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.

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.

AI/ML Overview

The Millenium Microkeratome is an electrically powered mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eye. Its intended use is in refractive surgery or other treatments requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

Acceptance Criteria and Device Performance:

Parameter	Acceptance Criteria (based on predicate devices)	Reported Device Performance (Millenium Microkeratome)
Indication for use	To perform microlamellar keratoplasty	To perform initial resection of the cornea
Operation principle	Gas turbine driven oscillating blade	Electric motor driven oscillating blade
Safety test function	None (for K970377) / Self-checking (for K980924)	Self-checking
System composition	Control unit, motor, head, blade, rings, lenses	Control unit, motor, head, blade, rings, lens
Control unit	Vacuum pump, valve, regulator, gauges, connectors	Vacuum pump, valve, motor controller, sensors, display, connectors
Keratome motor	Gas powered, adjustable speed up to 20,000 RPM (recommended 14,000 RPM)	Electric motor, adjustable speed up to 28,000 RPM (pre-set 14,000 RPM)
Keratome head	Fixed single piece head, depth depends on modification	Fixed Base and different Inserts to produce predetermined depth of cut
Equivalence in corneal lamellar resection	Equivalent to predicate devices (implied)	Equivalent to predicate devices

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The study was conducted on "porcine eyes." The number of porcine eyes is not specified.
- Data Provenance: The study was non-clinical and conducted on porcine eyes. There is no mention of country of origin, as it's an animal model study. It is a prospective study in the sense that the device was used on these eyes for testing.
Number of Experts and Qualifications:
- No information provided regarding the number or qualifications of experts used to establish ground truth.
Adjudication Method:
- No information provided on an adjudication method. The assessment appears to be a direct comparison of the corneal lamellar resection to that achieved by predicate devices.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This study is for a medical device (a microkeratome) that performs a surgical procedure, not an imaging or diagnostic device that requires human interpretation.
Standalone Performance Study:
- Yes, a standalone study was performed. The device was tested directly on porcine eyes to evaluate its ability to perform corneal lamellar resection. The results were then compared to the performance of predicate devices.
Type of Ground Truth Used:
- The ground truth was established by comparing the corneal lamellar resection produced by the Millenium Microkeratome to that produced by "predicated devices." The equivalence was determined based on the physical characteristics of the resected tissue. This implicitly refers to device performance characteristics rather than a clinical ground truth like pathology or patient outcomes.
Training Set Sample Size:
- Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.
How Ground Truth for Training Set was Established:
- Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

Summary of the Study:

The study was a non-clinical test on porcine eyes to demonstrate that the Millenium Microkeratome could achieve corneal lamellar resection equivalent to that produced by predicate devices (Plancon microlamellar keratome and Evolution power unit). The fundamental conclusion was that the technological differences (primarily electric motor vs. gas turbine) did "not raise any new issues of safety, effectiveness, or performance of the product." The focus was on establishing functional equivalence for the intended use rather than clinical efficacy or human-in-the-loop performance.

Summary

{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 keratomeEvolution power unit
510(k)	K980924
- Company:	Plancon Instruments
- Device:	Plancon microlamellar keratome
510(k)	K970377

8.4. Device description.

{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
Indicationfor use	: To perform: microlamellar: keratoplasty	: To perform: microlamellar: keratoplasty	: To perform initial: resection of the: cornea
Operationprinciple	: 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 testfunction	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.
Systemcomposition	: 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}------------------------------------------------

Keratomemotor	: 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).
Keratomehead	: 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)

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.