The Ahmed® Glaucoma Valve Model FP7 is indicated for the management of refractory glaucomas, 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 medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.

Device Description

The Ahmed® Glaucoma Valve Model FP7 (AGV-FP7) (Modified) 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 mechanism. This valve mechanism is the same in the predicate AGV-FP7 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the eye over the surface of the endplate. The valve in the AGV-FP7 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.

AI/ML Overview

This FDA 510(k) Premarket Notification is for the Ahmed® Glaucoma Valve Model FP7, which is a medical device and not an AI/ML product. Therefore, it does not involve the typical acceptance criteria and study designs pertinent to AI/ML devices, such as performance metrics like sensitivity, specificity, AUC, or the involvement of human readers for ground truth establishment.

Instead, the submission focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device after a material change.

The core information relevant to the provided query, adjusted for a physical medical device, is as follows:

The proposed device, Ahmed® Glaucoma Valve Model FP7 (Modified), is a modification of the previously cleared Ahmed® Glaucoma Valve Model FP7 (K162060). The change involves modifying the endplate material from one grade of silicone (NuSil MED 4840) to a slightly firmer grade of silicone (NuSil MED 4850).

1. A table of acceptance criteria and the reported device performance

The document states that the testing "utilized well-established methods to evaluate the proposed change, all testing methods and acceptance criteria are the same as the proposed predicate devices." While specific numerical acceptance criteria are not tabulated in the provided text, the types of tests and their reported outcomes are:

Acceptance Criteria Category (Test)	Reported Device Performance
Cytotoxicity	Results indicated that the change did not pose any new risk
Sensitization	Results indicated that the change did not pose any new risk
Irritation	Results indicated that the change did not pose any new risk
Pyrogenicity	Results indicated that the change did not pose any new risk
Physical Stability testing	Results indicated that the change did not pose any new risk
Chemical Testing	Results indicated that the change did not pose any new risk
Aqueous Aging Testing (Hydrolytic Stability)	Results indicated that the change did not pose any new risk

The overarching acceptance criterion is that the modified device's performance in these non-clinical tests should not introduce new questions of safety or effectiveness compared to the predicate device. The reported performance is that this criterion was met for all tested aspects.

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (Cytotoxicity, Sensitization, etc.) nor the detailed provenance of the data (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full submission, but is summarized here. The tests are non-clinical (laboratory/bench testing) rather than human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device and testing. The "ground truth" for non-clinical performance of a material change is established by adherence to recognized testing standards and methods (e.g., ISO standards for biocompatibility) and comparison against established performance benchmarks for the original material or predicate device. There isn't a direct "expert interpretation" of test results in the same way as an AI/ML diagnostic output.

4. Adjudication method for the test set
Not applicable. This refers to consensus methods for expert interpretation, which is not relevant for standardized non-clinical material testing.

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
Not applicable. This is not an AI/ML device, and no human-in-the-loop study was conducted or required for this type of 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests listed (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Physical Stability, Chemical Testing, Aqueous Aging) is based on established scientific and regulatory standards for biocompatibility and material performance. For instance, biocompatibility tests like cytotoxicity would be evaluated against ISO 10993 series standards, where specific cell responses or material properties indicate acceptability.

8. The sample size for the training set
Not applicable. This concept applies to AI/ML models, not physical medical devices undergoing material changes.

9. How the ground truth for the training set was established
Not applicable. This concept apples to AI/ML models, not physical medical devices undergoing material changes.

Summary

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May 12, 2023

New World Medical, Inc. Mr. Victor Arellano Senior Global Regulatory Affairs Manager 19763 Edison Court Rancho Cucamonga, California 91730

Re: K230975

Trade/Device Name: Ahmed® Glaucoma Valve Model FP7 Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous shunt Regulatory Class: Class II Product Code: KYF Dated: March 28, 2023 Received: April 5, 2023

Dear Mr. Arellano:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Claudine H. Krawczyk -S

for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230975

Device Name Ahmed® Glaucoma Valve Model FP7

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K230975

This 510(k) Summary has been prepared in accordance with 21 CFR 807.92

A. Date Prepared: 05/11/2023

B. Address and Registration

New World Medical, Inc. Submitter:

The address and registration number of the manufacturer and sterilization site of all Ahmed® Glaucoma Valve Models are:

Manufacturer	Sterilization Site
New World Medical, Inc.	Sterigenics U.S., LLC
10763 Edison Court	344 Bonnie Circle
Rancho Cucamonga, CA 91730	Corona, CA 92880
Phone: 909-466-4304
Fax: 909-466-4305
Contact Person: Victor Arellano
FDA REGISTRATION#: 1000125279	FDA REGISTRATION #: 2029275

Table 1: Manufacturer & Sterilization Information

C. Device Name

Device Trade Name:	Ahmed® Glaucoma Valve Model FP7
Common Name:	Glaucoma Drainage Device
Classification Name:	Aqueous Shunt (21 CFR 886.3920)
Product Code:	KYF
Device Class:	Class II - Ophthalmic Panel

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D. Predicate Device

510 (K) Number:	K162060
Device Name:	Ahmed ® Glaucoma Valve Model FP7
Decision date:	10/24/2016

E. Intended Use

This is the same intended use as the previously cleared Ahmed® Glaucoma Valve FP7, 510(k) Number K162060

F. Device Description and Technological Characteristics

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Special 510(k) Ahmed® Glaucoma Valve Model FP7 (K230975)

mechanism, the AGV-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.

G. Proposed Change

The AGV-FP7 (modified) is a modification to the AGV-FP7 (original) in which the endplate material has been changed from one grade of silicone (NuSil MED 4840) to a slightly firmer grade of silicone (NuSil MED 4850).

H. Testing

The Ahmed® Glaucoma Valve Model FP7 (Modified) was tested for Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Physical Stability testing, Chemical Testing, and Aqueous Aging Testing (Hydrolytic Stability) to support the purposed change.

The results of the testing indicated that the change to the material did not pose any new risk to the device. All testing provided in the submission utilized well-established methods to evaluate the proposed change, all testing methods and acceptance criteria are the same as the proposed predicate devices.

I. Conclusion

In conclusion, the change to the endplate material to a slightly firmer grade of silicone does not raise new questions of safety and efficacy. Based on the non-clinical performance data, Ahmed® Glaucoma Valve Model FP7 (modified) described in this submission is substantially equivalent to the predicate device.

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.”