The Blunt Tip Ex-PRESS Mini Glaucoma Shunts are indicated for use in reduction of intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

Device Description

The blunt tipped Ex-PRESS Mini Glaucoma Shunts capture aqueous fluid from the anterior chamber of the eye and transport it distally into a conjunctival bleb.

The blunt tipped Ex-PRESS shunts are comprised of a surgical grade stainless steel tube with a rounded tip at the proximal end and a flat angled flange at the distal end. Three transverse reserve openings near the proximal end of the device serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the devices serves as a reservoir and prevents intrusion into the eye. The external spur in the middle of the implant serves as an anchor and prevents extrusion from the eye.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a medical device, the Optonol Ex-PRESS™ Mini Glaucoma Shunt, and its substantial equivalence to a predicate device. However, it does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, the basis for equivalence is primarily qualitative and comparative, focusing on manufacturing, materials, and functional similarity.

The performance section merely states: "Bench testing was conducted per the guidance document 'Guidance for Industry and for FDA Reviewers/Staff Aqueous Shunts - 510(k) Submissions' - November 16", 1998." Without access to this specific guidance document or details of the bench testing results, we cannot populate a table with numerical acceptance criteria and reported device performance.

If we infer acceptance criteria based on the substantial equivalence claim, they would be:

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence: Device must perform the same function as the predicate device (diverting aqueous humor from anterior chamber to subconjunctival space to reduce intraocular pressure).	"Bench testing demonstrates that the devices are functionally equivalent." (Direct statement comparing the blunt tip Ex-PRESS with the predicate Ex-PRESS, implying similar flow characteristics and pressure reduction capabilities as assessed by bench testing.)
Material Equivalence: Must be manufactured from the same materials as the predicate device.	"The devices are manufactured from the same materials..." (Direct statement of equivalence.)
Process Equivalence: Must use the same manufacturing processes as the predicate device.	"...using the same processes." (Direct statement of equivalence.)
Indication for Use Equivalence: Must have the same indication for use as the predicate device.	"Both devices have the same indication for use, 'reducing intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed'..." (Direct statement of equivalence.)
Flow Restriction Mechanism Equivalence: Must have identical flow restriction mechanisms as the predicate device.	"The flow restriction mechanisms are identical." (Direct statement of equivalence.)

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

The document mentions "Bench testing" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically refers to laboratory-based evaluations, not clinical studies with patient data.

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

This information is not applicable and not provided in the document. The study described is bench testing, which does not involve human experts establishing ground truth in the way a clinical study or image interpretation study would. Ground truth in this context would likely be based on physical measurements and engineering specifications, not expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for bench testing of a physical device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and not provided in the document. The device is a physical glaucoma shunt, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable and not provided in the document. The device is a physical implant, not an algorithm. Standalone performance refers to the performance of an AI algorithm without human involvement, which is not relevant here.

7. The Type of Ground Truth Used

For the bench testing mentioned, the "ground truth" would be established by:

Engineering Specifications: Predefined design parameters, material properties, and functional performance targets.
Physical Measurements: Data obtained from instruments measuring flow rates, pressure differentials, material integrity, dimensional accuracy, etc., under controlled laboratory conditions.
Comparison to Predicate Device: The performance of the predicate device (Ex-PRESS Models R30 and R50) under similar bench test conditions would serve as a crucial reference point for establishing equivalence.

The document does not explicitly state these, but they are the standard types of ground truth for bench testing of medical devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical implant, not a machine learning model, so there is no "training set."

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

This information is not applicable and not provided in the document, as there is no training set for a physical device.

Summary

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Summary of Safety & Effectiveness

OPTOnOL
Advancing Medical Technologies
Ltd.

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.

APPLICANT	Optonol Ltd.Communication CenterNeve Ilan 90850, IsraelTel: (972) (2) 5349666Fax: (972) (2) 5349660
OFFICIALCORRESPONDENT	Penny Northcutt, RACSenior Specialist, Surgical Regulatory AffairsCIBA Vision Corporation11460 Johns Creek ParkwayDuluth, GA 30097 USATel: (678) 415-3214Fax: (678) 415-3990e-mail: penny.northcutt@cibavision.novartis.com
TRADE NAME:	Blunt Tip Ex-PRESS Mini Glaucoma Shunt
COMMON NAME:	Anterior chamber drainage device
CLASSIFICATIONNAME:	Implant, Eye Valve
DEVICECLASSIFICATION:	Class II per 21 CFR § 886.3920
PRODUCT CODE	86 (KYF)
PREDICATE DEVICE:	Ex-PRESS Mini Glaucoma ShuntModels R-30, R-50 - K012852

SUBSTANTIALLY EQUIVALENT TO:

The blunt tipped Optonol Ex-PRESS™ Mini Glaucoma Shunt Model R30-1S and R50-1S is substantially equivalent to the predicate Optonol Ex-PRESS Models R30 and R50 Glaucoma Shunt cleared under 510(k) K012852.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The blunt tipped Ex-PRESS Mini Glaucoma Shunts capture aqueous fluid from the anterior chamber of the eye and transport it distally into a conjunctival bleb.

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INDICATION FOR USE:

The Blunt Tip Ex-PRESS Mini Glaucoma Shunts are indicated for use in reduction of intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

TECHNICAL CHARACTERISTICS:

PERFORMANCE DATA:

Bench testing was conducted per the guidance document "Guidance for Industry and for FDA Reviewers/Staff Aqueous Shunts - 510(k) Submissions" - November 16", 1998.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The Blunt Tip Ex-PRESS Mini Glaucoma Shunt is substantially equivalent to its predicate, the Ex-PRESS Model R30 and R50 Glaucoma Shunt cleared under 510(k) K012852. Both devices have the same indication for use, "reducing intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed" and both devices are designed to divert aqueous humor through the implant from the anterior chamber to a subconjunctival space - the bleb. The devices are manufactured from the same materials, using the same processes. The flow restriction mechanisms are identical. Bench testing demonstrates that the devices are functionally equivalent.

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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ontonol Ltd. c/o Penny Northcutt, RAC Surgical Regulatory Affairs CIBA Vision Corporation 11460 Johns Creek Parkway Duluth, GA 30097

Re: K030350 Trade/Device Name: Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous shunt Regulatory Class: II Product Code: KYF Dated: January 31, 2003 Received: February 3, 2003

Dear Ms. Northcutt:

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. Iisting 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.

Image /page/2/Picture/9 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures in the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAR 1 3 2003

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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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

A helyi korentthal

A. Ralph Rosenthal, 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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Page 1 of 1

510(k) Number (if known): _KO30350

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Device Name: EX-PRESS™ Miniature Glaucoma Family of Implants

Indications for Use:

The EX-PRESS™ Miniature Glaucoma Family of Implants are intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K030350
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Prescription Use (Per 21 CFR 801.109)	X	OR	Over-The-Counter Use (Optional Format 1-2-96)
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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.”