(57 days)
Not Found
None
No
The summary describes a replacement blade for a microkeratome, which is a mechanical device. There is no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is a microkeratome blade, which is an instrument used to cut tissue, not to treat a disease or condition.
No
The device is described as replacement blades for a microkeratome, which is a surgical instrument used to create a flap in the cornea during eye surgery, not for diagnosis.
No
The device description clearly states it is a "Microkeratome Blade," which is a physical hardware component used in surgery. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a replacement blade for a microkeratome, which is a surgical instrument used in ophthalmology. This is a surgical device, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a "Microkeratome Blade," reinforcing its role as a surgical tool.
- 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 about a patient's health status
- Using reagents or assays
Therefore, the Med-Logics 7020CLB microkeratome blade is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome.
Product codes
HNO
Device Description
Not Found
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)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Med-Logics, Inc. c/o Mr. Mark Moyer Vice President 26061 Merit Circle, Suite 102 Laguna Hills, CA 92653
Re: K022716
Trade Name: Med-Logics Model 7020CLB™ Microkeratome Blade Classification Regulation Number: 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: August 14, 2002 Received: August 15, 2002
Dear Mr. Moyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Mark Moyer
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address littp://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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| MED-LOGICS | 510(k) Notification | ||
|---|---|---|---|
| Model 7020CLB™ Microkeratome Blade | Page 4 | ||
| PNS 500-0102 | File Document |
INDICATIONS FOR USE FORM
| 510(k) number (if known): | K022716 |
|---|---|
| Device Name: | Microkeratome Blade |
| Indications for Use: | The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | ||
|---|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises | ||
| 510(k) Number | K022716 | |
| Prescription Use Per 21 CFR 801.109 | ✓ | OR Over-the-Counter Use (Optional Format 1-2-96) |
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For Use By Affiliates Of Med-Logics, Inc.
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