materials used in the manufacturing of this device are of medical grade quality. No metallic or toxic substances are used in the manufacturing of this device. The AGV™ is terminally sterilized by gamma radiation. The AGV™ has a surface area of 184mm².
In this application, AGV™ with an attached Bi-plate is being compared with Molteno Double Plate for Substantial Equivalence and to demonstrate that AGV Bi-plate is safe and effective, In case of AGV Bi-plate, the attachment of Bi-plate is provided after the valve, as shown in this flow diagram: The image shows a diagram of the Ahmed Glaucoma Valve. The diagram shows the flow of aqueous humor from the anterior chamber through a narrow silicone tube into the valve body. The valve controls hypotony, and the aqueous flows freely onto a distributing plate attached to the valve. Finally, the aqueous flows through silicone tubing connecting to the Bi-Plate. Narrow silicone tubing connecting Bi-Plate.
From the stand point of materials, chemical composition and design characteristics, the AGV and the Molteno implant are similar in that each uses a silicone tube to carry excess aqueous in the eyes anterior chamber to the valve body. The valve body and the body of the second plates both in AGV and Molteno are made of polypropylene. Additionally the AGV has molded silicone water impermeable elastomeric valve membrane. This valve membrane prevents both hypotony, and the build-up of excessive pressure within the anterior chamber. The valve also prevents fluid back flow.
Dimensionally, the AGV Bi-Plate is Oval in shape, with a width of 13.0 mm, length of 16.0 mm, surface area of 360 mm², and height of 1.9 mm. Its inlet tube connecting to the Anterior Chamber has an inner diameter of 0.3 mm and outer diameter of 0.6 mm. The tube connecting the first plate to the second plate also has an inner diameter of 0.3 mm and outer diameter of 0.6 mm. The base plate and second plate are made of Polypropylene, and the inlet tube from the anterior chamber to the valve body and the connecting tube are Silicone tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye / Anterior Chamber
Indicated Patient Age Range
The clinical study included subjects ranging in age from 1 year to 87 years.
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
The clinical study of the AGV was performed in 50 patients at five centers for six months, as reported in 510(k) submission K925636. Fifty subjects were recruited for the study. After a pre-operative assessment, subjects were monitored at three immediate and intermediate post-operative periods (up to six weeks), and at additional intervals throughout a six month period. The subjects, ranging in age from 1 year to 87 years and consisting of 22 males (44%) and 28 females (56%), were found to have Glaucoma of various etiologies: Neovascular (13 subjects, 26%), Primary Open Angle (13 subjects, 26%), Closed-angle (10 subjects, 20%), Traumatic (1 subject, 2%), Juvenile (3 subjects, 6%), Infantile (3 subjects, 6%), Congenital (3 subjects, 6%), Comliued (3 subjects, 6%), and Secondary (1 subject, 2%).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
Non-clinical testing of AGV encompassed three main types: in vitro laboratory physical testing, in vitro and in vivo biocompatibility testing, and implant studies.
- In vitro laboratory physical testing: Involved fluid flow and pull tests. These tests demonstrated the valve's efficacy, one-way maintenance of proper pressure, strength of physical integrity, and acceptability of functional characteristics. Besides from destructive testing, no valve failures were observed.
- In vitro biocompatibility testing: Sensitive tests performed by several methods demonstrated that the valve and its components are non-toxic, non-irritating, and biocompatible.
- In vivo animal studies: Long-term and short-term animal studies using rabbits, where AGV was implanted, demonstrated its efficacy in controlling IOP (with the fellow eye used as a control) and tolerance of the device, further accepting it as a model for biocompatibility of the valve and its components.
Clinical Testing:
A clinical study of the AGV was performed in 50 patients at five centers for six months, as previously reported in 510(k) submission K925636.
- Sample Size: 50 patients (159 eyes for a separate clinical study by Huan et al. of the AGV not the Bi-plate specific to this 510k, but the data is referenced here. This separate study involved 144 patients.)
- Key Results:
- All fifty patients had a history of uncontrolled high IOP's, averaging 38.52 mm Hg.
- In the immediate post-operative period (4-28 hours), the mean pre-operative pressure dropped significantly to 9.66 ± 7.06 mm Hg.
- Four cases of hypotonia were reported (none with collapsed chambers) in the immediate post-operative period, attributed to iatrogenic causes, all resolved within the first few days.
