The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

Device Description

The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Kahook Dual Blade Glide, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly present a table of quantitative acceptance criteria with corresponding performance directly within the "Performance Data" section for each specific test in the same way a software validation might. However, it states that "Results of the non-clinical bench testing demonstrate that the Kahook Dual Blade Glide meets the defined specifications and functions as intended." It broadly indicates that "All samples met the acceptance criteria" for tests like corrosion, endotoxin, visual inspection, bubble leak, tensile test, and non-cytotoxicity, non-sensitizer, non-irritant, and non-toxic for biocompatibility.

For clinical effectiveness, the primary endpoint was used as an acceptance criterion, and device performance is reported against it.

Test/Criteria Category	Acceptance Criteria	Reported Device Performance
Bench Testing	(Implicit: Meets defined specifications and functions as intended)
Cytotoxicity	Non-cytotoxic (ISO 10993-5)	Non-Cytotoxic
Sensitization	Non-sensitizer (ISO 10993-10)	Non-Sensitizer
Irritation	Non-irritant (ISO 10993-10)	Non-irritant
Acute Systemic Toxicity	Non-toxic (ISO 10993-11)	Non-toxic
Sterilization	Sterility Assurance Level of 10^-6 (ISO 11137-1, ISO 11137-2)	Assurance level of 10^-6
Corrosion testing	All samples meet acceptance criteria (ISO 13402)	All samples met the acceptance criteria
Autoclave Testing	Material's Heat Deflection Temperature < 121°C (ISO 13402)	Material's Heat Deflection Temperature shall be less than 121°C (This is listed as the criterion for this test, implying the device met it, though not directly stated as "met")
Endotoxin Testing	All samples meet acceptance criteria (ANSI/AAMI ST72)	All samples met the acceptance criteria
Shelf-Life Testing	Not explicitly stated, but includes Visual Inspection, Seal Strength, Bubble leak test
- Visual Inspection	All samples meet acceptance criteria (ASTM F1886)	All samples met the acceptance criteria
- Seal Strength	All units have a seal strength above 0.75 lbf (ASTM F88)	All units had a seal strength above 0.75 lbf
- Bubble leak test	All samples meet acceptance criteria (ASTM F2096)	All samples met the acceptance criteria
Additional Testing
- Deflection test	Devices not deflect under normal use	Devices did not deflect under normal use
- Tensile Test	Devices pass Tensile stress test	Devices passed the Tensile stress test
Clinical Effectiveness
KDB-phaco cohort	Proportion of eyes at 12 months with IOP reduction of ≥ 20% OR IOP medication reduction of ≥ 1 compared with baseline	93.7% (74/79 eyes) met the criterion. Mean IOP decreased from 18.5 (0.4) mmHg to 15.4 (0.4) mmHg. Mean IOP meds reduced from 1.3 (0.1) to 0.3 (0.1).
KDB-Standalone cohort	(Secondary analysis reported for context) Proportion of eyes with an IOP reduction of ≥ 20% compared to baseline (counting SSI and lost to follow-up as failures)	42.9% (18/42 eyes) met the criterion. Mean IOP reduced by 3.94 (1.1) mmHg (n=35). Mean IOP meds reduced by 0.31 (0.23) (n=35). (Note: The primary endpoint for this study was simply "IOP reduction compared to baseline," not a specific proportional target. The 20% reduction metric was an additional analysis.)

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

KDB Glide Procedure Performed with Cataract Surgery (Falkenberry et al.):
- Test Set Sample Size: 82 eyes of 82 subjects (KDB-phaco cohort). 79 eyes were available for the 12-month visit.
- Data Provenance: Prospective, randomized, active-controlled, parallel group clinical trial. Conducted at 9 study sites in the U.S.
KDB Glide Procedure Performed Standalone (ElMallah et al.):
- Test Set Sample Size: 42 eyes of 35 subjects. 35 eyes were available for the 12-month visit (6 required SSI, 1 lost to follow-up).
- Data Provenance: Retrospective, multicenter case series. Collected from 8 surgeons at 8 study sites (6 in the U.S. and 2 in Mexico).

