(281 days)
Not Found
No
The summary describes a mechanical microkeratome and does not mention any AI/ML components or functionalities. The performance studies focus on mechanical outcomes like flap thickness and smoothness.
Yes.
The device is used to create a corneal flap for LASIK surgery or other treatments requiring lamellar resection of the cornea, which are considered therapeutic procedures as they aim to treat a medical condition.
No
Explanation: The device is a microkeratome used for creating a corneal flap during LASIK surgery, which is a surgical tool, not a device that diagnoses a condition or disease.
No
The device description lists multiple hardware components (Power unit, Motor, Suction rings, Applanator lenses, Footswitches, Keratome head, Keratome blade) which are integral to the device's function.
Based on the provided information, 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.
- Device Description: The components listed are all related to a surgical instrument used for cutting tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens.
The in-vitro studies mentioned were likely performed on excised animal eyes to test the device's performance before human use, which is a common practice for surgical devices, not an indication that the device itself is an IVD.
N/A
Intended Use / Indications for Use
The M3 microkeratome is intended for use in the making of a comeal flap in patients undergoing of LASIK surgery or other treatments requiring initial lamellar resection of the cornea.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
List of components
- Power unit .
- Motor ●
- Suction rings .
- Applanator lenses .
- Footswitches .
- Keratome head 1
- Keratome blade .
a) Power unit
The power unit used for the M3 microkeratome is the same as the power unit used for the The power unit used for the M5 microReratome (K003594) & Plancon
predicate devices CARRIAZO BARRAQUER Microkeratome (KA by our company predicate devices CARRAZO DrineriQ SER
The power unit includes pumps for producing vacuum.
I he power unit incrudes pullips for producting - counting - counting 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 The dive by 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 The blade 15 made 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, sample size, AUC, MRMC, standalone performance, key results)
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 100 human eyes showed that the M3 microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a able to - creater, and thickness and bed smoothness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
September 10", 2003 Premarket Notification
Section 4 page 1
510(k) SUMMARY
Submitter's identification 1.
- 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.
Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com
- Date Summary Prepared: c.
September 10th, 2003
Device name 2.
M3 microkeratome Trade Name:
Classification name 3.
Keratome (per CFR 886.4370)
Substantial equivalence বা
Substantial equivalence is being claimed to the following legally marketed devices:
| Device name: | CARRIAZO BARRAQUER II Microkeratome |
|---|---|
| Company name: | MORIA S.A. |
| Document control number: | K002191 |
| Device name: | Plancon microlamellar Keratome |
|---|---|
| Company name: | PLANCON INSTRUMENTS |
| Document control number: | K970377 |
| Device name: | Automatic Corneal Shaper Surgical Instrument |
| Company name: | CHIRON VISION CORP. |
| Document control number: | K941550 |
JUN 1 8 2004
1
September 10", 2003 Premarket Notification
Section 4 page 2
Device description 5.
List of components
- Power unit .
- Motor ●
- Suction rings .
- Applanator lenses .
- Footswitches .
- Keratome head 1
- Keratome blade .
a) Power unit
The power unit used for the M3 microkeratome is the same as the power unit used for the The power unit used for the M5 microReratome (K003594) & Plancon
predicate devices CARRIAZO BARRAQUER Microkeratome (KA by our company predicate devices CARRAZO DrineriQ SER
The power unit includes pumps for producing vacuum.
I he power unit incrudes pullips for producting - counting - counting 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
ວອຸນາ Premarket Notification
Section 4 page 3
Keratome motor b)
The drive system has two built-in electrical motors (one motor for the blade oscillation and The dive by the advance of the microkeratome).
Keratome head c)
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.
Applanator lenses e)
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
September 10 , 2003 Premarket Notification
K032@36
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 The blade 15 made in contact with the patient's eye.
Statement of intended use 6.
The M3 microkeratome is intended for use in making of a comeal flap in patients undergoing of The M3 microkeratorie is intended for ass in missing
LASIK surgery or other treatments requiring initial lamellar resection of the cornea.
Discussion of tests and results 7.
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 100 human eyes showed that the M3 microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a able to - creater, and thickness and bed smoothness.
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 wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JUN 1 8 2004
Moria S.A. c/o Ms. Melanie Renaud-Samiri Regulatory & Quality Assurance Manager 15 Rue Georges Besse Antony, France 92160
Re: K032836 Trade/Device Name: M3 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Microkeratome, Keratome Regulatory Class: Class I Product Code: HNO Dated: September 10, 2003 Received: April 28, 2004
Dear Ms. Renaud-Samiri:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 910(x) premier is substantially equivalent (for the indications referenced above and have determined the arrass are devices marketed in interstate for use stated in the encrosule) to regally manation to the Medical Device Amendments, or to commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosmetic Act (Act) that to hot require approvine of the general controls provisions of the Act. The You may, the sible, market the devices, belyer to users for annual registration, listing of general controls provisions of the 110 110 1100 1100 1100 1100 1100 1100 1100 1100 110 adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controller Links. good to 898. In addition, FDA may be found in the Court of Pouchar In Concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dr 3 issualled of a complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that IDA has made a determinations administered by other Federal agencies. You must of ally rederal statures and regaratents, including, but not limited to: registration and listing comply with an the Act 3 requirements, metally, good manufacturing practice requirements as set (21 CFR Fall 807), labornig (21 OFR Part 820); and 820); and If applicable, the electronic form in the quality systems (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) I his iciter wif anow you to ought thating of substantial equivalence of your device to a legally premaince notifications "Thesults 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 If you desire specific at notiation 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 other golleral micronational 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 Paléyi 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
:*
Section 5 page 1
510(k) Number (if known):
Device Name:
M3 microkeratome
Indications for use:
The M3 microkeratome is intended for use in the making of a corneal flap in patients The M3 microkeratome is intended for use in the manning of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF. NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use | (Per 21 CFR 801.109)
Over-The-Counter Use OR (Optional Format 1-2-96)
Dennis L. McCarthy
Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
Ko32836 510(k) Number