(56 days)
No
The summary describes a mechanical microkeratome and its components, with no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
No.
The M2 SINGLE USE microkeratome is used to create a corneal flap, which is a preparatory step for other treatments like LASIK surgery, rather than directly treating a disease or condition itself.
No
This device is used to create a corneal flap for surgery, which is a therapeutic intervention, not a diagnostic one. It does not analyze patient data or provide information about a patient's condition.
No
The device description explicitly lists multiple hardware components (Power unit, Motor, Suction rings, Applanator lenses, Footswitches, Keratome head with pre-inserted Keratome blade).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create a corneal flap in patients undergoing LASIK surgery or other treatments requiring lamellar resection of the cornea. This is a surgical procedure performed directly on a living patient's tissue.
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The components listed are all parts of a surgical instrument used for cutting tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
This device is a surgical instrument used for a specific procedure on the human body, not for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The M2 SINGLE USE microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
HMY
Device Description
The M2 SINGLE USE microkeratome consists of the following components:
- Power unit: The power unit is the same as used for predicate devices (K003594 and K002191). It includes pumps for producing vacuum and is designed to operate the Keratome by an electric motor or gas turbine motor. It has a front panel with vacuum pressure gauge, gas pressure gauge, battery level and charge indicators, and connectors for DC motor outlet, gas outlet, and vacuum outlet. The back panel has connectors for gas inlet, foot pedals, and battery charger. All connectors are of different types to prevent incorrect connections.
- Keratome motor:
- Option 1: Turbine motor, gas powered (medical grade nitrogen recommended). This turbine has been marketed by MORIA since six years (see predicate device PLANCON MICROLAMELLAR KERATOME K970377).
- Option 2: Electrical motor system with two built-in electrical motors (one for blade oscillation, one for microkeratome advance).
- Keratome head: Includes the blade moved by the motor. Different heads are available to adjust cut thickness.
- Suction rings: Used to fixate and pressurize the eye and provide a base for the microkeratome.
- Applanator lenses: Made of clear methylmethacrylate with a stainless steel handle. Used with rings to control disk diameter before the cut. The upper face is convex for magnification, and the base face (contact face) is plane with an engraved and calibrated reticule diameter.
- Keratome blade: Made of two parts: the blade edge in low carbon steel, and the blade holder (not in contact with the patient's eye).
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: In-vitro studies
-
Sample size: Not specified (on porcine eyes)
-
Key results: Demonstrated flap thickness consistency, safety of corneal resections, and good quality of corneal resections.
-
Study type: In-vivo studies
-
Sample size: 72 human eyes
-
Key results: Showed that the M2 SINGLE USE microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
MORIA S.A. M2 SINGLE USE microkeratome
July 2nd, 2002 Premarket Notification KOZZ560
SEP 2 7 2002
Section 4 page 1
510(k) SUMMARY
1. Submitter's identification
- a. MORIA S.A. 15, rue Georges Besse 92160 ANTONY France Tel: (33-1) 46 74 46 36 Fax: (33-1) 46 74 46 70
- Contact person: Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager
E mail: mrenaud@moria-int. com
July 2nd, 2002 C. Date Summary Prepared:
2. Device name
b.
M2 SINGLE USE microkeratome Trade Name:
3. Classification name
Keratome (per CFR 886.4370)
4. Substantial equivalence
Substantial equivalence is being claimed to the following legally marketed devices:
Device name: CARRIAZO BARRAQUER SINGLE USE Microkeratome Company name: MORIA S.A. Document control number: K003594
And
Device name: CARRIAZO BARRAQUER II Microkeratome Company name: MORIA S.A. Document control number: K002191
1
Section 4 page 2
5. Device description
List of components
- a) Power unit
- b) Motor
- c) Suction rings
- d) Applanator lenses
- e) Footswitches
- f) Keratome head with pre-inserted Keratome blade
Power unit a)
The power unit used for the M2 SINGLE USE microkeratome is the same as the power unit used for the predicate devices CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) & CARRIAZO BARRAQUER II Microkeratome (K002191) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum.
The power unit has been designed to operate the Keratome by means of electric motor or by means of a gas turbine motor.
Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel.
The front panel has several displays and features:
- Vacuum pressure gauge, -
- Gas pressure gauge, -
- -Battery level indicator,
- Battery charge indicator, -
- -Connectors:
- . DC motor outlet,
- . Gas outlet.
- Vacuum outlet, ●
The back panel has several displays and features:
- -Connectors:
- Gas inlet,
- . Foot pedals,
- . Battery charger.
All connectors are of different type for preventing connecting mistakes.
2
Section 4 page 3
b) Keratome motor
Option 1: Turbine motor
The turbine motor is gas powered. The recommended gas is medical grade nitrogen. The turbine has been marketed by MORIA since six years (see predicate device PLANCON MICROLAMELLAR KERATOME K970377).
Option 2: The electrical motor
The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome).
Keratome head C)
The Keratome head includes the blade that is moved by the motor.
Different heads are available in order to adjust the thickness of the cut.
d) Suction rings
The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome.
e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to control disk diameter before the cut.
The upper face is convex for magnification.
The base face (contact face) is plane, with an engraved and calibrated reticule diameter.
3
Section 4 page 4
f) Keratome blade
The blade is made of two parts: the blade edge in low carbon steel, and the blade holder, which is not in contact with the patient's eye.
6. Statement of intended use
The M2 SINGLE USE microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
7. Discussion of tests and results
Keratomes have been used for lamellar keratoplasty for more than 30 years.
In-vitro studies on porcine eyes demonstrated:
- -The flap thickness consistency,
- The safety of corneal resections, -
- The good quality of corneal resections. -
In-vivo studies on 72 human eyes showed that the M2 SINGLE USE microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MORIA S.A. c/o Mrs. Melanie Renaud-Samiri Ouality Assurance & Regulatory Affairs Manager 15, Rue Georges Besse 92160 Antony France
Re: K022560
Trade/Device Name: M2 Single Use microkeratome Regulation Number: 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HMY Dated: July 2, 2002 Received: August 2, 2002
Dear Mrs. Renaud-Samiri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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.
5
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
6
:
Section 5 page 1
510(k) Number (if known):
Device Name:
:
M2 SINGLE USE microkeratome
Indications for use:
The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Qevice Eyaluation (ODE)
(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises
510(k) Number_ ( 0 2 2 5 6 0 2 2 5 6 0 -
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)