The AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting from aphakia or uveitis.

Device Description

The AHMED® ClearPath Glaucoma Drainage Device is a non-valved drainage device designed to shunt aqueous in eyes suffering from refractory glaucoma. Two models CP250 are available covering surface areas of approximately 250mm². The implant consists of a medical grade silicone tube secured to a medical grade silicone episcleral plate near the anterior suture points. The anterior suture points are located on the anterior side of the plate, flanking each side of the tubing track. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI and plain skull films. The plate conforms to the shape of the globe at its equator and provides a surface from which fluid can be dispersed. Each AHMED® ClearPath is supplied with a 23-gauge hypodermic needle and a 2-inch polypropylene ripcord (pre-loaded in the lumen of the tube) in a sterile, sealed double- pouch. The supplied needle and ripcord are for optional use and are available to be incorporated into the implantation procedure per the surgeon's usual routine. The device is for single use only.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (AHMED® ClearPath Glaucoma Drainage Device), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria as would be done for an AI/ML medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because this is a submission for a physical medical device (an aqueous shunt) and not a software/AI medical device. The "acceptance criteria" here refers to the device meeting its design specifications and demonstrating equivalence to a predicate, not performance metrics like sensitivity/specificity for an AI model.

However, I can extract and present the relevant information provided in the document:

Acceptance Criteria and Study for AHMED® ClearPath Glaucoma Drainage Device

This 510(k) submission demonstrates substantial equivalence of the AHMED® ClearPath Glaucoma Drainage Device to a legally marketed predicate device (Baerveldt Glaucoma Implant), rather than proving the device meets specific acceptance criteria through a clinical performance study as would be typical for an AI/ML device. The "acceptance criteria" for this device are its ability to meet design specifications and perform comparably to the predicate device in bench testing, and its biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Design Input/Intent)	Reported Device Performance (Bench Test Results)
Design Specifications & Functional Performance (ANSI Z80.27 Compliant)
Pressure/Flow Characterization	Met original design input and intent. Results establish equivalence to the Baerveldt Glaucoma Implant.
Structural Integrity	Met original design input and intent.
Dimensional Verification	Met original design input and intent.
Effectiveness of tube occlusion (with ripcord)	Results establish equivalence to the Baerveldt Glaucoma Implant.
Sterilization Validation
Sterility Assurance Level (SAL) of 10-6	A minimum exposure dose of 15 kGy (gamma irradiation) was substantiated per ISO 11137-1:2015 and ISO 11137-2:2015.
Packaging & Shelf Life (2-year expiration)
Maintenance of functional requirements	Test results confirm the device meets functional requirements after simulated distribution and aging.
Maintenance of sterile barrier (package integrity)	Test results confirm the sterile barrier remains intact after simulated distribution and aging, justifying the 2-year shelf life.
Biocompatibility (ISO 10993-1 Compliant)
Non-Cytotoxic	Achieved (MEM Elution and Direct Contact Cytotoxicity).
Non-Irritant	Achieved (Guinea Pig Maximization Sensitization, Intraocular Irritation in Rabbit, 4 & 13 Week Intramuscular Implant in Rabbit).
Non-Toxic	Achieved (Acute Systemic Toxicity in Mouse).
Non-Mutagenic	Achieved (Bacterial Mutagenicity – Ames Assay).
Non-Pyrogenic	Achieved (Material mediated pyrogenicity).

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

Test Set (Bench Testing Sample Size): Not explicitly stated how many devices or samples were tested for each bench test. The document refers to "the AHMED® ClearPath glaucoma drainage device was evaluated" and "results establish that the AHMED® ClearPath glaucoma drainage device meets the defined specifications." These are laboratory tests, not clinical studies with patients.
Data Provenance: The bench testing was conducted internally or by validated labs as part of the device development process.
Retrospective/Prospective: N/A (Bench testing, not clinical data)

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

Number of Experts: N/A (Ground truth established by standardized test methods and comparisons to a physical predicate device, not by expert consensus on clinical images/data).
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: N/A (No human interpretation requiring adjudication for bench tests).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: N/A (This is a physical medical device, not an AI/ML software).
Effect Size of Human Reader Improvement: N/A

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

Standalone Performance: N/A (This is a physical medical device, not an algorithm).

