(38 days)
Not Found
No
The device description explicitly states the lenses are "hand painted by skilled artists" and there is no mention of AI, ML, or any automated image processing or analysis.
No
The device is primarily indicated for cosmetic purposes (enhancing/altering eye color, ocular masking) and refractive error correction. While it mentions "occlusive therapy" for conditions like diplopia, amblyopia, or extreme photophobia, this function isn't its primary or sole intended use, and the device description emphasizes its hand-painted cosmetic features.
No
The device is a prosthetic contact lens used to enhance or alter eye color and to correct refractive errors or provide occlusive therapy, not to diagnose a condition.
No
The device description clearly identifies the device as a physical contact lens made of hioxifilcon A, which is a hardware component.
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 Function: The Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens is a medical device that is placed on the eye for cosmetic, refractive correction, or therapeutic purposes (like occlusion). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its function as a contact lens for masking, cosmetic enhancement, refractive correction, and occlusive therapy. None of these involve in vitro testing.
Therefore, this device falls under the category of a medical device, specifically a contact lens, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.
Product codes
LPL
Device Description
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be hand painted in a nonsighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially or totally opaquing the lens with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioners
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Prosthetic (hefilcon A) Soft Lens ~ K992950
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 3 0 2004
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K041700 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
| Date Prepared: | June 1, 2004 |
|---|---|
| Name: | Cantor & Nissel Limited |
| Address | Manor Road, Brackley |
| Northamptonshire | |
| England NN13 7DP | |
| Contact Person: | Mr. David Cantor |
| Managing Director/President | |
| Phone Number: | 011 44 1280 702002 |
| Fax: | 011 44 1280 703003 |
| USA Consultant: | Martin Dalsing, |
| Med-Vice Consulting, Inc. | |
| Consultant for Cantor & Nissel, Inc. | |
| 623 Glacier Drive | |
| Grand Junction, CO 81503 | |
| (970) 243-5490 | |
| Fax #: (970) 243-5501 | |
| E-mail: Marty@FDApproval.com |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) |
| Soft Contact Lens for Daily Wear |
Lens, Soft Contact, Daily Wear
Classification Name:
1
Substantially Equivalent Devices:
The "Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear" is substantially equivalent to the "Prosthetic (hefilcon A) Soft Lens ~ K992950".
Device Descriptive Characteristics:
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is a I hand painted lens with an iris pattern to mask a disfiguring or unsightly eye condition. The lens may be nand painted inns or a non-sighted eye or clear in the center for a sighted eye. Lens opacity is obtained by partially of enses with FDA "listed" color additives in amounts not to exceed the minimum reasonably required to accomplish the intended iris pattern. The colorants are permanent and are not leached from a lens. The lenses are painted by skilled artists to an eye care practitioners specifications.
INDICATIONS FOR USE:
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
The lens is disinfected using a hydrogen peroxide lens care system only.
2
The following table summarizes Cantor & Nissel Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.
| | Characteristic | CANTOR & NISSEL
Hand Painted PROSTHETIC | Prosthetic (hefilcon A) Soft
Contact Lens ~ K992950 |
|-----|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INTENDED USE | Cosmetic Management of
conditions such as corneal, iris,
or lens abnormalities. | Cosmetic Management of conditions
such as corneal, iris, or lens
abnormalities. |
| 2.) | INDICATIONS FOR
USE STATEMENT | The CANTOR & NISSEL Hand
Painted PROSTHETIC
(hioxifilcon A) Soft Contact Lens
are indicated for daily wear to
enhance or alter the apparent eye
color, including ocular masking,
either in sighted or non-sighted
eyes that require a prosthetic
contact lens for cosmetic
management of conditions such
as corneal, iris or lens
abnormalities. The lens may also
be prescribed for the correction of
refractive ametropia (myopia,
hyperopia and astigmatism) in
aphakic and not aphakic persons
or for occlusive therapy for
conditions such as diplopia,
amblyopia or extreme
photophobia. The lens is
disinfected using a hydrogen
peroxide lens care system only. | The Prosthetic (hefilcon A) Soft
Contact Lens is indicated for daily
wear to enhance or alter the apparent
eye color, including ocular masking,
either in sighted or non-sighted eyes
that require a prosthetic contact
lenses for cosmetic management of
conditions such as corneal, iris or
lens abnormalities. The lens may
also be prescribed for the correction
of refractive ametropia (myopia,
hyperopia and astigmatism) in
aphakic and not aphakic persons or
for occlusive therapy for conditions
such as diplopia, amblyopia or
extreme photophobia. The lens may
be disinfected with a chemical
disinfection system. |
| 3.) | OPACITY | One or more FDA listed color
additives | Partially or totally White |
| 4.) | COLOR ADDITIVE
CHARACTERISTICS | The color additives used are not
removed by lens handling and
approved cleaning/disinfecting
procedures. The optical and
performance characteristics are
not altered by the lens coloring
process. | The color additives used are not
removed by lens handling and
approved cleaning/disinfecting
procedures. The optical and
performance characteristics are not
altered by the lens coloring process. |
| 5.) | OPAQUING AGENT
USED | Use of FDA listed reactive dyes
in amounts to accomplish desired
hand painted iris patterns. | Titanium Dioxide |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the bird. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2004
Cantor & Nissel Ltd. c/o Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Dr. Grand Junction, CO 81503
Re: K041700
Trade/Device Name: Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 1, 2004 Received: June 23, 2004
Dear Mr. Dalsing:
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 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.
4
Page 2 - Martin Dalsing
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,
Aherl 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
5
INDICATIONS FOR USE STATEMENT
Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens Device Name: for Daily Wcar
INDICATIONS FOR USE:
The Cantor & Nissel Hand Painted Prosthetic (hioxifilcon A) Soft Contact Lens for Daily Wear is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in midred or non-sighted eyes that require a prosthetic contact lens for cosmetic management of conditions sighted or non bighted by or lens abnormalities. The lens may also be prescribed for the correction of refractive suon as contrally in or lease in and astigmatism) in aphakic and not aphakic persons or for occlusive ameropa (if your are as diplopia, amblyopia or extreme photophobia. The lens is disinfected using a hydrogen peroxide lens care system only.
(PLEASE DO OT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K041700 |
|---|---|
| --------------- | --------- |
or
| Prescription Use (Per 21 CFR 801.109) | x |
|---|---|
| Over-The-Counter Use |
(Optional Format 1-2-96)