(131 days)
The epiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
The EpiTome System is a fully automated, AC powered ophthalmic keratome system designed for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea. The EpiTome Control Console is comprised of a Vacuum System, Software, and Controls that allow the System User to set the procedure specific cutting parameters. The motorized handpiece contains two motors controlling the oscillation and translation of the cutting blade across the epithelium. The EPI-Head assembly includes a base, an applanation part, and blade unit that fits securely onto the handpiece. The precisely machined EPI-Separator controls the depth of the delamination. The EpiTome System includes a choice of suction rings to allow the System User to select the appropriate ring on an individual patient basis. The EpiTome system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gebauer EpiTome System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) premarket notification summary for the Gebauer EpiTome System (K041206) does not explicitly state specific pass/fail acceptance criteria in a quantifiable manner (e.g., minimum accuracy percentages, specific tolerance ranges for cut thickness, etc.) within the provided text.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (CIBA Centurion SES™ Epikeratome, K032978) based on:
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Intended Uses are the Same | Confirmed as the Same as predicate device. |
| Operating and Cutting Principles (Effectiveness) are the Same | Confirmed as the Same as predicate device. Demonstrated through in-vitro testing for "highly precise epithelial incisions with constant cut thickness." |
| Operational Features are the Same or Similar | Confirmed as the Same or Similar to predicate device. |
| Safety Features are the Same or Very Similar | Confirmed as the Same or Very Similar to predicate device. Complies with electrical standards (UL 2601-1, IEC 60601-1, IEC 601-1-1, IEC 601-1-2). Includes operational safety features (vacuum level gauge, low suction LED, audible tones, automatic cutting stop, foot pedal controls). |
| No New Issues of Safety, Effectiveness, or Performance | Confirmed that the device "does not raise any new issues of safety, effectiveness or performance" compared to the predicate device. |
The "device performance" in this context is the assertion that it meets these substantial equivalence points, supported by non-clinical (in-vitro) data and compliance with electrical safety standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "in-vitro testing" was performed to confirm the effectiveness of the device (creating precise epithelial incisions with constant cut thickness). However, the specific sample size (e.g., number of corneas, number of cuts, etc.) for this in-vitro test set is not provided in the given text.
- Data Provenance: The data is described as "In-Vitro non-clinical performance data." The country of origin for this data is not explicitly stated, but the sponsor is Gebauer Medizintechnik GmbH in Germany, suggesting the testing likely occurred in Germany or was overseen by the German entity. The testing is retrospective in the sense that it was conducted prior to this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the in-vitro testing described. The evaluation of functional ability to create precise epithelial incisions and constant cut thickness would likely rely on objective measurements rather than expert consensus on a subjective interpretation.
4. Adjudication Method for the Test Set
Since there is no mention of experts establishing a subjective ground truth, there is no adjudication method described for a test set in the provided text. The in-vitro testing would presumably rely on direct measurement and objective assessment of cut characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical performance data has been submitted." Therefore, an MRMC comparative effectiveness study was not performed or submitted for this 510(k) premarket notification.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described is a medical instrument (keratome system), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance, as typically understood in AI/software validations, does not apply to this device. The in-vitro testing assessed the standalone performance of the device itself.
7. The Type of Ground Truth Used
For the in-vitro testing, the type of ground truth used would be objective measurements of physical properties. The text states the testing "was designed to evaluate the functional ability of the Gebauer EpiTome System to create highly precise epithelial incisions with constant cut thickness." This implies direct measurement of incision characteristics (e.g., depth, uniformity, smoothness) as the ground truth.
8. The Sample Size for the Training Set
The EpiTome System is a mechanical device, not a machine learning or AI algorithm in the context of "training data." Therefore, the concept of a "training set" for an algorithm does not apply to this submission.
9. How the Ground Truth for the Training Set Was Established
As established above, the concept of a "training set" for an AI algorithm is not applicable to this device.
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SEP 1 5 2004
SPONSOR Gebauer Medizintechnik GmbH Monbachstr. 7/1 D-75242 Neuhausen Germany
Phone: +49(0)7234-9421-0 Fax: +49(0)7234-9421-20
Designated Contact Person Alden Kay Director of Regulatory and Quality VisiJet Inc. 192 Technology Drive, Suite Q Irvine, CA 92618-2403 Phone: (949) 417-9827 Fax: (949) 450-1689
Gebauer Medizintechnik GmbH
EpiTome SYSTEM
510(k) PREMARKET NOTIFICATION SUMMARY
Date Summary Prepared: August 23, 2004
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Gebauer EpiTome SYSTEM
510(k) PREMARKET NOTIFICATION SUMMARY
| •Device Trade or Proprietary Name: | EpiTome System |
|---|---|
| •Common/Classification Name: | Keratome, AC Powered |
| •Class: | Class I |
| •Classification Panel: | 86 |
·Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician.
