(128 days)
FluoroPerin 92 Dk 92 Rigid Gas Permeable Contact Lens marketed by Paragon Vision Sciences (PMA P820063)
Not Found
No
The summary describes rigid gas permeable contact lenses and their material properties and clinical performance compared to a predicate device. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a contact lens indicated for the correction of visual acuity, which serves a corrective rather than a therapeutic purpose.
No
The device is a contact lens intended for correcting visual acuity, not for diagnosing medical conditions. Its use is limited to compensation for refractive errors in non-diseased eyes.
No
The device description clearly describes a physical contact lens made of a specific material with defined dimensions and characteristics. There is no mention of software as the primary component or function of the device.
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 PVS BASICS ™ contact lenses are described as rigid gas permeable contact lenses intended for the correction of visual acuity. They are worn on the surface of the eye.
- Intended Use: The intended use clearly states they are for correcting vision in individuals with various refractive errors (nearsightedness, farsightedness, astigmatism, presbyopia). This is a therapeutic and corrective function, not a diagnostic one performed on a sample.
- No Sample Analysis: The device description and performance studies do not mention any analysis of biological samples. The clinical evaluation focuses on the performance of the lens on the eye (visual acuity, comfort, lens-eye relationship, etc.).
Therefore, the PVS BASICS ™ contact lens is a medical device, but it falls under the category of devices used for correction and therapy, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric 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 or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D.
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are made from a material called Paflufocon E. They are indicated for daily wear, have a water content of grade 2, edema reports > grade 2, injection reports > grade 2, or neovasc. reports > grade 2 for both PVS Basics (68 eyes) and Paflufocon A (22 eyes).
- Two eyes were discontinued from the PVS Basics group, and none from the Paflufocon A group.
- Symptoms/Problems/Complaints for Completed Control Eyes (Paflufocon A) and Completed Trial Eyes (PVS Basics) were monitored across initial dispensing, intermediate, and final visits, showing various levels of discomfort, blurred vision, dryness, etc., but no significant safety issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Clinical parameters such as Visual Acuity, Comfort, Lens-Eye Relationship, Movement, Slit lamp Findings, Functional Wetting were evaluated for equivalence. Adverse events and symptoms were tracked.
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.
FluoroPerin 92 Dk 92 Rigid Gas Permeable Contact Lens marketed by Paragon Vision Sciences (PMA P820063).
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
4/21/99
K 9 8 4 4 3 6
APPENDIX H 510(k) Summary
Company Name: Paragon Vision Sciences Submitter. Address: 945 East Impala Ave. Phone: 602-892-7602 Fax: 602-892-3226 Registration: Owner Operator # 9024618
Manufacturer:
Company Name: Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: 602-892-7602 Fax: 602-892-3226: Registration. Site Registration #2020433
Official Correspondent: William E. Meyers, Ph.D. % Paragon Vision Sciences Address: 945 East Impala Ave. Mesa AZ 85204 Phone: 602-507-7606 Fax: 602-892-3226 Reason for 510(k) Submission: Material change
Date of submission 12/10/98
Device Identification:
Trade Name: PVS BASICS ™ 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 wear
Indications For Use:
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas perical, aspheric 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 or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) 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:
| Parameters | PVS BASICS TM |
|---|---|
| Material | Paflufocon E |
| Indication | Daily wear |
| Water content | GRADE 2 |
| EDEMA REPORTS >GRADE 2 | 0 |
| INJECTION REPORTS >GRADE 2 | 0 |
| NEOVASC. REPORTS >GRADE 2 | 0 |
| VISITS | 44 |
| MISSED VISITS | 0 |
4
SUMMARY OF SYMPTOMS PROBLEMS AND COMPLAINTS
Completed Control Eyes
| | Initial Dispensing
Visit | | Intermediate Visits | | | |
|------------------------|-----------------------------|---------|---------------------|---------|--------|---------|
| | 1 | | 2 | | | |
| Total Eyes at Visit | 22 | | 22 | | 22 | |
| | Number | Percent | Number | Percent | Number | Percent |
| None | 19 | 86.4 | 16 | 72.7 | 14 | 63.6 |
| Discomfort | 3 | 13.6 | 4 | 18.2 | 6 | 27.3 |
| Excess Tearing * | 0 | 0 | 0 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 0 | 0 | 0 | 0 |
| Halos | 0 | 0 | 0 | 0 | 0 | 0 |
| Itching/Burning | 0 | 0 | 1 | 4.5 | 4 | 18.2 |
| Spectacle Blur* | 0 | 0 | 0 | 0 | 0 | 0 |
| Variable Vision | 0 | 0 | 0 | 0 | 4 | 18.2 |
| Blurred Vision | 2 | 9.1 | 3 | 13.6 | 8 | 36.4 |
| Lens Needs Cleaning | 2 | 9.1 | 3 | 13.6 | 2 | 9.1 |
| Other | | | | | | |
| Dryness | 2 | 9.1 | 3 | 13.6 | 6 | 27.3 |
| Total Positive Reports | 9 | | 14 | | 24 | |
Completed Trial Eyes
| | Initial Dispensing
Visit | | Intermediate Visits | | | |
|------------------------|-----------------------------|---------|---------------------|---------|--------|---------|
| | | | 1 | | 2 | |
| Total Eyes at Visit | 70 | | 68 | | 68 | |
| | Number | Percent | Number | Percent | Number | Percent |
| None | 55 | 78.6 | 52 | 76.5 | 45 | 66.2 |
| Discomfort | 6 | 8.6 | 4 | 5.9 | 8 | 11.8 |
| Excess Tearing | 0 | 0 | 0 | 0 | 0 | 0 |
| Photophobia | 0 | 0 | 0 | 0 | 0 | 0 |
| Halos | 2 | 2.9 | 0 | 0 | 2 | 2.9 |
| Itching/Burning | 1 | 1.4 | 2 | 2.9 | 2 | 2.9 |
| Spectacle Blur | 0 | 0 | 0 | 0 | 0 | 0 |
| Variable Vision | 0 | 0 | 6 | 8.8 | 5 | 7.4 |
| Blurred Vision | 4 | 5.7 | 4 | 5.9 | 2 | 2.9 |
| Lens Needs Cleaning | 0 | 0 | 6 | 8.8 | 4 | 5.9 |
| Other | Dryness | | | | | |
| Dryness | 5 | 7.1 | 5 | 7.4 | 6 | 8.8 |
| Total Positive Reports | 18 | | 27 | | 29 | |
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 1993
William E. Meyers, Ph.D. Vice President, Science & Technology PARAGON VISION SCIENCES 947 East Impala Mesa, AZ 85204
Re: K984436 Trade Name: PVS BASICS ™ (paflufocon E) Rigid Gas Permeable Contact Lenses For Daily Wear (Spherical, Aspheric, Toric and Bifocal) Clear and Violet Tinted (with D&C Violet # 2 and D & C Red # 17) Regulatory Class: II Product Code: 86 HQD Dated: March 2, 1999 Received: March 3, 1999
Dear Dr. Meyers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect
6
Page 2 - William E. Meyers, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications Statement
510(k) Number (if known):
Device Name: PVS BASICS TM (paflufocon E)Contact Lens
Indications For Use:
The PVS BASICS "M (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) rigid gas permeable spherical, aspheric 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 or less that does not interfere with visual acuity. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ Bifocal lenses are indicated for presbyopic persons (far or near sighted) 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 OR
Over-The Counter Use
(Optional Format 1-2-96)
Erica
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K 984436