(567 days)
Not Found
No
The device description focuses on a mechanical process using a water beam and does not mention any AI/ML components or image processing.
Yes
The device is described as performing surgical resections to the cornea, which is a therapeutic intervention.
No
The device is described as a surgical tool for performing corneal resections, not for diagnosing conditions.
No
The device description explicitly states that the VisiJet Hydrokeratome includes a system console, footswitch, and handpiece with interchangeable suction rings, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- VisiJet Hydrokeratome Function: The VisiJet Hydrokeratome is a surgical device used to perform a physical procedure (lamellar resection) directly on the cornea of a patient. It does not analyze specimens taken from the body.
The device description clearly outlines a surgical tool that uses a water beam to cut tissue, which is a direct intervention on the patient, not an in vitro test.
N/A
Intended Use / Indications for Use
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Product codes
86 MYD
Device Description
The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.
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
The VisiJet™ Hydrokeratome™ has been designed and will be tested to applicable safety standards. All components in contact with tissue are manufactured from known biocompatible material. All motors are UL approved. The specifications and intended use of the VisiJet Hydrokeratome are the same or very similar to predicate devices. In addition, the VisiJet Hydrokeratome was found to perform equivalently to the predicate devices, the Baron Microkeratome System, Automatic Corneal Shaper (ACS) and the Medjet Hydrobrush, and as intended in all cases. Therefore, the technological differences between the VisiJet Hydrokeratome and the predicated devices do not raise any new issues of safety, effectiveness, or performance of the product.
Key Metrics
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
VisiJet, Inc. VisiJet™ Hydrokeratome™
OCT 2 0 2000
March 29, 1999 Premarket Notification
SECTION 14
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Submitter's name, address, telephone number, contact person, and date summary prepared:
a. Applicant:
VisiJet, Inc. 188 Technology Drive Suite D Irvine, CA 92718 (949) 450-1660 (949) 453-9652 (fax)
b. Contact Person:
Randy Bailey, President
Randall G. Bailey
c. Date Summary Prepared: March 26, 1999
2. Name of device, including trade name and classification name:
- Trade/Proprietary Name: VisiJet™ Hydrokeratome™- Model 50 a.
- b. Classification Name: Keratome
-
- Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | Barron Precision Instruments, L.L.C. |
|---|---|
| Device: | Barron Microkeratome System Model B2000 |
| 510(k): | K973317 |
1
Company: Medjet, Inc. Device: HydroBrush 510(k): K971078
Company: Device: 510(k):
Hansa Research and Development, Inc. Automatic Corneal Shaper (ACS) 913697
A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.
5. Statement of intended use:
The VisiJet Hydrokeratome is intended for use in performing anterior lamellar circular corneal resections.
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
A summary of the comparative technological characteristics between the VisiJet Hydrokeratome and comparable legally marketed devices immediately follows this page.
2
VisiJet, Inc. VisiJet™ Hydrokeratome™
March 29, 1999 Premarket Notification
Brief summary of nonclinical tests and results: 7.
The VisiJet™ Hydrokeratome™ has been designed and will be tested to applicable safety standards. All components in contact with tissue are manufactured from known biocompatible material. All motors are UL approved. The specifications and intended use of the VisiJet Hydrokeratome are the same or very similar to predicate devices. In addition, the VisiJet Hydrokeratome was found to perform equivalently to the predicate devices, the Baron Microkeratome System, Automatic Corneal Shaper (ACS) and the Medjet Hydrobrush, and as intended in all cases. Therefore, the technological differences between the VisiJet Hydrokeratome and the predicated devices do not raise any new issues of safety, effectiveness, or performance of the product.
3
March 26, 1999
Premarket Notification
VisiJet, Inc.
VisiJet™ Hydrokeratome™
omparative Technological Characteristic
| CHARACTERISTICS | Barron - Microkeratome
System | Hansa - Automatic Corneal
Shaper | Medjet, Inc. - HydroBrush | VisiJet™ HydrokeratomeTM |
|---------------------------|---------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | Partial Anterior Circular
Lamellar Corneal Resections | Lamellar Corneal Resections | Corneal Epithelial Removal | Lamellar Corneal Resections |
| Operating Principle | Electrically driven oscillating
blade | Electrically driven oscillating
blade | High-velocity water beam | High-velocity water beam |
| Suction Ring | 1 Fixed Height Suction Ring
(Disposable - Stainless Steel) | Adjustable Height Suction Ring
(Reusable Stainless Steel) | N/A | Suction-applanation Ring
(Disposable - polysulfone) |
| Blade Drive Source | Electric Motor 9V DC
(Disposable) | Electric Motor 12V DC
(Reusable) | Electric Motor
(Reusable) | Electric motor 12V DC
(Reusable) |
| Thickness Control | Fixed Depth Keratome Head
(130u, 160u, or 180u) | Thickness Plates | Angle of impingement on flat
plate | Clear applanation plate that is
part of the suction-applanation
rings (140u, 160u, 180u, 200u) |
| Blade Speed | Blade Oscillation 20,000 RPM | Blade Oscillation 7,500 RPM | NA | NA |
| Blade/Fluid Beam Angle | 25° | 25° | 7 - 9° | 0° |
| Blade Movement | Reciprocating Sideways | Reciprocating Sideways | Manual, Variable | Non-reciprocating Tranlsation |
| Blade Material | Stainless Steel | Stainless Steel | High-velocity fluid beam
(Sterile solution or WFI); 35
micron cross-section | High-velocity fluid beam
(Sterile solution or WFI); 35
micron cross-section |
| Flap Diameter | Fixed at 8 or 9.5 mm | Variable at 9 mm | N/A | 8 - 10 mm |
| Flap Width | Unknown | Unknown | N/A | Variable, programmable and
determined by user. Between 0
- 10 mm |
| Keratome Head Movement | Manual | Automatic | | Automatic |
| Console Details | | | | |
| Electrical | Universal AC - 85V to 260V | 110/120 AC | | Universal AC - 85V to 260V |
| Vacuum Pump | DC Powered | AC Powered | | DC Powered |
| Blade Height Verification | At factory with Optical
Comparator | Clinic Measured with
Microscope | | At factory with Optical
Comparator |
| Foot Controls | DC Powered | DC Powered | | DC Powered |
୧ର
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its head turned to the left, and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 2000
Visijet, Inc. c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 18732 Saginaw Irvine, Ca 92614
K991124 Re:
Trade Name: VisiJet™ Hydrokeratome™ Model 50 Regulatory Class: I Reserved Product Code: 86 MYD Regulation: 886.4370 Dated: September 15, 2000 Received: September 15, 2000
Dear Dr. Gordon:
We have reviewed your Section 510(t) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
5
Page 2- Judy F. Gordon, D.V.M.
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anow you to begal mainsance of your device to a legally marketed notification. The FDA inding of substantial equireatios on your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific atyice for your doiled of contact the Office of Compliance at (301) additionally 607.10 for the may accessor on the promotion and advertising of your device, please 374-0415. Nuditionaly, for questions only 59-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information "Misbranding by reletence to phants may be obtained from the Division of Sinsion of Sinish Manufacturers
on your responsibilities under the Aca 100 cm 11 cm 1200 cm commended on your responsibilities and its the 100 %38-2041 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
6
VisiJet, Inc. VisiJet™ Hydrokeratome™
March 26, 1999
Premarket Notification
SECTION 6
INDICATIONS FOR USE
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
Eneue HR Beem
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number J