(781 days)
No
The device description and performance studies focus on a mechanical surgical tool and its clinical outcomes, with no mention of AI/ML components or data processing related to learning or prediction.
Yes
The device is intended to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma, which is a therapeutic intervention.
No
The device is a surgical instrument designed to remove tissue for therapeutic purposes, specifically to reduce intraocular pressure. It does not diagnose conditions.
No
The device description clearly states it is a single-use ophthalmic knife made of surgical-grade stainless steel with physical blades, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The Kahook Dual Blade Glide is a surgical knife used within the eye to remove tissue. It is a surgical instrument, not a diagnostic test performed on a sample.
- Intended Use: The intended use is to surgically remove tissue to reduce intraocular pressure, which is a treatment for glaucoma, not a diagnostic test.
Therefore, the Kahook Dual Blade Glide is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OUO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trabecular Meshwork
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: The non-clinical bench testing performed on the Kahook Dual Blade Glide device consisted of design 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. 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.
Clinical Evidence:
-
KDB Glide Procedure Performed with Cataract Surgery (Falkenberry et al.):
- Study Type: prospective, randomized, active-controlled, parallel group clinical trial
- Sample Size: 82 eyes of 82 subjects (KDB-phaco cohort); 79 eyes available at 12 months.
- Key Results:
- 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.
- Most common adverse event: increased IOP (31.7%).
-
KDB Glide Procedure Performed Standalone (ElMallah et al.):
- Study Type: retrospective, multicenter case series
- Sample Size: 42 eyes of 35 subjects; 35 eyes available at 12 months.
- Key Results:
- 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).
- The proportion of eyes with an IOP reduction of 20% or greater compared to baseline was 42.9% (18/42 eyes).
- Most common adverse event: postoperative elevated IOP (7.1%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Falkenberry et al. (KDB-Phaco):
- Proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline: 93.7% (74/79 eyes)
- Mean (SD) IOP reduction: 18.5 (0.4) mmHg to 15.4 (0.4) mmHg at 12 months.
- Mean (SD) IOP-lowering medications reduction: 1.3 (0.1) at baseline to 0.3 (0.1) at 12 months.
ElMallah et al. (KDB-Standalone):
- Mean (SE) IOP reduction: 3.94 (1.1) mmHg (n = 35) at 12 months.
- Mean (SE) number of IOP-lowering medications reduction: 0.31 (0.23) at 12 months (n = 35).
- Proportion of eyes with an IOP reduction of 20% or greater compared to baseline (all treated eyes): 42.9% (18/42 eyes).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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.
2
Page
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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
3
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
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.
5
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.
| Device
Characteristic | Subject Device
Kahook Dual Blade Glide | Primary Predicate Device
NMX-1000 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | CFR 878.4400 | CFR 878.4400 |
| 510(k) Number | K220891 | K040584 |
| Product Code | QUQ
CFR 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 |
| Device
Characteristic | Subject Device | Primary Predicate Device |
| | Kahook Dual Blade Glide
incisions of the trabecular
meshwork | NMX-1000
meshwork into the ablative bipolar
electrodes as the instrument is
advanced along Schlemm's canal. |
| Design/Mechanism
of Action | Inserted through a previously
created clear corneal incision.
The anterior chamber is inflated
with viscoelastic.
Under gonioscopic evaluation,
insert the tip and the neck through
the clear corneal incision and
advance to the opposite side of the
anterior chamber.
Engage the trabecular meshwork
across from the clear corneal
incision with the pointed tip and
pierce through the trabecular
meshwork and into Schlemm's
canal.
Advance in the direction of the
trabecular meshwork to be cut by
pivoting and advancing/ retracting
the thin neck along the clear
corneal incision while keeping the
footplate in Schlemm's canal.
Detach the trabecular meshwork
strip by use of the KDB or
microforceps.
After cutting the trabecular
meshwork, retract through the
original clear corneal incision. | Inserted through a previously created
clear corneal incision.
The anterior chamber is maintained
with irrigation fluid.
