(190 days)
No
The device description and intended use focus on mechanical components and their functions for creating a corneal flap. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended to incise the cornea to create a flap, which is a therapeutic intervention for ophthalmic procedures like LASIK.
No
The device is described as making an incision in the cornea to create a flap, which is a surgical procedure, not a diagnostic one. It does not mention any diagnostic functions like measuring or analyzing a condition.
No
The device description clearly outlines multiple hardware components including a control box, hand piece, foot pedal, blade holder, applanation plate, disposable blade, and suction ring.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nidek MK-2000, Keratome is a surgical device used to physically cut a flap in the cornea on the patient's eye. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for "incising the cornea," which is a surgical procedure performed directly on the patient.
Therefore, based on the provided information, the Nidek MK-2000, Keratome is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.
The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a The Nidek NIT 2007 Relates and diameter using a high speed oscillation blade of stainless steel.
Product codes
86HNO
Device Description
This DEVICE is an AC powered device consisting of three main parts:
- CONTROL BOX: The FRONT PANEL consists of: LED for Power Indicator, Suction Indicator, Confirmation Indicator. Pressure Gauge with a pointer for suction pressure. Self Test button to perform a pre-test. Hand Piece Connector Connector for suction and suction pressure monitoring. The REAR PANEL consists of a AC Power Inlet, Power Switch and a Foot Pedal Connector. The MOTOR CONTROL is Bi-directional control (forward/reverse), one way control for oscillation.
- HAND PIECE: The Handpiece contains the blade running and reversing mechanism, the oscillation mechanism, an attachment slot for the Suction Ring, the Blade Holder, and a connector for the Control Box. The Handpiece is made of aluminum. Blade Holder: is made of Stainless Steel. Applanation Plate: that determines the thickness of the incised cornea (flap) and is fixed to the top of the blade holder. Three Applanation Plates are available dependent on the desired flap thickness (130, 160 & 180 um). Blade: the keratome blade is pre-sterilized and made of "Stainless Steel" and is a one-time-use disposable blade. Single Suction Ring: fixes the hollow part of the suction ring to the eyeball under suction. 2 suction ports, one to monitor suction pressure and a second to provide suction. Three suction ring sizes are available, dependent on the desired flap diameter (8.5 mm, 9.5 mm or 10.5 mm). There are NO gear mechanism or sliding guide around the suction ring.
- FOOT PEDAL: Consists of: "SUCTION SWITCH" to control the applying and stopping of the suction pressure to the suction ring. "FORWARD SWITCH" to control the running and oscillation of the blade. "REVERSE SWITCH" control the reverse motion of the blade. "CABLE" allow connection to the Control Box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea / Eyeball
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)
No clinical performance data has been provided. Non-clinical performance data not provided. The effectiveness of the device was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K912697, K972808, K973294, K981141, K981155, K974004
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
APPENDIX III
510(k) SUMMARY
[As required by 21 CFR 807.93]
I GENERAL INFORMATION
Applicant's Name & Address: Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474
Mr. Jerry Tsutsumi Regulatory/Quality Manager
Date Summary Prepared:
16 March 1999
DEVICE NAME II
Contact:
Trade or Proprietary Name: Model Number:
Nidek Keratome, MK-2000 MK-2000
Common/Classification Name: Class: Classification Panel: Regulation Number:
Keratome Class I 86 886.4370
III PREDICATE DEVICES
The Nidek MK-2000 Keratome is claimed to be substantially equivalent to the following currently Marketed Predicate Devices:
| Submitter | Model | 510(k) Number | Date |
|---|---|---|---|
| Hansa R&D* | AUTOMATED CORNEAL SHAPER | K912697 | 05-Nov-91 |
| Hansa R&D | HANSATOME | K972808 | 24-Oct-97 |
| Innovative Optics | INNOVATOME | K973294 | 03-Oct-97 |
| MORIA | CARRAZIO BARRAQUER | K981141 | 24-Jul-98 |
| Hawken Industries | FLAPMAKER | K981155 | 14-Aug-98 |
| LaserSight Tech. | ADK | K974004 | 08-Jan-98 |
- The 510(k) for the AUTOMATED CORNEAL SHAPER was submitted by Hansa Research and Development, Inc., but his product is currently being sold by CHIRON INTRAOPTICS as identified in APPENDIX VII.
1
IV PRODUCT DESCRIPTION
This DEVICE is an AC powered device consisting of three main parts:
-
- CONTROL BOX: The FRONT PANEL consists of:
- LED for Power Indicator, Suction Indicator, Confirmation Indicator. .
