The Ahmed™ Glaucoma Valve is indicated for the management of refractory qlaucomas, 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 dlaucoma, and refractory glaucomas resulting from aphakia or uveitis.

Device Description

The Ahmed™ Glaucoma Valve (AGV) S3 is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve membrane. The valve membrane is sandwiched between a top plate made of polyprolylene and a complementary bottom plate made of polypropylene. The bottom plate is extended to provide for aqueous distribution and drainage. The valve body conforms to the shape of the globe at its equator and protects the valve from blockage by fibrous tissue growth.

The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3. The M4 valve system is enclosed within a porous material (MEDPOR®) made of polyethylene (MEDPOR® is well established as a safe material and has been approved by the FDA for ocular use).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ahmed Glaucoma Valve Model M4. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove specific performance against detailed acceptance criteria using a clinical study with quantifiable metrics like sensitivity or specificity for an AI device.

Therefore, the following information is extracted based on the context of a 510(k) for a medical device that is not an AI algorithm. The device, an Ahmed Glaucoma Valve Model M4, is a physical implant, and the "study" referred to is biocompatibility and comparative physical/biological effects, not an AI performance study.

Here's the breakdown based on the provided text, adapted to reflect that this is not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-AI medical device, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, particularly concerning safety and effectiveness through biocompatibility and functional comparison. Specific performance metrics like sensitivity/specificity for AI are not applicable here.

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
Material Biocompatibility: The new material (MEDPOR®) in Model M4 should be biocompatible.	The M4 valve system is enclosed within MEDPOR® (polyethylene), which is "well established as a safe material and has been approved by the FDA for ocular use." An animal study specifically compared the AGV™-S3 and AGV™-M4 and was "successful in demonstrating the biocompatibility of the M4."
Functional Equivalence: The M4 valve system should function similarly to predicate devices (S2 and S3) in terms of aqueous outflow regulation.	"The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3" in its core valving mechanism. The animal study showed that "resistance to outflow from the M4 to the surrounding tissue was significantly reduced when compared to the S3," suggesting an improvement in outflow characteristics related to the new porous material. The overall design for regulating intraocular pressure is considered equivalent.
Reduced Fibrosis/Improved Vascularization (with new material): The porous material in M4 should ideally improve tissue integration compared to non-porous designs.	The animal study showed that "the use of porous polyethylene in the M4 resulted in decreased collagen synthesis and increased vascularization in the tissue surrounding the implant when compared to the S3."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Animal Study): Not explicitly stated. The text only mentions "An animal study comparing the AGV™-S3 and AGV™-M4 was conducted."
Data Provenance: The study was an "animal study" conducted at "Duke University." It lasted "for over six months." It is a prospective study in an animal model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable to a non-AI medical device animal study. Ground truth, in the context of an animal study for a physical implant, would be derived from objective measurements (e.g., histology for collagen synthesis and vascularization, pressure measurements for outflow resistance, direct observation of biocompatibility).

4. Adjudication Method for the Test Set

Not applicable to a non-AI medical device animal study. Adjudication methods like 2+1 or 3+1 are typically used for human expert review in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-assisted) where human readers interpret cases. The study mentioned is an animal study evaluating the physical and biological characteristics of a glaucoma implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the animal study comparing the AGV™-M4 and AGV™-S3, the ground truth would be based on:

Histopathology/Biological Markers: For "decreased collagen synthesis and increased vascularization."
Physiological Measurements: For "resistance to outflow."
Clinical Observation/Pathology: For "biocompatibility."

8. The Sample Size for the Training Set

Not applicable. This is a physical implant, not an AI algorithm. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a physical implant.

Summary

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Kob044

SEP 1 8 2006

PREMARKET NOTIFICATION [510(K)] SUMMARY

This summary information is been submitted in accordance to the requirements of The Safe Medical Devices Act of 1990

Distributor :	New World Medical, Inc.10763 Edison CourtRancho Cucamonga, CA 91730
Manufacturer :	New World Medical, Inc.10763 Edison CourtRancho Cucamonga, CA 91730
Telephone/Fax :	909/466-4304; Fax 909/466-4305
Company Contact Person :	A. Mateen Ahmed, PhD/President
Trade Name :	Ahmed Glaucoma Valve Model M4
Common Name :	Glaucoma Implant
Classification :	Class : II 886.3920Panel : Ophthalmic (OP)Product Code : KYF
Date Summary Prepared :	June 5th, 2006

Substantial Equivalence :

The Ahmed Glaucoma Valve Model M4 is substantially equivalent to the Ahmed Glaucoma Valve Model S2 and S3 currently manufactured by New World Medical, Inc.

Intended Use :

The Ahmed Glaucoma Valve Model M4 is intended for use in patients with intractable glaucoma to reduce intraocular pressure where medical and conventional surgical treatments have failed.

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KD60644

General Description :

An animal study comparing the AGV™-S3 and AGV™-M4 was conducted at Duke University. The study lasted for over six months and was successful in demonstrating the biocompatibility of the M4. In addition, it showed that the use of porous polyethylene in the M4 resulted in decreased collagen synthesis and increased vascularization in the tissue surrounding the implant when compared to the S3. Furthermore, resistance to outflow from the M4 to the surrounding tissue was significantly reduced when compared to the S3.(Dozier, 2006)

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Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 8 2006

New World Medical, Inc. c/o A. Mateen Ahmed, Ph.D. President 10763 Edison Court Rancho Cucamonga, CA 91730

Re: K060644

Trade/Device Name: Ahmed Glaucoma Valve Model M4 Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: August 25, 2006 Received: August 28, 2006

Dear Dr. Ahmed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelman SimWD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Applicant :___New World Medical, Inc.

510(k) Number (if Known):

Device Name : Ahmed Glaucoma Valve Implant Model M4

Indications for Use:

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Current of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises	(Per 21 CFR 801.109) (Optional Format 1-2-96)
510(k) Number	K060644

Regulation Number and Section

§ 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.”