The Molteno3 S-Series glaucoma implant 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 Description

The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.

The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.

The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.

The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.

AI/ML Overview

The provided text describes the Molteno3 S-Series Glaucoma Implant and its comparison to the predicate Molteno3 G-Series implant for 510(k) clearance. The document focuses on demonstrating substantial equivalence rather than defining and proving acceptance criteria with specific performance metrics against a predetermined threshold for a novel device.

Therefore, the acceptance criteria are implicitly defined by the demonstrated substantial equivalence to the predicate device, meaning the new device performs "as safe and effective" as the predicate device. The study aims to show that there is "no clinically significant difference in outcome" between the new and predicate device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details, particularly specific performance acceptance criteria with numerical thresholds, are not explicitly stated in this type of substantial equivalence document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds defined for the new device's performance but rather the demonstration that its performance is equivalent to the predicate device. The "reported device performance" refers to the outcomes observed in the clinical study for the S-Series device and the comparison to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (S-Series vs. Predicate)
Safety and Effectiveness equivalent to predicate device	Clinical comparison established "no clinically significant difference in outcome" between the S-Series and the predicate G-Series implant.
IOP (Intraocular Pressure) reduction	Outcome data for IOP reduction evaluated; found to be not clinically significantly different from predicate.
Post-operative reductions (other relevant parameters)	Outcome data evaluated; found to be not clinically significantly different from predicate. (Specific parameters not detailed beyond IOP)
Visual Acuity	Outcome data for visual acuity evaluated; found to be not clinically significantly different from predicate.
Adverse Events	Data on relevant adverse events evaluated; found to be not clinically significantly different from predicate.
Material composition and manufacturing process	Identical to predicate device.
Sterilization effectiveness (Bacterial Endotoxin Testing)	In conformity with FDA's recommended limit of ≤0.2 EU/device. (This is a specific, explicitly stated acceptance criterion met by bench testing.)

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

Sample Size for Test Set: Data from 70 patients receiving the S-Series implant.
Data Provenance:
- S-Series Data: Clinical data developed in the United States.
- Predicate (G-Series) Data: Published historical data from the Otago Glaucoma Surgery Outcome study (country not explicitly stated, but Otago is in New Zealand) and a Finnish study, along with additional unpublished data from the Otago study.
Retrospective or Prospective: Not explicitly stated for either dataset. The S-Series data "developed using both the G-Series implants" then specifying "clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data" suggests the S-Series data might be prospective or a compiled registry, while the predicate data is explicitly historical.

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

The text does not describe a ground truth established by experts in the context of interpreting data for the study. Instead, the "ground truth" (or reference for comparison) for the S-Series device's performance is the clinical outcome data (IOP, visual acuity, adverse events) reported for both the S-Series patients and the historical predicate device cohorts. The assessment of "no clinically significant difference" would likely have been performed by clinical researchers or statisticians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical outcome data. This type of method is more common in studies where subjective assessments (e.g., image interpretation) need consensus. Here, the outcomes are objective clinical measurements (IOP, visual acuity, adverse events).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not performed. The study described compares clinical outcomes of a medical device in patients, not the performance of human readers with or without AI assistance. The device itself is an implant, not an AI diagnostic tool.

6. Standalone Performance Study

This is not applicable as the Molteno3 S-Series Glaucoma Implant is a medical device for implantation, not an algorithm. Its "performance" is measured by its clinical effect in vivo (reduce intraocular pressure, maintain visual acuity, safety profile), as opposed to an algorithm's standalone diagnostic accuracy. The clinical study described in Section VII.B is effectively the standalone performance study for the device's clinical impact.

7. Type of Ground Truth Used

The "ground truth" used for assessing the device's performance comprises clinical outcome data including:

Intraocular Pressure (IOP) measurements
Visual acuity measurements
Post-operative reductions (other unspecified clinical parameters)
Adverse event rates

This outcome data is used to determine if the device is "safe and effective."

8. Sample Size for the Training Set

The document describes a clinical comparison study, not the training of an algorithm or AI model. Therefore, there is no training set in the context of machine learning. The clinical data serves as evidence for device performance.