- Pressure Gauge with a pointer for suction pressure. .
- Self Test button to perform a pre-test. .
- Hand Piece Connector ●
- Connector for suction and suction pressure monitoring .
The REAR PANEL consists of a AC Power Inlet, Power Switch and a Foot Pedal Connector. The MOTOR CONTROL is Bi-directional control (forward/reverse), one way control for oscillation.
-
- HAND PIECE: The Handpiece contains the blade running and reversing mechanism, the oscillation mechanism, an attachment slot for the Suction Ring, the Blade Holder, and a connector for the Control Box. The Handpiece is made of aluminum.
- Blade Holder: is made of Stainless Steel .
- Applanation Plate: that determines the thickness of the incised cornea ● (flap) and is fixed to the top of the blade holder. Three Applanation Plates are available dependent on the desired flap thickness (130, 160 & 180 um).
- Blade: the keratome blade is pre-sterilized and made of "Stainless Steel" . and is a one-time-use disposable blade.
- Single Suction Ring: fixes the hollow part of the suction ring to the eyeball ● under suction. 2 suction ports, one to monitor suction pressure and a second to provide suction. Three suction ring sizes are available, dependent on the desired flap diameter (8.5 mm, 9.5 mm or 10.5 mm). There are NO gear mechanism or sliding guide around the suction ring.
2. FOOT PEDAL: Consists of:
- "SUCTION SWITCH" to control the applying and stopping of the suction . pressure to the suction ring.
- "FORWARD SWITCH" to control the running and oscillation of the blade. .
- "REVERSE SWITCH" control the reverse motion of the blade. ●
- "CABLE" allow connection to the Control Box. .
INDICATIONS FOR USE V
Intended Use: The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a pre-selected thickness and diameter.
2
VI CLINICAL PERFORMANCE DATA
No clinical performance data has been provided.
VII NON-CLINICAL PERFORMANCE DATA
None provide.
VIII RATIONAL FOR SUBSTANTIAL EQUIVALENCE
Our claim of Substantial Equivalence is based on the following;
- The INTENDED USES and the OPERATING & CUTTING PRINCIPLES of the . Nidek MK-2000 Keratome is the same as the SIX predicate devices.
- The OPERATIONAL FEATURES of the Nidek MK-2000 Keratome are the same . or similar to those offered on one or more of the predicate devices.
- The SAFETY FEATURES of the Nidek MK-2000 Keratome are the same or very ● similar to those offered on one or more of the predicate devices.
IX SAFETY AND EFFECTIVENESS
This device is designed to comply with the electrical standards of the Underwriters Laboratories UL2601-1, International Electro-technical Commissions IEC601-1-1 and IEC601-1-2 which reasonably assures the device to be Safe when used as directed for its prescribed intended use. Additionally several operational safety features are designed into this device (Vacuum Level Gauge, a low suction LED and "audible tone" indicators, automatic cutting stop if vacuum level drops, and forward & reverse foot pedal controls). The effectiveness of the device was confirmed by use of QWF050B, Nidek MK-2000 Keratome Validation Test Procedure.
CONCLUSION ×
The data submitted in this 510(k) Premarket Notification, for the Nidek MK-2000 Keratome demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features, to other legally market predicate devices. With the information provided, the safety and effectiveness of this product can be reasonably assured, and thus we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 1999
Mr. Jerry Tsutsumi Regulatory/Quality Manager Nidek Incorporated 47651 Westinghouse Drive Fremont, California 94539-7474
Re: K990900 Trade Name: Nidek Keratome, MK 2000 Regulatory Class: I Product Code: 86 HNO Dated: August 26, 1999 Received: August 27, 1999
Dear Mr. Tsutsumi:
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. Jerry Tsutsumi
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 yours,
Alvey L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
APPENDIX II
Trade or Proprietary Name: Common or Classification Name: Model Number: Class: Classification Panel: Product Code: Regulation Number:
Nidek MK-2000 Keratome Keratome MK-2000 Class I ૪૯ 886.4370
INDICATIONS FOR USE:
The Nidek MK-2000, Keratome is intended to make a flap by incising the cornea at a The Nidek NIT 2007 Relates and diameter using a high speed oscillation blade of stainless steel.
Denis L. McCarthy
Division Sign-Off) Division of Ophthalmic Devices 510(k) Number. 9900
YES Prescription Use . (Per 21 CFR 801.109)