(78 days)
Not Found
No
The device description and performance studies focus on mechanical separation of the epithelium using an oscillating separator, with no mention of AI or ML technologies.
No.
The device is used for preparing the eye for subsequent surgical procedures, not for treating a disease or condition itself.
No
The device description states it is used for "making a separation or flap by incising the epithelium," which are surgical procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a control unit, handpiece, suction ring, foot pedal, tubing set, and epithelial separator. It is an AC-powered device used for physical incision.
Based on the provided information, the CIBA Centurion SES Epikeratome is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed on the patient's cornea (separation of epithelium, making a corneal flap). IVD devices are used to examine specimens from the body (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical instrument with components like a handpiece, suction ring, and oscillating separator, all designed for direct interaction with the patient's eye during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would be performed in vitro (in glass, or outside the living organism).
Therefore, the CIBA Centurion SES Epikeratome is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
Product codes
HNO, HOG
Device Description
The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA.
The device consists of the following main components and accessories: the control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.
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
Bench testing demonstrates that the Centurion SES device is functionally equivalent to the Visitome 20-10 and that any minor differences between the Centurion SES and the predicate device do not affect safety and effectiveness.
All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible. This 510(k) notice includes functional and electrical that demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and equivalently to the predicate devices.
Based on the performance testing, it can be concluded that the CIBA Centurion SES Epikeratome with EpiEdge Epithelial Separator has demonstrated equivalence to the predicate devices with respect to intended use and technological characteristics.
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
AUG 2 1 2003
Image /page/0/Picture/2 description: The image shows the logo for CIBA Vision, a Novartis company. The logo features the word "CIBA" in bold, uppercase letters above the word "Vision." The "i" in Vision is replaced with an eye symbol. Below the logo, the text "A Novartis Company" is written in a smaller font.
CIBA Vision Corporation
11460 Johns Creek Parkway Duluth, Georgia 30097-1556
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, Georgia 30097, USA |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
Correspondent | Penny Northcutt, RAC
Surgical Regulatory Affairs
Tel: (678) 415-3214
Fax: (678) 415-4024
e-mail: penny.northcutt@cibavision.novartis.com |
| TRADE NAME: | CIBA Centurion SES™ Epikeratome |
| CLASSIFICATION
NAME: | AC Powered Keratome |
| DEVICE
CLASSIFICATION
AND PRODUCT | Class 1 per 21 CFR §886.4370 , HNO
Class 1 per 21 CFR §886.4070 , HOG |
SUBSTANTIAL EQUIVALENCE:
The Centurion SES Epikeratome is substantially equivalent to the Biovision Visitome 20-10, the Alcon Pallikaris Brush, and the Amoils Epithelial Scrubber. Each of these devices have a similar indication for use, utilizing suction to the cornea and oscillation principles to separate epithelium from the cornea. Bench testing demonstrates that the Centurion SES device is functionally equivalent to the Visitome 20-10 and that any minor differences between the Centurion SES and the predicate device do not affect safety and effectiveness.
Code
(
1
DESCRIPTION OF THE DEVICE:
The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA.
The device consists of the following main components and accessories: the control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.
INDICATIONS FOR USE:
The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
TECHNICAL CHARACTERISTICS:
The CIBA Centurion SES Epikeratome contains a suction positioning ring which allows the cornea to protrude through the ring. The epithelial separator is suspended from the end of the suction positioning ring by a support (holder) that is moved by a drive mechanism, along a forward path between the suction positioning ring while oscillating laterally. Drive control and vacuum for the suction positioning ring are provided by user command via the control unit and foot pedal.
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible. This 510(k) notice includes functional and electrical that demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and equivalently to the predicate devices.
CONCLUSION:
The Centurion SES is substantially equivalent to the Biovision Visitome 20-10 cleared under 510(k) K01400. Both devices have a equivalent technological characteristics and performance testing demonstrated their equivalence.
The Centurion SES is substantially equivalent to the Alcon Pallikaris Brush cleared under K960261 and the Amoils Epithelial Scrubber cleared under K962989 with respect to intended use - to separate the epithelium from the cornea
Based on the performance testing, it can be concluded that the CIBA Centurion SES Epikeratome with EpiEdge Epithelial Separator has demonstrated equivalence to the predicate devices with respect to intended use and technological characteristics.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CIBA Vision Corporation c/o Penny Northcutt, RAC Surgical Regulatory Affairs 11460 Johns Creek Parkway Duluth, Georgia 30097
Re: K031735
Trade/Device Name: CIBA Vision Centurion SES " Epikeratome Regulation Number: 21 CFR 886.4370; 21 CFR 886.4070 Regulation Name: Keratome, AC-Powered; Burr, Corneal, Battery-Powered Regulatory Class: Class I: Class I Product Code: HNO; HOG Dated: May 30, 2003 Received: June 4, 2003
Dear Ms. Northcutt:
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.
3
Page 2 - Penny Northcutt, RAC
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,
A. Palagi forentthal
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
4
510(k) Number (if known): _ K031735
Device Name: CENTURION SESTM EPIKERATOME
Indications for Use:
The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dexie Hesi
(Division Sign vision of Onhthalmic Ea
510(k) Number K031735
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109) 1-2-96)
(Optional Format