(289 days)
Not Found
Not Found
No
The device description focuses on the material composition, physical structure, and surgical implantation process of an artificial cornea, with no mention of AI or ML capabilities.
Yes
The device is used to treat corneal opacity, restoring vision and serving a therapeutic purpose by replacing damaged tissue.
No
This device is an artificial cornea (keratoprosthesis) designed to replace the natural cornea in patients with corneal opacity, allowing light transmission into the eye. It is an implantable medical device for treatment, not for diagnosing a condition.
No
The device description clearly describes a physical implantable device made of hydrogel with an optical core and a sponge rim, requiring a two-stage surgical implantation process. This is a hardware medical device, not software.
Based on the provided information, 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 Description: The AlphaCor artificial cornea is a surgically implanted device designed to replace a damaged cornea. It is a physical implant, not a test performed on a sample.
- Intended Use: The intended use is to treat corneal opacity by providing an artificial cornea, not to diagnose a condition using a sample.
Therefore, the AlphaCor artificial cornea falls under the category of a medical device, specifically a prosthetic device, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The AlphaCor artificial cornea is intended for use as a keratoprosthesis in adult patients with corneal opacity to include the following:
- Eyes that are not suitable for standard penetrating keratoplasty with donor tissue.
- Eyes in patients who have declined to have standard penetrating keratoplasty performed . with donor tissue.
- Eyes in which the adjunctive measures required to prevent graft rejection are medically contraindicated.
Product codes
HQM
Device Description
The AlphaCor artificial cornea is made of flexible hydrogel PHEMA and comprises an optically clear core surrounded by a peripheral opaque sponge rim, which allows tissue ingrowth. The core allows transmission of light and provides refractive power, while the sponge skirt allows fibrovascular ingrowht for long term securing of the device into place. The AlphaCor device is implanted in a two stage surgical process using a modified intrastromal lamellar technique that places the posterior surface of the optic in direct communication with the anterior chamber. covers the anterior surface of the optic with the anterior corneal lamella and, usually, a conjunctival flap, and places the skirt within the lamellar pocket. The second stage of the surgical process consists of opening the anterior covering layers about 12 weeks post-implant, which exposes the anterior surface of the AlphaCor optic and allows light transmission into the eye. The AlphaCor is available in two different powers: AlphaCor-A™ for aphakic eyes and AlphaCor-P™ for phakic and pseudophakic eyes. AlphaCor-A™ delivers additional positive power to compensate for the absence of a lens in the aphakic eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal
Indicated Patient Age Range
adult patients
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
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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)
Dohlman Doane Type I Keratoprosthesis
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.3400 Keratoprosthesis.
(a)
Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”
0
| AlphaCor 510(k) Submission
Argus Biomedical Pty Ltd
| October 26, 2001 | AUG 2 9 2002 | Page 104 |
|---|---|---|
| ---------------------------------------------------------------------------- | -------------- | ---------- |
510(k) SUMMARY
| NAME OF FIRM: | Argus Biomedical Pty Ltd |
|---|---|
| 510(k) CONTACT PERSON: | Barbara S. Fant, Pharm.D. |
| Consultant | |
| TRADE NAMES: | AlphaCOR™™, AlphaCor-A™™, AlphaCor-Pтм |
| COMMON NAME: | Artificial Cornea |
| CLASSIFICATION: | 886.3400(II) Keratoprosthesis, permanent implant |
PRODUCT CODE: HQM
SUBSTANTIALLY Dohlman Doane Type I Keratoprosthesis EQUIVALENT DEVICE:
INTENDED USE:
The AlphaCor artificial cornea is intended for use as a keratoprosthesis in adult patients with corneal opacity to include the following:
- Eyes that are not suitable for standard penetrating keratoplasty with donor tissue. ●
- Eyes in patients who have declined to have standard penetrating keratoplasty performed . with donor tissue.
- . Eyes in which the adjunctive measures required to prevent graft rejection are medically contraindicated.
DEVICE DESCRIPTION:
The AlphaCor artificial cornea is made of flexible hydrogel PHEMA and comprises an optically clear core surrounded by a peripheral opaque sponge rim, which allows tissue ingrowth. The core allows transmission of light and provides refractive power, while the sponge skirt allows fibrovascular ingrowht for long term securing of the device into place. The AlphaCor device is implanted in a two stage surgical process using a modified intrastromal lamellar technique that places the posterior surface of the optic in direct communication with the anterior chamber. covers the anterior surface of the optic with the anterior corneal lamella and, usually, a conjunctival flap, and places the skirt within the lamellar pocket. The second stage of the surgical process consists of opening the anterior covering layers about 12 weeks post-implant, which exposes the anterior surface of the AlphaCor optic and allows light transmission into the eye. The AlphaCor is available in two different powers: AlphaCor-A™ for aphakic eyes and AlphaCor-P™ for phakic and pseudophakic eyes. AlphaCor-A™ delivers additional positive power to compensate for the absence of a lens in the aphakic eye.
SUBSTANTIAL EQUIVALENCE:
The AlphaCor keratoprosthesis was shown to be substantially equivalent to the Dohlman Doane Type I keratoprosthesis. Both devices are indicated as permanent implantable keratoprostheses for eyes that are not corneal transplant candidates and are made of materials that have been proven to be biocompatible.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble ribbons or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2002
Argus Biomedical Pty Ltd. c/o Barbara S. Fant, Pharm.D. Clinical Research Consultants 3307 Clifton Avenue Cincinnati, OH 45220
Re: K013756
Trade/Device Name: AlphaCor™-A and AlphaCor™-P Artificial Cornea Regulation Number: 21 CFR 886.3400 Regulation Name: Keratoprosthesis Regulatory Class: II Product Code: HQM Dated: June 27, 2002 Received: June 28, 2002
Dear Dr. Fant:
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
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Page 2 – Barbara S. Fant, Pharm.D.
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 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,
David M. Whipple
/A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal. 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) Number (if known): ____________________________________________________________________________________________________________________________________________________
AlphaCor; AlphaCor-P; AlphaCor-A Device Name:
Indications For Use:
Adult patients with corneal opacity not suitable for standard penetrating keratoplasty with donor tissues, or where donor tissue has been declined, or where adjunctive measures required to prevent graft rejection are medically contraindicated.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Forma+ 3-10-98)
Duane R. Vachner
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K013756