(128 days)
Not Found
No
The device description focuses on mechanical components (motors, blades, suction rings) and electrical controls (power unit, footswitch). There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are based on in-vitro and in-vivo testing of the mechanical separation process.
No.
The device is used for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures, rather than for treating a disease or condition itself.
No
The device is intended for the mechanical separation of the epithelium from the cornea for surgical procedures, rather than for diagnosing a condition.
No
The device description clearly lists multiple hardware components including a power unit, footswitch, handpiece with motors, head and blade separator, and suction rings. This is not a software-only device.
Based on the provided information, the Epi-K 1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea." This is a surgical procedure performed directly on a living patient's eye.
- Device Description: The components (power unit, handpiece, head and blade separator, suction rings) are all designed for a surgical procedure.
- Anatomical Site: The device is used on the "cornea," which is part of the human body.
- Performance Studies: The studies described are "in-vitro studies on porcine eyes" and "in-vivo studies on 77 human eyes," both of which relate to the device's performance in a surgical context.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Epi-K 1 does not perform this function. It is a surgical instrument used on the body.
N/A
Intended Use / Indications for Use
The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.
Product codes (comma separated list FDA assigned to the subject device)
HNO
Device Description
List of components
- Power unit and footswitch.
- Handpiece / submitted device motor.
- Head and blade separator.
- Suction rings.
a) Power unit and footswitch
The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor.
The front panel includes several displays and features:
- Vacuum pressure gauge, Battery level indicator,
- Battery charge indicator,
- Connector for the motorized handpiece of the submitted device .
- Vacuum outlet connector.
The back panel includes connectors for footswitches and battery charger
b) Handpiece / submitted device motor
The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).
c) Head and blade separator
The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:
- The metal part in low carbon steel, and
- The plastic holder of the blade separator, which is not in contact with the patient's eye.
d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:
- Reusable
- Disposable
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)
In-vitro studies on porcine eyes with the submitted device Epi-K 11" demonstrated:
- The safety and efficacy of the submitted device for creating an epithelial flap
- The quality of the epithelium separation.
In-vivo studies on 77 human eyes showed that the submitted device –Epi-K " is a safe device able to create a hinged circular epithelial flap of predetermined dimensions.
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
Image /page/0/Picture/1 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a solid black circle with a thin vertical line extending upwards from its center. Below the word "Moria" is the text "Section 4 page 1".
MAR 2 5 2005
510(k) SUMMARY
Submitter's identification 1.
- થ. MORIA S.A. 15, rue Georges Besse 92160 ANTONY France Tel: (33-1) 46 74 46 36 Fax: (33-1) 46 74 46 70
- b. Contact person:
Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com Or Alain DUPRAT Chief Executive Officer and President
E mail: aduprat@moria-int. com
November 15, 2004
c. Date Summary Prepared:
- Device name
..
Epi-K™M Trade Name:
3. Classification name
Keratome (per 21CFR section 886.4370)
4. Substantial equivalence
Substantial equivalence is being claimed to the following legally marketed devices:
| Trade or Proprietary or Model Name: | OneUse - Plus Microkeratom |
|---|---|
| Manufacturer: | MORIA S.A. |
| 510(k) number: | K040297 |
Trade or Proprietary or Model Name: Centurion SESTM Epikeratome Manufacturer: CIBA Vision Corporation 510(k) number: K032978
1
Image /page/1/Picture/0 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a disco ball graphic. The disco ball is hanging from a thin line, suggesting it is suspended in the air. The text is in black and the background is white.
Section 4 page 2
Trade or Proprietary or Model Name: EpiTome SYSTEM Manufacturer: GEBAUER MEDZINTECHNIK GmbH 510(k) number: K041206
న్. Submitted device description
List of components
- Power unit and footswitch .
- Handpiece / submitted device motor .
- Head and blade separator .
- Suction rings .
a) Power unit and footswitch
The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum. The power unit has been designed to operate the Keratome by means of electric motor.
The front panel includes several displays and features:
- . Vacuum pressure gauge, Battery level indicator,
- . Battery charge indicator,
- Connector for the motorized handpiece of the submitted device .
- Vacuum outlet connector .
The back panel includes connectors for footswitches and battery charger
b) Handpiece / submitted device motor
The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).
c) Head and blade separator
The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:
-
The metal part in low carbon steel, and
-
The plastic holder of the blade separator, which is not in contact with the patient's eye.
2
Image /page/2/Picture/0 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a disco ball graphic, which is suspended by a thin line from above. The font is bold and black, and the background is white. The image appears to be a logo or a stylized wordmark.
Section 4 page 3
d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:
-
Reusable
-
Disposable
Statement of intended use 6.
The submitted device Epi-K is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.
7. Discussion of tests and results
Epi-keratome predicate devices are already legally marketed and have been used to cleave the epithelium from the cornea (CIBA Centurion SESTN Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).
In-vitro studies on porcine eyes with the submitted device Epi-K 11" demonstrated:
- The safety and efficacy of the submitted device for creating an epithelial flap -
- -The quality of the epithelium separation.
In-vivo studies on 77 human eyes showed that the submitted device –Epi-K "" is a safe device able to create a hinged circular epithelial flap of predetermined dimensions.
The intended uses and the operating and separating principles (i.e.; Effectiveness) of the submitted device Epi-K ™ are the same as the predicate devices (CIBA Centurion SEST™ Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).
The operational features of the submitted device Epi-K™ are the same or similar to those offered by the predicate device (MORIA OneUse-Plus Microkeratome K040297).
The safety features of the submitted device Epi-KTM are the same or very similar to those offered by the predicate devices (CIBA Centurion SES 11 Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).
3
Image /page/3/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 overlapping wing shapes, representing health, services, and people. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2005
Moria S.A. c/o Mélanic Renaud-Samiri QA & Regulatory Affairs Manager 15 Rue Georges Besse F 92160 Antony FRANCE
Re: K043183 Trade/Device Name: Epi-KTM Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 16, 2005 Received: March 18, 2005
Dear Mrs. Renaud-Samiri:
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.
4
Page 2 - Mélanie Renaud-Samiri
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) 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
5
Section 5 page 1
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Devicc Name:
Epi-KTM
Indications for use:
The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.
Marsha L. Burke hi cholova
Division Sign-Off) Division of Onnihalmic Ear, Nose and Throat Devises
510(k) Number K042183
Prescription Use V (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)