(26 days)
Not Found
No
The description focuses on mechanical separation using an oscillating separator and does not mention any AI/ML components or functions.
No
The device is used to prepare the cornea for subsequent surgical procedures by making a separation or flap, which is an ancillary function rather than directly treating a disease or condition.
No
The device is described as an epikeratome used for surgical procedures like separating epithelium or making corneal flaps, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a drive control unit, handpiece, separator drive assembly, suction positioning ring assembly, foot pedal, and tubing set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure performed directly on the patient's cornea. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a surgical instrument used for cutting and separating tissue. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the CIBA Centurion SES Epikeratome is a surgical device, not an In Vitro Diagnostic device.
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 drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly, a foot pedal, a tubing set with fluid collection assembly (accessory), and an 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
Functional and electrical safety test results demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and is equivalent to the predicate device.
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
KO32978
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: | 1. AC Powered Keratome
2. Battery-Powered Corneal Burr |
| DEVICE
CLASSIFICATION
AND PRODUCT
CODE | 1. Class 1 per 21 CFR §886.4370, HNO
2. Class 1 per 21 CFR §886.4070, HOG |
SUBSTANTIAL EQUIVALENCE:
The modified Centurion SES Epikeratome is substantially equivalent to the Centurion SES Epikeratome cleared under K031735. The modifications made to the device include a separate dedicated handpiece for the epikeratome function. Minor design modifications were made to the suction ring, separator drive assembly, DCU vacuum pump, and DCU software to accommodate the new. The modified Centurion SES™ Epikeratome has the same intended use and basic scientific technology as the original model.
Both devices have the same indication for use statement, and utilize suction to the cornea and oscillation principles to separate the epithelium from the cornea. Bench testing has demonstrated that the modified Centurion SES device is functionally equivalent to the predicate Centurion SES device and that any minor differences between the modified device and the predicate device do not affect safety or effectiveness.
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 drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly, a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator,
INDICATIONS FOR USE:
The CIBA Centurion SES Epikeratome is intended for use in the separation of the enithelium 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 ring that allows the cornea to protrude through the ring. The epithelial separator is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring while oscillating laterally. Drive control and vacuum for the suction ring are provided by user command via the drive 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. Functional and electrical safety test results demonstrate that the Centurion SES separator removes epithelium in a consistent and reproducible way and is equivalent to the predicate device.
CONCLUSION:
Based on the performance testing, it can be concluded that the modified CIBA Centurion SES Epikeratome is equivalent to the predicate CIBA Centurion SES Epikeratome with respect to intended use and technological characteristics.
2
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.
OCT 2 0 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 Pkwy. Duluth, GA 30097
Re: K032978
Trade/Device Name: CIBA Vision Centurion SES " Epikeratome Regulation Number: 21 CFR 886.4370; 21 CFR 886.4070 Regulation Name: Keratome; AC-Powered corneal burr Regulatory Class: Class I Product Code: HNO: HOG Dated: September 23, 2003 Received: September 24, 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,
Akagi Korenthal
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
4
510(k) Number (if known):
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CENTURION SES™ 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K032978 |
| Date | 10-17-2003 |
| Prescription Use | |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use |