(27 days)
Not Found
Not Found
No
The 510(k) summary describes standard soft contact lenses and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML devices.
No
The device corrects visual acuity (it corrects refractive errors like myopia, hyperopia, and astigmatism). It is not used to treat a disease, but rather provide vision correction.
No
Explanation: The device is a soft contact lens intended for the correction of visual acuity (myopia, hyperopia, and refractive astigmatism), not for diagnosing a condition or disease.
No
The device description clearly states it is a soft contact lens, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in the eye. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The device is a soft contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a disease or condition based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and Toric Soft Contact Lenses For Daily Wear, are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, and/or possess refractive astigmatism not exceeding 10 Diopters. They are available for either conventional wear or planned replacement modalities.
Product codes
LPL
Device Description
Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A) Sphere and Toric Soft Contact Lenses for Daily Wear
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2004
Alden Optical Laboratories, Inc. c/o Charles H. Creighton, President 13295 Broadway Alden, NY 14004
Re: K042242
Trade/Device Name: Alden HP 55 (methafilcon A) and Alden HP59G (hioxifilcon A) Sphere & Toric Soft Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II
Product Code: LPL Dated: August 17, 2004 Received: August 19, 2004
Dear Mr. Creighton:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becarely be device 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 encroours) to regardy and the Medical Device Amendments, or to connieres that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have occh recise in a trequire approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The 1 ou may, merciolo, market the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to satil additions, 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 I least of advised that I Dris 1558aarse or our device complies with other requirements of the Act that I DA has made a acterimalations administered by other Federal agencies. You must of any I ederal statutes and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), acceming (21 CFR Part 820); and if applicable, the electronic forul in the quality by over in the end of the Act); 21 CFR 1000-1050.
1
Page 2 - Charles H. Creighton
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 Kalpi 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
Attachment E
Indications For Use Statement
| Device Name: | Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A)
Sphere and Toric Soft Contact Lenses for Daily Wear |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Alden HP 55 (methafilcon A) and Alden HP 59G (hioxifilcon A)
Sphere and Toric Soft Contact Lenses For Daily Wear, are indicated
for the correction of visual acuity in aphakic and not aphakic persons with
non-diseased eyes with myopia or hyperopia, and/or possess refractive
astigmatism not exceeding 10 Diopters. They are available for either
conventional wear or planned replacement modalities. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use x
(Per 21 CFR 801.109)
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Emanuel W. Branson, Ph.D.
Division of Ophthalmic Devices
510(k) Number K042242