7. The type of Ground Truth Used

Ground Truth:
- Bench Testing: Engineering specifications, functional requirements, and direct comparison to the physical predicate device (Baerveldt Glaucoma Implant) for "pressure/flow characterization and effectiveness of tube occlusion utilizing a ripcord." Standards such as ANSI Z80.27 and ISO 11137-1/2, ISO 10993-1 were used as references for test methodologies and acceptance criteria.
- Clinical Efficacy/Safety: Substantial equivalence is supported by reference to published clinical literature on the predicate device (Budenz et al. 2015, 2016) and other relevant literature for specific design features (Kahook et al. 2006 for placement, Sherwood & Smith 1993, An et al. 2018 for ripcord use). The device itself did not undergo a de novo clinical trial.

8. The Sample Size for the Training Set

Training Set Sample Size: N/A (This is a physical medical device. No "training set" in the AI/ML sense).

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

Ground Truth Establishment for Training Set: N/A (No training set for this type of device).

Summary

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January 18, 2019

New World Medical, Inc. Mukesh Sabarad Manager, Regulatory Affairs 10763 Edison Ct Rancho Cucamonga, California 91730

Re: K182518

Trade/Device Name: AHMED® ClearPath Glaucoma Drainage Device Regulation Number: 21 CFR 886.3920 Regulation Name: Aqueous Shunt Regulatory Class: Class II Product Code: KYF Dated: December 14, 2018 Received: December 17, 2018

Dear Mukesh Sabarad:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tieuvi H. Nguyen -S

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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Indications for Use

510(k) Number (if known) K182518

Device Name

AHMED® ClearPath Glaucoma Drainage Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

☑ Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER	New World Medical, Inc10763 Edison CtRancho Cucamonga, CA 91730USA(909) 466-4304
Contact Person:	Mukesh SabaradManager, Regulatory AffairsNew World Medical, Inc.(909) 466-4304 Ext146

January 17, 2019 Date Summary Prepared:

II. DEVICE

Trade Name:	AHMED® ClearPath Glaucoma Drainage Device
Common Name:	Glaucoma Implant
Classification Name:	Aqueous shunt (21 CFR 886.3920)
Device Class:	Class II
Device Product Code:	KYF

III. PREDICATE DEVICES

Predicate devices information
510(k) Number: K905129Device Name: Baerveldt Glaucoma Implant (BGI)Decision Date: 02/11/1991	510(k) Number: K955455Device Name: Baerveldt Pars Plana Glaucoma Implant (BGI)Decision Date: 02/18/1997
Reference device information
510(k) Number: K162060Device Name: Ahmed Glaucoma ValveDecision Date: 10/24/2016

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IV. DEVICE DESCRIPTION

V. INTENDED USE

The AHMED® ClearPath glaucoma drainage device has the same intended use as the predicates and all other devices regulated within the generic type of device known as aqueous shunts in accordance with 21 CFR 886.3920. The device is a prescription (Rx) device that is intended to be permanently implanted to reduce intraocular pressure for the management of refractory glaucoma. The AHMED® ClearPath glaucoma drainage device will bear the following indications for use statement:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITHTHE VI. PREDICATE DEVICES

The technological characteristics of the AHMED® ClearPath glaucoma drainage device and the Baerveldt glaucoma implant are similar. Furthermore, the differences in technological characteristics that exist between the AHMED® ClearPath glaucoma drainage device and both legally marketed predicate devices do not raise different questions of safety and effectiveness.

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Comparison of the AHMED® ClearPath glaucoma drainage device and the Predicate Devices

