(50 days)
No
The summary describes a physical contact lens and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for the management of multiple ocular conditions and ocular surface diseases, and explicitly states it can be prescribed for "therapeutic use".
No
Explanation: The provided text describes the Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses as a medical device for managing and correcting various ocular conditions and refractive errors. It is a therapy or correction device, not one that performs diagnostic measurements or analyses to identify a condition.
No
The device description clearly states it is a physical contact lens made from specific materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Custom Stable Rigid Gas Permeable Scleral Contact Lens is a medical device that is placed on the eye for therapeutic and refractive purposes. It does not analyze biological specimens.
- Intended Use: The intended use clearly describes the management of ocular conditions and correction of refractive error, which are direct treatments and corrections applied to the body, not diagnostic tests performed on samples.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Custom Stable (TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
HOD
Device Description
The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
The Custom Stable"" Rigid Gas Permeable Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is the Bonasse Flat Bed Soaking Case, Model SC 106-with 510(k) clearance under K991206. When shipped "wet", The Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is packaged and shipped in the Menicon Unique pH multipurpose solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A.B.C.D&E) Daily Wear Contact Lens (the predicate device).
Additionally, the following testing was performed on the finished Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Valley Contac, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Valley Contax, Inc. demonstrated that the colony forming units (CFU) per lens was less than 1, which is within the established acceptance criteria of less than 100 CFU per lens.
Clinical Studies
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A,B,C,D&E) Daily Wear Contact Lens (the predicate device).
Additionally, a series of clinical case reports demonstrate the performance of the Custom Stable" Rigid Gas Permeable Scleral Contact Lens when prescribed for the proposed indications for use.
Conclusions Drawn from Testing
Testing presented in this submission for the Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2017
Valley Contax, Inc. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn. OR 97068
Re: K170335
Trade/Device Name: Custom Stable TM Rigid Gas Permeable Scleral Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 30, 2017 Received: February 2, 2017
Dear Mr. Andre:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose and Throat Devices Office of Device Evaluation Center of Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170335
Device Name
Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses
Indications for Use (Describe)
The Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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:
Applicant information:
| Date Prepared: | January 30th, 2017 |
|---|---|
| Name: | Valley Contax, Inc. |
| Address | 200 South Mill St. Springfield, Oregon 97477 |
| Contact Person: | Josh Adams |
| Vice President | |
| Phone number: | (541) 744-9393 |
| Consultant/Correspondent: | EyeReg Consulting, Inc. Bret Andre |
| Phone number | (503) 372-5226 |
| Fax number | (503) 419-4475 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | Custom StableTM Rigid Gas Permeable |
| Scleral Contact Lens |
5
Predicate Devices:
The Custom Stable "1" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the following predicate device(s)
- "BostonSight PD Prosthetic Device" . - Primary Predicate Manufactured by Boston Foundation for Sight 510(k) number; K161461
- "Optimum GP (roflufocon A,B,C.D&E) Daily Wear Contact Lens" . - Reference Predicate Manufactured by Contamac Ltd. 510(k) number; K033594
Device Description:
The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials:
- · roflufocon D (supplied by Contamac Ltd.)
- · roflufocon E (supplied by Contamac Ltd.)
The physical properties of the Custom Stable" Rigid Gas Permeable Scleral Contact Lens are as follows:
| ROFLUFOCON D | ROFLUFOCON E | |
|---|---|---|
| Refractive Index | 1.4333 | 1.4332 |
| Light Transmission (clear) | >97% | >97% |
| Light Transmission (tinted) | >90% | >90% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA |
6
The parameters for the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens are as follows:
- Chord Diameter: ન્ન્સ
- Center Thickness: 米
- 米 Base Curve:
- 米 Spherical Powers:
14.8 mm to 17.8 mm 0.20 mm to 0.40 mm 6.6 mm to 11.0 mm -30.00 Diopters to +30.00 Diopters (0.125 Diopter steps)
The Custom Stable"" Rigid Gas Permeable Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is the Bonasse Flat Bed Soaking Case, Model SC 106-with 510(k) clearance under K991206. When shipped "wet", The Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is packaged and shipped in the Menicon Unique pH multipurpose solution.
