(307 days)
Not Found
Not Found
No
The 510(k) summary describes a rigid gas permeable contact lens and its material composition and dimensions. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is indicated for the correction of visual acuity, which is a refractive purpose, not a therapeutic one. It does not treat or cure a disease but rather corrects a vision defect.
No
Explanation: The device is a contact lens indicated for the correction of visual acuity, which is a treatment, not a diagnostic purpose.
No
The device description clearly details a physical contact lens made of specific materials and dimensions, which is a hardware 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 for the correction of visual acuity in the eye. This is a direct interaction with the body for a therapeutic purpose (correcting vision), not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details a physical contact lens designed to be worn on the eye.
- Anatomical Site: The anatomical site is the eyes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device, specifically a contact lens, but it falls under the category of devices used for vision correction, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray, or blue-violet tinted varieties and blue tint with UV-blocker. Each is a shell of the following dimensions. Spherical Contact Lens: Horizontal Lens Size: 6.5 mm to 11.50mm Base Curve: 6.50mm to 9.50mm Distance Powers: +12.00D to -20.00D Center Thickness: for low minus 0.05mm to 0.30mm for plus 0.10mm to 0.70mm Aspheric Lens Eccentricity 0 to 1.5 Peripheral Curves 0.1 to 1.0mm Toric Lens Axis 1 to 180 degrees in 1 degree steps Cylinder power 0.50 to 4.00D Translating Bifocal Contact Lens: Horizontal Lens Size: 8.00mm to 10.50mm Base Curve: 6.50mm to 8.50mm Distance Power: +12.00D to -20.00D Add Power 1.00 to 4.00D. The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
The age range of the test population was from 15 to 58
Intended User / Care Setting
Not Found
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)
Clinical Studies: A clinical trial of 3 months usage of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical Contact Lenses by 37 subjects, wearing lenses on a daily wear schedule, showed that the product is substantially equivalent to other lenses available on the market.
Toxicology: The lens material was shown to be non-toxic in all tests, including Agar Overlay Cytotoxicity, Systemic toxicity, and Acute Ocular irritation.
Microbiology: The material has a water content less than 1%, and is therefore exempt from the microbiological requirements for hydrophobic contact lenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Light Transmittance for ONSI™-56 (onsifocon A):
clear: >95% T
blue: >70% T
green: >70% T
gray: >70% T
blue-violet: >70% T
blue UV: >70% T (400-780nm), 0% T (200-380nm)
Incidence of Slit Lamp Findings (initial vs. final):
NO FINDINGSª: Initial 90.5, Final 90.8
EDEMA®: Initial 0.0, Final 0.0
NEOVASCUL.: Initial 1.4, Final 0.0
STAINING: Initial 5.4, Final 3.2
HYPEREMIA: Initial 1.4, Final 0.0
PALPEBRAL ABNORM.: Initial 1.4, Final 0.0
OTHER: Initial 0.0, Final 0.0
Selected Symptoms, Problems and Complaints:
NONEa: 75.7%
LENS AWARENESSb: 5.7%
READING PROBLEMS: 5.5%
NEED FOR CLEANING: 5.2%
DRYNESS: 4.6%
Discontinuations: 1 subject (3%) was discontinued.
Visual Acuity: All eyes had a final visual acuity within 1 line of the initial best corrected acuity.
Wear Time: Remained essentially unchanged over the three months.
Lens Replacements: 10 lenses replaced during the study, 6 for visual acuity (5 of which within the first month).
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.
Not Found
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
SEP 16 2004
510(k) SUMMARY FOR FREEDOM OF INFORMATION
ONSI™-56 (onsifocon A) RIGID GAS PERMEABLE SPHERICAL, ASPHÈRIC, TORIC AND BIFOCAL CONTACT LENS FOR DAILY WEAR
| 1. Submitted by: | The Lagado Corporation
2890 South Tejon St
Englewood, CO 80110 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | John M. Szabocsik, Ph.D.