· Predicate Device for Substantial Equivalence Comparison:
The EpiTome System is claimed to be substantially equivalent to the following currently marketed Predicate Device:
| Manufacturer | Device Name | 510-K Number | Decision Date |
|---|---|---|---|
| CIBA VisionCorporation | CIBA Centurion SES™Epikeratome | K032978 | October 20, 2003 |
·Device Description:
The EpiTome System is a fully automated, AC powered ophthalmic keratome system designed for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
The EpiTome Control Console is comprised of a Vacuum System, Software, and Controls that allow the System User to set the procedure specific cutting parameters. The motorized handpiece contains two motors controlling the oscillation and translation of the cutting blade across the epithelium. The EPI-Head assembly includes a base, an applanation part, and blade unit that fits securely onto the handpiece. The precisely machined EPI-Separator controls the depth of the delamination.
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The EpiTome System includes a choice of suction rings to allow the System User to select the appropriate ring on an individual patient basis. The EpiTome system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.
·Indications for Use Statement:
The EpiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
• Clinical Performance Data
No clinical performance data has been submitted.
· Non-Clinical Performance Data
In-Vitro non-clinical performance data is provided in the submission.
·Rationale for Substantial Equivalence
-
- The INTENDED USES and the OPERATING and CUTTING PRINCIPLES (ie. Effectiveness) of the Gebauer EpiTome System are the SAME as the predicate device.
-
- The OPERATIONAL FEATURES of the Gebauer EpiTome System are the SAME or SIMILAR to those offered by the predicate device.
-
- The SAFETY FEATURES of the Gebauer EpiTome System are the SAME or very SIMILAR to those offered by the predicate device.
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Therefore, in summary, the EpiTome System is substantially equivalent to the identified predicate device that has previously been allowed for commercial distribution in the United States, in terms of ALL key aspects of the device: device effectiveness/operation, device intended usage, device features/surgical parameters and safety features.
·Safety and Effectiveness
The EpiTome System complies with the electrical standards of the Underwriters Laboratories UL 2601-1 and has passed an inspection to these standards by an independent testing house. Furthermore, the Lasitome, a sister device to the EpiTome System (devices are identical in terms of electrical and EMI issues) underwent independent scrutiny and testing by UL-Germany to assess the overall electrical safety and EMI safety. UL-Germany after extensive evaluation determined that the Lasitome System met all electrical and electromagnetic compatibility (EMI) safety requirements set forth in the International Electro-technical Commissions (IEC) 60601-11:1988 +A1 +A2 (EN 60601-1:1990 + A1 +A2) International Electro-technical Commissions IEC 601-1-1 and IEC 601-1-2 which reasonably assures the device is safe when used as directed for its prescribed intended use.
Additionally several operational safety features are designed into the EpiTome (vacuum level gauge, a low suction LED and "audible tone" indicators, automatic cutting stop if vacuum level drops and forward and reverse foot pedal controls). The effectiveness of the device was confirmed during in-vitro testing which was designed to evaluate the functional ability of the Gebauer EpiTome System to create highly precise epithelial incisions with constant cut thickness.
The Gebauer EpiTome System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device.
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• Conclusions
The data submitted in this 510(k) Premarket Notification, for the Gebauer EpiTome System demonstrates that this product is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to another legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.
D
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2004
Gebauer Medizintechnik GmbH % Kimberly Doney 54 Forest Street Lexington, MA 02421
Re: K041206
Trade/Device Name: Epitome System Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: April 30, 2004 Received: May 11, 2004
Dear Ms. Doney:
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 iddictions 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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr w 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, ilsting 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, TDA 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 Isting (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 seconic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Kimberly Doney
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 Kalyl Rosenthal
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
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Indications for Use
510(k) Number : Original Premarket Notification 510(k) K041206 Device Name: Gebauer epiTome System Indications for Use:
The epiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
Prescription Use
(Per 21 CFR 801.109)
Clay R. Battema
510(k) Number K041206
§ 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.