(72 days)
Not Found
No
The description focuses on mechanical components (blade, motor, vacuum) and electrical control, with no mention of AI, ML, image processing, or data-driven decision making.
No.
This device is designed to perform a surgical procedure (lamellar sectioning of the cornea) rather than directly treating a disease or condition. While its use might be part of a therapeutic intervention, the device itself is a surgical instrument.
No
The device description clearly states its purpose is to perform lamellar sectioning of the cornea to create a flap, which is a surgical procedure, not a diagnostic one.
No
The device description clearly outlines hardware components including a single-use Microkeratome with a motor, blade, vacuum ring, tubing, and electrical components, as well as a reusable Control Console. This is not a software-only device.
Based on the provided information, the Barron Microkeratome System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "performing lamellar sectioning of the cornea." This is a surgical procedure performed directly on a living patient's eye.
- Device Description: The device is a surgical instrument designed to cut tissue (the cornea). It is used to prepare the eye for procedures like LASIK.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. The Barron Microkeratome System does not analyze any specimens.
The device is a surgical tool used on the body, not a device used to analyze samples from the body.
N/A
Intended Use / Indications for Use
The Barron Microkeratome is intended to be used for creating a lamellar section from the cornea to create a flap with predetermined diameter, thickness, and flap hinge width.
The Barron Microkeratome System is indicated for performing lamellar sectioning of the cornea.
Product codes
86HNO
Device Description
The Barron Microkeratome System consists of two components: a single-use Microkeratome and a Control Console that provides 9V DC and vacuum to the Microkeratome.
The Barron Microkeratome is designed to perform a lamellar section of the cornea to vield a flap of predetermined diameter, thickness, and flap hinge width. The product will be offered in various sizes to provide flap diameters from 7.5 mm to 10.5 mm, and flap thickness of 130 um, and 180 um. The lamellar section is obtained by an oscillating stainless steel blade that is driven by a small motor in the Microkeratome. The Microkeratome is fixated on the eye by use of vacuum which is applied to a Vacuum Ring that seats on the eye. The vacuum exhaust from the Microkeratome is isolated from the ambient atmosphere by a 0.45-um hydrophobic filter.
The Microkeratome is supplied in a sterile package, and includes all components that are necessary to perform the section. The package contains the fully assembled and inspected Microkeratome including Vacuum Ring, Luer Lok connector with filter, Vacuum Tubing, Blade, Electrical wire, and Electrical connector. There are no reusable components to be sterilized, and there are no reusable motor and drive mechanisms that are subject to long term wear. The entire Microkeratome, including the motor and the blade drive mechanism, are disposable. The only reusable portion of the Barron Microkeratome is the electronic Control Console, which is outside the operative sterile field.
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
Non-clinical testing on porcine eyes and cadaver eyes was found to result in corneal lamellar sections equivalent to predicate devices.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Barron Microkeratome System has been designed and tested to applicable safety standards such as IEC60601-1, Medical Electrical Equipment - Part 1:General The specifications and intended use of the Barron Requirements for Safety . Microkeratome are the same or very similar to predicate devices. Non-clinical testing on porcine eyes and cadaver eyes was found to result in corneal lamellar sections equivalent to predicate devices. Therefore, the technological differences between the Barron Microkeratome System and predicate devices do not raise any new issues of safety, effectiveness, or performance of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974004, K913697, K973294, K903912
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
K 983317
2 1998 DEC
Barron Precision Instruments, L.L.C.
Document: FDA 510(k) Application
Subject: Barron Microkeratome System
Section: 11 Revision: 1.1 Effective Date: 9/14/98 Page: 1 of 4
Issued by: M.B. Barron
SECTION 11 - 510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the Barron Microkeratome System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, and boling oubrinted in doevice Evaluation guidance concerning the presentation and content of a 510(k) summary.
