(97 days)
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.
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.
Acceptance Criteria and Study for VISITOME 20-10 MICROKERATOME
Based on the provided 510(k) summary for the VISITOME 20-10 Microkeratome (K014000), here's an analysis of the acceptance criteria and the study performed:
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily relies on demonstrating substantial equivalence to a predicate device (Hansatome Microkeratome, K010260) rather than presenting a formal table of explicit acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied by the claim of equivalence in technological characteristics, safety, and effectiveness. The performance evaluation focuses on whether the device meets all performance specification requirements to be considered equivalent.
The comparison table outlines the technological characteristics of both devices, which serve as the basis for demonstrating equivalence in performance.
| Characteristic | Predicate Device (Hansatome Microkeratome) | VISITOME 20-10 Microkeratome (Reported Performance) | Implied Acceptance Criteria (for equivalence) |
|---|---|---|---|
| Indications For Use | Making a corneal flap for LASIK/lamellar resection | Making a corneal flap for LASIK/lamellar resection | Same indications for use. |
| Operating Principle | Electrically driven oscillating blade, gear rack, footswitch control | Electrically driven oscillating blade, gear rack, 3-pedal footswitch control | Electrically driven oscillating blade, similar mechanism for advancement and control. |
| Type of Hinge or Flap | Nasal and Superior | Nasal and Superior | Capability to create Nasal and Superior hinges/flaps. |
| Manual or Automatic Blade Advancement | Automatic | Automatic | Automatic blade advancement. |
| Blade Advancement Rate | Unknown | 1 to 10 mm/sec | Functionally appropriate range for corneal flap creation. (No direct comparison is made due to "Unknown" for predicate) |
| Oscillation Rate | Unknown | 0 to 12,000 rpm | Functionally appropriate range for corneal flap creation. (No direct comparison is made due to "Unknown" for predicate) |
| Flap Diameter Resection | 8.5 & 9.5 mm; accuracy unknown | Range of 7.5 to 10.5 mm | Capability to resect flaps within a clinically acceptable diameter range. |
| Thickness of Resection | 160 & 180 microns | 120, 160 & 180 microns | Capability to resect flaps at clinically relevant thicknesses. (VISITOME offers more options) |
| Eye Fixation Method | Suction Ring (sizes 8.5 & 9.5 mm) | Suction Ring (sizes 10.5, 11.5, & 12.0 mm) | Use of a suction ring for eye fixation. (VISITOME offers different sizes) |
| Disposable Blade with Fixed Holder? | Yes | Yes | Disposable blade with fixed holder. |
| Blade Angle | 25 degrees | 32 degrees | Clinically effective blade angle for corneal incision. (Difference accepted as not affecting safety/effectiveness) |
| Keratome Blade Material | Stainless Steel | Stainless Steel | Stainless Steel blade material. |
| Handpiece Material | Stainless Steel | Titanium | Biocompatible and durable material for the handpiece. (Difference accepted as not affecting safety/effectiveness) |
| Components That Contact the Patient | Blade, Keratome Head, Suction Ring | Blade, Suction Ring | Biocompatible and properly sterilized components in contact with patient. |
| Safety Features | 1. Internal diagnostics, 2. Vacuum check before cut, 3. Cut stops if vacuum drops. | 1. Internal diagnostics, 2. Vacuum check before cut, 3. Alarm/cut stops if vacuum lost. | Comparable safety features to prevent adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states "The device underwent performance evaluation testing in pig eyes." It does not specify the number of pig eyes used.
- Data Provenance: The testing was conducted in "pig eyes," indicating an in vitro or ex vivo animal model study. This is prospective testing performed for the device. The country of origin of the data is not specified, but the applicant company is Biovision AG from Bern, Switzerland.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The summary does not mention the use of experts to establish ground truth for the performance evaluation testing in pig eyes. The assessment of whether the device "meets all performance specification requirements" would likely be based on objective measurements (e.g., flap thickness, diameter, smoothness) rather than expert opinion on clinical outcome, as it's an animal model.
4. Adjudication Method for the Test Set
Not applicable. The performance evaluation described is technical testing in an animal model, not interpretative assessment by experts requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The VISITOME 20-10 Microkeratome is a surgical instrument, and its evaluation focuses on mechanical performance and safety, not diagnostic interpretive accuracy.