Under gonioscopic evaluation, insert
the tip through the clear corneal
incision and advance to the opposite
side of the anterior chamber.
Engage the trabecular meshwork
across from the clear corneal incision
with the tip and penetrate the
trabecular meshwork and advance
along Schlemm's canal.
Feed trabecular meshwork into the
ablative bipolar electrodes as the tip
advances along the Schlemm's canal.
Aspirate to remove the trabecular
meshwork.
After cutting the trabecular
meshwork, retract through the
original clear corneal incision. |
| | Viscoelastic | Separate viscoinjector used to
stabilize anterior chamber |
| Materials | Stainless steel tip, stainless steel
shaft and plastic handle | Stainless steel probe and ABS plastic
handpiece |
| User Interface | Handheld | Handheld |
| Sterile andSingle
Use | Yes | Yes |
| Sterility Assurance
Level | 10-6 | 10-6 |
Table 1 Kahook Dual Blade (KDB) Glide Substantial Equivalence
6
VI. PERFORMANCE DATA
Bench Testing
The non-clinical bench testing performed on the Kahook Dual Blade Glide device consisted of design
7
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 of | |
| medical devices - Part 5: Tests for in vitro | ||
| cytotoxicity | Non-Cytotoxic | |
| Sensitization | ISO 10993-10 - Biological evaluation of | |
| medical devices - Part 10: Tests for irritation | ||
| and skin sensitization | Non-Sensitizer | |
| Irritation | ISO 10993-10 - Biological evaluation of | |
| medical devices - Part 10: Tests for irritation | ||
| and skin sensitization | Non-irritant | |
| Acute Systemic | ||
| Toxicity | ISO 10993-11 - Biological evaluation of | |
| medical devices - Part 11: Tests for systemic | ||
| toxicity | Non-toxic | |
| Sterilization | ISO 11137-1 - Sterilization of health care | |
| products - Radiation - Part 1 | ||
| ISO 11137-2 -- Sterilization of health care | ||
| products. Radiation - Part 2: Establishing | ||
| the sterilization dose | Assurance level of | |
| 10-6 | ||
| Corrosion testing | ISO 13402 - Surgical and dental hand | |
| instruments -- Determination of resistance | ||
| against autoclaving, corrosion and thermal | ||
| exposure | All samples met the | |
| acceptance criteria | ||
| Autoclave Testing | ISO 13402 - Surgical and dental hand | |
| instruments -- Determination of resistance | ||
| against autoclaving, corrosion and thermal | ||
| exposure | Material's Heat | |
| Deflection | ||
| Temperature shall be | ||
| less than 121°C | ||
| Endotoxin Testing | ANSI/AAMI ST72 - Bacterial endotoxins - | |
| Test methods, routine monitoring, and | ||
| alternatives to batch testing | ||
| Endotoxin Testing Recommendations for | ||
| Single-Use Intraocular Ophthalmic Devices | ||
| Guidance for Industry and Food and Drug | ||
| Administration Staff | Routine monitoring | |
| All samples met the | ||
| acceptance criteria | ||
| Shelf-Life Testing | ||
| Visual Inspection | ASTM F1886 | All samples met the |
| acceptance criteria | ||
| Test Performed | Standard/Guidance | Results |
| Standard Test Method for Determining | ||
| Integrity of Seals for Flexible Packaging by | ||
| Visual Inspection | ||
| Seal Strength | ASTM F88 | |
| Standard Test Method for Seal Strength of | ||
| Flexible Barrier Materials | All units had a seal | |
| strength above 0.75 | ||
| lbf | ||
| Bubble leak test | ASTM F2096 | |
| Standard Test Method for Detecting Gross | ||
| Leaks in Packaging by Internal | ||
| Pressurization (Bubble Test) | All samples met the | |
| acceptance criteria | ||
| Additional Testing | ||
| Deflection test | Devices did not deflect under normal use | |
| Tensile Test | Devices passed the Tensile stress test |
8
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:
9
| 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 IOP
Mean ± 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 Capsule
Opacification | 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 IOP
Mean ± 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
11
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.