-
- Submitter's name, address, telephone number, contact person, and date the summary was prepared:
a. Applicant
- Submitter's name, address, telephone number, contact person, and date the summary was prepared:
Barron Precision Instruments, L.L.C. PO Box 973 8170 Embury Road Grand Blanc, MI 48439
(810) 695-2080 b. Telephone Number ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(810) 695-0948 .. Mark Barron c. Contact Person
d. Date Summary Prepared
September 14, 1998
General Manager
-
- Name of the Device, including trade name, the common or usual name, and the classification
| a. Device Trade Name | Barron Microkeratome System Model B2000 |
|---|---|
| b. Common name | Keratome |
| c. Classification Name | Keratome, AC-Powered |
| Ophthalmology (21 CFR 886.4370) | |
| d. Class of Device | Class I |
| e. Product Code | 86HNO |
1
3. Identification of legally marketed predicate devices to which equivalence is being claimed
| Company | Device | 510(k) |
|---|---|---|
| LaserSight Technologies | Automated Disposable Keratome | K974004 |
| Hansa Research & Development | Automated Corneal Shaper | K913697 |
| Innovative Optics, Inc. | INNOVATOME | K973294 |
| Micro Precision Instrument Co | Micro Refractive System Model 1000 | K903912 |
4. Description of the Device
The Barron Microkeratome System consists of two components: a single-use Microkeratome and a Control Console that provides 9V DC and vacuum to the Microkeratome.
The Barron Microkeratome is designed to perform a lamellar section of the cornea to vield a flap of predetermined diameter, thickness, and flap hinge width. The product will be offered in various sizes to provide flap diameters from 7.5 mm to 10.5 mm, and flap thickness of 130 um, and 180 um. The lamellar section is obtained by an oscillating stainless steel blade that is driven by a small motor in the Microkeratome. The Microkeratome is fixated on the eye by use of vacuum which is applied to a Vacuum Ring that seats on the eye. The vacuum exhaust from the Microkeratome is isolated from the ambient atmosphere by a 0.45-um hydrophobic filter.
The Microkeratome is supplied in a sterile package, and includes all components that are necessary to perform the section. The package contains the fully assembled and inspected Microkeratome including Vacuum Ring, Luer Lok connector with filter, Vacuum Tubing, Blade, Electrical wire, and Electrical connector. There are no reusable components to be sterilized, and there are no reusable motor and drive mechanisms that are subject to long term wear. The entire Microkeratome, including the motor and the blade drive mechanism, are disposable. The only reusable portion of the Barron Microkeratome is the electronic Control Console, which is outside the operative sterile field.
5. Intended use of the device
The Barron Microkeratome is intended to be used for creating a lamellar section from the cornea to create a flap with predetermined diameter, thickness, and flap hinge width.
2
6. Summary of the technological characteristics of the submitted device compared to predicate devices
| Predicate #1 | Predicate #2 | Predicate #3 | Predicate #4 | ||
|---|---|---|---|---|---|
| 510(k): K974004 | 510(k): K913697 | 510(k): K973294 | 510(k): K903912 | ||
| Parameter | Barron Precision | Lasersight | Chiron Vision | Innovative Optics | Micro Precision |
| Indications for use | Partial Anterior | ||||
| Circular Lamellar | |||||
| Resection of the | |||||
| Cornea. | Shaving a Partial | ||||
| Lamellar Section | |||||
| of the Cornea | Initial Lamellar | ||||
| Corneal | |||||
| Resections | Resection of a | ||||
| Circular Anterior | |||||
| Lamellar Flap | Lamellar | ||||
| Sectioning of the | |||||
| Cornea | |||||
| Suction Ring | 1 Fixed Height | ||||
| Suction Ring | |||||
| (Disposable - | |||||
