The Horizon Epikeratome™ is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar connections of preselected thickness and diameter and for the separation of the epithelium from the comea for subsequent surgical procedures and thatleter

Device Description

The device consists of a control console and disposable HORIZON EPIKERATOME™ microkeratome hand pieces. The control console contains a suction pump, electronics, and a flexible cable to actuate the disposable microkeratome. The basic system sold consists of the control unit, disposable microkeratomes (sold sterile) for corneal resection, a special microkeratome for epithelial separation, practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.

The HORIZON EPIKERATOME™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes a separator also made of biocompatible polycarbonate plastic.. It is sold sterile and is for single use only. Each individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation. The hand ieces for corneal resection use a surgical -grade steel blade instead of a plastic separartor.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by a flexible mechanical transmission cable. The motors are ULand CE approved. The central unit also supplies the suction. The single cable transmits both the motion to cause the blade (or separator) to oscillate and translate the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

AI/ML Overview

The Horizon Epikeratome is a medical device designed for ophthalmological procedures, specifically for separating the epithelium from the cornea for subsequent surgical interventions. The information provided outlines the regulatory submission and claims of equivalence rather than a detailed performance study with specific acceptance criteria tables.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there is no explicit table of acceptance criteria or quantified performance metrics presented for the Horizon Epikeratome itself. The submission primarily relies on the device being "identical to the predicate device" in technology and principles, implying that the performance of the predicate device serves as the de facto benchmark.

However, the non-clinical tests conducted suggest implied acceptance criteria in certain areas:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with relevant standards for electrical safety	"The Horizon Epikeratome has had electrical safety tests..."
Electromagnetic Compatibility (EMC)	Compliance with relevant standards for EMC	"...and electromagnetic compatibility tests."
Biocompatibility	Plastic materials in contact with tissue must be biocompatible	"Plastic Materials in contact with tissue have been tested for biocompatibility."
Motor Approval	Motors must meet UL and CE approval standards	"All motors are UL and CE approved."
Blade Material	Blades must be surgical-grade stainless steel	"Blades are surgical-grade stainless steel."
Efficacy (Animal Studies)	Demonstrate comparable efficacy to predicate devices	"Animal studies have been performed to demonstrate the efficacy of the unit. It was compared to the predicate devices in tests with enucleated eyes."
Clinical Equivalence	No significant change in technology or principles compared to predicate, implying similar clinical outcomes. (This is a claim, not a measured performance metric for the Horizon Epikeratome directly from clinical trials).	"This device is identical to the predicate device... Since there is no change in technology or principles, a clinical test is not required."

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

Test Set Sample Size: Not explicitly stated. The document mentions "tests with enucleated eyes" for animal studies, but the number of eyes or animals is not provided.
Data Provenance:
- Animal Studies: Performed on "enucleated eyes." The species or origin of these eyes is not specified.
- Clinical Studies: No human clinical test set was used for the Horizon Epikeratome's performance evaluation as it was deemed not required due to equivalence with a predicate device.

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

Not applicable. As no human clinical test set was required for the Horizon Epikeratome due to its equivalence claim, there was no need for experts to establish ground truth in this context. The animal studies would likely have been evaluated by veterinarians or ophthalmic researchers, but specific details are not provided.

4. Adjudication Method for the Test Set:

Not applicable. Since no human clinical test set or formal multi-reader evaluation was conducted and reported, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Since there is no change in technology or principles, a clinical test is not required" for the Horizon Epikeratome.

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

Not applicable. The Horizon Epikeratome is a mechanical microkeratome system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used:

Animal Studies: For the animal studies on enucleated eyes, the ground truth would likely have been based on direct observation and measurement of the outcomes of the corneal and epithelial separation, potentially compared against the known effects of the predicate devices. This would involve surgical assessment, potentially histology, or other direct physical measurements on the excised eyes.
Clinical Equivalence Claim: The ultimate "ground truth" for the device's market approval relied on its substantial equivalence to legally marketed predicate devices (Hawken Flapmaker, K981155, and the Norwood Abbey Centurion, K051486), asserting that their established safety and efficacy serve as the ground truth for an equivalent device.

8. The Sample Size for the Training Set:

Not applicable. The Horizon Epikeratome is a mechanical device and does not involve AI or machine learning, thus there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Horizon Epikeratome

Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters. The characters are 'K052891'. The characters are written in a bold, handwritten style.

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Hawken Industries Inc. Horizon Epikeratome Microkeratome 510(k) Submission

510(k) Summary

(1) Submitter Information

Name: Hawken Industries Inc.

Address: 26650 Renaissance Pkwv. Suite 3 Cleveland, Ohio 44128

Telephone Number: 216-831-6782

Contact Person: Dr. George Myers Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: October 4, 2005

Name of Device:

Trade Name: Horizon Epikeratome Microkeratome Common Name: Disposable Microkeratome Classification Name: Keratome, A-C powered

(3) Equivalent legally-marketed devices:

The predicate devices for the Horizon Epikeratome are Hawken Flapmaker, K981155, and the Norwood Abbey Centurion, K051486.

(4) Description

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Horizon Epikeratome

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K05289.

individual microkeratome is separately packaged in Tyvek, and is sterilized by gamma radiation. The hand ieces for corneal resection use a surgical -grade steel blade instead of a plastic separartor.

The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by a flexible mechanical transmission cable. The motors are ULand CE approved. The central unit also supplies the suction. The single cable transmits both the motion to cause the blade(or separator) to oscillate and translate the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the central unit must be made before the operation. Separate units are available for different resection diameters and depths. The suction tubes are sold sterile one unit for a patient, and are sold with the microkeratomes.

(5) Intended Use

The Horizon Epikeratome ™ is a single-use microkeratome system intended to be used for the separation of the epithelium from the cornea for subsequent surgical procedures on denuded cornea.

(6) Performance data

(1) Non-clinical tests

The Horizon Epikeratome has had electrical safety tests and electromagnetic compatibility tests. Plastic Materials in contact with tissue have been tested for biocompatibility. All motors are UL and CE approved. 3) ades are surgical-grade stainless steel. Animal studies have been performed to demonstrate the efficacy of the .nit. It was compared to the predicate devices in tests with enucleated eyes.

(2) Clinical tests

This device is identical to the predicate device, K981155 (Flapmaker) except that only one cable is used and a special separator is used for epithelial separation. Since there is no change in technology or principles, a clinical test is not required.

(3) Conclusions

The Horizon Epikeratome microkeratome is equivalent in safety and efficacy to the legally-marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures, represented by curved lines, overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

Hawken Industries Inc. c/o Dr. George Myers Medsys Inc. 377 Rt. 17 South Hasbrouck Heights, NJ 07604

Re: K052891

: Trade/Device Name: Horizon Epikeratome Disposable Microkeratome System Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 14, 2006 Received: March 15, 2006

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro rowed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. George Myers

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

J. Sarcra

Malvina 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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Horizon Epikeratome

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Indications for Use

510(k) Number (if known):

Device Name: Horizon Epikeratome

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Givette Reyes

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K0528

510(k) Number

Regulation Number and Section

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.