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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Molteno3 Glaucoma Implant:

Limitations of the Provided Information:

It's crucial to note that the provided documents (a 510(k) summary and the FDA's clearance letter) are extremely limited in their detail about the study and acceptance criteria. They are focused on establishing substantial equivalence for regulatory purposes, not on providing a comprehensive scientific publication of a study. As such, many of the requested details are not present in the given text.

Acceptance Criteria and Study Details for the Molteno3 Glaucoma Implant

Based on the provided K062252 510(k) summary:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion/Performance Metric (Implied)	Reported Device Performance
Clinical Equivalence (Overall Patient Outcomes)	"The outcomes through 22 months are substantially equivalent" to the original Double Plate Molteno Implant.
Safety Profile	(Not explicitly stated as a separate metric, but implied by "substantially equivalent clinical performance").
Intraocular Pressure (IOP) Reduction	(Not numerically stated, but the primary function for which it's compared).
Device Material Composition	"Identical in material composition to predicate Molteno Implant devices."

Note: The 510(k) process for substantial equivalence does not typically require predefined, specific numerical acceptance criteria in the same way a PMA or clinical trial for a novel device would. The "acceptance criterion" here is largely demonstrating equivalence to a predicate device.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Current data of 44 patients receiving the GS-175mm2".
- Data Provenance: Not specified (e.g., country of origin, specific clinics). The data is described as "current data," implying it's new data collected for this submission, which typically aligns with a prospective or concurrently collected retrospective study. However, without more information, it's impossible to definitively state if it was purely prospective. It's compared to "historical data," which by definition is retrospective.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not mentioned. The document does not provide any information about "ground truth" establishment by experts for the clinical outcomes data. Clinical outcomes in this context (IOP reduction, success/failure of the implant) are usually objective physiological measurements or predefined clinical endpoints (e.g., meeting target IOP, avoiding reoperation).
Adjudication Method for the Test Set:
- Not mentioned. There is no indication of an adjudication method in the provided text.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is specifically relevant to image-based diagnostic devices where multiple readers interpret cases. The Molteno3 Glaucoma Implant is a therapeutic device, so an MRMC study is not applicable here.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- N/A. The Molteno3 Glaucoma Implant is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.
The Type of Ground Truth Used:
- Clinical Outcomes/Patient Data: The "ground truth" implicitly refers to the actual clinical performance and outcomes in patients who received the Molteno3 Glaucoma Implant, particularly regarding its ability to reduce intraocular pressure and control disease progression. This is measured directly from patient follow-up. It's compared against the "historical data" of the predicate device for equivalence.
Sample Size for the Training Set:
- Not applicable/Not mentioned. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set." The Molteno3 is a "third generation design" based on prior engineering and clinical experience with earlier Molteno implants, so fundamental design principles would have been "trained" by years of experience, but not in the computational sense.
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As there is no training set in the computational sense, this question is not relevant. The device design would have evolved based on clinical feedback and performance of previous generations of the implant.

Summary

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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

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and head. The logo is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the bird symbol.

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 (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. 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:

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

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.”