(99 days)
N/A
N/A
No
The device is a replacement blade for a microkeratome, a mechanical surgical instrument. The summary contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a replacement blade for a microkeratome, which is a surgical tool used to perform a keratectomy (part of refractive eye surgery). While surgery can be therapeutic, the blade itself is a component of a surgical instrument, not a therapeutic device. It facilitates a medical procedure rather than directly providing a therapeutic effect.
No
Explanation: The device is a replacement blade for a microkeratome, used to perform lamellar keratectomy procedures (a surgical procedure). It is a surgical tool, not a diagnostic one.
No
The device described is a physical microkeratome blade, which is a hardware component used in ophthalmic surgery. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Blade Works 7061 microkeratome blades are surgical tools used to cut tissue (lamellar keratectomy) during ophthalmic procedures. They are used on the body, not to analyze samples from the body.
- Intended Use: The intended use clearly states they are replacement blades for a microkeratome to perform a surgical procedure.
Therefore, based on the provided information, this device falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blade Works 7061 microkeratome blades are to be used as replacement blades for the Moria LSK-One microkeratome, to perform lamellar keratectomy procedures.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
APR 1 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blade Works, Inc. c/o Mr. Mark Moyer Mover Enterprises 1816 Towhee Street San Marcos, CA 92069
Re: K020079
Trade/Device Name: BladeWorks Microkeratome Blade, Model 7061 Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: March 15, 2002 Received: March 19, 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 for the basic is 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 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
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| 510(k) Notification | |
|---|---|
| Page 4 | |
| BLADE WORKS | Model 7061 Microkeratome Blade |
| PNS 500-0101 | File Document |
INDICATIONS FOR USE FORM
| 510(k) number (if known): | K020079 |
|---|---|
| Device Name: | Microkeratome Blade |
Indications for Use:
The Blade Works 7061 microkeratome blades are to be used as replacement blades for the Moria LSK-One 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)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Ear, | |
| Nose and Throat Devises | |
| 510(k) Number | K020079 |
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| Per 21 CFR 801.109 | (Optional Format 1-2-96) |
For Use By Affiliates Of Blade Works, Inc.
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