(97 days)
Not Found
No
The device description details a mechanical microkeratome with a high-speed oscillating blade and control unit, with no mention of AI or ML capabilities.
No.
The device is used to create a corneal flap for LASIK surgery, which is a surgical procedure, not a therapeutic treatment itself, and the device functions as a surgical instrument.
No
The device description indicates that the Visitome 20-10 Microkeratome is used for making a corneal flap through incision, which is a surgical intervention, not a diagnostic one. Its function is to perform a physical action on the cornea, not to detect, identify, or determine the presence of a medical condition or disease.
No
The device description clearly outlines multiple hardware components including a control unit, surgical unit (handpiece, drive assembly, positioning ring, applanator, blade holder), foot pedal, tubing kit, and fluid collection container. It is an AC-powered device with a physical oscillating blade.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Visitome 20-10 Microkeratome is a surgical device used to physically cut a flap in the cornea during a surgical procedure (LASIK). 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 surgery or other treatment requiring initial lamellar resection of the cornea." This is a surgical procedure, not a diagnostic test performed on a sample.
The device description and intended use clearly indicate it's a surgical instrument, not a diagnostic tool that analyzes samples.
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 surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
86 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, tubing kit (accessory), and a fluid collection container (accessory).
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.
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 will be tested in accordance with applicable electrical safety standards. The device underwent performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate device.
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
KO14000
510(k) SUMMARY VISITOME 20-10 MICROKERATOME
1. SUBMITTER INFORMATION
MAR 1 1 2002
| A. | Company Name: | Biovision AG |
|---|---|---|
| B. | Company Address: | 60 Eigerstrasse |
| Bern, Switzerland CH-3007 | ||
| C. | Company Phone: | |
| Company Fax: | 031-372-4404 | |
| 031-372-4412 | ||
| D. | Contact Person: | Edmond Baumgartner |
| General Manager | ||
| Biovision AG | ||
| E. | Date Summary Prepared: | November 26, 2001 |
2. DEVICE IDENTIFICATION
| A. | Classification Name: | Keratome, AC-Powered |
|---|---|---|
| B. | Trade/Proprietary Name: | Visitome 20-10 Microkeratome |
| C. | Classification: | Class I (886.4370) |
| D. | Product Code: | 86 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, tubing kit (accessory), and a fluid collection container (accessory).
Image /page/0/Picture/10 description: The image shows a circle with the text "DMC" written inside it. Below the text, the number "3/14" is written. The circle appears to be hand-drawn with a thick marker or pen, and the text is also handwritten.
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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.
INTENDED USE 4.
The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
ડ. SUBSTANTIAL EQUIVALENCE
The Biovision AG. Visitome 20-10 Microkeratome is equivalent to the following predicate device (predicate device information can be found in Section 10):
| Predicate
| Device | 510(K) Owner | 510(k) No. | Date Cleared |
|---|---|---|---|
| Hansatome | |||
| Microkeratome | Bausch & Lomb | ||
| Surgical | K010260 | April 27, 2001 |
TECHNOLOGICAL CHARACTERISTICS Q.
A comparison of the technological characteristics of the Visitome 20-10 Microkeratome and the predicate device has been performed, and the results are
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summarized in the table below. The results of this comparison demonstrate that the Visitome 20-10 Microkeratome has the same basic technological characteristics as the predicate device and is equivalent to the marketed predicate device. The differences between the Visitome 20-10 Microkeratome and the predicate device are insignificant and do not affect the safety or effectiveness of the device.
