MOLTENO3

K062252 · Iop, Inc. · KYF · Sep 27, 2006 · Ophthalmic

Device Facts

• Record ID: K062252
• Device Name: MOLTENO3
• Applicant: Iop, Inc.
• Product Code: KYF · Ophthalmic
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3920
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aqueous shunt is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

Device Story

Molteno3 Glaucoma Implant is an aqueous shunt designed to manage intraocular pressure. Device consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. Implanted surgically by ophthalmologists to facilitate aqueous humor drainage, reducing pressure in eyes where conventional treatments failed. Third-generation design optimizes single-quadrant bleb performance and simplifies surgical insertion and postoperative management. Benefits include disease progression control in refractory glaucoma cases.

Clinical Evidence

Clinical study of 44 patients receiving the GS-175mm2 implant compared to historical data of the original Double Plate Molteno Implant. Outcomes evaluated through 22 months showed substantial equivalence.

Technological Characteristics

Aqueous shunt comprising a flexible silicone translimbal tube and a polypropylene episcleral plate. Designed for single-quadrant placement.

Indications for Use

Indicated for patients with neovascular glaucoma or glaucoma refractory to medical and conventional surgical treatments to reduce intraocular pressure.

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

• Double Plate Molteno Implant

Submission Summary (Full Text)

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### This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is:

Contact person:

K062252 - -

Jason Malecka President IOP, Inc. 3184-B Airway Avenue Costa Mesa, CA 92626

Date Prepared:

July 24, 2006

Device Name and Classification

Proprietary Name: Common Name: Classification Name: Product Code: Regulation No .:

Molteno3 Glaucoma Implant Aqueous Shunt KYF 886.3920

#### Device Description

The Molteno3 Glaucoma implant consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. This third generation design is intended to maximize single quadrant bleb performance and simplify insertion and postoperative management.

#### Indications for Use

The aqueous shunt is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

#### Summary of Testing

Current data of 44 patients receiving the GS-175mm2 were compared to historical data of the original Double Plate Molteno Implant. The outcomes through 22 months are substantially equivalent.

#### Substantial Equivalence Claim

The Molteno3 is identical in material composition to predicate Molteno Implant devices and has demonstrated substantially equivalent clinical performance.

SEP 2 7 2006

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 7 2006

IOP, Inc. c/o Mr. Jason Malecka President 3184 Airway Avenue, Building B Costa Mesa, CA 92626

Re: K062252

Trade/Device Name: Molteno3 Glaucoma Implant Regulation Number: 21 CFR 886.3920 Regulation Name: Glaucoma Implant Regulatory Class: II Product Code: KYF Dated: July 27, 2006 Received: August 3, 2006

Dear Mr. Malecka:

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 (OS) 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 - Mr. Jason Malecka

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. Egdelsin SimD

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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# Indications for Use

510(k) Number (if known): 上の62252

Molteno3 Glaucoma Implant Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular The Molten.> Elawoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kridalika Virani

Division Sign-Off vision of Ophthalmic Ear. Nose and Throat Devise

510(K) Number Y(062252