(112 days)
Sphere/Asphere: AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric: AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non- aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Multifocal Toric: AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/ planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.
The AVAIRA VITALITY (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as a sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens. The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk). The AVAIRA VITALITY (fanfilcon A)) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling. A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye. The AVAIRA VITALITY (fanfilcon A) lens is supplied sterile, packaged in a buffered saline solution. The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.
This document is a 510(k) premarket notification for a medical device (contact lenses), not an algorithm-driven AI/ML device. Therefore, the detailed requirements regarding AI/ML device acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable.
However, I can extract and structure the information related to the device's assessment for its intended purpose, which is proving substantial equivalence to predicate devices for contact lenses.
Here's an attempt to adapt the requested structure as much as possible, reinterpreting the questions for a non-AI/ML medical device context:
Device: Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lenses
1. Table of Acceptance Criteria and the Reported Device Performance
The concept of "acceptance criteria" for this contact lens is substantial equivalence to legally marketed predicate devices, meaning it is as safe and effective. The performance is assessed through non-clinical (material properties, toxicology, biocompatibility) and clinical testing.
| Acceptance Criteria (Reinterpreted for Contact Lenses) | Reported Device Performance (Summary) |
|---|---|
| Non-clinical: | |
| Material Properties Comparison (Predicate 1: CooperVision AVAIRA (enfilcon A)) | Water Content: 55% (vs 46% for predicate) Refractive Index @ 20℃: 1.40 (vs 1.40) Specific Gravity g/mL: 1.026 (vs 1.06) Oxygen Permeability (Dk): 90 (vs 100) Base Curve, mm: 8.4 (vs 8.5) Diameter, mm: 14.2 (vs 14.2) |
| Material Properties Comparison (Predicate 2: CooperVision MyDay (stenfilcon A)) | Water Content: 55% (vs 54% for predicate) Refractive Index @ 20℃: 1.40 (vs 1.40) Specific Gravity g/mL: 1.026 (vs 1.033) Oxygen Permeability (Dk): 90 (vs 80) Base Curve, mm: 8.4 (vs 8.4) Diameter, mm: 14.2 (vs 14.2) |
| In-vitro & In-vivo Preclinical Toxicology & Biocompatibility (General) | Lens material and/or extracts are non-toxic, non-irritating, and non-sensitizing. Lens physical and material properties are consistent with currently marketed lenses. |
| Clinical: | |
| Safety (Slit lamp findings, Adverse Event rates) | Found to be substantially equivalent to the Control contact lens for safety. |
| Efficacy (Visual Acuity Comparisons) | Found to be substantially equivalent to the Control contact lens for efficacy. |
| Secondary Measures (Average lens wearing times, Subjective lens comfort assessed by frequency or symptoms) | Not explicitly detailed if these met specific numeric "acceptance criteria," but they were assessed as secondary outcomes. |
| Overall Substantial Equivalence | The device is as safe and effective as the predicate device when used as directed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Clinical Study (Test Set): 90 subjects (60 subjects for Test lenses, 30 subjects for Control lenses).
- Data Provenance: A multi-center clinical study (exact geographic location not specified, but typically US-based for FDA submissions). The study was conducted retrospectively to collect the data from the clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is not applicable in the context of a contact lens study seeking substantial equivalence. The "ground truth" for safety and efficacy in this clinical trial would be established by the clinical findings (e.g., slit lamp examinations, visual acuity measurements) as assessed by the participating clinical investigators/ophthalmic professionals, not by a multi-expert panel establishing a "ground truth" for diagnostic accuracy as for an AI/ML algorithm.
