(535 days)
Not Found
No
The description details a mechanical device with fixed parameters and automated functions based on vacuum and motor control, with no mention of adaptive learning, data analysis for decision making, or any terms associated with AI/ML.
Yes
The device is used to prepare the cornea for subsequent surgical procedures by either separating the epithelium or creating a corneal flap, which directly relates to treating a medical condition (vision correction surgery).
No
The device is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures and for making a corneal flap. It is a surgical tool, not a diagnostic one.
No
The device description explicitly details numerous hardware components including a console, handpiece, footswitch, single-use sets, and a disposable tubing system, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, the EpiVision™ SL System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the separation of the epithelium from the cornea and making a corneal flap for surgical procedures (LASIK). This is a direct surgical intervention on the patient's eye.
- Device Description: The device is a motor driven Microkeratome that physically cuts or separates tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The EpiVision™ SL System does not perform any such analysis of biological specimens. It is a surgical tool used in vivo (on the living body).
The device is clearly a surgical instrument used for preparing the cornea for subsequent procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure.
With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge.
The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters.
The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechnik GmbH.
The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium.
The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator.
The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum.
The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL system is designed for use with disposable tubing that is readily available/commercially approved within the United States for other approved microkeratome systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
No clinical performance data has been submitted.
In-Vitro non-clinical performance data is provided in the submission.
The effectiveness of the device was confirmed during bench testing which was designed to evaluate the functional ability of the Gebauer EpiVision™ SL System to create highly precise epithelial incisions with constant cut thickness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
02
Gebauer EpiVision™ SL SYSTEM
JAN 1 6 2009
510(k) PREMARKET NOTIFICATION SUMMARY
· Device Trade or Proprietary Name: Ep1Vision™ SL System
•Common/Classification Name: Keratome, AC Powered ·Class: Class I
·Classification Panel: કર્ણ •Product Code HNO
·Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician
· Predicate Devices for Substantial Equivalence Comparison:
The EpIVision™ SL System is claimed to be substantially equivalent to the
following currently marketed Predicate Devices
| Manufacturer | Device Name | 510-K
number | Decision
Date |
|-----------------------------------|------------------------------------------------------------------------------------------|-------------------------|------------------------------|
| Gebauer
Medizintechnik
GmbH | EpiTome
System and Lasitome
System Keratome
AC powered
*Now EpiVision System | K041206 | 09/15/2004 |
| BioVision | Visitome 20-10
Microkeratome | K014000
&
K042083 | 3/11/2002
&
11/16/2004 |
- The name was changed from EpiTome to EpiVision System and LasiTome System on 06/10/2005
1
· Device Description:
The EpiVision™ SL System is a fully automated, AC powered ophthalmic keratome system. The EpiVision™ SL System is used to produce a lamellar corneal flap in an Epithelial Separation or LASIK procedure.
With these methods, the refraction of the comea is changed using a laser treatment, a comeal flap is created. However, this flap is not completely separated (except when an epithelial free flap is desired), but remains connected by a small segment of the flap to the eyeball. This segment is called the hinge.
The hinge size, the advancing speed during cutting, and the oscillation frequency of the cutter are fixed parameters. The user cannot change these parameters.
The EpiVision™ SL System's function is to remove an eye's upper corneal layer (epithelium) using an Epithelial Separation method or to create a cut in the epithelium of the cornea for using a LASIK operation method, after which the contour of the cornea is treated with a vision-correcting laser is not manufactured by Gebauer Medizintechik GmbH.
The oscillating Separator/Blade, with fixed parameters creates a separation between the epithelium and Bowman's layers, or a cut in the epithelium.
The EpiVision™ SL System is a motor driven Microkeratome which is composed of a Console with power-cable, a Handpiece with a removable Handpiece-cable, a Footswitch, with different colored Foot-pedals, a Single-Use-Set/Single-Use LASIK Set for EpiVision™ SL and a Disposable Tubing System for Epi Vision™ SL System. The Single-Use Set/Single-Use LASIK Set for EpiVision™ SL consists of a Head, a Suction-Ring and a Separator.
The components should be assembled per the assembly description in Section 7 of the Users Manual. The EpiVision™ SL System is operated exclusively
2
by the Footswitch. On top of the Console are LEDs which provide optical signals for "on" and "off" of the console, activated vacuum, vacuum level and run cycle. In addition to LEDs there are acoustical signals which sound when 0.75 bar vacuum is achieved, when the vacuum is deactivated, when the vacuum level drops below 0.6 bar during a run cycle, and when the Handpiece has reached the forward stop and the reverse stop. The EpiVision™ SL Control Console is comprised of a Vacuum.
The EpiVision™ SL System includes a choice of sterile Single-Use Sets/Single-Use LASIK Sets to allow the System User to select the appropriate ring size and head on an individual patient basis. The EpiVision™ SL 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 EpiVision™ SL System is indicated for the following uses:
The EpiVision™ SL System is indicated for 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 treatment.
·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.
3
·Rationale for Substantial Equivalence
- The INTENDED USES and the OPERATING and CUTTING 1 PRINCIPLES (1e. Effectiveness) of the Gebauer Ep1Vision™ SL System are the SAME as the predicate devices
- The OPERATIONAL FEATURES of the Gebauer Ep1V1s10n™ SL 2 System are the same/comparable to those offered to the predicate devices
- The SAFETY FEATURES of the Ep1Vision™ SL System are the ಗ same, very similar or better to those offered on one or more of the predicate devices
Therefore, in summary, the Ep1Vision™ SL System is substantially equivalent to the two identified predicate devices that have 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
1 - 2
The EpIVision™ SL System is designed to comply with the electrical standards of the Underwriters Laboratories UL 2601-1 and has passed an unspection to these standards by an independent testing house Furthermore, the EpiVision, a sister device to the EpiVision™ SL 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 Ep1Vision System met all electrical and electromagnetic compatibility (EMI) safety requirements set forth in the International Electro-technical Commissions (IEC) 60601-1 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
4
Additionally several operational safety features are designed into the Ep1Vision™ SL (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 bench testing which was designed to evaluate the functional ability of the Gebauer EpiVision™ SL System to create highly precise epithelial incisions with constant cut thickness
The Gebauer Epi Vision™ SL System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices
·Conclusions
The data submitted in this 510(k) Premarket Notification, for the Gebauer EpiVision™ SL 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.
5
Image /page/5/Picture/14 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gebauer Medizintechnik GMBH c/o Kımberley Doney 54 Forest Street Lexington, Massachusetts 02421
JAN 1 6 2009
Re K072102
Trade/Device Name Ep1Vision™ SL System Regulation Number 21 CFR 886 4370 Regulation Name AC Powered Keratome Regulatory Class I Product Code HNO Dated January 12, 2009 Received January 13, 2009
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 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, Insting 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
6
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Malvina B. Eystad, ud
Malvina B. Eydelman, MI Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): Original Premarket Notification
Device Name: EpiVision™ SL System
Indications for Use:
The EpiVision™ SL System is indicated for the separation of the epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea and for use in the making of a corneal flap in patients undergoing LASIK treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
Page 1 of__1_
6
Daryl L. Kaufman
(Division Sign-Off) Division of Or: Thairms . . . . . . Nose and Throal Davices
510(k) Number_