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

The clinical studies involved surgeons performing the procedures and evaluating outcomes, but the text does not detail an independent panel of experts establishing ground truth for the data points themselves outside of the study design. For a clinical trial/case series, the "ground truth" for IOP measurements and medication usage would typically be based on direct clinical assessment by the ophthalmologists at the study sites. The document does not specify the number or qualifications of these individual ophthalmologists/surgeons beyond them being "surgeons" at "study sites."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes in either study. Clinical data collection in these types of trials typically relies on the assessments made by the treating physicians/investigators at each site.

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

No, an MRMC comparative effectiveness study was not done. The studies focused on the effectiveness and safety of the KDB Glide procedure itself (alone or with cataract surgery) and compared it to other procedures (e.g., iStent trabecular micro-bypass in Falkenberry et al.) or evaluated it standalone. There is no mention of human readers evaluating cases with and without AI assistance to determine an effect size of AI improvement. The device is a surgical tool, not an AI diagnostic/interpreting system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Kahook Dual Blade Glide is a physical surgical device, not an algorithm. Therefore, an "algorithm only" or "standalone" (in the AI context) performance study is not relevant. The "KDB Glide Procedure Performed Standalone" refers to the surgical procedure without concurrent cataract surgery, not an AI algorithm.

7. Type of Ground Truth Used

Bench Testing: Engineering specifications, industry standards (ISO, ASTM), and laboratory test results.
Clinical Studies (Falkenberry et al. and ElMallah et al.): Clinical outcomes data, primarily:
- Intraocular Pressure (IOP) measurements (medicated and unmedicated)
- Number of IOP-lowering medications
- Occurrence and type of adverse events
  These are measurements taken directly from patients in a clinical setting by medical professionals.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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May 17, 2024

New World Medical, Inc. Victor Arellano Sr. Manager. Global Regulatory Affairs 10763 Edison Court Rancho Cucamonga, California 91730

Re: K220891

Trade/Device Name: Kahook Dual Blade Glide (KDB Glide) Regulation Number: 21 CFR 878.4400 Regulation Name: Knife, Intraocular Pressure Lowering Regulatory Class: Class II Product Code: OUO Dated: October 23, 2023 Received: October 24, 2023

Dear Victor 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 (the 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 available 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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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Page

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

Claudine Krawczyk Assistant 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) K220891

Device Name Kahook Dual Blade Glide

Indications for Use (Describe)

The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY K220891

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

I. SUBMITTER INFORMATION

New World Medical, Inc 510(k) Owner: 10763 Edison Court Rancho Cucamonga, CA 91730 USA (909) 466-4304
Contact Information: Victor Arellano Sr. Manager, Global Regulatory Affairs New World Medical, Inc. Phone: (909) 466-4304 Ext118 Fax: (909) 466-4305 Email: varellano@newworldmedical.com

Date Summary Prepared: May 16, 2024

II. DEVICE INFORMATION

Trade / Proprietary Name:	Kahook Dual Blade Glide
Common Name:	Surgical Knife
Regulation Numbers:	21 CFR 878.4400
Device Classification:	Class II
Predicate Device:	NMX-1000™, NeoMedix Corporation (K040584)
Reference Device:	OMNI Surgical System, Sight Sciences, Inc. (K202678)

III. DEVICE DESCRIPTION

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Image /page/5/Picture/0 description: The image shows a blue medical device with a silver tip. The device has a long, slender body with a textured grip in the middle. The tip of the device is sharp and pointed. The device has the word "Glide" printed on the side.

Figure 1. Kahook Dual Blade Glide (Part# 10-0065)

IV. INDICATIONS FOR USE

The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

V. TECHNICAL CHARACTERISTICS (IN COMPARISON TO PREDICATE DEVICE)

New World Medical believes that the Kahook Dual Blade Glide described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed Class II predicate device, the NMX-1000. Table 1 provides a tabular presentation of the Kahook Dual Blade Glide compared to the predicate device, cleared by FDA in K040584 and intended for use as an ophthalmic surgical tool to surgically remove a strip of trabecular meshwork.

