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.

Device Description

The CARRIAZO BARRAQUER microkeratome system composition includes: 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 can operate the keratome by means of a 12 V DC motor or by means of a nitrogen motor. The keratome head adapts to the turbine or to the motor and includes the blade. Different heads are available to adjust the thickness of the cut. The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome. The applanator lenses are made of clear methylmethacrylate with a stainless steel handle and are used with the rings to control disk diameter before the cut.

AI/ML Overview

Here's an analysis of the provided text regarding the MORIA CARRIAZO BARRAQUER microkeratome, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and a detailed study explicitly proving the device meets them are not directly stated. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against predefined numerical targets.

However, we can infer the implicit "acceptance criteria" through the comparative statements made for substantial equivalence and the intended use. The performance is then deemed "met" by stating equivalence.

Acceptance Criteria (Inferred)	Reported Device Performance
Creation of circular lamellar resection of the cornea of predetermined diameter and thickness.	"The CARRIAZO BARRAQUER keratome performs equivalently to the predicate devices for creating circular lamellar resection of a predetermined diameter and thickness..." (Section 7)
No raising of new issues of safety and effectiveness.	"...and do not raise new issues of safety and effectiveness." (Section 7)
Functionality in creating lamellar resection for surgery or other treatment.	"The CARRIAZO BARRAQUER microkeratome is intended for use in patient undergoing surgery or other treatment requiring initial lamellar resection of the cornea..." (Section 6 & Indications for Use)
Ability to operate using a power unit (AC/DC) with pumps for vacuum, displays, and connectors.	Device description details a power unit with these features (Section 5a).
Ability to operate with a motor (turbine or electric DC).	Device description details both turbine and electrical 12V DC motor options (Section 5b).
Ability to adapt various keratome heads to adjust cut thickness.	Device description states "Different heads are available in order to adjust the thickness of the cut." (Section 5c)
Ability of suction rings to fixate and pressurize the eye and provide a base with precision guideways.	Device description details suction rings with these functions (Section 5d).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a specific test set with a sample size. The demonstration of safety and effectiveness is based on the claim of substantial equivalence to legally marketed predicate devices, not on a new, independent clinical or performance study with a defined test set.

Sample Size: Not applicable/not provided for a specific test set.
Data Provenance: Not applicable, as no new clinical or performance data is presented. The claim relies on the established safety and effectiveness of the existing predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no new test set or clinical study is described, there's no mention of experts establishing ground truth for such a set within this document. The "ground truth" for the device's acceptability is the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

As there is no described test set that required human adjudication, no adjudication method is mentioned or applicable in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in this document. The submission relies on substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a surgical instrument (microkeratome), not an algorithm or a diagnostic tool with a standalone performance. Therefore, the concept of "standalone performance" for an algorithm is not applicable here. Its performance is always inherent in its use by a surgeon.

7. The Type of Ground Truth Used

The "ground truth" relied upon for this submission is the historical regulatory approval and established safe and effective use of the predicate devices (PLANCON microlamellar keratome, HANSA Automatic corneal shaper, and HANSA Hansatome) that have been used for similar intended purposes for years. The assumption is that if this new device performs "equivalently," its safety and effectiveness are also established.

8. The Sample Size for the Training Set

There is no mention of a training set in this document. This submission is for a physical medical device, not a machine learning or AI-based system that would typically employ training sets.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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K981741|

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

1. Classification name :
  Microkeratome

Subtantial equivalence : 4.

Substantial equivalence is being claimed to the following legally marketed devices

a.	Company :Device :	PLANCON INSTRUMENTSPLANCON microlamellar keratomeEVOLUTION power unit
	510 (K) :	K 980 924
b.	Company :Device :510 (K) :	HANSA Research & DevelpmentAutomatic corneal shaperK 913 697
c.	Company :Device :510 (K) :	HANSA Research & DevelopmentHansatomeK 972 808

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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.

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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.

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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

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.

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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.

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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

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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)

Regulation Number and Section

§ 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.