Official agent Szabocsik and Associates
203 N. Wabash, Ste 1200
Chicago, IL 60601
(312) 553-0828 |
| 2. Date prepared: | June 30, 2004 |
| 3. Device:
Common Name | ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,
Toric and Bifocal Contact Lens |
| Trade Name | ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,
Toric and Bifocal Contact Lens |
| 4. Classification | Class II (Performance Standards)
21 CFR 886.5916 (b) (1)
Rigid Gas Permeable Contact Lens for Daily Wear |
| 5. Substantial
Equivalence | This product is substantially equivalent to other currently marketed rigid lenses, such as Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses |
| 6. Device
Description | The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,
Toric and Bifocal Contact Lenses are available in spherical designs in the
clear untinted or blue, green, gray, or blue-violet tinted varieties and blue
tint with UV-blocker. Each is a shell of the following dimensions. |
| | Spherical Contact Lens:
Horizontal Lens Size: 6.5 mm to 11.50mm
Base Curve: 6.50mm to 9.50mm
Distance Powers: +12.00D to -20.00D
Center Thickness:
for low minus 0.05mm to 0.30mm
for plus 0.10mm to 0.70mm |
| | Aspheric Lens
Eccentricity 0 to 1.5
Peripheral Curves 0.1 to 1.0mm |
| | Toric Lens
Axis 1 to 180 degrees in 1 degree steps |
| | Cylinder power 0.50 to 4.00D |
FOI Summary, Pg 1
1
Translating Bifocal Contact Lens: | |||
---|---|---|---|
Horizontal Lens Size: | 8.00mm | to | 10.50mm |
Base Curve: | 6.50mm | to | 8.50mm |
Distance Power: | +12.00D | to | -20.00D |
Add Power | 1.00 | to | 4.00D |
The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propylmethacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone. The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet contain D&C Green No. 6 and D&C Violet No. 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
7. Intended use
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
- Comparison to predicate devices: see following table
SUBSTANTIAL EQUIVALENCE
Water Content | OXYCON (wilofocon A) | ONSITM-56 (onsifocon A) |
---|---|---|
95% T | ||
blue | ||
green | 93% | |
gray | 87% | |
blue-violet | ||
blue UV | ||
0% T (200-380nm) |
Introduction
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric, Toric and Bifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in notaphakic persons with non-diseased eyes that are myopic, or presbyopic and which may exhibit corneal astigmatism.
Contained in the submission are comparisons of the product to the predicate device, information on the chemistry and manufacturing, results of toxicological tests, and the report of a clinical trial of 37 subjects, who have used the product over a period of three months.
I. Chemistry and Manufacturing
The lens material, onsifocon A, is trifluoroethyl methacrylate polymer with tris (trimethylsiloxy)methacryloxypropylsilane 3-trimethoxysily|propy|methacrylate methacrylic acid 1,3-bis(3- methacryloxypropyl)tetrakis(trimethylsiloxy)disiloxane ethylene glycol dimethacrylate 2-hydroxyethyl methacrylate N-vinylpyrrolidone.
The blue tinted lenses contain D&C Green No. 6; the green lenses contain D&C Green No 6 and CI Solvent Yellow 18; the gray lenses contain D&C Green No 6, D&C Violet No. 2, and CI Solvent Yellow 18; the blue-violet lenses contain D&C Green No 6 and D&C Violet No 2; the blue-UV lenses contain D&C Green No 6 and a UV absorber, NORBLOC 7966. The colorants are used in quantities approved for use in contact lenses and proportions required to obtain the desired color.
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical. Aspheric, Toric and Bifocal Contact Lenses are available in spherical designs in the clear untinted or blue, green, gray or blue-violet tinted varieties and blue with UV-blocker. Each is a shell of the following dimensions.
Spherical Contact Lens: | |||
---|---|---|---|
Horizontal Lens Size: | 6.5 mm | to | 11.50mm |
Base Curve: | 6.50mm | to | 9.50mm |
Distance Powers: | +12.00D | to | -20.00D |
Center Thickness: | |||
for low minus | 0.05mm | to | 0.30mm |
for plus | 0.10mm | to | 0.70mm |
Aspheric Lens | |||
Eccentricity | 0 | to | 1.5 |
Peripheral Curves | 0.1 | to | 1.0mm |
3
ONSITM-56 (onsifocon A) Rigid Gas Permeable Contact Lenses. FOI
Toric Lens Axis 1 to 180 degrees in 1 degree steps Cylinder power 0.50 to 4.00D
Translating Bifocal Contact Lens: | |||
---|---|---|---|
Horizontal Lens Size: | 8.00mm | to | 10.50mm |
Base Curve: | 6.50mm | to | 8.50mm |
Distance Power: | +12.00D | to | -20.00D |
Add Power | 1.00 | to | 4.00D |
II. Toxicology
The toxicological testing is summarized below. The lens material was shown to be non-toxic in all tests.
A. Agar Overlay Cytotoxicity:
The ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material was tested in a direct contact cytotoxicity assay. The lenses were noncytotoxic.
B. Systemic toxicity:
Saline and cottonseed oil extracts of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material were evaluated for systemic toxicity by intraperitoneal (ip) or intravenous (iv) injection in healthy mice, 50ml/kg body weight. The animals were observed over a 72 hour period, and showed no difference from control animals. The lenses passed the test requirements, that there be no difference between the response of test and control animals.
C. Acute Ocular irritation:
Saline and cottonseed oil extracts of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens material were evaluated for ocular irritation by instillation into the inferior ocular cul-de-sac of rabbits. The eyes were examined over a 72 hour period and showed no irritation.
III. Microbiology
The material has a water content less than 1%, and is therefore exempt from the microbiological requirements for hydrophobic contact lenses. Bioburden testing will be performed periodically on finished product.
IV. Clinical Studies
A clinical trial of 3 months usage of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical Contact Lenses by 37 subjects, wearing lenses on a daily wear schedule, showed that the product is substantially equivalent to other lenses available on the market. Comparison was made to historical controls wearing wilofocon A. The clinical summary follows.