DeviceCharacteristic	Subject DeviceKahook Dual Blade Glide	Primary Predicate DeviceNMX-1000
Regulation	CFR 878.4400	CFR 878.4400
510(k) Number	K220891	K040584
Product Code	QUQCFR 878.4400	Primary : GEI (Electrosurgical cutting and coagulation device)Secondary : HQR (Apparatus, Cautery, RF, AC-Powered)
Device Class	Class II	Class II
Intended Use	Ophthalmic surgical tool to cut trabecular meshwork	Ophthalmic surgical tool to cut trabecular meshwork
Indications for Use	The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open-angle glaucoma.	The NMX-1000 is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.
Prescription Status	Prescription use only	Prescription use only
Target Anatomy	Trabecular Meshwork	Trabecular Meshwork
Operating Principle	Manual cutting to remove trabecular meshwork	Bipolar electro-surgical pulse to remove trabecular meshwork
Device Shape	Ramped tip to facilitate lift and stretch of the trabecular meshwork while dual blades create parallel	90 degree tip bent to create triangular footplate to penetrate trabecular meshwork. Feeds trabecular
DeviceCharacteristic	Subject Device	Primary Predicate Device
	Kahook Dual Blade Glideincisions of the trabecularmeshwork	NMX-1000meshwork into the ablative bipolarelectrodes as the instrument isadvanced along Schlemm's canal.
Design/Mechanismof Action	Inserted through a previouslycreated clear corneal incision.The anterior chamber is inflatedwith viscoelastic.Under gonioscopic evaluation,insert the tip and the neck throughthe clear corneal incision andadvance to the opposite side of theanterior chamber.Engage the trabecular meshworkacross from the clear cornealincision with the pointed tip andpierce through the trabecularmeshwork and into Schlemm'scanal.Advance in the direction of thetrabecular meshwork to be cut bypivoting and advancing/ retractingthe thin neck along the clearcorneal incision while keeping thefootplate in Schlemm's canal.Detach the trabecular meshworkstrip by use of the KDB ormicroforceps.After cutting the trabecularmeshwork, retract through theoriginal clear corneal incision.	Inserted through a previously createdclear corneal incision.The anterior chamber is maintainedwith irrigation fluid.Under gonioscopic evaluation, insertthe tip through the clear cornealincision and advance to the oppositeside of the anterior chamber.Engage the trabecular meshworkacross from the clear corneal incisionwith the tip and penetrate thetrabecular meshwork and advancealong Schlemm's canal.Feed trabecular meshwork into theablative bipolar electrodes as the tipadvances along the Schlemm's canal.Aspirate to remove the trabecularmeshwork.After cutting the trabecularmeshwork, retract through theoriginal clear corneal incision.
	Viscoelastic	Separate viscoinjector used tostabilize anterior chamber
Materials	Stainless steel tip, stainless steelshaft and plastic handle	Stainless steel probe and ABS plastichandpiece
User Interface	Handheld	Handheld
Sterile andSingleUse	Yes	Yes
Sterility AssuranceLevel	10-6	10-6

Table 1 Kahook Dual Blade (KDB) Glide Substantial Equivalence

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VI. PERFORMANCE DATA

Bench Testing

The non-clinical bench testing performed on the Kahook Dual Blade Glide device consisted of design

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verification and functional product testing, sterilization validation, packaging, shelf-life testing, and biocompatibility testing. Results of the non-clinical bench testing demonstrate that the Kahook Dual Blade Glide meets the defined specifications and functions as intended (see Table below). The Kahook Dual Blade Glide functional characteristics are well defined and sufficient to establish equivalence to the predicate device. The device was evaluated to verify the design outputs met the original design inputs and intent.