| COMPARISON CHART | ||
|---|---|---|
| Biovision AG Visitome 20-10 | ||
| Microkeratome | Hansatome Microkeratome | |
| Predicate Device - K010260 | ||
| Indications For | ||
| Use | The Visitome 20-10 | |
| Microkeratome is indicated for | ||
| use in the making of a corneal | ||
| flap in patients undergoing | ||
| LASIK surgery or other | ||
| treatment requiring initial | ||
| lamellar resection of the cornea. | The Hansatome Microkeratome is a | |
| precision-manufactured instrument | ||
| indicated for use in the making of a | ||
| corneal flap in patients undergoing | ||
| LASIK surgery or other treatment | ||
| requiring initial lamellar resection | ||
| of the cornea. | ||
| Operating | ||
| Principle | Electrically driven oscillating | |
| blade housed in a head which | ||
| guides the blade across the | ||
| cornea on a gear rack. A foot | ||
| pedal with 3 pedal switches is | ||
| used as the control mechanism. | Electrically driven oscillating blade | |
| housed in a head which guides the | ||
| blade across the cornea on an | ||
| elevated gear rack. A footswitch | ||
| (single or dual) is used as the | ||
| control mechanism. | ||
| Type of Hinge | ||
| or Flap | Nasal and Superior | Nasal and Superior |
| COMPARISON CHART | ||
| Biovision AG Visitome 20-10 | ||
| Microkeratome | Hansatome Microkeratome | |
| Predicate Device - K010260 | ||
| Manual or | ||
| Automatic | ||
| Blade | ||
| Advancement | Automatic | Automatic |
| Blade | ||
| Advancement | ||
| Rate | 1 to 10 mm/sec | Unknown |
| Oscillation | ||
| Rate | 0 to 12,000 rpm | Unknown |
| Flap Diameter | ||
| Resection | Range of 7.5 to 10.5 mm | 8.5 & 9.5 mm; accuracy of each |
| diameter unknown | ||
| Thickness of | ||
| Resection | 120, 160 & 180 microns | 160 & 180 microns |
| Eye Fixation | ||
| Method | Suction Ring (sizes 10.5, 11.5, | |
| & 12.0 mm) | Suction Ring (sizes 8.5 & 9.5 mm) | |
| Disposable | ||
| Blade with | ||
| Fixed Holder? | Yes | Yes |
| Blade Angle | 32 degrees | 25 degrees |
| Keratome | ||
| Blade Material | Stainless Steel | Stainless Steel |
| Handpiece | ||
| Material | Titanium | Stainless Steel |
| Components | ||
| That Contact | ||
| the Patient | Blade | |
| Suction Ring | Blade | |
| Keratome Head | ||
| Suction Ring | ||
| Safety Features | 1. Internal diagnostics feature | |
| ensures system integrity | ||
| prior to each procedure. |
- Cutting motion will not start
until appropriate vacuum
level is reached. - If vacuum is lost during the | 1. Internal diagnostics feature
ensures system integrity prior
to each procedure. - Cutting motion will not start
until appropriate vacuum level
is reached. - Cutting stops if vacuum drops |
| COMPARISON CHART | | |
| Biovision AG Visitome 20-10
Microkeratome | Hansatome Microkeratome
Predicate Device - K010260 | |
| cut, an alarm will sound and
the low vacuum light will
come on. Cutting will stop
automatically. | below threshold. | |
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·
4
PERFORMANCE DATA 7.
The Visitome 20-10 Microkeratome has been designed and will be tested in accordance with applicable electrical safety standards. The device underwent performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate device.
CONCLUSIONS 8.
Biovision AG has demonstrated through its evaluation of the Visitome 20-10 Microkeratome that the device is equivalent to the predicate device with respect to intended use, technological characteristics, and safety and effectiveness.
132 . . . . . . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows a black and white logo. The logo consists of a stylized bird with three curved lines representing its wings and body. The bird is enclosed within a circle, and the text "HUMAN SERVICES - USA" is written around the circumference of the circle. The text is slightly blurred, and the overall image has a somewhat grainy quality.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 11 2002
Biovision AG c/o Mr. David S. Fernquist Regulatory Affairs Consultant Visitome, Inc. 27 Mauchly, Unit 206 Irvine, CA 92618
Re: K014000
Trade/Device Name: Visitome 20-10 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: February 20, 2002 Received: February 22, 2002
Dear Mr. Fernquist:
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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Page 2 - Mr. David S. Fernquist
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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
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INDICATIONS FOR USE
| 510(k) Number: | K014000 (To Be Assigned By FDA) |
|---|---|
| Device Trade Name: | VISITOME 20-10 MICROKERATOME |
| Indications For Use: | The Visitome 20-10 Microkeratome is indicated for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. |
|---|---|
| ---------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devices |
| Prescription Use | ✓ |
|---|---|
| 510(k) Number | K014000 |
| OR | |
| Over-The-Counter Use |
(Per 21 CFR 801.109)