(30 days)
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.
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used 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, 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. 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 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.
This submission, K051486, describes the Centurion SES™ Epikeratome, an AC-powered device for separating the corneal epithelium. The submission focuses on a new console for the device and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionally equivalent to the predicate device (Johnash OEO Epikeratome) | "Bench testing has demonstrated that the new console is functionally equivalent to the Denin testing has dominated inor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Able to drive the separator assembly to remove epithelium in a consistent and reproducible way. | "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." |
| No effect on safety or effectiveness due to modified console. | "Bench testing has demonstrated that the new console is functionally equivalent to the Denin testing has dominated inor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Equivalent to the predicate device with respect to intended use and technological characteristics. | "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. Sample size used for the test set and the data provenance
The document explicitly states "Bench testing" and "Functional test results." This implies a series of laboratory-based tests rather than studies involving human subjects or patient data.
- Sample Size: Not specified. Standard engineering and functional testing would likely involve testing multiple units of the device and observing performance over a range of operational parameters, but no specific count is given.
- Data Provenance: The testing appears to be prospective bench testing conducted by Norwood Abbey Limited in Australia. There is no mention of patient data, retrospective analysis, or specific country of origin for any human-derived data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The device is for a surgical procedure (mechanical separation of epithelium), and its performance evaluation focused on its mechanical and functional equivalence to a predicate device, as demonstrated through bench testing. There is no mention of human-interpreted data (like medical images) that would require experts to establish ground truth.
4. Adjudication method for the test set
Not applicable. As the performance evaluation was based on functional and bench testing, there's no "ground truth" to adjudicate in the typical sense of expert review for diagnostic devices.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a mechanical surgical device, not a diagnostic imaging device with AI assistance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in spirit. The performance evaluation was entirely "standalone" in the sense that the device's functional characteristics were assessed directly through bench testing without human-in-the-loop performance testing in a clinical diagnostic context. The focus was on the machine's ability to perform its stated mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation was defined by:
- Functional equivalence to the predicate device: The new console had to demonstrate it could perform the same functions as the predicate device.
- Consistency and reproducibility: The device had to consistently and reproducibly drive the separator assembly to remove epithelium.
- Lack of impact on safety or effectiveness: The modifications should not negatively affect the device's safety or its ability to perform its intended use.
These "ground truths" were assessed via a combination of engineering specifications, comparison to a predicate device's known performance, and functional testing to ensure consistent mechanical operation. It does not involve biological or clinical "ground truth" as you would find in diagnostic device submissions (e.g., pathology for a cancer detection device).
8. The sample size for the training set
Not applicable. This submission is for a mechanical surgical device without any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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 Limited63 Wells RoadChelsea HeightsVictoria 3196Australia |
|---|---|
| Official Correspondent | Paul ClarkManager Quality Assurance and Regulatory AffairsTel: +613 9782 7308Fax: +613 9782 7335e-mail: pclark@norwoodabbey.com.au |
| Trade Name: | Centurion SES™ Epikeratome |
| Classification Name: | AC Powered KeratomeBattery-Powered Corneal Burr |
| Device Classification andProduct 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
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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.
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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.
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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
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Change to Centurion SES Epikeratome Console
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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)
§ 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.