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

As there is no training set for an algorithm, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 17, 2015

Innovative Ophthalmic Products, Inc. (iop) % Mr. James Ravitz Partner Arent Fox. LLP 1717 K Street. NW Washington, DC 20006

Re: K152996

Trade/Device Name: Molteno3 Glaucoma Implant Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: October 12, 2015 Received: October 14, 2015

Dear Mr. Ravitz:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Y. Alexander -A

for 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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510(K) SUMMARY

I. SUBMITTER

Innovative Ophthalmic Products, Inc. (IOP, Inc.) 3184-B Airway Avenue Costa Mesa, CA 92626

Contact Person: Bryan Weinmann Phone: 714-549-1185 Fax: 714-549-0577

Date Prepared: November 13, 2015

II. DEVICE

Name of Device: Molteno3 S-Series Common or Usual Name: Glaucoma Implant Classification Name: Aqueous Shunt (21 CFR 886.3920) Regulatory Class: II Product Code: KYF

III.PREDICATE DEVICE

Molteno3 G-Series Implant (K062252). This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.

AFDOCS/12673853.1

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V. INDICATIONS FOR USE

	Molteno3 G-Series (K062252)	Molteno3 S-Series
Indication for Use	The Molteno3 G-Series Glaucoma Implantis intended to reduce intraocular pressure inneovascular glaucoma and glaucoma wheremedical and conventional surgicaltreatments have not been successful tocontrol the progression of disease.	The Molteno3 S-Series Glaucoma Implantis intended to reduce intraocular pressurein neovascular glaucoma and glaucomawhere medical and conventional surgicaltreatments have not been successful tocontrol the progression of disease.
Materials/Composition	Polypropylene episcleral plate attached tosilicone drainage tube using siliconeadhesive. No color additives used - allcomponents are colorless.	Polypropylene episcleral plate attached tosilicone drainage tube using siliconeadhesive. No color additives used – allcomponents are colorless.
Surface Area of Plate	GS = 175mm² single plate GL = 230mm²single plate	SS = 185mm² single plate SL = 245mm²single plate
Plate Thickness	0.4mm	0.4mm
Ridge Height aboveLower Surface of Plate	1.15mm	0.95mm
Maximum Plate Length	GS = 14.2mmGL = 16.0mm	SS = 15.4mmSL = 17.4mm
Maximum Plate Width	GS = 13.6mmGL = 15mm	SS = 13.6mmSL = 15mm
Tubing	Internal diameter: 0.34mm Externaldiameter: 0.64mm	Internal diameter: 0.34mm Externaldiameter: 0.64mm
Translimbal TubeLength	GS = 19mmGL = 17mm	SS = 19mmSL = 17mm
Sterilization Method	Steam Autoclave ISO 17665:1	Steam Autoclave ISO 17665:1
Recommended Usage	Single Use	Single Use
How Supplied	Sterile	Sterile
Shelf Life	5 years from sterilization	5 years from sterilization
Packaging	Polypropylene Presentation Box	Polypropylene Presentation Box

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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The S-Series device differs from the predicate G-Series device only in that the S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position As a result of these changes, the overall plate length has increased very slightly.

VII. PERFORMANCE DATA

A. Bench Testing

As described in the substantial equivalence comparison chart above, the materials used for the Molteno3 S-Series implant are identical to the FDA-cleared device. Moreover, the devices is virtually identical and the devices are produced by the identical manufacturing process. Accordingly, the bench testing described in FDA's 1998 guidance document entitled "Aqueous Shunts - 510(k) Submissions" and the associated ANSI Standard Z80.27 "for Ophthalmics - Implantable Glaucoma Devices" was deemed to be unnecessary. Although sterilization procedures have also not changed, bacterial endotoxin testing was nevertheless carried out at a US testing facility and confirmed that the devices are in conformity with FDA's recommended limit of ≤0.2 EU/device.

B. Clinical Evidence Supporting Substantial Equivalence

Clinical data developed using both the G-Series implants support the conclusion that the performance of the S-Series implant is equivalent to that of the G-Series. More specifically, clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data from the Otago Glaucoma Surgery Outcome study and a similar Finnish study, along with additional unpublished data from the Otago study. Clinical performance of the aqueous shunt under investigation was compared to appropriate historical populations, and the analysis included data from 70 patients receiving the S-Series implant followed out for at least one year. Outcome data for IOP and post-operative reductions, as well as visual acuity, were evaluated, along with data on relevant adverse events. The comparison established that there is no clinically significant difference in outcome between the devices, confirming that the Molteno3 S-Series implant is as safe and effective as the predicate Molteno3 G-Series implant.

VIII. CONCLUSIONS

In summary, the Molteno3 S-Series implant and the G-Series implant are manufactured from the same materials and according to the same manufacturing process, are packaged and labeled identically, and have the same Indication for Use and the same technological characteristics. Clinical data establish that the S-Series device is as safe and effective as the predicate G-Series device. The information presented in this submission thus establishes that the Molteno3 S-Series implant is substantially equivalent to the Molteno3 G-Series implant.

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.”