(80 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of disposable keratome blades, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a keratome blade used for cutting the cornea, which is a surgical tool, not a therapeutic device designed to treat or prevent disease.
No
The device description indicates that the keratome blades are used for cutting the cornea, which is a surgical action, not a diagnostic one.
No
The device description clearly states it is a disposable keratome blade with a holder, which is a physical surgical instrument, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical cutting of the cornea using a keratome. This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical blade and holder designed for use with a keratome instrument. It focuses on the physical characteristics and function of the blade for cutting tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other manufacture's keratome. These blades are for use in the Insight Technologies Instruments, Model K-SERIES Keratome.
Product codes (comma separated list FDA assigned to the subject device)
86 HNO
Device Description
This summary of 510K safety and effectiveness information is being submitted for the MICROspecialties Disposable Keratome Blades with Holder, which an equivalence determination could be based. There are three blade styles as part of this submission, which have very slight differences in blade depth dimension. All of the blades are designed to fit Insight Technologies Instruments keratomes. The blades are manufactured out of the same materials, packaged and sterilized using the same methods.
Blades without holders are assembled to keratome drivers with reusable holders. Blades with holders that are being submitted have the holder assembled to the blade thereby making the assembly of the keratome system easier and more convenient.
The blades are equivalent to the Med-Logics ML Lasik Blade and the Howard Instruments CBALK-1000 Blade. The difference is the integration of the holder as part of the blade assembly. The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns. The holders of these blades will be color coded as a means of additional identification to the labeling.
The keratome blades with holders are single-use, disposable. Both blades are packages in a foam case for protection and then pouched. Each blade will be sold in single units.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510K Summary MICROspecialties. Inc. Disposable Keratome Blades with Holder
1 1998 MAY
MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460 Tel: 203-874-1832 Fax: 203-877-3762
Churles Vassalla
Submitters Name:
Charles Vassallo
Date
MAG
300/ H800
18
Ref: 510K Premarket Notification
To: Document Control Clerk:
This summary of 510K safety and effectiveness information is being submitted for the MICROspecialties Disposable Keratome Blades with Holder, which an equivalence determination could be based. There are three blade styles as part of this submission, which have very slight differences in blade depth dimension. All of the blades are designed to fit Insight Technologies Instruments keratomes. The blades are manufactured out of the same materials, packaged and sterilized using the same methods.
Blades without holders are assembled to keratome drivers with reusable holders. Blades with holders that are being submitted have the holder assembled to the blade thereby making the assembly of the keratome system easier and more convenient.
| Trade/Proprietary Name: | Disposable Keratome Blade with Holder |
|---|---|
| Common/Usual Name: | Keratome Blade |
| Classification Name: | Blade, surgical, saw, general and plastic surgery |
| Establishment Registration Number: | In process at FDA |
1
Performance Standard:
The MICROspecialties disposable keratome blade is similar in design construction, and function to the devices as marketed by:
- Howard Instruments, Inc. . Tuscaloosa, AL 35405 Cbalk-1000 LASIK Blade Reference 510k: K972727
- Med-Logics, Inc. . Temple City, CA 91780 ML Microkeratome Blade Reference 510k: K962661
Although these blades are supplied without holders their function is the same when fully assembled to the keratome.
Descriptive Comparison:
The blades are equivalent to the Med-Logics ML Lasik Blade and the Howard Instruments CBALK-1000 Blade. The difference is the integration of the holder as part of the blade assembly. The three (3) blades depths dimensions that control the depth of cut on the cornia are; 135 microns, 160 microns, and 200 microns. The holders of these blades will be color coded as a means of additional identification to the labeling.
Characteristics:
The keratome blades with holders are single-use, disposable. Both blades are packages in a foam case for protection and then pouched. Each blade will be sold in single units.
Certification of Safety and Effectiveness:
When used according to the keratome manufacturers' instructions, there are no adverse safety indications for the either the blades.
Components that come in direct contact with tissue are made of surgical stainless steels commonly used in other surgical blades. The blades will be presterilized by ethylene oxide gas.
Labeling:
The pouch will indicate MICROspecialties name, address, product identification, lot number, sterilization notes, single use, and federal law statements. The blades could be relabeled for sale for other companies. These include Oasis Medical, Howard Instruments, Eye-Med, and S.C.M.D.
There will be no advertising using the word "Lasik" in any sales literature, manuals, etc.
2
Sterilization Methodology:
Presterilized by ethylene oxide gas in accordance with ANSVAAMI/ISO 11135-1994, Medical Device-Validation and Routine Control, Ethylene Oxide Sterilization.
Materials:
The material used in the blade is a 400 Series Stainless Steel.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with three heads, which are stylized and abstract. The eagle is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 MAY
Mr. Charles Vassallo MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460
Re: K980510 Trade Name: Keratome Blade Regulatory Class: I Product Code: 86 HNO Dated: February 6, 1998 Received: February 10, 1998
Dear Mr. Vassallo:
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.
4
Page 2 - Mr. Charles Vassallo
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. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use MICROspecialties. Inc. Disposable Keratome Blades with Holder
K980510 510(k) Number (if known):
Device Name: Disposable Keratome Blades with Holder
The Microspecialties, Inc., 300135, 300160 and 300200 keratome blades are designed for use with other These blades are for use in the Insight Technologies Instruments, Model Kmanufacture's keratome. SERIES Keratome. i
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Division Sign-Off) Division of Ophthalmic Devices 1980510 510(k) Number.
(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)