4. Adjudication Method for the Test Set
- Not explicitly described as an "adjudication method" in the AI/ML sense. The clinical study was a "randomized, masked, concurrent control study." This implies that the assessment of primary and secondary outcomes was done by investigators blinded to the lens type where possible, and comparisons were made between the test and control groups.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This is not an AI/ML device, and no MRMC study or human-in-the-loop performance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a contact lens, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- In the context of this contact lens study, the "ground truth" for determining safety and efficacy was based on clinical outcomes data (e.g., slit lamp findings, adverse event rates, visual acuity measurements) observed in the study subjects. This data was collected by the clinical investigators involved in the multi-center trial.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/ML device that requires a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, possibly black or dark blue. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
CooperVision, Inc. Mr. Dan O'Mara Regulatory Affairs Manager 6150 Stoneridge Mall Rd.. Suite 370 Pleasanton, CA 94588
Re: K160803
Trade/Device Name: Avaira Vitality (fanfilcon A) Soft (hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 1, 2016 Received: June 2, 2016
Dear Mr. O'Mara:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise L. Hampton -S
for Malvina B. Eydelman, 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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Indications for Use
510(k) Number (if known) K160803
Device Name
Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
Sphere/Asphere:
AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Toric:
AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
Multifocal:
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric:
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| Date: | 6 July 2016 | |
|---|---|---|
| Submitter Information: | CooperVision, Inc.6150 Stoneridge Mall RoadSuite 370Pleasanton, CA 94588USA(800) 972-6724 | |
| Contact: | Dan O'MaraRegulatory Affairs Managerdomara@coopervision.com(585) 756-9589 | |
| Device Identification: | Common Name:Trade Name:Class. Name: | Soft Contact LensAVAIRA VITALITY(fanfilcon A) Soft Contact LensSoft (hydrophilic) Contact Lens –Daily Wear |
| Classification: | Class II [21 CFR 886.5925 (b) (1)] | |
| Product Code: | LPL, MVN | |
| Predicate Device(s): | Primary (Indication, Wear Schedule and Material) | |
| CooperVision AVAIRA (enfilcon A)K113759(Silicone Hydrogel, Daily wear - frequent replacement) | ||
| Secondary (Indication, Wear schedule and Material) | ||
| CooperVision MyDay (stenfilcon A)K131378(Silicone Hydrogel, Daily wear - single use) |
{5}------------------------------------------------
Description of Device
- . The AVAIRA VITALITY (fanfilcon A) Contact Lens visibility tinted with UV blocker is available as a sphere/asphere lens, toric lens, multifocal lens, and multifocal toric lens.
- . The lenses are made of a silicone hydrogel material which is not surface treated and is characterized by high oxygen permeability (Dk).
- . The AVAIRA VITALITY (fanfilcon A)) Contact Lens is tinted blue using Reactive Blue #246 to make the lens more visible for handling.
- . A Norbloc UV blocker is used to reduce the amount of ultraviolet light transmitted into the eye.
- . The AVAIRA VITALITY (fanfilcon A) lens is supplied sterile, packaged in a buffered saline solution.
- . The composition of the lens is 45% fanfilcon A and 55% water by weight when hydrated and stored in buffered saline solution.
{6}------------------------------------------------
Indications for Use
| Lens Design | Indication |
|---|---|
| Sphere/Asphere | AVAIRA SPHERE and ASPHERE (fanfilcon A) SoftContact lenses are indicated for the correction of ametropia (myopiaand hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lensesmay be worn by persons who exhibit astigmatism of 2.00 dioptersor less that does not interfere with visual acuity. |
| Toric | AVAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses areindicated for the correction of ametropia (myopia or hyperopia withastigmatism) in aphakic and non- aphakic persons with non-diseasedeyes in powers from -20.00 to +20.00 diopters and astigmaticcorrections from -0.25 to -10.00 diopters. |
| Multifocal | AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lensesare indicated for the correction of refractive ametropia(myopia and hyperopia) and emmetropia with presbyopia inaphakic and non-aphakic persons with non-diseased eyes inpowers from -20.00 to +20.00 diopters and with add powers from+0.25 to +4.00 diopters. The lenses may be worn by persons whoexhibit astigmatism of 2.00 diopters or less that does not interferewith visual acuity. |
| Multifocal Toric | AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC SoftContact lenses are indicated for the optic correction of distance andnear vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with addpowers from +0.25 to +4.00 diopters and astigmatism correctionsfrom -0.25 to -10.00 diopters. |
- Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear.
When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/ planned replacement wear, the lenses may be disinfected using a chemical disinfection only.
When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.
