(91 days)
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No
The document describes a replacement blade for a microkeratome, a mechanical surgical device. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
No
The device is a microkeratome blade used for lamellar keratectomy procedures, which are surgical interventions, not therapeutic treatments.
No
The device is described as a microkeratome blade used for performing lamellar keratectomy procedures, which is a surgical procedure. It is a tool used in a therapeutic intervention, not for diagnosing conditions.
No
The device is described as a "Microkeratome Blade," which is a physical, hardware component used in surgical procedures. The summary does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform lamellar keratectomy procedures, which are surgical procedures on the eye. This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Device Description: It's a microkeratome blade, a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement blades for the AMO Amadeus™ Microkeratome, to perform lamellar keratectomy procedures.
Product codes
HNO
Device Description
ML7090 Microkeratome Blade
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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 and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
JAN 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Med-Logics, Inc c/o Rod Ross, CEO 2601 Merit Circle Laguna Hills, CA 92653
Re: K033293
Trade/Device Namc: ML 7090 Microkeratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: October 10, 2003 Received: October 16, 2003
Dear Mr. Ross:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bected by agains is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic 71ct) that as novely subject to the general controls provisions of the Act. The T ou may, therefore, manel the Act include requirements for annual registration, listing of general condois providering practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device is classimod (600 aboro) as Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affect may be subject to such additional controller Linksing in 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 docs not mcan Please be advised that 1 Dri- installios of wouldevice complies with other requirements of the Act that I DV has made a acterimmalations administered by other Federal agencies. You must or any I edelul statules and roginements, including, but not limited to: registration and listing Compry with an the Act 3 requirements, and 801); good manufacturing practice requirements as set (21 CFR Part 607), laboring (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Rod Ross, CEO
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 http://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
Enclosure
2
| 510(k) Notification | |||
|---|---|---|---|
| MED-LOGICS, INC. | |||
| Model ML7090 Microkeratome Blade | Page 4 | ||
| PNS 500-0103 | File Document |
INDICATIONS FOR USE FORM
| 510(k) number (if known): | K033293 |
|---|---|
| Device Name: | Microkeratome Blade |
Indications for Use:
The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement
blades for the AMO Amadeus
TM Microkeratome, to perform lamellar keratectomy
procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| Per 21 CFR 801.109 | OR | Over-the-Counter Use |
|---|---|---|
| Marsha R. Burke Nicholas (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises | (Optional Format 1-2-96) | |
| 510(k) Number |
For Use By Affiliates Of MED-LOGICS, Inc.
This document contains proprietary information. It may not be reproduced or disclosed without prior written approvation THE USER OF THIS DOCUMENT IS RESPONSIBER FOR VERIES POR VERIENT REVISION BEFORE USING THIS DOCUMENT