AHMED GLAUCOMA VALVE, MODEL M4

K060644 · New World Medical, Inc. · KYF · Sep 18, 2006 · Ophthalmic

Device Facts

• Record ID: K060644
• Device Name: AHMED GLAUCOMA VALVE, MODEL M4
• Applicant: New World Medical, Inc.
• Product Code: KYF · Ophthalmic
• Decision Date: Sep 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3920
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Ahmed Glaucoma Valve Model M4 is a valved aqueous drainage implant for intractable glaucoma. Device consists of silicone drainage tube connected to valve membrane sandwiched between polypropylene plates. M4 system is identical to S2/S3 models but enclosed within porous polyethylene (MEDPOR) material. Implanted by ophthalmic surgeons to regulate intraocular pressure. Porous polyethylene enclosure promotes tissue integration, decreasing collagen synthesis and increasing vascularization compared to non-porous models, while reducing outflow resistance to surrounding tissue. Benefits include improved biocompatibility and pressure regulation in patients failing conventional surgical treatments.

Clinical Evidence

Bench testing and a six-month animal study conducted at Duke University. Study compared AGV-S3 and AGV-M4. Results demonstrated M4 biocompatibility, decreased collagen synthesis, increased tissue vascularization, and significantly reduced resistance to outflow compared to the S3 model.

Technological Characteristics

Valved aqueous drainage implant. Materials: silicone drainage tube, polypropylene valve plates, porous polyethylene (MEDPOR) enclosure. Principle: passive pressure-regulated valve. Form factor: conforms to globe equator. Non-electronic, mechanical device.

Indications for Use

Indicated for management of refractory glaucomas where previous surgery failed or is known to be unsatisfactory. Includes neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital/infantile glaucoma, and refractory glaucomas from aphakia or uveitis.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Ahmed Glaucoma Valve Model S2
• Ahmed Glaucoma Valve Model S3

Submission Summary (Full Text)

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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.<br>10763 Edison Court<br>Rancho Cucamonga, CA 91730 |
|--------------------------|-----------------------------------------------------------------------------|
| Manufacturer : | New World Medical, Inc.<br>10763 Edison Court<br>Rancho Cucamonga, CA 91730 |
| Telephone/Fax : | 909/466-4304; Fax [phone] |
| Company Contact Person : | A. Mateen Ahmed, PhD/President |
| Trade Name : | Ahmed Glaucoma Valve Model M4 |
| Common Name : | Glaucoma Implant |
| Classification : | Class : II 886.3920<br>Panel : Ophthalmic (OP)<br>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 :

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).

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 [phone]. 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 [phone] or [phone] 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:

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.

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 |