{7}------------------------------------------------
Technological Characteristics:
The technological characteristics of the AVAIRA VITALITY (fanfilcon A) Contact Lenses are compared to the characteristics of the predicate device, CooperVision AVAIRA (enfilcon A) Contact Lens, in the following tables.
| Material Comparison | |||
|---|---|---|---|
| Predicate Device | Subject Device | ||
| Product Name | CooperVisionAVAIRA | CooperVisionAVAIRA VITALITY | |
| Material USAN Name | enfilcon A | fanfilcon A | |
| 510(k) Number | K113759 | TBD - Current Submission | |
| FDA Category (Group) | Silicone Hydrogel | Silicone Hydrogel | |
| Manufacturing Method | Molded | Molded | |
| Sterilization | Moist Heat | Moist Heat | |
| Packaging | Blister | Blister | |
| Visibility Tint | Phthalocyanine Blue | Reactive Blue #246 |
| Parameter Comparison | |||
|---|---|---|---|
| Predicate Device | Subject Device | ||
| CooperVisionAVAIRA(enfilcon A)K113759 | CooperVisionAVAIRA VITALITY(fanfilcon A)TBD - Current Submission | ||
| Water Content, % | 46% | 55% | |
| Refractive Index @ 20℃ | 1.40 | 1.40 | |
| Specific Gravity g/mL | 1.06 | 1.026 | |
| Oxygen Permeability(Dk)* | 100 | 90 | |
| Base Curve, mm | 8.5 | 8.4 | |
| Diameter, mm | 14.2 | 14.2 |
*Dk units: x 10-11 (cm²/sec) x (ml O2)/(ml x mm Hg)
{8}------------------------------------------------
Technological Characteristics:
The technological characteristics of the AVAIRA Vitality (fanfilcon A) Contact Lenses are compared to the characteristics of the predicate device, CooperVision MyDay (stenfilcon A) Contact Lens, in the following tables.
| Material Comparison | |||
|---|---|---|---|
| Predicate Device | Subject Device | ||
| Product Name | CooperVisionMyDay | CooperVisionAVAIRA VITALITY | |
| Material USAN Name | stenfilcon A | fanfilcon A | |
| 510(k) Number | K131378 | TBD – Current Submission | |
| FDA Category (Group) | Silicone Hydrogel | Silicone Hydrogel | |
| Manufacturing Method | Molded | Molded | |
| Sterilization | Moist Heat | Moist Heat | |
| Packaging | Blister | Blister | |
| Visibility Tint | Reactive Blue #246 | Reactive Blue #246 |
| Parameter Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| CooperVisionMyDay(stenfilcon A)K131378 | CooperVisionAVAIRA VITALITY(fanfilcon A)TBD - Current Submission | |
| Water Content, % | 54% | 55% |
| Refractive Index @ 20oC | 1.40 | 1.40 |
| Specific Gravity g/mL | 1.033 | 1.026 |
| Oxygen Permeability(Dk)* | 80 | 90 |
| Base Curve, mm | 8.4 | 8.4 |
| Diameter, mm | 14.2 | 14.2 |
*Dk units: x 10-11 (cm²/sec)x(ml O2)/(ml x mm Hg)
{9}------------------------------------------------
Non-clinical Testing
A series of in-vitro and in-vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.
The results of the non-clinical testing/evaluation demonstrate that:
- The lens material and/or extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions; and
- The lens physical and material properties are consistent with currently marketed lenses.
Clinical Testing
A three-month clinical study was completed to evaluate the safety and efficacy of the AVAIRA VITALITY (fanfilcon A) Contact Lens for daily wear with a replacement schedule of one month (up to 30 days).
The study was a multi-center, randomized, masked, concurrent control study that evaluated ninety (90) male and female subjects who were dispensed lenses in a 2:1 ratio with 60 subjects dispensed into the Test lenses and 30 subjects dispensed into the Control lenses. The primary outcome measures were slit lamp (biomicroscopy) findings and adverse event rates along with lens visual acuity comparisons between the Test and the Control contact lenses. Secondary outcome measures included average lens wearing times and subjective lens comfort assessed by frequency or symptoms.
The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy.
{10}------------------------------------------------
Conclusion Drawn from Studies
Validity of Scientific Data:
A contract laboratory under Good Laboratory Practice Regulations conducted toxicology studies. Microbiology, chemistry, shelf-life stability, and leachability studies were conducted by Cooper Vision laboratories and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.
Substantial Equivalence:
Information presented in this Premarket Notification establishes that the AVAIRA VITALITY (fanfilcon A) Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and the requested indication.
Risk and Benefits:
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.