(134 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other terms typically associated with AI/ML in medical devices. The intended use is a mechanical action (producing a corneal flap).
Yes
The MMK-1000 is intended to produce a corneal flap, which is a direct medical intervention on the body to achieve a therapeutic outcome (e.g., in LASIK surgery for vision correction).
No
The device is described as producing a corneal flap, which is a surgical procedure rather than a diagnostic one.
No
The intended use explicitly states the device is designed to "produce a corneal flap," which is a physical action requiring a hardware component, not solely software.
Based on the provided information, the MMK-1000 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to produce a corneal flap." This is a surgical procedure performed on a living patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Anatomical Site: The anatomical site is "corneal," which is part of the eye in a living organism.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
Therefore, the MMK-1000 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MMK-1000 is designed to produce a corneal flap.
Product codes
86 HMY, 86 HNO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 1998
Mr. Jack Howard Official Correspondent Howard Instrument, Inc. 4749 Appletree Ln. Tuscaloosa, Alabama 35405
K974598 Re: Trade Name: Microkeratome Regulatory Class: I Product Code: 86 HMY, 86 HNO Dated: April 14, 1998 Received: April 20, 1998
Dear Mr. Howard:
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 - Mr. Jack Howard
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
2
Page 2 of 2
5 10(k) Number (if known): K 974598
Device Name: _microkeratome
Indications For Use:
The MMK-1000 is designed to produce a corneal flap.
ﻤﺎ: ﻓ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Bruce Drum | |
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K974598 |
| Prescription Use | OR | Over the Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)