(45 days)
No
The device description details a mechanical cutting instrument with an electric motor and vacuum control, with no mention of AI or ML technologies.
Yes
The device is indicated for use in "refractive surgery, or other treatment requiring initial lamellar resection of the cornea," which falls under the definition of a therapeutic purpose.
No
Explanation: The device is described as a surgical tool for cutting corneal tissue, not for identifying a medical condition or disease.
No
The device description clearly states it is an "electrically powered manual mechanical cutting instrument" and details hardware components like a Fixation Ring, cutting Head, Electric Motor, and Control Unit. This is not a software-only device.
Based on the provided information, the Millenium Microkeratome is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Millenium Microkeratome Function: The description clearly states that the Millenium Microkeratome is a surgical instrument used to cut a thin layer of corneal tissue directly on the eye (in vivo). It is a mechanical cutting device used during surgery.
- Intended Use: The intended use is for refractive surgery and other treatments requiring lamellar resection of the cornea, which are surgical procedures performed on the patient's eye.
The device's function and intended use are entirely focused on a surgical procedure performed on the living patient, not on testing specimens outside the body.
N/A
Intended Use / Indications for Use
Millenium Microkeratome is intended for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.
Product codes
86 HMY
Device Description
Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.
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
Non-clinical testing on porcine eyes was found to result in corneal lamellar resection equivalent to predicated devices. Therefore, the technological differences between Millenium Microkeratome and predicated device do not raise any new issues of safety, effectiveness, or performance of the product.
Key Metrics
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
SEP 2 4 1999
8-1
8. 510(k) Summary.
8.1. Submitter's identification.
- Industrial & Medical Design, Inc. u 6230 Wilshire Blvd., Suite 410 Los Angeles, CA 90048
- Yevgeniy Kuklin Contact person: -President
- Date Summary Prepared: July 15, 1999 -
8.2. Submitted device name.
- Millenium Microkeratome Trade name: -
- Keratome Classification name: -
8.3. Identification of predicate device.
| - Company: | Plancon Instruments |
|---|---|
| - Device: | Plancon microlamellar keratome |
| Evolution power unit | |
| 510(k) | K980924 |
| - Company: | Plancon Instruments |
| - Device: | Plancon microlamellar keratome |
| 510(k) | K970377 |
8.4. Device description.
Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.
1
8.5. Intended use of the device.
Millenium Microkeratome is intended for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.
8.6. Comparative technological characteristics of submitted and predicate devices.
| Parameter | : Plancon Instruments : Plancon Instruments | : Submitted device
: K970377 : K980924 | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication
for use | : To perform
: microlamellar
: keratoplasty | : To perform
: microlamellar
: keratoplasty | : To perform initial
: resection of the
: cornea |
| Operation
principle | : Gas turbine driven
: oscillating blade.
: Manual movement
: of the keratome head | : Gas turbine driven
: oscillating blade.
: Manual movement
: of the keratome head | : Electric motor driven
: oscillating blade.
: Manual movement
: of the keratome head |
| Safety test
function | None | : Self-checking.
: Efficiency of pumps,
: input pressure and
: pressure applied to
: the turbine check. | : Self-checking.
: Efficiency of the pump,
: battery charge level, and
: rotation speed of the
: electric motor check. |
| System
composition | : Control unit
: Turbine motor
: Fixed keratome
: head
: Keratome blade
: Fixation ring
: Applanation lenses | : Control unit
: Turbine motor
: Fixed keratome
: head
: Keratome blade
: Fixation ring
: Applanator lenses | : Control unit
: Electric motor
: Adjustable keratome
: head
: Keratome blade
: Fixation ring
: Applanator lens |
| Control unit | : Vacuum pump.
: Vacuum release
: valve.
: Gas regulator.
: Gas & vacuum
: gauges.
: Vacuum & turbine
: quick connectors. | : Two vacuum pumps
: Vacuum release
: valve.
: Gas regulator.
: Gas & vacuum
: sensors.
: LED display
: Vacuum & turbine
: quick connectors. | : Vacuum pump.
: Vacuum release
: valve.
: Electric motor controller
: Vacuum sensors and
: rotation speed control.
: LED display
: Vacuum & electrical
: quick connectors. |
2
| Keratome
motor | : Gas powered.
: Adjustable speed up
: to 20,000 RPM
: (recommended
: 14,000 RPM). | : Gas powered.
: Adjustable speed up
: to 20,000 RPM
: (recommended
: 14,000 RPM). | : Electric motor.
: Adjustable speed up
: to 28,000 RPM
: (pre-set 14,000RPM). |
|-------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Keratome
head | : Fixed single piece
: head. Depth of cut
: depends on the head
: modification.
: Stainless steel | : Fixed single piece
: head. Depth of cut
: depends on the head
: modification.
: Stainless steel | : Fixed Base and different
: Inserts to produce
: predetermined depth
: of the cut.
: Stainless steel |
8.7. Discussion of tests and results.
The specifications and intended use of Millenium Microkeratome are the same or very similar to predicated devises. Non-clinical testing on porcine eyes was found to result in corneal lamellar resection equivalent to predicated devices. Therefore, the technological differences between Millenium Microkeratome and predicated device do not raise any new issues of safety, effectiveness, or performance of the product.
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or waves.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. Yevgeniy Kuklin President Industrial & Medical Design, Inc. 6230 Wilshire Blvd., Suite 410 Los Angeles, CA 90048
Re: K992687 Trade Name: Millenium Microkeratome Regulatory Class: II Product Code: 86 HMY Dated: September 10, 1999 Received: September 13, 1999
Dear Mr. Kuklin:
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 - Mr. Yevgeniy Kuklin
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.
Sincerely vours,
Alvez L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5. Indication for Use Statement.
Industrial & Medical Design Inc. Applicant:
K992687 510(k) Number:
Millenium Microkeratome. Device Name:
Indications for Use:
Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Denis L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K992687
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)