(161 days)
No
The device description focuses on mechanical and electrical components, with no mention of AI or ML capabilities. The performance studies also do not indicate any AI/ML involvement.
Yes
The device is used to make anterior lamellar connections of preselected thickness and diameter and for the separation of the epithelium from the cornea for subsequent surgical procedures, which are indications for therapeutic use.
No
Explanation: The device description states its purpose is to create anterior lamellar connections and separate the epithelium from the cornea for subsequent surgical procedures, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description clearly outlines hardware components including a control console, disposable microkeratome hand pieces, a suction pump, electronics, cables, footpedals, motors, and surgical blades. It is a physical medical device with software controlling some functions, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to make anterior lamellar connections of the cornea and separate the epithelium. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The description details a microkeratome system with a control console, handpieces, blades, and a separator. These are all components used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for 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.
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
Product codes
HNO
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 pieces for corneal resection use a surgical -grade steel blade instead of a plastic separator.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
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)
(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. Blades are surgical-grade stainless steel. Animal studies have been performed to demonstrate the efficacy of the unit. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
Page 5-2
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
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
1
Horizon Epikeratome
Page 5-3
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.
2
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.
3
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
4
Horizon Epikeratome
Page 4-1
Indications for Use
510(k) Number (if known):
Device Name: Horizon Epikeratome
Indications For Use:
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
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