(80 days)
Not Found
No
The 510(k) summary describes single-use, disposable keratome blades, which are mechanical devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device, a keratome blade, is designed for use in surgical procedures (specifically LASIK) to cut tissue, which is a therapeutic intervention. However, the blade itself is a component used with a keratome, and acts as an instrument rather than a standalone device that directly provides therapy or treatment to a patient.
No
The device description indicates that the keratome blades are used with other manufacturers' keratomes for surgical procedures, not for diagnosing conditions.
No
The device description clearly states that the device is a physical, single-use, disposable keratome blade, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the blades as being used with keratomes for surgical procedures. This is a surgical device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical characteristics of the blades and their packaging, consistent with a surgical instrument.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, the Microspecialties, Inc., 500500 and 400400 keratome blades are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer's keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.
Product codes
86 HNO
Device Description
There are two blade styles as part of this submission, which have very slight differences in width dimension. The catalog number 500500 blade is designed to fit Chiron Keratomes, the 400400 blade will fit S.C.M.D. Keratomes. Both blades are manufactured out of the same materials, packaged and sterilized using the same methods. The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit. Both blades are packages in a plastic "clamshell" for protection and then double pouched. Each blade will be sold in single units. 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. The material used in the blade is a 400 Series Stainless Steel.
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
Not Found
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
510K Summary MICROspecialties.Inc. Disposable Keratome Blades
MAY 1998
Ref. K980508
MICROspecialties, Inc. 16 Higgins Drive Milford, CT 06460 Tel: 203-874-1832 Fax: 203-877-3762
Submitters Name:
Churla Vanilla
Charles Vassallo
9 Mac 98
Date
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, which an equivalence determination could be based. There are two blade styles as part of this submission, which have very slight differences in width dimension. The catalog number 500500 blade is designed to fit Chiron Keratomes, the 400400 blade will fit S.C.M.D. Keratomes. Both blades are manufactured out of the same materials, packaged and sterilized using the same methods.
| Trade/Proprietary Name: | Disposable Keratome Blade |
|---|---|
| Common/Usual Name: | Keratome Blade |
| Classification Name: | Keratome |
| 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
Descriptive Comparison:
The 500500 blade is equivalent to the Med-Logics ML Lasik Blade and the Howard Instruments CBALK-1000 Blade. The 400400 blade is designed for use in the S.C.M.D. Keratomes of Arizonia.
Characteristics:
ं.
The 500500 and the 400400, keratome blades are single-use, disposable. The 500500 blade is for use in the Chiron keratome while the 400400 blade is used in the S.C.M.D. unit.
Both blades are packages in a plastic "clamshell" for protection and then double 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 500500 or 400400 blade.
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 outer pouch will indicate MICROspecialties name, address, product identification, lot number, sterilization notes, single use, and federal law statements. The inner pouch will bear the catalog number and lot number.
The blades could be relabeled for sale for other companies. These include Oasis Medical, Howard Instruments, Eye-Med, Insight Technologies Instruments, 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 logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
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: K980508 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 Roerl lorentthal
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
¥980508 510(k) Number (if known):
Device Name: Disposable Keratome Blades
The Microspecialties, Inc., 500500 and 400400 keratome blades are designed for use with other manufacturer's keratome. The 500500 blade is for use in the Chiron Keratome while the 400400 blade is used in the S.C.M.D. Keratome.
Daryl Kaufman
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) Number_ 1980508
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
X Prescription Use __ (Per 21 CFR 801.109)
OR
Over The Counter Use (Optional Format 1-2-96)