Feature	AHMED® ClearPath (ACP)	Baerveldt Glaucoma Implant (BGI)
Intended Use	To be permanently implanted to reduceintraocular pressure for the management ofGlaucoma	To be permanently implanted to reduceintraocular pressure for the management ofGlaucoma
Indication for Use	The AHMED® ClearPath GlaucomaDrainage Device is indicated for themanagement of refractory glaucoma whereprevious surgical treatment has failed or isnot expected to provide satisfactory results.Such refractory glaucoma may include but isnot limited to neovascular glaucoma,congenital or infantile glaucoma, andrefractory glaucoma resulting from aphakiaor uveitis.	The Baerveldt Glaucoma Implant isindicated for use in patients (with priorvitrectomy for Pars Plana) with medicallyuncontrollable glaucoma and poor surgicalprognosis, such as, but not limited to:neovascular glaucoma, aphakic/pseudophakicglaucomas, patients who have failedconventional surgery, congenital glaucomasand secondary glaucomas due to uveitis,epithelial downgrowth, etc.
RegulationNumber/Product Code	886.3920, KYF	886.3920, KYF
Rx or OTC	Rx	Rx
Permanent Implant	Yes	Yes
Anatomical Site	The tube is implanted in the anterior chamberand the endplate is implanted under theconjunctiva	The tube is implanted in the anterior chamberand the endplate is implanted under theconjunctiva
Material (endplate)	Medical grade silicone, barium impregnated	Medical grade silicone, barium impregnated
Material (tube)	Medical grade silicone	Medical grade silicone
Location of anteriorsuturing holes(relative to the limbus)	6-8mm	8-10 mm for model BG101-350 and BG103-250. Model BG102-350 with Pars Plana Clip itis 2-7mm
Mechanism of action	Creates a channel via a tube for aqueous flowfrom the anterior chamber to thesubconjunctival space resulting in a blebformed within the encapsulatedpolypropylene.	Creates a channel via a tube for aqueous flowfrom the anterior chamber to thesubconjunctival space resulting in a blebformed within the encapsulated polypropylene
Design	Silicone tube attached to a silicone endplate	Silicone tube attached to a silicone endplate
Plate Footprint Area(Surface area)	250 mm2 and 350 mm2	250 mm2 and 350 mm2
Tube Dimensions	Length: 32 mmInner diameter: 0.30 mmOuter Diameter: 0.63 mm	Length: 32 mmInner diameter: 0.305 mmOuter Diameter: 0.635 mm
Feature	AHMED® ClearPath (ACP)	Baerveldt Glaucoma Implant (BGI)
Plate Thickness	0.81mm	0.84mm (1.5mm for the Pars-Plana Clip)
Sterilization	Gamma	Gamma
How Supplied	Sterile	Sterile
Single Use	Yes	Yes

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VII. PERFORMANCE DATA

Bench Testing:

The nonclinical bench testing conducted on the AHMED® ClearPath glaucoma drainage device included design verification and functional product testing, sterilization validation, packaging and shelf life testing, and biocompatibility testing. Results of the nonclinical testing demonstrate that the AHMED® ClearPath glaucoma drainage device meets the defined specifications.

Design Verification and Functional Product Testing:

The AHMED® ClearPath glaucoma drainage device was evaluated to verify that the design output met the original design input and intent. This testing was based on tests described in ANSI Z80.27, Implantable Glaucoma Devices, which includes: pressure/flow characterization, structural integrity, and dimensional verification. The results establish that the AHMED® ClearPath glaucoma drainage device meets the design intent and complies with the applicable requirements.

Device Performance Comparison to Predicate Device Baerveldt Glaucoma Implant

The AHMED® ClearPath glaucoma drainage device was evaluated against the predicate Baerveldt Glaucoma Implant for pressure/flow characterization and effectiveness of tube occlusion utilizing a ripcord. The results establish that the AHMED® ClearPath glaucoma drainage device and Baerveldt Glaucoma Implant are equivalent.

Sterilization Validation:

The gamma irradiation sterilization method was validated using the VDmax 15 method described in BS EN ISO 11137-1:2015 and BS EN ISO 11137-2:2015. Validation results demonstrate that a minimum exposure dose of 15 kGy has been substantiated for the routine sterilization of the AHMED® ClearPath glaucoma drainage device to provide a 10th sterility assurance level (SAL).

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Packaging and Shelf Life Testing:

The AHMED® ClearPath glaucoma drainage device is labeled with an expiration date of 2 (two) years. The shelf life study evaluated the functional performance of the AHMED® ClearPath glaucoma drainage device, as well as the packaging integrity. Additional testing was completed to evaluate the impact of environmental conditioning and distribution factors. Test results confirm that the AHMED® ClearPath glaucoma drainage device meet their functional requirements and the sterile barrier (package integrity) remains intact after simulated distribution and aging. This testing provides the justification for the 2-year shelf life and the maintenance of the sterile barrier.

