(99 days)
The ONE UP disposable keratome head 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.
The ONE UP disposable keratome head and suction ring are identical in design, concept and principle to the predicate PLANCON microlamellar keratome single piece head K 970 377, the only difference being that the keratome head, the ring and the handle are made of high density plastic material. The stainless steel blade and the plastic blade holder are similar to the blade and blade holder of the above predicate. The keratome head has dovetails guides which engage in the dovetails of the suction ring. The blade oscillates by means of the same turbine of the predicate device referred above. The power unit is similar in characteristics, principles and functions to the power units of legally marketed keratomes. The ONE UP disposable keratome head comes preassembled and presterilized in a copolyester sealed tray, sealed with TYVEK ® peel off cover. The sterilisation is performed under validated gamma radiation cycle with sterility assurance level of 10 ° and dosimetric release. The plastic materials used for patient contact portion of device have been tested according to classification of USP and the grades used passes classes I through VI, and are deemed to be biocompatible.
The provided document focuses on the substantial equivalence of the MORIA ONE UP disposable keratome head to predicate devices and does NOT contain information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert involvement as requested.
The submission is a 510(k) premarket notification, which primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing design, materials, and intended use, rather than extensive new clinical trials or performance studies with specific acceptance criteria as might be seen for novel devices or PMA submissions.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document states: "The ONE UP disposable keratome head 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." (Section 7. Discussion of tests and results). This statement is the core of their "proof" of meeting safety and effectiveness, based on substantial equivalence to existing devices.
{0}------------------------------------------------
981742
AUG 25 1998
MORIA ONE UP disposable keratome head
May 18, 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
b. Contact person :
Alain DUPRAT
Chief Executive Officer
Date Summary Prepared : May, 18th, 1998 C.
-
- Device name :
Trade Name :
- Device name :
ONE UP keratome head
-
- Classification name :
Microkeratome
- Classification name :
4. Subtantial equivalence :
Substantial equivalence is being claimed to the following legally marketed devices
-
- Automated disposable keratome LASERSIGHT Technologies, Inc. Company : 510 K : K 974 004
-
- PLANCON microlamellar keratome (single piece head) Company : PLANCON INSTRUMENTS 510 K : K 970 377
{1}------------------------------------------------
MORIA ONE UP disposable keratome head
5. Device description
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
a. General device description
The ONE UP disposable keratome head and suction ring are identical in design, concept and principle to the predicate PLANCON microlamellar keratome single piece head K 970 377, the only difference being that the keratome head, the ring and the handle are made of high density plastic material.
The stainless steel blade and the plastic blade holder are similar to the blade and blade holder of the above predicate.
The keratome head has dovetails guides which engage in the dovetails of the suction ring.
The blade oscillates by means of the same turbine of the predicate device referred above.
The power unit is similar in characteristics, principles and functions to the power units of legally marketed keratomes.
The ONE UP disposable keratome head comes preassembled and presterilized in a copolyester sealed tray, sealed with TYVEK ® peel off cover. The sterilisation is performed under validated gamma radiation cycle with sterility assurance level of 10 ° and dosimetric release.
The plastic materials used for patient contact portion of device have been tested according to classification of USP and the grades used passes classes I through VI, and are deemed to be biocompatible.
b. System composition
- Power unit "
- Keratome head -
- Keratome blade ...
- Nitrogen powered turbine -
- Footswitches -
- -Applanator lenses
- -Suction rings
{2}------------------------------------------------
MORIA ONE UP disposable keratome head
May 18, 1998 Premarket Notification Section 5 page 3
- Power unit b1)
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, ı
- Battery charge indicator, ।
- Connectors : i
- · Gas inlet,
- · Gas outlet,
- · Vacuum outlet,
- · Foot pedals,
- · Battery charger.
All connectors are of different type for preventing connecting mistakes.
b2) Turbine
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.
b3) Keratome head
The keratome head adapts to the turbine by means of a threaded part.
The keratome head includes the blade which is moved by the turbine.
Different heads are available in order to adjust the thickness of the cut.
The head is a single piece, thus no assembly or adjustment are necessary. This is a major improvement which avoids the risk of uncorrect assembly and results in a much safer procedure.
- Suction rings b4)
The suction rings are used to fixate and pressurize the eye and provide a base for the microkeratome. High precision dovetails ensure accurate cut depth and translation accross the cornea.
{3}------------------------------------------------
Statement of intended use 6.
The ONE UP keratome head 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 ONE UP disposable keratome head 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1998
MORIA S.A. ATTN: Alain Duprat General Manager 15 Rue Georges Besse Antony, France
Re: K981742 Trade Name: One up Disposable Keratome Head Regulatory Class: I Product Code: 86 HNO Dated: July 10, 1998 Received: July 13, 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. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
MORIA ONE UP disposable keratome head
May 18, 1998 Premarket Notification Section 4 page 1
510(k) Number (if known) :
Device Name :
... ... ... ..
ંગ્રહ્ર્
ONE UP disposable keratome head
Indications for use :
The ONE UP disposable keratome head 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)
Daryl L. Kinchen.
(Division Sign-Off) Division of Ophthalmic Devices K981742 510(k) Number_
Prescription Use _x (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.