Test Performed	Standard/Guidance	Results
Cytotoxicity	ISO 10993-5 - Biological evaluation ofmedical devices - Part 5: Tests for in vitrocytotoxicity	Non-Cytotoxic
Sensitization	ISO 10993-10 - Biological evaluation ofmedical devices - Part 10: Tests for irritationand skin sensitization	Non-Sensitizer
Irritation	ISO 10993-10 - Biological evaluation ofmedical devices - Part 10: Tests for irritationand skin sensitization	Non-irritant
Acute SystemicToxicity	ISO 10993-11 - Biological evaluation ofmedical devices - Part 11: Tests for systemictoxicity	Non-toxic
Sterilization	ISO 11137-1 - Sterilization of health careproducts - Radiation - Part 1ISO 11137-2 -- Sterilization of health careproducts. Radiation - Part 2: Establishingthe sterilization dose	Assurance level of10-6
Corrosion testing	ISO 13402 - Surgical and dental handinstruments -- Determination of resistanceagainst autoclaving, corrosion and thermalexposure	All samples met theacceptance criteria
Autoclave Testing	ISO 13402 - Surgical and dental handinstruments -- Determination of resistanceagainst autoclaving, corrosion and thermalexposure	Material's HeatDeflectionTemperature shall beless than 121°C
Endotoxin Testing	ANSI/AAMI ST72 - Bacterial endotoxins -Test methods, routine monitoring, andalternatives to batch testingEndotoxin Testing Recommendations forSingle-Use Intraocular Ophthalmic DevicesGuidance for Industry and Food and DrugAdministration Staff	Routine monitoring
		All samples met theacceptance criteria
Shelf-Life Testing
Visual Inspection	ASTM F1886	All samples met theacceptance criteria
Test Performed	Standard/Guidance	Results
	Standard Test Method for DeterminingIntegrity of Seals for Flexible Packaging byVisual Inspection
Seal Strength	ASTM F88Standard Test Method for Seal Strength ofFlexible Barrier Materials	All units had a sealstrength above 0.75lbf
Bubble leak test	ASTM F2096Standard Test Method for Detecting GrossLeaks in Packaging by InternalPressurization (Bubble Test)	All samples met theacceptance criteria
Additional Testing
Deflection test	Devices did not deflect under normal use
Tensile Test	Devices passed the Tensile stress test

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VII. CLINICAL EVIDENCE

The reference device, OMNI Surgical System (K202678), was used to support the scientific methodology to evaluate the ability of KDB to reduce IOP in adult patients with POAG and a systematic literature review was performed to characterize the safety of the predicate device, NMX-1000.

KDB Glide Procedure Performed with Cataract Surgery (Falkenberry et al.)

Falkenberry S, Singh IP, Crane CJ, Haider MA, Morgan MG, Grenier CP et al. Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma. J Cataract Refract Surg. 2020; 46(8):1165-71.

Falkenberry et al. conducted a prospective, randomized, active-controlled, parallel group clinical trial of the KDB Glide procedure combined with cataract surgery. The study was conducted at 9 study sites in the U.S. and surgeries were performed between June 2016 and January 2019. The purpose of the study was to compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) Glide vs iStent trabecular micro-bypass (Glaukos, Inc.) implantation, both combined with phacoemulsification, in eyes with mild-to-moderate open-angle glaucoma (OAG). This 510(k) summary focuses on the results of the KDB-phaco cohort only.

The study consisted of eyes diagnosed with open-angle glaucoma, including pseudoexfoliative glaucoma and pigmentary glaucoma. The KDB-phaco cohort consisted of 82 eyes of 82 subjects. The majority of study eyes (n = 75, 95.1%) had a diagnosis of primary open-angle glaucoma (POAG); 5 eyes (6.1%) had pseudoexfoliative glaucoma (PEG) and the remainder (n = 2, 2.4%) had pigmentary glaucoma (PG). The glaucoma severity was characterized as mild (79.3%) to moderate (20.7%). Subjects were followed for 12 months and were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively.

Baseline characteristics were as follows:

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Baseline Characteristics	KDB-Phaco(N = 82)
Mean Age ± SD	70.2 ± 0.91 years
Sex	Female: 44 (53.7%)Male: 38 (46.3%)
Ethnicity	White: 66 (80.5%)African American: 10 (12.2%)Asian: 3 (3.7%)Hispanic: 1 (1.2%)Other: 2 (2.4%)
Medicated IOPMean ± SD	18.5 ± 0.36 mmHg
Glaucoma Medications Mean± SD	1.31 ± 0.07 meds
C/D Ratio	0.60 ± 0.018

The key inclusion criteria consisted of subjects 18-90 years of age with mild-moderate POAG, PEG, or PG who were on 1-3 topical ocular hypotensive medications. In order to qualify, subjects needed a baseline IOP of 14-28 mmHz (inclusive) and a visually significant cataract planned for elective extraction. Subjects using oral medications that could affect IOP, previous glaucoma surgery, recent (≤ 3 months) glaucoma laser therapy, closed angles, or a history of steroid response were identified as key exclusion criteria.

