(74 days)
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.
The Ahmed™ Glaucoma Valve (AGV™) is a 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 a build-up of excessive intraocular pressure, by venting aqueous humor from the eye. The AGV™ implant consists of a silicone drainage tube and polypropylene valve body to house the valve membrane and protect it from occlusion by fibrosis. All materials used in the manufacture of the device are of medical grade quality. No toxic substances are used in the manufacturing process. The AGV is terminally sterilized by gamma ray radiation.
The Acceptance Criteria and Device Performance for the Ahmed™ Glaucoma Valve Model S3 are based on a clinical study of its predicate device, the Ahmed™ Glaucoma Valve Model S2. The S3 model was deemed substantially equivalent to the S2 model.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Success Definition) | Reported Device Performance (at 6 months post-operatively) |
|---|---|
| "Success": Post-operative Intraocular Pressure (IOP) of ≤ 21 mmHg and ≥ 5 mmHg, while maintaining or improving visual acuity, without the use of glaucoma medications. | Visual acuity was preserved or improved, and IOPs were reduced to 21 mmHg or less and greater than 5 mmHg in 43 out of 50 subjects (86%). The mean post-operative IOP at six months was 15.33 ± 4.5 mmHg. The document implies without medication, as a "qualified success" would delineate medication use. |
| "Qualified Success": Post-operative IOP of ≤ 21 mmHg and ≥ 5 mmHg, while maintaining or improving visual acuity, with the use of glaucoma medications. | Not explicitly reported as a separate metric; however, the "Success" rate (86%) indicates a high proportion of patients met the primary endpoint, presumably without needing additional medication in many cases. Any patients needing medication while still meeting the IOP and visual acuity criteria would fall into this category. |
| "Failure": Post-operative IOP of > 21 mmHg. | 7 out of 50 subjects (14%) were considered "failures" according to this definition. |
| No valve failures observed in non-clinical experiments (in vitro and in vivo animal studies). | "Aside from destructive testing, no valve failures were observed in any experiments." |
| Biocompatibility and non-toxicity of materials. | "Sensitive in vitro biocompatibility testing, performed by several methods, demonstrated that the valve and its components are non-toxic, non-irritating, and biocompatible." |
| Efficacy in controlling IOP in animal models. | "An in vivo, long-term and short-term animal studies using rabbits in which the AGV™ was implanted demonstrated it efficacy with regard to control of IOP, with the fellow eye used as a control, tolerance of the device, and offered further substantiation in this animal model of biocompatibility of the valve and its components." |
| Mechanism to prevent anterior chamber collapse due to hypotony and vent aqueous humor from the eye. | "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 a build-up of excessive intraocular pressure, by venting aqueous humor from the eye." "No cases of collapsed chambers were reported." |
| Immediate control of intraocular pressure upon implantation. | "In the immediate post-operative period (4-28 hours), the mean preoperative IOP decreased to 9.66 ± 7.06 mmHg." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: 50 subjects.
- Data Provenance: Prospective clinical study conducted at six (6) institutions. The country of origin is not explicitly stated, but the submission is to the US FDA, implying it was likely conducted in the US or under US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth:
- The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. For medical device studies of this nature, clinical investigators (ophthalmologists, for this device) at the participating institutions would be responsible for patient assessments and data collection, which inherently forms the basis of the "ground truth." The study involved monitoring by medical professionals.
4. Adjudication Method:
- The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set. Clinical trials typically involve multiple investigators and a study monitor following a pre-defined protocol. The results presented are the aggregated outcomes from the participating institutions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the performance of a medical device (Ahmed™ Glaucoma Valve) in human subjects, not an assessment of human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone (algorithm only) performance study was not done. The device is a physical implant, not an AI algorithm. The studies focused on the performance of the physical device after implantation.
7. Type of Ground Truth Used:
- The ground truth was established through clinical outcomes data collected directly from patients after device implantation. This included measurements of intraocular pressure (IOP), assessment of visual acuity, and monitoring for post-operative complications, evaluated by medical professionals.
8. Sample Size for the Training Set:
- This information is not applicable. The device is a physical implant, not an AI algorithm that requires a "training set" in the computational sense. The "training" or development of the device would involve engineering, material science, and pre-clinical testing, not a data-based training set.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable for the same reason as above. The "ground truth" for the development of the physical device would be derived from physiological principles, material properties, and pre-clinical models (in vitro and animal studies) that guide its design and demonstrate its intended function.
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APR 20 1998
- 12.1
510(k) SUMMARY
(1) Submitter Information:
New World Medical, Inc. 10574 Acacia Street, Suite D-1 Rancho Cucamonga, CA 91730 Telephone: (909) 466-4304
Contact Person: A. Mateen Ahmed, Ph.D. Date of Summary Preparation: April 9, 1998
(2) Device Name: Ahmed™ Glaucoma Valve
- Proprietary Name: Ahmed™ Glaucoma Valve a) Model S2
- Classification Name: Eye Valve Implant b)
The predicate device to which substantial Equivalence is demonstrated is the 3)
Ahmed™ Glaucoma Valve Implant Model S2, as manufactured by New World Medical, Incorporated, and described in their Premarket Notification, K925636. The new Device is Ahmed™ Glaucoma Valve Model S3, K980657.
