(51 days)
No
The device description focuses on mechanical components and electrical controls, with no mention of AI, ML, or image processing for decision-making or analysis.
No.
The device is used to create a corneal flap for LASIK surgery, which is a surgical procedure. While it is related to treating a medical condition, the device itself is an instrument used in a surgical context rather than directly providing a therapeutic effect.
No
This device is a surgical tool used to create a corneal flap; it does not diagnose medical conditions.
No
The device description explicitly lists multiple hardware components including a power unit, motor, suction rings, applanator lenses, footswitches, keratome head, and keratome blade.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea." This describes a surgical procedure performed directly on a patient's eye.
- Device Description: The components listed (power unit, motor, suction rings, applanator lenses, footswitches, keratome head, keratome blade) are all instruments used for a surgical procedure.
- Anatomical Site: The anatomical site is the "cornea," which is part of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information. The device is used to physically alter the cornea during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The OneUse - Plus Microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.
Product codes
HMY
Device Description
List of components
- Power unit
- Motor
- Suction rings
- Applanator lenses
- Footswitches
- Keratome head
- Keratome blade
a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & 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.
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 motors outlets, Gas turbine 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 types for preventing connection mistakes.
b) Keratome 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).
c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
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 to provide a base for the microkeratome heads.
e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.
f) Keratome blade
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.
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
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 54 human eyes showed that the OneUse - Plus 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)
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
MORIA S.A. OneUse - Plus Microkeratome
February 5, 2004 Premarket Notification
MAR 3 1 2004
Section 4 page 1
510(k) SUMMARY
1. Submitter's identification
- MORIA S.A. a. 15, rue Georges Besse 92160 ANTONY France (33-1) 46 74 46 36 Tel: (33-1) 46 74 46 70 Fax:
- Contact person: b.
040297
Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com
February 5, 2004
- Date Summary Prepared: C.
2. Device name
OneUse - Plus Microkeratome Trade Name:
Classification name 3.
Keratome (per CFR 886.4370)
Substantial equivalence 4.
Substantial equivalence is being claimed to the following legally marketed devices:
| Device name: | One Up Disposable keratome Head |
|---|---|
| Company name: | MORIA S.A. |
| Document control number: | K981742 |
| 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
- Power unit ●
- Motor .
- Suction rings ●
- Applanator lenses .
- Footswitches .
- Keratome head ●
- Keratome blade ●
a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & 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.
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 motors outlets, Gas turbine 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 types for preventing connection mistakes.
2
Section 4 page 3
b) Keratome 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).
c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
Different heads are available in order to adjust the thickness of the cut.
Suction rings d)
The suction rings are used to fixate and pressurize the eye and to provide a base for the microkeratome heads.
e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.
3
Section 4 page 4
Keratome blade f)
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.
Statement of intended use 6.
The OneUse - Plus Microkeratome is intended for use in making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.
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 54 human eyes showed that the OneUse - Plus 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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2004
Moria S.A. c/o Mrs. Melanie Renaud-Samiri Quality Assurance & Regulatory Affairs Manager 15 Rue Georges Besse Antony France 92160
Re: K040297
Trade/Device Name: OneUse - Plus Microkeratome Regulation Number: 21CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HMY Dated: February 5, 2004 Received: February 9, 2004
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
Page 2 - Mrs. Melanie Renaud-Samiri
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Aherl 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
Enclosure
6
MORIA S.A. OneUse - Plus Microkeratome
February 5, 2004 Premarket Notification
Section 5 page 1
510(k) Number (if known):
Device Name:
OneUse - Plus Microkeratome
Indications for use:
The OneUse - Plus Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the comea.
3-29-2004
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number. K040297
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮐﮯ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Optional Format 1-2-96)