Under ophthalmic viscosurgical device and using a gonioprism for visualization, the KDB Glide was introduced through a clear corneal incision approximately 180° from the targeted excision site. The pointed tip of the device engaged trabecular meshwork (TM), with the heel positioned within Schlemm's canal and the blade was advanced to excise a strip of trabecular meshwork (TM) approximately 3-4 clock hours in length using the parallel blades of the device. The KDB Glide was then removed through the corneal incision.

The primary effectiveness endpoint was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline. Secondary effectiveness endpoints included the percentage reduction in IOP and the mean decrease in the number of IOP-lowering medications.

Of the 82 eyes treated with KDB-phaco, 79 eyes were available for the 12-month visit and 3 eyes were considered lost to follow-up. There were no eyes with glaucoma secondary surgical intervention (SSI) for IOP control during the 12-month study; therefore, the effectiveness analyses included all 79 available eyes. The proportion of eyes at 12 months with an IOP reduction of 20% or greater from baseline or IOP medication reduction of 1 or more medication from baseline was 93.7% (74/79 eyes). Mean (SD) IOP decreased from a baseline of 18.5 (0.4) mmHg to 15.4 (0.4) mmHg at 12 months. Mean (SD) IOP-lowering medications were reduced from 1.3 (0.1) at baseline to 0.3 (0.1) at 12 months.

Safety outcomes included corrected distance visual acuity loss by 2 lines or more from best recorded to final visit, operative complications, device malfunctions, IOP elevations of 10 mmHg or greater from baseline, and adverse events. The following adverse events were reported:

Adverse Event	KDB-Phaco(N = 82)
Increased IOP	26 eyes (31.7%)
Posterior CapsuleOpacification	7 eyes (8.5%)
Hyphema	3 eyes (3.7%)

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Adverse Event	KDB-Phaco(N = 82)
Cyclodialysis Cleft	1 eye (1.2%)

The most common adverse event was increased IOP, reported as occurring at least one postoperative visit in 26/82 (31.7%) eves: these all resolved spontaneously or with medical management. Posterior capsule opacification (PCO) occurred in 7/82 (8.5%) eyes. Blood persisting in the anterior chamber beyond the first postoperative week (hyphema) occurred in 3/82 (3.7%) of study eyes. One eye (1.2%) developed a cyclodialysis cleft.

KDB Glide Procedure Performed Standalone (ElMallah et al.)

ElMallah MK, Berdahl JP, Williamson BK, Dorairaj SK, Kahook MY, Gallardo MJ et al. Twelve-month outcomes of stand-alone excisional goniotomy in mild to severe glaucoma. Clin Ophthalmol. 2020; 14:1891-97.

ElMallah et al. conducted a retrospective, multicenter case series of the KDB Glide performed as a standalone procedure. Data was collected from 8 surgeons at 8 study sites (6 in the U.S. and 2 in Mexico). The purpose of the study was to characterize the reductions in intraocular pressure (IOP) and IOP-lowering medication following excisional goniotomy with KDB Glide standalone in eyes with medically uncontrolled glaucoma.

The study enrolled 42 eyes of 35 subjects with no restrictions for glaucoma sub-type or severity. The majority of eyes had a diagnosis of primary open angle glaucoma (n = 36, 85.7%), but the study also included a small number of eyes diagnosed with pigmentary glaucoma (n = 3. 7.1%), pseudoexfoliative glaucoma (n =2, 4.8%), and angle-closure glaucoma (n = 1, 2.4%). Glaucoma severity was evaluated according to the International Classification of Diseases-10 (ICD-10) criteria, and was characterized as mild (19.0%), moderate (61.9%), or severe (19.0%). Subjects were followed for 12 months and were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively.