The study was conducted over 3 months of wear, subjects being seen initially, and after 1, 2 weeks and 1, 2 and 3 months.
4
ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses, FOI
Three (3) investigators enrolled a total of 37 test subjects. The age range of the test population was from 15 to 58, with 27 (73%) females and 10 (27%) males. Of the 37 subjects, 36 (97%) completed 3 months of wear, and 1 (3%) discontinued.
FINDINGS a. SAFETY:
(1) Adverse Reactions
The FDA regulations for medical devices (21 CFR 812.3) define an unanticipated adverse device effect as:
"any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that related to the rights, safety or welfare of the subject"
There were no adverse events during this study.
(2) Slit Lamp Findings:
A positive slit lamp finding is a routinely occurring complication that can be expected with or without the presence of contact lenses. The degree of severity may range from very slight, representing no medical concern, to serious, requiring medical treatment.
The following table shows the incidence of slit lamp findings at the initial and final visits.
INCIDENCE OF SLIT LAMP FINDINGS | ||
---|---|---|
FINDING FINDING | INITIAL ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | FINAL |
NO FINDINGSª | 90.5 | વેરે '8 |
EDEMA® | 0.0 | 0.0 |
NEOVASCUL. | 1.4 | 0.0 |
STAINING | 5.4 | 3.2 |
HYPEREMIA | 1.4 | 0.0 |
PALPEBRAL | ||
ABNORM. | 1.4 | 0.0 |
OTHER | 0.0 | 0.0 |
a Percent of eyes examined with no findings, initial or final scheduled follow-up visits only
b Percent of eyes with finding, initial or final scheduled follow-up visits only
(3) Symptoms, Problems and Complaints:
Symptoms, problems and complaints were reported by the investigators at each visit. "No symptoms" were reported at 76% of the scheduled follow up visits, and at all interim visits. The most frequent symptoms were of lens awareness and reading problems, followed by need for cleaning and dryness. The "other" symptoms in the population were: tired or fatigue (4 reports, 4 eyes of 2 subjects); cloudy or fogging (8 reports, 4 eyes of 2 subjects); scratchy sensation or itch (4 reports, 4 eyes of 2 subjects); difficult to remove (6 reports, 2 eyes of 1 subject).
5
SELECTED SYMPTOMS, PROBLEMS AND COMPLAINTS
SYMPTOM | INCIDENCE |
---|---|
NONEa | 75.7% |
LENS AWARENESSb | 5.7% |
READING PROBLEMS | 5.5% |
NEED FOR CLEANING | 5.2% |
DRYNESS | 4.6% |
- a Percent of eyes examined with no findings, regularly scheduled visits only b Percent of eyes with finding, regularly scheduled visits only
(4) Discontinuations:
Throughout the study, 1 subject (3%) was discontinued.
b. EFFICACY:
(1) Visual Acuity:
All eyes had a final visual acuity within 1 line of the initial best corrected acuity.
(2) Wear Time:
Wear time remained essentially unchanged over the three months of the study, indicating continuing comfort and cleanliness with the investigational lenses.
(3) Lens Replacements:
A total of 10 lenses were replaced during the study, 6 for visual acuity, 5 of the 6 within the first month. These results indicate that the lenses are effective in the correction of myopia.
Gender Comparisons:
The overall population was 73% female, 27% male. No further gender analysis was warranted.
OVERALL CONCLUSION OF THE CLINICAL STUDY:
The data of the clinical trial demonstrate the safety and efficacy of the ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical Contact Lenses.
6
Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the upper half of the circle. Inside the circle is an abstract symbol of an eagle with three lines representing the wings and a stylized body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
The Lagado Corporation c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601
Re: K033599
KUSSJ77
Trade/Device Name: ONST™ – 56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: July 7, 2004 Received: July 8, 2004
Dear Dr. Szabocsik:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of Price 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). and Oosmeter for (10) and the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general conable pro resuring 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 If your device is elassinos (tional controls. Existing major regulations affecting your device can may oe subject to back acceral 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 I Tease of advised that I Driseanter sever device complies with other requirements of the Act that 1 Dri has made a assoc regulations administered by other Federal agencies. You must of any I ederal statutes uncrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic forth in the quality of events (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2 - John M. Szabocsik, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally promance houried.com "consification 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), please If you active of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Kalipi 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
Enclosure
8
510(k) NUMBER (IF KNOWN) K033599
ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, DEVICE NAME Aspheric, Toric and Bifocal Contact Lens
INDICATIONS FOR USE
The ONSIJ-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism.
The lenses may be disinfected only by using chemical disinfection
Prescription Use
(Part 21CFR 801 Subpart D)
Over-The-Counter-Use OR (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE | |
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Page 1 of 1 | |
(Division Sign-Off) | |
Division of Ophthalmic Ear, |
Division of Ophthal
Nose and Throat Devises
510(k) Number K033599
510(k) Number