(203 days)
Not Found
No
The summary describes rigid gas permeable contact lenses and their physical properties and intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
Explanation: The device is indicated for the correction of visual acuity (nearsightedness, farsightedness, astigmatism, presbyopia) and not for treating a disease or disorder.
No
This device is a contact lens intended for the correction of visual acuity, not for diagnosing eye conditions. Its stated purpose is to correct existing vision problems like myopia, hyperopia, and astigmatism.
No
The device description clearly outlines physical characteristics and dimensions of rigid gas permeable contact lenses, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to correct visual acuity in the eye. This is a direct interaction with the patient's body for a therapeutic purpose (correcting vision), not for diagnosing a condition by examining samples outside the body.
- Device Description: The description details the physical properties and parameters of a contact lens, which is a medical device placed on the eye.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This contact lens does not fit that description.
N/A
Intended Use / 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.
Product codes
HQD
Device Description
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.
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
eye care practitioner
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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 |
| 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 | 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 |