Baseline Characteristics	KDB-Standalone(N = 42)
Mean Age ± SE	71.3 ± 1.8 years
Sex	Female: 25 (59.5%)Male: 17 (40.5%)
Ethnicity	White: 19 (45.2%)Black: 13 (31.0%)Hispanic: 9 (21.4%)Asian: 1 (2.4%)
Medicated IOPMean ± SE	21.6 ± 0.84 mmHg
Glaucoma Medications Mean± SE	2.55 ± 0.22 meds

Baseline characteristics were as follows:

Included subjects were ≥ 18 years of age, phakic or pseudophakic, and with any glaucoma sub-type or severity. There were no baseline IOP requirements other than inadequate IOP control on at least 1 and up to 3 ocular hypotensive medications. Indication(s) for surgery included reducing IOP, reducing medication

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burden, or both. Subjects with a recent history (within 3 months) of IOP-lowering medication addition, laser trabeculoplasty, indotomy, or initiation of systemic beta-blocker therapy were excluded from the study. Other exclusion criteria included any previous glaucoma surgery, and uncontrolled systemic conditions that might confound study measurements. Both eyes of a single subject were included if both qualified.

Following entry into the anterior chamber through a peripheral corneal incision, the KDB Glide distal tip was used to pierce the trabecular meshwork (TM) and enter Schlemm's canal. The tip was advanced along the canal to elevate and guide the TM onto two parallel blades which then excise a strip of tissue. Approximately 3-5 clock hours of TM were excised.

The primary effectiveness endpoint was IOP reduction compared to baseline. The reduction in IOPlowering medications was evaluated as the secondary effectiveness endpoint. Eyes with glaucoma secondary surgical intervention (SSI) for IOP control were excluded from the primary and secondary effectiveness analyses. Of the 42 eyes treated with KDB as a standalone procedure, 35 were available for the 12-month visit. Six eyes (n =6) required SSI for IOP control through 12 months and one eye (n =1) was considered lost to follow-up. At the 12-month visit, mean (SE) IOP was reduced by 3.94 (1.1) mmHg (n = 35). Mean (SE) number of IOP-lowering medications was reduced by 0.31 (0.23) at 12 months (n = 35).

In addition to the primary and secondary endpoints, ElMallah et al. report additional effectiveness outcomes for all treated eyes (N = 42) where eyes requiring SSI (n = 6) and the eye that was lost to follow-up (n = 1) were counted as failures. These additional analyses included the proportion of eyes with an IOP reduction of 20% or greater compared to baseline which was 42.9% (18/42 eyes).

Adverse Event	KDB Standalone(N = 42)
Increased IOP	3 eyes (7.1%)
Descemet's tear(intraoperative)	1 eye (2.4%)

Safety reporting consisted of the incidence of intraoperative and postoperative adverse events. The following adverse events were reported:

The most common adverse event was postoperative elevated IOP (n = 3, 7.1%). One case resolved with medical therapy, and the other two required a secondary surgical intervention. One eye experienced an intraoperative tear in Descemet's membrane, which was localized and did not require subsequent treatment during the 12-month study. No other adverse events were reported. Over the course of 12 months, 6 eyes required additional surgeries for inadequate IOP control. These included trabeculectorny (n = 4; 2 of which had concurrent Ex-Press mini-shunt) and Ahmed valve implantation (n = 2).

Conclusion

The non-clinical and clinical data demonstrate that the device is substantially equivalent to the legally marketed predicate device, NMX-1000.

VIII. SUBSTANTIAL EQUIVALENCE CONCLUSIONS

The indications for use of the Kahook Dual Blade Glide fall within the intended use of the NecMedix predicate device and, therefore, the two devices have the same intended use. Although the operating principle differs, there are no particular technological aspects of the Kahook Dual Blade Glide (manual cutting to remove trabecular meshwork) that were not evaluated in the context of the premarket review for

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the predicate device (bipolar electro-surgical pulse to remove trabecular meshwork). Specifically, a manual operating principle raises the same or fewer questions related to safety and effectiveness as compared to an electrosurgical operating principle for the same intended use; there are not different types of safety and effectiveness questions related to the simpler technological characteristics of the Kahook Dual Blade Glide.

The Kahook Dual Blade Glide meets all product design requirements and applicable device standards. The conclusions drawn from the nonclinical and clinical performance data demonstrate that the Kahook Dual Blade Glide is substantially equivalent to the predicate device for the same intended use.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.