Device Description (4)
The Ahmed™ Glaucoma Valve (AGV™) is a 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 a build-up of excessive intraocular pressure, by venting aqueous humor from the eye. The AGV™ implant consists of a silicone drainage tube and polypropylene valve body to house the valve membrane and protect it from occlusion by fibrosis.
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All materials used in the manufacture of the device are of medical grade quality. No toxic substances are used in the manufacturing process. The AGV is terminally sterilized by gamma ray radiation.
The AGV™ implant begins to control intraocular pressure immediately upon implantation, which is accomplished in a single, simple procedure. The polypropylene valve body is sutured to the episclera, between the superior medial or lateral rectus muscles. The silicone drainage tube is inserted into the anterior chamber at the limbus.
(5) Intended Use:
The AGV™ is indicated in the management of intractable glaucoma. This may be generally defined as primary glaucoma, where previous filtering procedures have failed or are known to provide unsatisfactory results. These may be generally defined as primary neovascular glaucoma and secondary glaucomas associated with clinically elevated IOP's in patients with previously failed glaucoma surgery associated with primary open angle glaucoma, angle closure glaucoma, aphakia and congenital or infantile glaucomas.
6(A) Technological Characteristics
From the standpoint of materials, chemical composition and design characteristics, the AGV™ Model S2 and the AGV™ S3 are similar in that each uses a silicone tube to carry excess aqueous in the eye's anterior chamber to the valve body. The valve body of both devices is made of polypropylene. Additionally, both have a molded silicone water impermeable elastomeric valve membrane. This valve membrane prevents the build-up of excessive intraocular pressure.
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Dimensionally, the following comparisons are tabulated for both the AGV Model S2 and the Ahmed™ Glaucoma Valve (AGV™) Model S3
| Valve Implant | Shape | Width(mm) | Length(mm) | Surface(mm) | Height(mm) |
|---|---|---|---|---|---|
| Ahmed™ Model S2 OvalSingle Plate | Oval | 13 | 16 | 184 | 1.9 |
| Ahmed™ Model S3 Oval | Oval | 9.6 | 10 | 96 | 1.9 |
| TubeInnerDiameter(mm) | TubeOuterDiameter(mm) | ||||
| Ahmed™ Model S2Single Plate | 0.317 | 0.635 | |||
| Ahmed™ Model S3 | 0.317 | 0.635 |
Surgical implantation of the AGV™ Model S2 is essentially identical to that of the AGV™ S3, as is the mechanism of encapsulation of the plate by tissue (bleb formation). After the bleb has been formed, the AGV™ S3 functions in a manner similar to that of AGVTM S2.
Nonclinical testing of the AGV™ encompassed three main types of (6) (b) (1) testing: in vitro laboratory physical testing, in vitro and in vivo biocompatibility testing, and animal implant studies. Aside from destructive testing, no valve failures were observed in any experiments.
In vitro laboratory physical testing involving fluid flow, and pull tests of various types, demonstrate the valve's efficacy and its one-way maintenance of proper pressure, the strength of its physical integrity, and acceptability of the device's functional characteristics.
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Image /page/3/Picture/0 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letters 'K9', followed by the digits '86', then '65', and ends with the digit '7'. The handwriting style is cursive, with some digits and letters connected.
Sensitive in vitro biocompatibility testing, performed by several methods, demonstrated that the valve and its components are non-toxic, non-irritating, and biocompatible.
An in vivo, long-term and short-term animal studies using rabbits in which the AGV™ was implanted demonstrated it efficacy with regard to control of IOP, with the fellow eye used as a control, tolerance of the device, and offered further substantiation in this animal model of biocompatibility of the valve and its components.
Clinical testing of the AGV™ Model S2 was performed at six (6) 6(b) (2) institutions, to determine the substantial equivalence of the device.
Fifty subjects were recruited for the study. After a pre-operative assessment, subjects were monitored at three immediate and intermediate postoperative 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 the following etiologies:
| Type of Glaucoma | No. Subjects | Percentages | |
|---|---|---|---|
| 1. | Neovascular | 13 | 26% |
| 2. | Primary Open Angle | 13 | 26% |
| 3. | Closed-Angle | 10 | 20% |
| 4. | Traumatic | 1 | 2% |
| 5. | Juvenile | 3 | 6% |
| 6. | Infantile | 3 | 6% |
| 7. | Congenital | 3 | 6% |
| 8. | Combined | 3 | 6% |
| 9. | Secondary | 1 | 2% |
All fifty patients had a history of uncontrolled high IOP's, averaging 38.52 mmHz. In the immediate post-operative period (4-28 hours), the mean preoperative IOP decreased to 9.66 ± 7.06 mmHg. Hypotony defined as ≤ 5 mmHg was reported in 16 patients. No cases of collapsed chambers were reported.
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At the second post-operative reporting period (1-2 weeks), the mean IOP was 10.40 ± 4.5 mmHg. Post-operative complications presented in 20 subjects (40%) at this stage and included mild and moderate iritis (12 cases), mild and moderate corneal edema (8 cases), hypotony (7 cases), hyphema (3 cases), choroidal detachment (3 cases), synechiae (3 subjects) tube/cornea contact (1 case).
