← Product Code [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO) · K014000 # VISTITOME 20-10 MICROKERATOME (K014000) _Biovision AG · HNO · Mar 11, 2002 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K014000 ## Device Facts - **Applicant:** Biovision AG - **Product Code:** [HNO](/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO.md) - **Decision Date:** Mar 11, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4370 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended 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. ## Device Story Visitome 20-10 Microkeratome is an AC-powered surgical instrument for creating corneal flaps during LASIK or lamellar resection. System comprises control unit, handpiece with drive assembly, positioning ring, applanator, stainless steel blade, foot pedal, and fluid collection container. Surgeon operates device by placing positioning ring on eye; vacuum secures cornea; high-speed oscillating stainless steel blade (driven by motor) moves along gear rack between ring and applanation shoe to incise cornea at predetermined thickness/diameter. Internal diagnostics verify system integrity; vacuum sensors prevent blade motion until threshold reached and stop cutting if vacuum is lost. Titanium handpiece construction. Device provides automated blade advancement. Output is a precise corneal flap for subsequent refractive surgery. ## Clinical Evidence No clinical data. Performance evaluation conducted via bench testing and animal model (pig eyes) to verify design specifications and functional equivalence to predicate. ## Technological Characteristics AC-powered, electromechanical microkeratome. Components: control unit, handpiece (titanium), positioning ring, applanator, stainless steel blade. Sensing: vacuum pressure monitoring. Actuation: electric motor-driven oscillating blade. Connectivity: foot pedal control. Safety: internal diagnostics, automated vacuum-interlocked cutting, automatic stop on vacuum loss. ## Regulatory 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. ## Predicate Devices - Hansatome Microkeratome ([K010260](/device/K010260.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. 11/29/01 128 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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.
2. Cutting motion will not start
until appropriate vacuum
level is reached.
3. If vacuum is lost during the | 1. Internal diagnostics feature
ensures system integrity prior
to each procedure.
2. Cutting motion will not start
until appropriate vacuum level
is reached.
3. 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. | | 11/29/01 {3}------------------------------------------------ · {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 . . . . . . . {5}------------------------------------------------ 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. {6}------------------------------------------------ # 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 {7}------------------------------------------------ # 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) --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K014000](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HNO/K014000) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com