(72 days)
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.
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.
The provided text describes a 510(k) summary for the Barron Microkeratome System and does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets these criteria in the way a modern AI/ML device submission would. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical testing.
Here's a breakdown of the information that can be extracted, and where the provided text falls short of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Create a lamellar section from the cornea (Intended Use) | The non-clinical testing on porcine eyes and cadaver eyes was found to result in corneal lamellar sections equivalent to predicate devices. |
| Achieve predetermined flap diameter (7.5 mm to 10.5 mm) | Flap Diameter: Fixed at 8 or 9.5mm (for the Barron Microkeratome System) - This implies it meets its own specified range, but no specific performance data on achieved diameter vs. target is presented. The device offers flap diameters from 7.5mm to 10.5mm, but the specific models tested were 8 or 9.5mm. |
| Achieve predetermined flap thickness (130 um, 160 um, 180 um) | Thickness Control: Fixed Depth Keratome Head (130u, 160u, or 180u) - Similar to flap diameter, this indicates the capability, but no performance data on achieved thickness vs. target is presented. |
| Achieve predetermined flap hinge width | No specific performance data on flap hinge width is presented. |
| Safety equivalent to predicate devices | Non-clinical testing found equivalence. Device designed and tested to IEC60601-1 (safety standard). |
| Effectiveness equivalent to predicate devices | Non-clinical testing found equivalence. |
| Performance equivalent to predicate devices | Non-clinical testing found equivalence. |
Missing Information/Not Applicable:
The submission in this 1998 510(k) is based on substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them with a standalone performance study. The "study" here refers to non-clinical testing to confirm equivalence.
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document mentions "non-clinical testing on porcine eyes and cadaver eyes," but the number of eyes or cases tested is not provided.
- Data provenance: "porcine eyes and cadaver eyes." This indicates ex vivo animal and human cadaveric tissue, not data from living patients or a specific country of origin in the conventional sense.
- Retrospective or prospective: Not applicable as it's non-clinical ex vivo testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Given the nature of the non-clinical testing (creating lamellar sections), the "ground truth" would likely be the physical measurement and observation of the resulting corneal flaps for their dimensions and quality, rather than expert interpretation of medical images. However, who performed these measurements and their qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. It's unlikely such a formal adjudication method (common in AI/ML studies involving human readers) would apply to this type of non-clinical device testing from 1998.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks. The Barron Microkeratome System is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable to the Barron Microkeratome System, as it is a physical surgical device, not an algorithm. The device's "performance" is its mechanical ability to create corneal sections. The device only performance was assessed in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was likely physical measurements and visual inspection of the lamellar sections created on porcine and cadaver eyes. The goal was to confirm that the device could consistently produce sections with characteristics "equivalent to predicate devices." This is a form of direct measurement and observation of the device's physical output.
8. The sample size for the training set
- This question is not applicable. The Barron Microkeratome System is a mechanical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for a mechanical device.
In summary, the provided 510(k) submission for the Barron Microkeratome System details a traditional approach to device clearance through substantial equivalence to existing predicate devices, supported by non-clinical ex vivo testing for basic performance and safety. It does not contain the kind of detailed clinical study design, acceptance criteria, or statistical analysis that would be expected for a modern AI/ML medical device submission.
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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-PoweredOphthalmology (21 CFR 886.4370) |
| d. Class of Device | Class I |
| e. Product Code | 86HNO |
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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.
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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 AnteriorCircular LamellarResection of theCornea. | Shaving a PartialLamellar Sectionof the Cornea | Initial LamellarCornealResections | Resection of aCircular AnteriorLamellar Flap | LamellarSectioning of theCornea |
| Suction Ring | 1 Fixed HeightSuction Ring(Disposable -Stainless Steel) | 1 Fixed HeightSuction Ring(Disposable -Plastic) | 1 AdjustableHeight SuctionRing (ReusableStainless Steel) | 1 Fixed HeightSuction Ring(ReusableStainless Steel) | 20 Suction Rings(ReusableStainless Steel) |
| Thickness Control | Fixed DepthKeratome Head(130u, 160u, or180u) | Fixed DepthKeratome Head(130u or 160u) | AdjustableKeatome Head to180u | Fixed at 175u | 1-500u Variable |
| Blade DriveSource | Electric Motor 9VDC (Disposable) | Electric Motor12V DC(Reusable) | Electric Motor12V DC(Reusable) | Electric Motor inConsole(Reusable) | Turbine Motor(Reusable) |
| Blade Speed | Blade Oscillation20,000 RPM | Blade Oscillation10,000 RPM | Blade Oscillation7,500 RPM | 12,000 RPM | 0-20,000 RPM |
| Blade Angle | 25° | 25° | 25° | Not Stated | 9° |
| Blade Movement | ReciprocatingSideways | ReciprocatingSideways | ReciprocatingSideways | ReciprocatingSideways | ReciprocatingSideways |
| Blade Material | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Flap Diameter | Fixed at 8 or9.5mm | Fixed at 9.5mm | Variable to 9mm | Variable 8 to10mm | Variable 7.5-8.5mm |
| Keratome HeadMovement | 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 GasVenturi |
| Blade HeightVerification | At Factory withOpticalComparator | At Factory withOpticalComparator | Clinic Measuredwith Microscope | At Factory | Clinic Measuredwith DigitalIndicator |
| Foot Controls | DC Powered | DC Powered | DC Powered | DC Powered | Pneumatic |
Comparative Technological Characteristics
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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.
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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 .
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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
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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
§ 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.