(79 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is very basic and suggests a simple template.
No
The device is described as a template to mark the cornea for surgical manipulation, which is a diagnostic or pre-surgical tool, not one that directly treats a condition.
No
The device's intended use is to mark a location on the cornea for surgical manipulation, not to diagnose a condition or disease.
Unknown
The provided 510(k) summary does not contain enough information to definitively determine if the device is software-only. It describes a "Corneal Template" used with a "skin marker," which could imply a physical template or a software-generated guide. The lack of details about the device's form factor or components makes it impossible to confirm if it's purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a location on the cornea for surgical manipulation. This is a direct interaction with the patient's body during a surgical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The OptiPoint Corneal Template does not involve testing samples from the body.
- Device Description: The description "OptiPoint Corneal Template" suggests a physical tool used externally or on the surface of the eye.
- Anatomical Site: The cornea is a part of the eye, and the device is used directly on it.
Therefore, the OptiPoint Corneal Template is a surgical tool or guide used in vivo (on a living organism), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for wind regally subsequent ophthalmic surgical manipulation.
Product codes
HMR, HMQ
Device Description
Not Found
Mentions image processing
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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
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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
§ 886.4570 Ophthalmic surgical marker.
(a)
Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.(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
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 2006
Refractec, Inc. c/o Gary Mocnik V.P. Regulatory Affairs 5 Jenner, Suite 150 Irvine, CA 92618
Re: K053475
Trade/Device Name: OptiPoint Corneal Template Regulation Number: 21 CFR 886.4570 Regulation Name: Ophthalmic Surgical Marker Regulatory Class: Class I Product Code: HMR; HMQ Dated: December 14, 2005 Received: January 4, 2006
Dear Mr. Mocnik:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 use suated in the encreated 776, 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
1
Page 2 - Mr. Gary Mocnik
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. 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
BEpleluns, uns
Malvina Eydelman, 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) Number (if known): K053475
Device Name: OptiPoint Corneal Template
Indication For Use:
The OptiPoint Corneal Template is to be used in conjunction with a legally marketed skin marker to provide the location on the cornea for wind regally subsequent ophthalmic surgical manipulation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Masha R. B Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear.
Nose and Throat Devises
510(k) Number K053475
Prescription Use
Per 21 CFR 801.109
OR
Over-The-Counter Use