| Stainless Steel) | 1 Fixed Height | ||||
| Suction Ring | |||||
| (Disposable - | |||||
| Plastic) | 1 Adjustable | ||||
| Height Suction | |||||
| Ring (Reusable | |||||
| Stainless Steel) | 1 Fixed Height | ||||
| Suction Ring | |||||
| (Reusable | |||||
| Stainless Steel) | 20 Suction Rings | ||||
| (Reusable | |||||
| Stainless Steel) | |||||
| Thickness Control | Fixed Depth | ||||
| Keratome Head | |||||
| (130u, 160u, or | |||||
| 180u) | Fixed Depth | ||||
| Keratome Head | |||||
| (130u or 160u) | Adjustable | ||||
| Keatome Head to | |||||
| 180u | Fixed at 175u | 1-500u Variable | |||
| Blade Drive | |||||
| Source | Electric Motor 9V | ||||
| DC (Disposable) | Electric Motor | ||||
| 12V DC | |||||
| (Reusable) | Electric Motor | ||||
| 12V DC | |||||
| (Reusable) | Electric Motor in | ||||
| Console | |||||
| (Reusable) | Turbine Motor | ||||
| (Reusable) | |||||
| Blade Speed | Blade Oscillation | ||||
| 20,000 RPM | Blade Oscillation | ||||
| 10,000 RPM | Blade Oscillation | ||||
| 7,500 RPM | 12,000 RPM | 0-20,000 RPM | |||
| Blade Angle | 25° | 25° | 25° | Not Stated | 9° |
| Blade Movement | Reciprocating | ||||
| Sideways | Reciprocating | ||||
| Sideways | Reciprocating | ||||
| Sideways | Reciprocating | ||||
| Sideways | Reciprocating | ||||
| Sideways | |||||
| Blade Material | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Flap Diameter | Fixed at 8 or | ||||
| 9.5mm | Fixed at 9.5mm | Variable to 9mm | Variable 8 to | ||
| 10mm | Variable 7.5- | ||||
| 8.5mm | |||||
| Keratome Head | |||||
| Movement | Manual | Automatic | Automatic | Automatic | Manual |
| Console Details | |||||
| Electrical | Universal AC - | ||||
| 85V to 260V | 110/120 AC | 110/120 AC | AC Powered | None | |
| Vacuum Pump | DC Powered | AC Powered | AC Powered | AC Powered | Nitrogen Gas |
| Venturi | |||||
| Blade Height | |||||
| Verification | At Factory with | ||||
| Optical | |||||
| Comparator | At Factory with | ||||
| Optical | |||||
| Comparator | Clinic Measured | ||||
| with Microscope | At Factory | Clinic Measured | |||
| with Digital | |||||
| Indicator | |||||
| Foot Controls | DC Powered | DC Powered | DC Powered | DC Powered | Pneumatic |
Comparative Technological Characteristics
3
7. Brief discussion of non-clinical tests and results
The Barron Microkeratome System has been designed and tested to applicable safety standards such as IEC60601-1, Medical Electrical Equipment - Part 1:General The specifications and intended use of the Barron Requirements for Safety . Microkeratome are the same or very similar to predicate devices. Non-clinical testing on porcine eyes and cadaver eyes was found to result in corneal lamellar sections equivalent to predicate devices. Therefore, the technological differences between the Barron Microkeratome System and predicate devices do not raise any new issues of safety, effectiveness, or performance of the product.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 DEC
Mr. Mark Barron General Manager Barron Precision Instruments, L.L.C. PO Box 973 8170 Embury Road Grand Blanc, Michigan 48439-0973
Re: K983317 Trade Name: Barron Microkeratome System Model B2000 Regulatory Class: I Product Code: 86 HNO Dated: November 16, 1998 Received: November 20, 1998
Dear Mr. Barron:
We have reviewed your Section 510(k) 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 - Mr. Mark Barron
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorentthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
Page 1 of 1
510(k) NUMBER: K983317
DEVICE NAME: Barron Microkeratome System, Model 2000
INDICATIONS FOR USE:
The Barron Microkeratome System is indicated for performing lamellar sectioning of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
Dennis L. McCarthy
Division of Ophthalmic Devices
510(k) Number K983317