(30 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical and electrical components and their functional performance, with no mention of AI/ML algorithms or data processing for decision-making or analysis.
No
The device is used to prepare the cornea for subsequent surgical procedures by separating the epithelium, rather than directly treating a disease or condition.
No
The device is used for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures. This describes a surgical tool, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a console, separator drive assembly, suction ring assembly, forceps, and an epithelial separator, and is described as an AC-powered device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to separate the epithelium from the cornea in preparation for subsequent surgical procedures. This is a surgical device used directly on the patient's body, not a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a mechanical device with a high-speed oscillating separator, suction rings, and a drive mechanism. This is consistent with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Norwood Abbey Centurion SES Epikeratome is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Norwood Abbey 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.
Product codes
HNO
Device Description
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used The Norwood Abbey Ocharish 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: console, The device separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional test results demonstrate that the Centurion SES system with new console r unfollowar tost Toodko "device console does to drive the separator assembly to remove epithelium in a consistent and reproducible way.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The new Johnanch OEO Epikeratome
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
Summary of Safety & EFFECTIVENESS
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 | Norwood Abbey Limited
63 Wells Road
Chelsea Heights
Victoria 3196
Australia |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Paul Clark
Manager Quality Assurance and Regulatory Affairs
Tel: +613 9782 7308
Fax: +613 9782 7335
e-mail: pclark@norwoodabbey.com.au |
| Trade Name: | Centurion SES™ Epikeratome |
| Classification Name: | AC Powered Keratome
Battery-Powered Corneal Burr |
| Device Classification and
Product Code | Class 1 per 21 CFR §886.4370, HNO |
SUBSTANTIAL EQUIVALENCE:
The new Centurion SES Epikeratome with modified console is substantially equivalent to The new Johnanch OEO Epikeratome. Both designs have the same intended use and basic scientific technology.
Bench testing has demonstrated that the new console is functionally equivalent to the Denin tosting has dombinetiated inor differences between the modified device and the predicate device do not affect safety or effectiveness.
DESCRIPTION OF THE DEVICE:
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used The Norwood Abbey Ocharish 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: console, The device separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator.
INDICATIONS FOR USE:
The Norwood Abbey 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.
TECHNICAL CHARACTERISTICS:
The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly
1
housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.
PERFORMANCE DATA:
Functional test results demonstrate that the Centurion SES system with new console r unfollowar tost Toodko "device console does to drive the separator assembly to remove epithelium in a consistent and reproducible way.
CONCLUSION:
Based on the qualification testing, it can be concluded that the new Norwood Abbey Dased on the qualified console is equivalent to the predicate Ochturion SES Epikeratome with respect to intended use and technological characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 - 2005
Norwood Abbey, LTD. c/o Mr. Paul Clark Quality & Regulatory Affairs Manager 63 Wells Road Chelsea Heights, Victoria 3196 Australia
Re: K051486
Trade/Device Name: Centurion SES™ Epikeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: June 2, 2005 Received: June 6, 2005
Dear Mr. Clark:
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
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a legally premated 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) 827-8910. 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/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Change to Centurion SES Epikeratome Console
Page 1 of 1
510(k) Number (if known): K051486
Device Name: CENTURION SES™ EPIKERATOME
Indications for Use:
The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of The Norwood Abbey Centunon OLO Epikelatorie is intention of subsequent surgical procedures on the denuded cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roscioli 7/5/2005
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K05/4
510(k) Number K051486
Prescription Use
(21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)