(105 days)
Not Found
No
The device description focuses on mechanical components and a high-speed oscillating blade, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is used for "making a corneal flap" as part of a "LASIK or other treatment requiring initial lamellar resection of the cornea," which are medical procedures to treat a condition.
No
The device is described as a surgical instrument used to create a corneal flap, not to diagnose a condition.
No
The device description explicitly details multiple hardware components including a control unit, surgical unit (handpiece, drive assembly, rings, applanator, blade holder), foot pedal, tubing kit, filter, and fluid collection container. This is clearly a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The VISITOME 20-10 MICROKERATOME is a surgical device used to physically cut a flap in the cornea during a surgical procedure. It directly interacts with the patient's body.
- Intended Use: The intended use clearly states it's for "making a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea." This is a surgical procedure, not a diagnostic test performed on a specimen.
The device description and intended use are consistent with a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
Product codes
HNO
Device Description
The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).
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)
The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards. The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) SUMMARY NOV 1 6 2004 VISITOME 20-10 MICROKERATOME
1. APPLICANT
| Company Name: | Biovision AG
27 Erlenstrasse
2555 Brugg, Switzerland |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dale Sadlik
Product Director
Visitome, Inc.
27 Mauchly, Unit 206
Irvine, CA 92618
Tel: 949-450-0770
Fax: 949-450-0990 |
| Date Summary Prepared: | November 3, 2004 |
2. DEVICE IDENTIFICATION
| A. | Classification Name: | Keratome, AC-Powered |
|---|---|---|
| B. | Trade/Proprietary Name: | Visitome 20-10 Microkeratome |
| C. | Classification: | Class I per 886.4370 |
| D. | Product Code: | HNO |
DEVICE DESCRIPTION 3.
The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).
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4. INTENDED USE
The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
5. SUBSTANTIAL EQUIVALENCE
The Biovision AG Visitome 20-10 Microkeratome is equivalent to the predicate devices listed below. Each of these devices has a similar indication for use and utilizes suction to the cornea. With respect to corneal resections, the Visitome and device uses a stainless steel blade to cut a corneal flap, while the IntraLase device uses a femtosecond laser for cutting/resection created by micro-photodisruption of the corneal tissue. Bench testing demonstrates that the Visitome 20-10 Microkeratome is equivalent to the predicate devices, and that any differences do not affect safety or effectiveness.
| Predicate
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| Visitome 20-10 | |||
| Microkeratome | Biovision AG | K014000 | March 11, 2002 |
| FS Laser | |||
| Keratome | Intralase | ||
| Corporation | K031960 | September 29, 2003 |
TECHNOLOGICAL CHARACTERISTICS 6.
The Visitome 20-10 Microkeratome contains a positioning ring which allows the cornea to protrude through the ring. The cornea is restrained by an applanation shoe surface, which may be pivoted away. A stainless steel blade is suspended from the end of the positioning ring by a blade support (holder) which is driven by a drive mechanism, so that the blade moves along a forward path between the positioning ring and the applanation shoe while oscillating laterally. Drive control and vacuum for the positioning ring are provided by user command via the control unit and foot pedal.
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7. PERFORMANCE DATA
The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards. The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate devices.
CONCLUSIONS 8.
Biovision AG has demonstrated through its evaluation of the Visitome 20-10 Microkeratome that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2004
Biovision AG c/o Mr. Dale Sadlik Visitome, Inc 27 Mauchly, Unit 206 Irvine, CA 92618
Re: K042083 Trade/Device Name: Visitome 20-10 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: July 19, 2004 Received: August 3, 2004
Dear Mr. Sadlik:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQth pe is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to togally to trgans and the Medical Device Amendments, or to commerce proof to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, devices mar nave been recuire approval of a premarket approval application (PMA). and Cosmetic Treef, market the device, subject to the general controls provisions of the Act. The Tou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is classified (500 a00 roy als. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of Pource concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that FDF 3 lobants of your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I cochar statutes and regulated including, but not limited to: registration and listing comply with an the Act 3 requirements, months.go
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 607), facemig (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Dale Sadlik
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 halyi korenthal
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:
(To Be Assigned By FDA)
Device Trade Name:
VISITOME 20-10 MICROKERATOME
Indications For Use:
The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doxeylin 11-8-2004
vision Sign-Off Division of Ophthalmic E Nose and Throat Devises
Page 1 of
510(k) Number
November 3, 2004