- At the second post-operative reporting period (1-2 weeks), the mean IOP was 10.4 ± 4.5 mm Hg. Post-operative complications were seen in 20 subjects (40%), including mild/moderate iritis (12 cases), mild/moderate corneal edema (8 cases), three cases of hyphema, three subjects with choroidal detachment, three subjects with synechiae, and one case of tube/cornea contact.
- At the third exam period (4-6 weeks post-operative), IOPs of 49 patients averaged 14.59 ± 5.43 mm Hg. Ten subjects (20.4%) presented with the same complications as at 1-2 weeks, including three subjects with occlusion of the tube and one subject with exposed scleral graft.
- By the third and sixth month reporting periods (involving 42 and 34 subjects respectively), all post-operative complications had resolved. No adverse reactions were reported.
- The mean post-operative IOP in 34 subjects at six months after surgery was 16.03 mm Hg.
- Reference to Huan et al. (1999) study on AGV (not specifically the Bi-plate but the base device): Mean IOP reduced from 32.7 ± 0.8 mmHg before surgery to 15.9 ± 0.6 mm Hg after surgery (P
§ 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
JUL 13.1999
Contact Person:
Date of Summary Preparation:
K99 1072
CONFIDENTIAL
807.92 510(k) Summary 807.92 a (1) The submitter's name:
New World Medical, Inc. 10763 Edison Court Rancho Cucamonga, CA 91730 Phone: (909) 466-4304 (909) 466-4305 Fax: Email: info@ ahmed valve.com Dr. A. Mateen Ahmed March 30, 1999
INFORMATION SUBMITTED PURSUANT TO 21 CFR 807.87 (a) - (d) 807.92 (a) (2) Proprietary Name: Classification Name: Eye Valve Implant
807.92 (a) (3) An Identification of the legally marketed device to which the submitter claims equivalence.
The predicate device to which Substantial Equivalence is demonstrated is the double plate Molteno Implant, as manufactured by STAAR SURGICAL, Corp., and described in their pre-market notification K875099.
807.92 (a) (4) Description of the device that is the subject of pre-market notification submission.
The Ahmed™ Glaucoma Valve Bi-plate is a modification of an already approved device called the Ahmed™ Glaucoma Valve (AGV™) Ref. 510 (k) 925636 dated November 12, 1993. The Ahmed™ Glaucoma Valve (AGV™) is an ophthalmic implant for use in intractable Glaucoma.
1
99 1872
The device features a specially engineered, one way silicone membrane valve system designed to prevent collapse of the anterior chamber (AC) due to hypotony (abnormally low intraocular pressure) and to reduce excessive intraocular pressure by venting aqueous out of the anterior chamber through this control one way valve. The AGV™ implant consists of a silicone drainage tube, a polypropylene valve body to house the valve membrane, and to protect it from occlusion due to fibrosis. All materials used in the manufacturing of this device are of medical grade quality. No metallic or toxic substances are used in the manufacturing of this device. The AGV™ is terminally sterilized by gamma radiation. The AGV™ has a surface area of 184mm². This single plate valve was compared with Molteno Single Plate implant in Pre-market Notification Ref. 510 (k) 925636, and was given approval on November 12, 1993. Since then AGV™ has been very well accepted in the market, and has been proven to be safe and effective.
Some doctors feel that by increasing the surface area would help in ultimate reduction of IOP over longer time periods. This has been demonstrated by Molteno 1981, Brown & Cairns 1983, Molteno 1986, Beebe 1989, Fellman 1989, Lieberman 1990, Llyod 1991, and Heuer 1992. Hence Molteno attached a second plate to the first plate calling it Double Plate Molteno. Molteno, and many other users, such as Brown, Beeb, Fellman, Lieberman, Lloyd, Minckler and others have implanted this Double Plate Molteno since 1981. This device is found to be safe and effective.
The most important clinically significant advantage of using the AGV was reduction in hypotony and complications. In a recently published clinical study by Huan et al "Intermediate-term clinical experience with the Ahmed™ Glaucoma Valve implant. " AmJ Ophthal. 1999; 127: 27-33. The results are reported as follows:
A multi-center, retrospective, clinical follow up of 159 eyes (144 patients) treated with AGV with a mean ± SEM follow up of 13.4± 0.7 months (range 4 to 44 months). The mean SEM age was 60.9 ± 1.9 years (range 0.1 to 103 years). The intraocular pressure was reduced from a mean of 32.7 ± 0.8 mmHg before surgery to 15.9 ± 0.6 mm Hg (P