(305 days)
Not Found
None
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
Yes
The device is used for "removal of the epithelium from the cornea," which implies a medical intervention to treat a condition, thus making it a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" states "Any condition which requires removal of the epithelium from the cornea." This describes a therapeutic procedure (removal of tissue), not a diagnostic one (identifying a condition).
Unknown
The provided text is a very incomplete 510(k) summary. It lacks crucial information about the device description, how it functions, and whether it includes any hardware components. Without this information, it's impossible to determine if it's a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Any condition which requires removal of the epithelium from the cornea." This describes a surgical or procedural intervention on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of these samples
- Using reagents or assays
The device appears to be a tool or instrument used in a medical procedure involving the cornea.
N/A
Intended Use / Indications for Use
Any condition which requires removal of the epithelium from the cornea.
Product codes
HQS
Device Description
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4070 Powered corneal burr.
(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
JAN 2 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eugene I. Gordon, Ph.D. Chairman Medjet Inc. 1090 King Georges Post Road, Suite 301 Edison, NJ 08837
Re: K971078/S2 Trade Name: HydroBrush ™ Keratome Regulatory Class: I Product Code: HQS Dated: March 24, 1997 Received: March 24, 1997
Dear Dr. Gordon:
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.
1
Page 2 - Eugene I. Gordon, Ph.D.
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 Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) Number (if known): _ K971078
Device Name: HydroBrush TM Keratome
Indications For Use:
Any condition which requires removal of the epithelium from the cornea.
. - : -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ene N.H. Beum PhD
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971078
Prescription Use_L (Per 21 CFR 801.109)
OR
Over-The-Counter Use -
(Optional Format 1-2-96)
0017