(67 days)
K 980 924, K 913 697, K 972 808
Not Found
No
The device description and performance studies focus on mechanical components and established surgical techniques, with no mention of AI or ML.
No
The device is used for surgery requiring initial lamellar resection of the cornea, which is not considered a therapeutic function. It is a surgical tool.
No
The device description and intended use indicate it is a surgical tool used for lamellar resection of the cornea, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a power unit, keratome head, blade, motor, footswitches, applanator lenses, and suction rings. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "initial lamellar resection of the cornea" during surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are all instruments used for a surgical procedure (cutting, suction, fixation).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to diagnose diseases or other conditions. This device is used in vivo (in the living body) for a surgical purpose.
N/A
Intended Use / Indications for Use
The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.
Product codes
86 HMY
Device Description
The MORIA CARRIAZO BARRAQUER microkeratome system is composed of:
a) Power unit
b) Keratome head
c) Keratome blade
d) Motor
e) Footswitches
f) Applanator lenses
g) Suction rings
The power unit includes pumps for producing vacuum and is designed to operate the keratome using either a 12 V DC motor or a nitrogen motor. It features a 2-position switch to select the power option, and a front panel with displays for vacuum pressure, gas pressure, battery level, battery charge, and various connectors.
The keratome motor has two options:
- Turbine motor: Gas-powered (recommended nitrogen, but accepts any medical gas), similar to those used in dental applications.
- Electrical 12 V DC motor.
The keratome head adapts to either the turbine or the motor via a threaded part and includes the blade, which is moved by the motor. Different heads are available to adjust the thickness of the cut.
Suction rings are used to fixate and pressurize the eye, providing a base for the microkeratome. They feature high precision guideways for accurate cut depth and translation across the cornea.
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, and the base face is plano with an engraved and calibrated reticle diameter.
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, sample size, AUC, MRMC, standalone performance, key results)
Keratomes have been used for lamellar keratoplasty for more than 30 years. The CARRIAZO BARRAQUER keratome performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness, and do not raise new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 980 924, K 913 697, K 972 808
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
JUL 2 4 1998
MORIA CARRIAZO BARRAQUER microkeratome
May 15, 1998 Premarket Notification Section 5 page 1
SUMMARY OF SAFETY AND EFFECTIVENESS
- Sumitter's identification : 1.
- MORIA a. 15 rue Georges Besse 92160 ANTONY · FRANCE
Contact person : b.
Alain DUPRAT
Chief Executive Officer
-
Date Summary Prepared : C.
-
May, 15th, 1998
-
Device name : 2.
Trade Name :
CARRIAZO BARRAQUER microkeratome
-
- Classification name :
Microkeratome
- Classification name :
Subtantial equivalence : 4.
Substantial equivalence is being claimed to the following legally marketed devices
| a. | Company :
Device : | PLANCON INSTRUMENTS
PLANCON microlamellar keratome
EVOLUTION power unit |
|----|------------------------------------|-------------------------------------------------------------------------------|
| | 510 (K) : | K 980 924 |
| b. | Company :
Device :
510 (K) : | HANSA Research & Develpment
Automatic corneal shaper
K 913 697 |
| c. | Company :
Device :
510 (K) : | HANSA Research & Development
Hansatome
K 972 808 |
1
MORIA CARRIAZO BARRAQUER microkeratome
5. Device description
System composition
- a) Power unit
- b) Keratome head
- c) Keratome blade
- d) Motor
- e) Footswitches
- f) Applanator lenses
- g) Suction rings
Power unit a)
The power unit includes pumps for producing vacuum.
The power unit has been designed to operate the keratome by means of 12 V DC motor or by means of nitrogen motor.
Only one of the above power options can be selected at the time by means of a 2 position switch 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 inlet,
- . Gas outlet,
- . Vacuum outlet.
- . Foot pedals,
- . Battery charger.
All connectors are of different type for preventing connecting mistakes.
2
Keratome motor b)
Option 1 : Turbine motor
The turbine motor is gas powered. The recommended gas is nitrogen but the turbine will accept any medical gas. The turbine is not specific to this device. It is already used in the U.S. in particular for dental use. It has been in the market for seven years.
Option 2 : Electrical 12 V DC motor
C) Keratome head
The keratome head adapts to the turbine or to the motor by means of a threaded part.
The keratome head includes the blade which 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. High precision guideways ensure accurate cut depth and translation accross the cornea.
The disks are mounted on the suction handle by means of a threaded tube welded on the ring.
3
Applanator lenses e)
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 plano, with an engraved and calibrated reticle diameter.
6. Statement of intended use
The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.
7. Discussion of tests and results
:
Keratomes have been used for lamellar keratoplasty for more than 30 years. The CARRIAZO BARRAQUER keratome performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness, and do not raise new issues of safety and effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 1998
MORIA S.A. ATTN: Alain Duprat General Manager 15 Rue Georges Besse Antony, France
Re: K981741 Trade Name: CARRIAZO BARRAQUER microkeratome Regulatory Class: I Product Code: 86 HMY Dated: July 1, 1998 Received: July 6, 1998
Dear Mr. Duprat:
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 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). 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.
5
Page 2 - Mr. Alain Duprat
This letter will allow you to begin marketing your device as described in your 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 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" (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 toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
MORIA CARRIAZO BARRAQUER microkeratome
May 15, 1998 Premarket Notification Section 4 page 1
510(k) Number (if known) :
Device Name :
CARRIAZO BARRAQUER microkeratome
Indications for use :
The CARRIAZO BARRAQUER microkeratorne is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea, circular and of 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)
Dease L. McCarthy
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K981741
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)