PVS BASIC 2; EPIC 2

{0}------------------------------------------------ # APR 2 5 2002 ## APPENDIX H # K013310 ## 510(k) Summary ## Submitter | Company Name: | | |---------------|--| | Address: | | | Phone: | | | Fax: | | | Registration: | | Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226 Owner Operator # 9024618 ## Manufacturer Information | Company Name: | Paragon Vision Sciences | |---------------|--------------------------------------| | Address: | 945 East Impala Ave., Mesa, AZ 85204 | | Phone: | 480-892-7602 | | Fax: | 480-892-3226 | | Registration: | Site Registration #2020433 | ## Official Correspondent | Name: | William E. Meyers, Ph.D. | |-------------------------------|-------------------------------------| | Address: | % Paragon Vision Sciences | | Address: | 945 East Impala Ave., Mesa AZ 85204 | | Phone: | 480-507-7606 | | Fax: | 480-892-3226 | | Reason for 510(k) Submission: | Material change | 10/02/01 Reason for 510(k) Submission: #### Date of Submission: Device Identification: | Trade Name: | PVS Basic™ 2 and Epic® 2 | |----------------------|------------------------------------------------------------------------------------------| | Common Name: | Contact lens | | Classification Name: | Rigid gas permeable contact lens for daily wear | | Reference: | 21 CFR 886.5916; rigid gas permeable contact lens, Class II - daily<br>wear contact lens | #### Indications For Use: The PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic™ 2 (migafooon A) and Epice 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D. {1}------------------------------------------------ The lenses have the following dimensions and characteristics. | Characteristics | PVS Basic™ 2 and Epic® 2 | |------------------------------------|--------------------------| | Material | migafocon A | | Indication | Daily Wear | | Water Content | < 1% | | Oxygen Permeability* | 74 x 10-11 Dk at 35° C. | | Oxygen Permeability** | 52 x 10-11 Dk at 35° C | | Luminous Transmittance (blue) *** | 87% | | Wetting Angle (receding angle)**** | 16 | | Hardness (Shore D) | 82.6 | | Refractive Index***** | 1.454 (nD at 25° C) | | Specific Gravity | 1.10 | | Color | Blue | * (cm2/sec) / (mL x mm Hg) Revised Method of I. Fatt ** (cm2/sec) / (mL x mm Hg) ISO/ANSI Method, ISO 9913-1 *** ANSI Z80.20 - 1998 and ISO 8699: 1994 **** After soaking in conditioning solution **** ISO 9914: 1995 #### Lens Parameters | Chord Diameter | 7.0 to 10.5 mm | |----------------------------------|---------------------------| | Center Thickness | 0.05 to 0.70 mm | | Base Curve | 6.50 to 9.00 mm | | Power | -20.00 to +12.00 Diopters | | Bifocal Add Power | + 0.25 to +4.00 Diopters | | Concentric Bifocal Add Diameter | 2.0 to 4.0 mm | | Monocentric Bifocal Add Diameter | 4.0 to 9.0 mm | | Monocentric Bifocal Prism | 0 to 2.5 Diopters | The PVS Basic" 2 (migafocon A) and Epic® 2 (migatocon A) rigid gas permeable contact lenses are available in blue. The blue tinted lenses contain D&C Green # 6. Under the conditions of the cytotoxicity study using the ISO Agarose Overlay Method, the test article showed no evidence of causing cell lysis or toxicity. The test article met the USP since the grade was less than a grade 2 (mild reactivity). The negative control and the positive control performed as anticipated. Under the conditions of the ISO acute systemic toxicity study in the mouse, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements. Under the conditions of the ISO ocular irritation study in the rabbit, the SC and CSO test article extracts would not be considered irritants to the ocular tissue of the rabbit. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) Dk 74 contact lenses are substantially equivalent to the PVS Basics™Dk 67 rigid gas permeable contact lens marketed by Paragon Vision Sciences which is presently approved for daily wear 510(k), K984436. The physical, optical and chemical properties of PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) contact lenses are substantially equivalent to PVS Basics™ (paflufocon E) contact lenses. See table of next page. {2}------------------------------------------------ # Similarities and Differences # Physical Characteristics | Parameters | PVS Basic™ 2 & Epic® 2 | PVS Basics™ | |---------------------------------------------------------------------------------------------------------------|------------------------|--------------| | Material | migafocon A | paflufocon E | | Indication | Daily Wear | Daily Wear | | Water Content/Absorption1 | < 1% | < 1% | | Oxygen Permeability, Revised Fatt Method 2 | 74 x 10-11 | 67 x 10-11 | | Oxygen Permeability, ISO/ANSI Method 3 | 52 x 10-11 | 35 x 10-11 | | Luminous Transmittance @ +12 D, 7mm<br>OZ, 7.8 BC, .45mm CT, harmonic mean<br>thickness over 7mm = 0.329 mm 4 | 87% | 87% | | Wetting Angle (receding angle)5 | 16 | 16 | | Hardness (Shore D) | 82.6 | 81.7 | | Refractive Index, nD @ 25°C 6 | 1.454 | 1.454 | | Specific Gravity | 1.10 | 1.10 | | Modulus (kgf/cm²) 7 | 16334 | 14962 | | Flexural Strength<br>Stress @ Break (kgf/cm²) 7 | 460 | 436 | | Flexural Strain 7 | 3.6% | 3.6% | | Toughness (gf - mm) 7 | 366 | 354 | | Color | Blue | Blue | | UV Absorber | None | None | 1 ANSI Z80.20 - 1998, Method 8.22 2 (cm²/sec) (mL x mm Hg) Revised Method of I. Fatt, [Dk (at 35°C)] : , , 3 (cm2/sec) {mL x mm Hg) ISO/ANSI Method, ISO 9913-1, [Dk (at 35°C)] 4 ANSI Z80.20 - 1998 and ISO 8599: 1994 § After soaking in conditioning solution 6 ISO 9914:1995 ' ANSI Z80.20 — 1998; ASTM D790M - 92 {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # APR 2 5 2002 Paragon Vision Sciences c/o William E. Meyers, Ph.D. 947 East Impala Mesa, AZ 85204 Re: K013310 Trade/Device Name: PVS Basic™ 2 and Epic® 2 Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: October 2, 2001 Received: October 4, 2001 Dear Mr. Meyers: 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 - William E. Meyers, Ph.D. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph 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 {5}------------------------------------------------ # Indications Statement 510(k) Number (if known): K013310 Device Name: PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) Contact Lenses Indications For Use: The PVS Basic™2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS Basic™ 2 (migafocon A) and Epic® 2 (migafocon A) rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes who are nearsighted (myopic); farsighted (hyperopic); and, who may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. PVS Basic" 2 (migafocon A) and Epic® 2 (migafocon A) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic" 2 (migafocon A) and Epic 2 (migafocon A) bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted), including astigmatic corrections up to + 4.00 D requiring add power of up to + 4.00 D. > PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | x | OR Over-The Counter Use | | |------------------|---|-------------------------|--| |------------------|---|-------------------------|--| *Daniel W. Brown Ph.D.* | (Division Sign-Off) | | |-----------------------------|---------| | Division of Ophthalmic Ear, | | | Nose and Throat Devises | | | 510(k) Number | K013310 |