Indication for Use:
The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Description of Testing:
- ~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A.B.C.D&E) Daily Wear Contact Lens (the predicate device).
Additionally, the following testing was performed on the finished Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Valley Contac, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
7
Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Valley Contax, Inc. demonstrated that the colony forming units (CFU) per lens was less than 1, which is within the established acceptance criteria of less than 100 CFU per lens.
- ~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A,B,C,D&E) Daily Wear Contact Lens (the predicate device).
Additionally, a series of clinical case reports demonstrate the performance of the Custom Stable" Rigid Gas Permeable Scleral Contact Lens when prescribed for the proposed indications for use.
~ Conclusions Drawn from Testing ~
Testing presented in this submission for the Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.
Substantial Equivalence:
The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness.
The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas:
- Components/Materials/Formulation (roflufocon D & E contact lens materials) ●
- FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate)
- Lathe cut manufacturing process
- Large diameter (scleral) design
- Actions and intended use
- . Therapeutic indications for use
8
The following table depicts the characteristics of the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens, as well as the predicate device(s).
| | Custom Stable™ Rigid Gas
Permeable Scleral Contact Lens | BostonSight PD Prosthetic
Device
K161461 | Optimum GP (roflufocon
A,B,C,D&E) Daily Wear
Contact Lens
K033594 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device |
| Indication for Use | Indicated for use for the management of
multiple ocular conditions, such as,
degenerations that lead to an irregular corneal
shape (e.g. keratoconus, keratoglobus,
pellucid marginal degeneration, Salzmann's
Nodular Degeneration), dystrophies (e.g.
Cogan's dystrophy, granular corneal
dystrophy, Lattice Corneal Dystrophy), post-
surgery (e.g. corneal transplant, LASIK,
radial keratotomy), and corneal scarring. The
lens may also be prescribed for the
management of ocular surface diseases (e.g.
dry eye syndrome, Keratoconjunctivitis Sicca
(Graft vs Host Disease, Sjogren's syndrome,
Filamentary Keratitis), limbal stem cell
deficiency, epidermal ocular disorders,
neurotrophic keratitis, and corneal
exposure/lagophthalmos). When prescribed
for therapeutic use, the Custom Stable RGP
Scleral Lenses is also indicated for correction
of refractive error in persons with myopia,
hyperopia or presbyopia. | Indicated for therapeutic use in eyes
with ocular surface disease from dry
eye (e.g. ocular Graft-versus-Host
disease, Sjögren's syndrome, dry eye
syndrome), limbal stem cell deficiency
(e.g.Stevens-Johnson syndrome,
chemical and thermal burns, radiation),
disorders of the skin (e.g. atopy,
ectodermal dysplasia), neurotrophic
keratitis (e.g. Herpes simplex, Herpes
zoster, Familial Dysautonomia), and
corneal exposure (e.g. anatomic,
paralytic) that might benefit from the
presence of an expanded tear reservoir
and protection against an adverse
environment. When prescribed for
therapeutic use for distorted cornea or
ocular surface disease, the BostonSight
PD Prosthetic Device may incidentally
provide correction of refractive error. | May be prescribed
in otherwise non-diseased
eyes that require
a rigid gas permeable lens for
the management
of irregular corneal conditions
such as; keratoconus, pellucid
marginal degeneration
of following penetrating
keratoplasty or following
refractive (e.g. LASIK)
surgery. |
| Device and
Classification | Class II
Lenses, Rigid Gas Permeable, Daily
Wear
HQD | Class II
Lenses, Rigid Gas Permeable,
Daily Wear
HQD | Class II
Lenses, Rigid Gas Permeable.
Daily Wear
HQD |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut |
| USAN | Roflufocon D
Roflufocon E | Roflufocon D
Roflufocon E
Oprifocon A
Hexafocon B | Roflufocon A
Roflufocon B
Roflufocon C
Roflufocon D
Roflufocon E |
| FDA Group # | Group # 3 Fluoro Silicone Acrylate | Group # 3 Fluoro Silicone
Acrylate | Group # 3 Fluoro Silicone
Acrylate |
| Water Content |