6. Standalone (Algorithm Only) Performance
Not applicable. As a surgical microkeratome, the device does not have an "algorithm only" performance component in the sense of an AI diagnostic tool. Its performance is entirely mechanical and involves human operation.
7. Type of Ground Truth Used for the Test Set
The ground truth for the performance evaluation testing in pig eyes would be objective measurements of the corneal flaps created, such as:
- Flap thickness
- Flap diameter
- Flap morphology/smoothness
- Integrity of the corneal bed
- Blade performance (e.g., sharpness after use)
This is a form of objective measurement against pre-defined specifications, rather than expert consensus, pathology, or outcomes data in humans.
8. Sample Size for the Training Set
Not applicable. The VISITOME 20-10 Microkeratome is a mechanical surgical device and does not involve machine learning or an "algorithm" in the sense that would require a training set. The device's design and engineering principles are based on established biomechanical and optical principles, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of mechanical device.
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KO14000
510(k) SUMMARY VISITOME 20-10 MICROKERATOME
1. SUBMITTER INFORMATION
MAR 1 1 2002
| A. | Company Name: | Biovision AG |
|---|---|---|
| B. | Company Address: | 60 EigerstrasseBern, Switzerland CH-3007 |
| C. | Company Phone:Company Fax: | 031-372-4404031-372-4412 |
| D. | Contact Person: | Edmond BaumgartnerGeneral ManagerBiovision 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).
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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):
| PredicateDevice | 510(K) Owner | 510(k) No. | Date Cleared |
|---|---|---|---|
| HansatomeMicrokeratome | Bausch & LombSurgical | 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 20-10Microkeratome | Hansatome MicrokeratomePredicate Device - K010260 | |
| Indications ForUse | The Visitome 20-10Microkeratome is indicated foruse in the making of a cornealflap in patients undergoingLASIK surgery or othertreatment requiring initiallamellar resection of the cornea. | The Hansatome Microkeratome is aprecision-manufactured instrumentindicated for use in the making of acorneal flap in patients undergoingLASIK surgery or other treatmentrequiring initial lamellar resectionof the cornea. |
| OperatingPrinciple | Electrically driven oscillatingblade housed in a head whichguides the blade across thecornea on a gear rack. A footpedal with 3 pedal switches isused as the control mechanism. | Electrically driven oscillating bladehoused in a head which guides theblade across the cornea on anelevated gear rack. A footswitch(single or dual) is used as thecontrol mechanism. |
| Type of Hingeor Flap | Nasal and Superior | Nasal and Superior |
| COMPARISON CHART | ||
| Biovision AG Visitome 20-10Microkeratome | Hansatome MicrokeratomePredicate Device - K010260 | |
| Manual orAutomaticBladeAdvancement | Automatic | Automatic |
| BladeAdvancementRate | 1 to 10 mm/sec | Unknown |
| OscillationRate | 0 to 12,000 rpm | Unknown |
| Flap DiameterResection | Range of 7.5 to 10.5 mm | 8.5 & 9.5 mm; accuracy of eachdiameter unknown |
| Thickness ofResection | 120, 160 & 180 microns | 160 & 180 microns |
| Eye FixationMethod | Suction Ring (sizes 10.5, 11.5,& 12.0 mm) | Suction Ring (sizes 8.5 & 9.5 mm) |
| DisposableBlade withFixed Holder? | Yes | Yes |
| Blade Angle | 32 degrees | 25 degrees |
| KeratomeBlade Material | Stainless Steel | Stainless Steel |
| HandpieceMaterial | Titanium | Stainless Steel |
| ComponentsThat Contactthe Patient | BladeSuction Ring | BladeKeratome HeadSuction Ring |
| Safety Features | 1. Internal diagnostics featureensures system integrityprior to each procedure.2. Cutting motion will not startuntil appropriate vacuumlevel is reached.3. If vacuum is lost during the | 1. Internal diagnostics featureensures system integrity priorto each procedure.2. Cutting motion will not startuntil appropriate vacuum levelis reached.3. Cutting stops if vacuum drops |
| COMPARISON CHART | ||
| Biovision AG Visitome 20-10Microkeratome | Hansatome MicrokeratomePredicate Device - K010260 | |
| cut, an alarm will sound andthe low vacuum light willcome on. Cutting will stopautomatically. | below threshold. |
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·
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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)
§ 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.