(72 days)
No
The summary describes a physical contact lens with specific material properties and designs. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for correcting refractive errors, not treating a disease or condition. While it can address issues arising from keratoconus or corneal surgery/trauma, its primary function is vision correction.
No
The device is a contact lens designed for vision correction, not for identifying or diagnosing a medical condition. Its function is to focus light rays onto the retina to correct refractive errors, not to detect disease.
No
The device is a physical contact lens, which is a hardware medical device, not software. The description details the materials, dimensions, and physical properties of the lens.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that these contact lenses are placed on the human cornea and act as a refracting medium to focus light rays onto the retina. Their purpose is to correct refractive errors and irregular corneas, directly interacting with the eye to improve vision.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
The device is a medical device, specifically a contact lens, used for vision correction.
N/A
Intended Use / Indications for Use
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
Product codes
HQD
Device Description
The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:
- in the power range of -20.00 to +20.00 diopters for sphere,
- with center thickness from 0.16 mm to 0.39 mm
- with base curves of 5.5 mm to 9.00 mm
- with diameter of 14.50mm
When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material.
The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes / Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
The lens materials are comprised of the same silicone Gas Permeable optic, and a soft silicone hydrogel skirt that surrounds the optic as was described in K083921. Biocompatibility testing (including Cytotoxicity, Ocular Irritation, Systemic Toxicity, and 21 Day Ocular Safety in Rabbits) as well as chemical, mechanical and optical characteristics, clinical performance and safety of the silicone hydrogel materials for use in daily wear contact lenses were addressed in K083921 per the FDA Contact Lens Daily Wear Guidance Document, May 1994.
Clinical Studies:
The safety and effectiveness of the design of the new lenses is the same as the design for lenses cleared under K056275 and K060102. Daily wear contact lenses for keratoconus with the Synergeyes reverse geometry design were shown to be safe and effective in clinical studies submitted in K052675 and daily wear contact lenses for post surgical refractive error and trauma were shown to be safe and effective in clinical studies submitted in K060102; both conducted per the FDA Contact Lens Daily Wear Guidance Document, May 1994.
The materials, processing, lens specifications, packaging and sterilization for the UltraHealth™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are identical to those described in K083921, which includes data to support that the materials and processing methods are biocompatible, safe and effective for use in daily wear contact lenses.
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/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" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
Synergeyes, Inc. Steven L. Ziemba, M.Sc. V.P., Quality Assurance & Regulatory Affairs 2232 Rutherford Road Carlsbad, CA 92008
Re: K142510
Trade/Device Name: UltraHealth™ SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for Keratoconus UltraHealth™ Flat Cornea SiH (petrafocon A Hem-larafilcon A) Hybrid Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lenses Regulatory Class: Class II Product Code: HQD Dated: September 18, 20014 Received: September 22, 2014
Dear Mr. Ziemba:
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.
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
1
Page 2 - Steven L. Ziemba, M.Sc.
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); 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142510
Device Name
Device Names: UltraHealth SiH (petrafocon A hem-larafilcon A) Hybrid Contact lens for Keratoconus UltraHealth Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses
Indications for Use (Describe)
UltraHealth™ (petrafocon A hem-larafilcon A) Hybrid Contact Lenses for keratoconus are indicated for the correction of hyperopic, myopic and astigmatic refractive error including presbyopia that manifest irregular corneas or irregular astigmatism, in aphakic and not aphakic, and otherwise non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) Hybrid Contact Lenses are for use in the correction of eyes with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism and irregular astigmatism in aphakic, nondiseased eyes, with or without presbyopia. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with irregular astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using a chemical disinfecting system compatible with both silicone-hydrogel and rigid gas permeable lenses.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY K142510
Date Prepared
04 November 2014
Submitter: Company Name: Address: Telephone: Fax:
Synergeyes, Inc. 5927 Priestly Avenue, Suite 210, Carlsbad, CA 92008 (760) 476-9410 (760) 431-0828
Official Correspondent:
| Name: | Steven L. Ziémba, M. Sc. |
|---|---|
| Title: | V.P., Quality Assurance, Clinical & Regulatory Affairs, Synergeyes, Inc. |
| Address: | 2232 Rutherford Road, Carlsbad, CA 92008 |
| E-mail: | sziemba@synergeyes.com |
| Telephone: | (760) 444-9687 |
| Fax: | (877) 819-9279 |
Establishment Registration Number: 3005087645
Device Name: Trade & USAN Names: TM UltraHealth SiH Hybrid Contact Lenses for Keratoconus TM UltraHealth Flat Cornea SiH Hybrid Contact Lenses
Contact Lens Common Name: Classification Panel: Ophthalmic Device Classification: Daily Wear Soft (hydrophilic)/RGP (hydrophobic) Combination Contact lens, Class II (21 CFR 886.5916) Device Product Code: 86 HQD
Indications for Use:
The UltraHealth™ Hybrid Contact lens for Keratoconus for daily wear are indicated for use in the correction of hyperopic, myopic and astigmatic refractive error including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and +4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
The UltraHealth™ Flat Cornea Hybrid Contact Lenses for daily wear are indicated for use in the correction of eves with refractive errors resulting from corneal surgery or trauma including hyperopia and myopia, astigmatism, and irregular astigmatism, including presbyopia, in aphakic and not aphakic, non-diseased eyes. The lenses are indicated for daily wear for the correction of up to +20.00 and -20.00 D in eyes with astigmatism up to 6.00 D. For presbyopia, add powers between +1.00 and
4
+4.00 D. The lenses may be disinfected using only a chemical disinfecting system compatible with both hydrogel and rigid gas permeable lenses.
