(136 days)
Not Found
No
The description details a mechanical microkeratome system with electric motors and cables, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a microkeratome used for making anterior lamellar corneal resections which is a surgical procedure, indicating a therapeutic purpose.
No
The FLAPMAKER™ is described as a surgical device (microkeratome) intended for making corneal resections, which is a therapeutic rather interventional procedure, not a diagnostic one. Its function is to physically alter the cornea, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a control console with a suction pump, electronics, motors, cables, and disposable microkeratomes made of plastic and surgical-grade steel. It is a physical device with mechanical and electrical components, not solely software.
Based on the provided text, the FLAPMAKER™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "make anterior lamellar corneal resections of preselected thickness and diameter." This is a surgical procedure performed directly on the patient's eye (in vivo).
- Device Description: The device is a microkeratome, a surgical instrument used to cut a flap in the cornea. It involves mechanical action (oscillating blade, movement across the cornea) and suction, all applied to the living tissue.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease. The FLAPMAKER™ does not perform any such analysis on bodily specimens.
The FLAPMAKER™ is a surgical device used for a specific ophthalmic procedure.
N/A
Intended Use / Indications for Use
The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.
Product codes
86 HNO
Device Description
The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.
The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. 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 microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic.
The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to 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
corneal
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)
Non-clinical tests: The FlapMaker has had electrical safety tests certified by the Canadian Standards Association. Plastic Materials in contact with tissue have been tested for biocompatibility. All motors are UL approved. Blades are surgical-grade stainless steel.
Clinical tests: This device is identical to the predicate devices, except that the motors have been moved to a central unit and the energy is transmitted by cables. Since there is no change in technology or principles, a clinical test is not required.
Conclusions: The FlapMaker 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
981155
Hawken Industries FlapMaker
Page A 3
AUG 1 4 1998
Hawken Industries Inc. FlapMaker Microkeratome 510(k) Submission
510(k) Summary
(1) Submitter Information
Name: Hawken Industries Inc.
Address: 26650 Renaissance Pkwy. Suite 3 Cleveland, Ohio 44128 U.S.A.
Telephone Number: 216-464-1119
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703
Date Prepared: March 19, 1998
(2) Name of Device:
Trade Name: FlapMaker Disposable Microkeratome Common Name: Disposable Microkeratome Classification Name: Keratome, A-C powered
(3) Equivalent legally-marketed devices:
The predicate devices for the FlapMaker are Chiron Automatic Corneal Shaper, K941550, the Steinway Micro-Kerato-trephone K8436646, and the HANSA Automatic Corneal Shaper, K913697.
(4) Description
The device consists of a control console and disposable FLAPMAKER™ microkeratomes. The control console contains a suction pump, electronics, and flexible cables to actuate the disposable microkeratome. The basic system sold consists of the control unit, 20 disposable microkeratomes (sold sterile), 5 practice microkeratomes (not sold sterile), and interconnection equipment, including hoses, cables, and footpedals.
1
The FLAPMAKER™ microkeratome is a clear, automated, completely assembled, disposable microkeratome. It is made of biocompatible polycarbonate plastic and includes the blade made from surgical-grade steel. 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 microkeratome is based upon the principle of the carpenter's plane. The blade, made from surgical stainless steel, oscillates at 12,500 rpm and is controlled by a unique patented flexible cable that is electronically driven. The blade extends a fixed distance from a transparent fixed plate and is at a 26° angle to the plate. Microkeratomes that create resection depths of 130 or 160 microns and resection diameters of 8.5mm and 10.5 mm are available. The microkeratome is mounted in a suction plate and is driven across the suction plate and protruding cornea at 6.8 mm/sec. by a patented flexible cable that is electrically actuated. The plastic suction ring, which supports the unit on the cornea, is made from biocompatible polycarbonate plastic.
The microkeratome itself is powered by two electric motors located in the control unit; motion is transmitted to the keratomes by mechanical transmission cables. The motors are UL approved. The central unit also supplies the suction. One cable transmits the motion to cause the blade to oscillate, and the other drives the device axially. As may be seen, there is no electricity transmitted to the keratome units. The microkeratome itself requires no assembly, but the connections to 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 FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.
(6) Performance data
(1) Non-clinical tests
The FlapMaker has had electrical safety tests certified by the Canadian Standards Plastic Materials in contact with tissue have been tested for Association. biocompatibility. All motors are UL approved. Blades are surgical-grade stainless steel.
(2) Clinical tests
2
Hawken Industries FlapMaker
This device is identical to the predicate devices, except that the motors have been moved to a central unit and the energy is transmitted by cables. Since there is no change in technology or principles, a clinical test is not required.
(3) Conclusions
The FlapMaker microkeratome is equivalent in safety and efficacy to the legallymarketed predicate devices.
3
Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG | 4 1998
Hawken Industries c/o George H. Myers, Sc.D Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604
Re: K981155 Trade Name: FlapMaker Disposable Microkeratome Regulatory Class: I Product Code: 86 HNO Dated: July 7, 1998 Received: July 8, 1998
Dear Dr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
4
Page 2 - George H. Myers, Sc.D
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Hawken Industries FlapMaker
Page 2011 - of of 1 - 1 1
510(k) Number (if known):
Device Name: Hawken FlapMaker Disposable Microkeratome
Indications for Use:
The FLAPMAKER™ is a disposable microkeratome that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter. It is sold sterile and is for single-use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices Ka81155 510(k) Number.
OR
Prescription Use_ 188/1 (Per 21 CFR 810.109) Over-the-Counter Use
(Optional Format 1-2-96)