(77 days)
Not Found
No
The 510(k) summary describes a contact lens and its material properties, intended uses, and manufacturing/testing processes. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for therapeutic use" for the management of irregular and distorted corneal surfaces and for eyes with ocular surface disease.
No
Explanation: The device is a contact lens indicated for therapeutic use, not for diagnosing medical conditions. It helps manage existing conditions or correct vision rather than identifying them.
No
The device description clearly states it is a physical contact lens made from a specific material (tisilfocon A) and is lathe cut. This indicates a hardware medical device, not software.
Based on the provided text, 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 New Vision SC and New Vision SC Daily Wear Ortho-K lenses are contact lenses designed to be worn on the eye. Their function is to physically correct vision, reshape the cornea, or provide therapeutic benefits to the ocular surface. They do not analyze biological samples to diagnose or monitor a medical condition.
- Intended Use: The intended uses described are for vision correction (myopia reduction), management of irregular/distorted corneal surfaces, and therapeutic use for ocular surface diseases. These are all related to the physical interaction of the lens with the eye, not the analysis of biological samples.
Therefore, this device falls under the category of a medical device, specifically a contact lens, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmam's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy. ectodermal dysplasia), neurotrophic keratiis (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 a distorted cornea or ocular surface disease, the New Vision SC (tisilfocon A) Scleral Lens may concurrently provide correction of up refractive error.
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.
Product codes (comma separated list FDA assigned to the subject device)
HQD, MUW
Device Description
The NewVision SC (tisilfocon A) Scleral Lens is a large diameter rigid gas permeable lens designed to vault over the cornea and rest on the conjunctiva overlying the sclera. The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens partly rests on the cornea, centrally or peripherally, and partly on the limbus or conjunctiva over the sclera. The NewVision SC and New Vision SC Daily Wear Ortho-K (tisilfocon A) Lenses are lathe cut from tisilfocon A, which is an FDA Group #3 fluoro-silicone acrylate material. The physical properties of the New Vision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses are as follows:
Refractive Index: 1.4378
Light Transmission (tinted): >91%
Water Content: 98% UVB >85% UVA
The NewVision SC (tisilfocon A) Scleral Lens is available in the following parameters:
Parameter | Range | Tolerance
Base Curve | 5.5mm to 25.00mm | ± 0.2mm
Center Thickness | 0.10mm to 3.00mm | ± 0.1mm
Diameter | 12.00mm to 26.00mm | ± 0.20mm
Spherical Power | -35.00 D to +35.00 D (in .12D steps) | ± 0.12 (0 to = 5D) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D)
Cylindrical Power | +10.00 D to -10.00 D (in .12 D steps) | ± 0.25 (0 to = 2D) ± 0.37 (2 to = 4D) ± 0.50 (over 4D)
Cylindrical Axis | 1º to 180º (in 1º steps) | ± 5°
Bifocal Add | +.12 D to +6.00 D (in .12 D steps) | ± 0.25D
The NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens for daily wear orthokeratology is available in following lens parameters:
Parameter | Range | Tolerance
Base Curve (BC) | 4.0mm to 12.00mm | ± 0.05 mm
Center Thickness | 0.10mm to 0.70mm | ± 0.02 mm
Diameter | 6.50mm to 13.50mm | ± 0.10mm
Secondary Curves | 0.10mm to 2.00mm (flatter or steeper than BC) | ± 0.10mm
Peripheral Curves | 0.10mm to 2.00mm (flatter or steeper than BC) | ± 0.10mm
Spherical Power | -10.00 D to +4.00 D (in 0.25D steps) | ± 0.12 (0 to = 5D) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D)
The New Vision SC and New Vision SC Daily Wear Ortho-K (tisilfocon A) Lenses are shipped "dry" in the Bausch + Lomb Boston® Scleral Lens Case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
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 tisilfocon A has been addressed by reference to previous 510(k) clearances.
Additionally, the following testing was performed on finished NewVision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Acculens, 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 Acculens, Inc. demonstrated that the colony forming units (CFU) per lens was 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 tisilfocon A with the labeled indications for use has been addressed through previous 510(k) clearances.
~ Conclusions Drawn from Testing ~
Results from testing and other information presented in this premarket notification supports the substantial equivalence claim by demonstrating no relevant differences regarding the safety and effectiveness of the NewVision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses compared to the predicate devices.
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.
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
§ 886.5916 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
June 16, 2023
Acculens, Inc. % Bret Andre Principal Consultant Eyereg Consulting Inc. 6119 Canter Lane West Linn, OR 97068
Re: K230910
Trade/Device Name: NewVision SC (tisilfocon A) Scleral Lens: NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD, MUW Dated: March 31, 2023 Received: March 31, 2023
Dear Bret 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230910
Device Name
NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
Indications for Use (Describe)
The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmam's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy).
The New Vision SC (tisilfocon A) Scleral Lens is indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy. ectodermal dysplasia), neurotrophic keratiis (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 a distorted cornea or ocular surface disease, the New Vision SC (tisilfocon A) Scleral Lens may concurrently provide correction of up refractive error.
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510 (k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K230910 |
|---|---|
| I. | |
| SUBMITTER | |
| Date Prepared: | June 6, 2023 |
| Name: | |
| Address | Acculens, Inc. |
| 5353 West Colfax Avenue | |
| Lakewood, Colorado 80214 | |
| United States | |
| Contact Person: | |
| Phone number: | Troy Miller |
| VP of Operations and Product Development | |
| (303) 232-6244 | |
| Consultant/ | |
| Correspondent: | |
| Phone number | EyeReg Consulting, Inc. |
| Bret Andre | |
| 6119 Canter Lane | |
| West Linn, OR 97068 | |
| (503) 372-5226 | |
| II. | |
| DEVICE | |
| Trade Name: | NewVision SC (tisilfocon A) Scleral Lens; |
| NewVision SC Daily Wear Ortho-K (tisilfocon A) | |
| Corneo-Scleral Lens | |
| Common | |
| Name: | Daily wear rigid gas permeable contact lens |
| Classification | |
| Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory | |
| Class: | Class II |
| Product Code: | HQD; MUW |
5
III. PREDICATE DEVICE
The NewVision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses are substantially equivalent to the following predicate device:
- . "Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses" Manufactured by Contamac Ltd. 510(k) number; K212631
IV. DEVICE DESCRIPTION
The NewVision SC (tisilfocon A) Scleral Lens is a large diameter rigid gas permeable lens designed to vault over the cornea and rest on the conjunctiva overlying the sclera. The New Vision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens partly rests on the cornea, centrally or peripherally, and partly on the limbus or conjunctiva over the sclera. The NewVision SC and New Vision SC Daily Wear Ortho-K (tisilfocon A) Lenses are lathe cut from tisilfocon A, which is an FDA Group #3 fluoro-silicone acrylate material. The physical properties of the New Vision SC and NewVision SC Daily Wear Ortho-K (tisilfocon A) Lenses are as follows:
| TISILFOCON A | |
|---|---|
| Refractive Index | 1.4378 |
| Light Transmission (tinted) | >91% |
| Water Content | 98% UVB |
85% UVA |
The NewVision SC (tisilfocon A) Scleral Lens is available in the following parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 5.5mm to 25.00mm | ± 0.2mm |
| Center Thickness | 0.10mm to 3.00mm | ± 0.1mm |
| Diameter | 12.00mm to 26.00mm | ± 0.20mm |
| Spherical Power | -35.00 D to +35.00 D | |
| (in .12D steps) | ± 0.12 (0 to = 5D) |