At the third exam period (4-6 weeks p.o.), IOPs of 49 patients averaged 14.59 ± 5.43 mmHg. Ten subjects (20.4%) presented with the same complications seen at the 1-2 week reporting period including three subjects with occlusion of the drainage tube, and one case of exposed scleral graft.
By the third and sixth month reporting periods, (involving 48 subjects), no adverse reactions were reported. The mean post-operative IOP in 48 subjects at six months after surgery was 15.33 ± 4.5 mmHg.
A comparison of results of the sponsor's clincial study of the Ahmed™ Glaucoma Valve Model S2 to the Ahmed™ Glaucoma Valve Model S3 was presented by the sponsor. This confirms the performance of the Ahmed™ Glaucoma Valve Model S3 is no different than the presently marketed device the Ahmed™ Glaucoma Valve Model S2.
(6) (b) (3)
The nonclinical tests described in this Summary demonstrate that the AGV™ is nontoxic, biocompatible, and physically functional. Another indicator of the safety, and to an extent, the efficacy of the device, was demonstrated by the successful outcome of animal implant experiments.
Additionally, another determination of the success or failure was made six months post-operatively. In the Ahmed™ valve study, "success" was defined as achievement of a post-operative IOP of 21 mmHg or less, while maintaining or improving visual acuity without the use of glaucoma medications.
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A "qualified success" was defined as achievement of a post-operative IOP of 21 mmHg or less, while maintaining or improving vision, with the use of glaucoma medications. Any subject having a post-operative IOP of greater than 21 mmHg was considered a "failure."
At six months post-operatively, visual acuity was preserved or improved and IOPs were reduced to 21 mmHg or less and greater than 5 mmHg in 43 of 50 subjects.
The lowering of intraocular pressure achieved with the Ahmed™ Glaucoma Valve is attributed to its physical properties which are similar to other eye valve implants. It creates a channel via the silicone tube for aqueous flow from the anterior chamber to a bleb formed around the encapsulated polypropylene plate. Clinically intraocular pressure is maintained at an acceptable level in 43 of 50 subjects at six months with this device design.
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Brown RD, Cairns, JE: Experience with the Molteno long tube implant. Trans. Oph. Soc. 1 U.K. 1983; 103: 297-311
Freedman J: The use of the single stage Molteno long tube seton in treating 2 resistant cases of glaucoma. Ophthalmic Surgery 1985; 16: 480-483.
Hoare Nairne JEA, Sherwood D, et al: Single stage insertior of the Molteno tube for 3 glaucoma and modificatons to reduce postoperative hypotony. Br J Ophthalmol 1988; 72: 846-851.
4 Lieberman MF, Ewing RH: Drainage implant surgery for refractory glaucoma. Internaitonal Ophthalmology Clinics 1990; 30: 198-208.
Lloyd MA, Sedlak T, Huer DK, et al: Clincial experience with the single-plate 5 Molteno implant in complicated glaucomas. Ophthalmology 1992; 99: 679-687.
Melamed S, Cahane M, Gutman I, Blumementhal M: Postoperative complications 6 after Molteno implant surgery. Am J Ophthalmol 1991; 111: 319-322.
Minckler DS, Heuer DK, Hasty B, et al: Clincial experience with the single-plate 7 Molteno implant in complicated glaucomas. Ophthalmology 1988; 95: 1181-1188.
Molteno ACB, Van Biljon G, Ancker E: Two-stage instertion of glaucoma drainage 8 implants. Trans Oph Soc New Zealand 1979; 31: 17-26.
Molteno ACB, Van Rooyen MMB, Bartholomew RS: Implants for draining ਰੇ neovascular glaucoma. Br J Ophthalmol 1977; 61: 120-125.
10 Molteno ACB: The optimal design of drainage implants for glaucoma. Trans. Ophthalmol Soc New Zealand 1981; 33: 39-41.
- Molteno ACB, Polkinghorne PJ, Bowbyes JA: The vicryl tie technique for inserting a draining implant in the treatment of secondary glaucoma. Aust, and NZ J Ophthalmolo 1986; 14: 343-354.
12 Wilson RP, Cantor L, Katz LJ, et al: Aqueous shunts - Molteno versus Schocket. Ophthalmology 1992; 99: 672-678.
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Image /page/7/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 20 1998
A. Mateen Ahmed, Ph.D. President New World Medical, Inc. 10574 Acacia Street Suite D-1 Rancho Cucamonga, CA 91730
Re: K980657 Trade Name: Ahmed Glaucoma Valve, Model S3 Regulatory Class: Class III Product Code: KYF Dated: February 2, 1998 Received: February 5, 1998
Dear Dr. Ahmed:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice reguirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - A. Mateen Ahmed, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1 -
510(k) Number (if known): ___________________K980657
Device Name:___Ahmed Glaucoma Valve, Model S3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Alexander he DRL
(Division Sign-Off) /
Division of Ophthalmic Devices
510(k) Number K980657
Prescription Use_Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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.”