(74 days)
Not Found
No
The summary describes a contact lens material and its clinical performance, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device, a contact lens, is indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia). This falls under correction of a physical condition, not treatment or prevention of a disease.
No
This device is a contact lens material for correcting ametropia, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a contact lens material, which is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to correct refractive errors in the eye by being placed directly on the eye. It does not involve testing blood, urine, tissue, or any other bodily fluid or sample.
- The device description focuses on the material properties of a contact lens. This is consistent with a medical device intended for direct application to the body, not a diagnostic test.
- The clinical testing evaluates the safety and efficacy of the contact lens in correcting vision. This is typical for a medical device, not an IVD which would evaluate the performance of a diagnostic test.
The device described is a medical device, specifically a contact lens, intended for the correction of vision.
N/A
Intended Use / Indications for Use
The BOSTON EO is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and notaphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
86 HQD
Device Description
The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49).
The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON EO. The results of all testing demonstrated that the safety and effectiveness of the BOSTON EO is equivalent to the currently marketed BOSTON ES lens material.
Toxicology:
In-Vitro Cytotoxicity:
USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.
Acute Ocular Irritation:
Acute Ocular Irritation test was performed and produced no ocular irritation.
Systemic Injection
The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic.
Solution Compatibility:
Studies were conducted on blue tinted lens material with the ultraviolet light absorber. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of ultraviolet and visible light (UV/vis) spectra, base curve, lens diameter, power and surface quality were recorded prior to and upon completion of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.
Clinical Testing
The study utilized a controlled, double masked design. The predicate device, BOSTON ES rigid gas permeable lens, was used as the control material.
A total of 240 eyes (120 patients) were entered into the study by 8 Investigators.
The primary endpoints for this study were:
- Safety: A difference of 15% in the proportion of total Grade 2 or greater . slit lamp findings, between the Test and Control lenses, will be considered clinically significant.
- Efficacy: A difference of 15% in the proportion of lens visual acuities at the level of 20/40 or better, between the Test and Control lenses, will be considered clinically significant.
Both the safety and efficacy endpoints, as defined in the study protocol, were achieved, and there were no significant differences seen between the Test and Control lens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
510(k) Premarket Notification BOSTON EO Contact Lens Material
Image /page/0/Picture/1 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter K, followed by the numbers 980741. The numbers are written in a bold, handwritten style, and there is a line underneath the sequence.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS MAY | | 1998
FOR
BOSTON EO
SUBMITTER INFORMATION: 1.
Polymer Technology, a division of Wilmington Partners, L.P. Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450
CONTACT PERSON: 2.
Manager, Regulatory Affairs 1400 North Goodman Street Address: Rochester, New York 14692 (716) 338-8638 Telephone No .: (716) 338-0702 Fax No .: dketchum@bausch.com E-mail Address:
Debra Ketchum
3. DEVICE IDENTIFICATION:
Classification Name: Rigid Gas Permeable (hydrophobic) Contact Lens Material BOSTON EO Proprietary Name: (enflufocon B) Contact Lens Material fluoro silicone acrylate rigid gas permeable contact lens Common Name: material
4. PREDICATE DEVICE:
BOSTON ES (enflufocon A) has been selected as the predicate device for BOSTON EO (enflufocon B).
ડ. DESCRIPTION OF THE DEVICE:
The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49).
The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).
1
INDICATIONS FOR USE: 6.
The BOSTON EO is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and notaphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only.
DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE: 7.
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON EO. The results of all testing demonstrated that the safety and effectiveness of the BOSTON EO is equivalent to the currently marketed BOSTON ES lens material. A summary of these results from the preclinical studies is presented below.
Toxicology:
In-Vitro Cytotoxicity:
USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.
Acute Ocular Irritation:
Acute Ocular Irritation test was performed and produced no ocular irritation.
Systemic Injection
The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic.
Shelf Life:
The BOSTON EO (enflufocon B) is a hydrophobic rigid gas permeable contact lens material with