Biocompatibility Testing

Biocompatibility of the final finished AHMED® ClearPath glaucoma drainage device was demonstrated through testing in accordance with BS EN ISO 10993-1 "Biological evaluation of medical devices. Part 1: Evaluation and testing within a risk management process" (refer to the table below for a listing of all tests performed). Testing was performed for the Implant, Ripcord, and Hypodermic Needle. The testing demonstrated that the device materials have an acceptable biocompatibility profile.

Test	Results
Cytotoxicity (MEM Elution)	Non-cytotoxic
Guinea Pig Maximization Sensitization	Non-irritant compared to negative control
Acute Systemic Toxicity (Mouse)	Non-toxic
Intraocular Irritation (Rabbit)	No evidence of irritation
Bacterial Mutagenicity – Ames Assay	Non-mutagenic
4 Week Intramuscular Implant (Rabbit)	Non-irritant compared to USP negative control
13 Week Intramuscular Implant (Rabbit)	Non-irritant compared to USP negative control
Material mediated pyrogenecity	Non-pyrogenic
Direct Contact Cytotoxicity	Non-cytotoxic

Listing of All Biocompatibility Tests Performed on All Patient Contacting Materials

Clinical Evidence Supporting Substantial Equivalence

Although the AHMED® ClearPath has not been clinically evaluated for performance, the following reference in the published clinical literature summarizes the performance of the predicate Baerveldt Glaucoma Implant.

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Budenz, Donald L., et al. "Five-year treatment outcomes in the Ahmed Baerveldt comparison o study." Ophthalmology 122.2 (2015): 308-316.
The following additional clinical literature is referenced in support of differences in design of the AHMED® ClearPath as compared to the predicate Baerveldt Glaucoma Implant.
Placement of Device: This study was conducted to determine optimal positioning of various glaucoma drainage devices posterior to the limbus while maintaining a safe distance relative to the optic nerve.
- Kahook, Malik Y., et al. "Location of glaucoma drainage devices relative to the optic o nerve." British Journal of Ophthalmology 90.8 (2006): 1010-1013.
Implant Design Ridge: The following studies evaluated the safety and effectiveness of the AGV-FP7 ● reference device to the predicate Baerveldt Glaucoma Implant and indicate that a lack of a ridge does not significantly impact implant performance.
- Budenz. Donald L., et al. "Five-vear treatment outcomes in the Ahmed Baerveldt comparison O study." Ophthalmology 122.2 (2015): 308-316.
- Budenz. Donald L., et al. "Postoperative complications in the Ahmed Baerveldt comparison study o during five years of follow-up." American Journal of Ophthalmology 163 (2016): 75-82.
Use of Ripcord for Tube Occlusion: A ripcord for optional use is provided within the tube lumen of ● the Ahmed ClearPath device. Tube occlusion via intraluminal ripcord is a common technique to prevent early postoperative hypotony in non-valved glaucoma drainage devices. Below are examples of medical publications that discuss this technique, its effectiveness and its impact on implant performance.
- Sherwood, Mark B., and M. Fran Smith. "Prevention of early hypotony associated with Molteno O implants by a new occluding stent technique." Ophthalmology 100.1 (1993): 85-90.
- O An, Selena J., et al. "Scheduled postoperative ripcord removal in Baerveldt 350 implants corresponds with increased complications: a prospective, randomized trial." Investigative Ophthalmology & Visual Science 59.9 (2018): 2073-2073.

VIII. SUBSTANTIAL EQUIVALENCE

The AHMED® ClearPath glaucoma drainage device has the same intended use as the legally marketed predicate devices identified in this 510(k) submission and all other aqueous shunts regulated by FDA under 21 CFR § 886.3920. The provision of the 23-gauge hypodermic needle and the 2-inch polypropylene ripcord for use (optional) with the AHMED® ClearPath glaucoma drainage device during the implantation procedure does not represent a departure from the standard of care because their use is common with non-valved shunt designs including the Baerveldt the predicate device.

Results of the nonclinical testing demonstrate that the AHMED® ClearPath glaucoma drainage

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device meets the defined specifications. In summary, the AHMED® ClearPath glaucoma drainage device is substantially equivalent to the Baerveldt glaucoma implant when used in the management of refractory glaucoma.

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.”