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

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study findings for the ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lens, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list "acceptance criteria" for the clinical study in a quantitative manner (e.g., minimum visual acuity improvement, maximum complication rate thresholds). Instead, it describes general safety and efficacy findings. The tables below summarize the product's physical properties compared to a predicate device and the clinical study findings:

Comparison to Predicate Device (Oxycon (wilofocon A))

Characteristic	Predicate Device (Oxycon)	ONSI™-56 (onsifocon A)
Water Content	<1%	<1.0%
Oxygen Permeability	$26 \times 10^{-11}$ Fatt Units (1990)	56.2 ANSI units
Refractive Index	1.44	1.452
Hardness	D/89 (Shore)	D/85 (Shore)
Specific Gravity	1.25	1.206
Residual Monomers	(not specified)	no leachable monomers detected
Wetting Angle	23.0° ± 2 (CLMA method)	7.25° ± 1.55 (sessile drop method)
Mechanical (flexural) Strength	(not specified)	2698 psi
Light Transmittance (Clear)	(not specified)	>95% T
Light Transmittance (Tinted)	93% (green), 87% (gray)	>70% T (blue, green, gray, blue-violet, blue UV)
Light Transmittance (Blue UV)	(not specified)	>70% T (400-780nm), 0% T (200-380nm)

Clinical Study Findings (Safety and Efficacy)

Finding / Metric	Initial (Baseline)	Final (3 Months)	General Observation / Interpretation
No Findings (Slit Lamp)	90.5% (eyes)	Not directly comparable (table shows "वेरे '8") - Likely a typo, assuming "reported as high" based on conclusion	High percentage of eyes with no adverse slit lamp findings.
Edema	0.0%	0.0%	No incidence of edema related to the lenses.
Neovascularization	1.4%	0.0%	Slight decrease in pre-existing neovascularization. Good safety.
Staining	5.4%	3.2%	Decrease in corneal staining incidence over time.
Hyperemia	1.4%	0.0%	Elimination of hyperemia during the study.
Palpebral Abnorm.	1.4%	0.0%	Elimination of palpebral abnormalities during the study.
Adverse Events	N/A	0 (zero)	No unanticipated adverse device effects observed during the study.
No Symptoms (Scheduled visits)	N/A	75.7% (eyes)	A high percentage of eyes reported no symptoms.
Lens Awareness	N/A	5.7%	Low incidence of lens awareness.
Reading Problems	N/A	5.5%	Low incidence of reading problems.
Need for Cleaning	N/A	5.2%	Low incidence of need for cleaning.
Dryness	N/A	4.6%	Low incidence of dryness.
Discontinuations	N/A	1 subject (3%)	Very low discontinuation rate, indicating good patient tolerance.
Visual Acuity	Baseline	Final	All eyes had a final visual acuity within 1 line of the initial best corrected acuity. (Efficacy met)
Wear Time	Baseline	3 Months	Remained essentially unchanged, indicating continuing comfort and cleanliness. (Efficacy met)
Lens Replacements	N/A	10 (6 for VA)	Low number of replacements, mostly for VA in the first month, supporting efficacy for myopia.

2. Sample Size and Data Provenance

Test Set Sample Size: 37 subjects.
Data Provenance: The 510(k) summary does not explicitly state the country of origin. It is a clinical trial, implying prospective data collection.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: Not explicitly stated, but the study involved "Three (3) investigators." These investigators would have been responsible for clinical assessments (e.g., slit lamp findings, visual acuity measurements), and thus contributed to establishing the "ground truth" through their clinical observations and measurements.
Qualifications of Experts: Not explicitly stated, but for a contact lens clinical trial, these investigators would typically be ophthalmologists, optometrists, or other eye care professionals experienced in contact lens fitting and evaluation, often with significant clinical experience.

4. Adjudication Method (Test Set)

The 510(k) summary does not describe any formal adjudication method (e.g., 2+1, 3+1). The findings are reported as collected by the investigators.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The clinical study compared the ONSI™-56 device to "historical controls wearing wilofocon A," rather than a concurrent study with human readers comparing AI-assisted vs. non-AI-assisted performance. This is a direct device performance study.
Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only) performance study was not done. This device is a physical contact lens, not a software algorithm. Therefore, "algorithm only" performance is not applicable. The study evaluated the lens's performance in human subjects.

7. Type of Ground Truth Used

The ground truth for the clinical study was established through expert clinical assessment and objective measurements by the investigators. This included:
- Slit lamp findings (presence/absence and severity of conditions like edema, neovascularization, staining, hyperemia, palpebral abnormalities).
- Visual acuity measurements.
- Patient-reported symptoms, problems, and complaints.
- Wear time.
- Lens replacements.

8. Sample Size for the Training Set

Not applicable. This study is for a physical medical device (contact lens) and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to this device submission.

Summary

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K033599

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 Corporation2890 South Tejon StEnglewood, CO 80110
Contact:	John M. Szabocsik, Ph.D.Official agent Szabocsik and Associates203 N. Wabash, Ste 1200Chicago, 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. SubstantialEquivalence	This product is substantially equivalent to other currently marketed rigid lenses, such as Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses
6. DeviceDescription	The ONSI™-56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric,Toric and Bifocal Contact Lenses are available in spherical designs in theclear untinted or blue, green, gray, or blue-violet tinted varieties and bluetint with UV-blocker. Each is a shell of the following dimensions.
	Spherical Contact Lens:Horizontal Lens Size: 6.5 mm to 11.50mmBase Curve: 6.50mm to 9.50mmDistance Powers: +12.00D to -20.00DCenter Thickness:for low minus 0.05mm to 0.30mmfor plus 0.10mm to 0.70mm
	Aspheric LensEccentricity 0 to 1.5Peripheral Curves 0.1 to 1.0mm
	Toric LensAxis 1 to 180 degrees in 1 degree steps
	Cylinder power 0.50 to 4.00D

FOI Summary, Pg 1

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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)
	<1%	<1.0%
Oxygen Permeability	$26x10^{-11}$Fatt Units(1990)	56.2ANSI units
Refractive Index	1.44	1.452
Hardness	D/89 (Shore)	D/85 (Shore)
Specific Gravity	1.25	1.206
Residual Monomers		no leachable monomersdetected
Wetting Angle	23.0$\nabla$2(CLMA method)	7.25E$\nabla$1.55(sessile drop method)
Mechanical (flexural)Strength		2698psi

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ONSI™-56 (onsifocon A) Rigid Gas Permeable Contact Lenses, FOI

Light Transmittance	OXYCON (wilofocon A)	ONSITM-56 (onsifocon A)
clear		>95% T
blue		>70% T
green	93%	>70% T
gray	87%	>70% T
blue-violet		>70% T
blue UV		>70% T (400-780nm)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

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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.

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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).

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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.

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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.

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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

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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 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
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

Regulation Number and Section

§ 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.