Device Description
The UltraHealth™ SiH Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea SiH Hybrid Contact Lenses are contact lenses that combine a gas permeable optic surrounded by a soft hydrophilic skirt that straddles the limbus of the eye:
- in the power range of -20.00 to +20.00 diopters for sphere, ●
- with center thickness from 0.16 mm to 0.39 mm
- with base curves of 5.5 mm to 9.00 mm
- with diameter of 14.50mm ●
When placed on the human cornea, the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealth™ Flat Cornea act as a refracting medium to focus light rays onto the retina. The devices are available as lathe cut contact lenses in the following designs: spherical, toric, multifocal, and aspheric surfaces in blue visibility tinted material.
The optics of the UltraHealth™ Hybrid Contact lens for Keratoconus and the UltraHealthI™ Flat Cornea lenses are a gas permeable polymer material (petrafocon A). The soft skirt is comprised of silicone hydrogel (hem-larafilcon A) with a 32% water content. The junction between the rigid material and soft material is bound by a proprietary method.
Substantial Equivalence
For design: The hybrid (RGP Center and soft skirt) reverse geometry designs were cleared for the predicate SynergEyes™ (paflufocon D-hem iberfilcon A) Hybrid Contact Lenses in K056275 and K060102. The new lenses, the UltraHealth™ SiH (petrafocon A hem-larafilcon A) hybrid contact lenses for keratoconus, and the UltraHealth™ Flat Cornea SiH (petrafocon A hem-larafilcon A) hybrid contact lenses have the same substantially equivalent reverse geometry lens designs as the predicate lenses.
For material: The lens materials are comprised of a silicone Rigid Gas Permeable (RGP) center optic, and a soft silicone hydrogel skirt that surrounds the center optic zone which match the materials cleared under K083921. Biocompatibility, optical performance and safety of the materials for use in daily wear contact lenses were addressed in that submission.
For Optics:
The aspheric anterior optic surface matches that of the lenses cleared under K083921 and K051035.
5
Characteristics:
UltraHealth™ SiH Hybrid Contact Lenses for Keratoconus
| NEW LENS | PREDICATE LENS | REFERENCE LENS | |
|---|---|---|---|
| Lens Characteristics | UltraHealth™ SiH Hybrid | ||
| Contact Lenses | |||
| for Keratoconus | Synergeyes KC (paflufocon D | ||
| hem-iberfilcon A) Hybrid Contact | |||
| Lens for Keratoconus (K052675) | Synergeyes SiH (petrafocon | ||
| A hem-larafilcon A) Hybrid | |||
| Contact Lens (K083921) | |||
| Manufacturer | Synergeyes, Inc. | Synergeyes, Inc. | Synergeyes, Inc. |
| Material | RGP Center: petrafocon A | ||
| Soft Skirt: hem-larafilcon A | RGP Center: paflufocon D | ||
| Soft Skirt: hem-iberfilcon A | RGP Center: petrafocon A | ||
| Soft Skirt: hem-larafilcon A | |||
| UV Blocking | Yes | No | Yes |
| Base Curves (varies | |||
| with vault) | 5.5 mm to 9.0 mm | 5.5 to 7.0 mm | 7.1 to 9.0 mm |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm | 6.0 mm to 6.5 mm |
| Design | Reverse geometry with | ||
| anterior aspheric surface | Reverse geometry with anterior | ||
| aspheric surface | Standard geometry with | ||
| anterior aspheric surface | |||
| RGP Center | 8.40mm | 8.40mm | 8.40 mm |
| Diameters: | 14.5mm | 14.5mm | 14.5 mm |
| Power Range | -20.00 to +20.00 | -20.00 to +20.00 | -20.00 to +20.00 |
| Add Powers (for | |||
| multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D | +1.00 D to +4.00 D |
| Refractive Index | |||
| (RGP) | RGP Center: | ||
| 1.442 | |||
| S/H Skirt: | |||
| 1.435 | RGP Center: | ||
| 1.442 | |||
| S/H Skirt: | |||
| 1.448 | RGP Center: | ||
| 1.442 | |||
| S/H Skirt: | |||
| 1.435 | |||
| Specific Gravity | |||
| (RGP) | 1.15 | 1.10 | 1.15 |
| Hardness (Shore D) | RGP: 76 | RGP: 79 | RGP: 76 |
| Modulus (kgf/cm²) | |||
| RGP Center | 14515.1 ±324 | 11137.9 ± 367 | 14515.1 ±324 |
| Tint | Visibility violet (D&C 2) | Visibility green (D&C Green #6) | Visibility violet (D&C 2) |
| Water Content | |||
| (Soft Skirt) |