(74 days)
No
The document describes a contact lens material and its clinical performance, with no mention of AI or ML technology.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia), which addresses a physical condition (vision impairment) but does not treat, mitigate, or prevent disease.
No
Explanation: The BOSTON XO contact lens material is indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia). It is a corrective device, not a device used to diagnose a medical condition.
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:
- Intended Use: The intended use clearly states that the device is a contact lens for correcting refractive errors in the eye. This is a direct interaction with the patient's body for a therapeutic/corrective purpose.
- Device Description: The description details the material composition and physical properties of a contact lens.
- Anatomical Site: The anatomical site is the eyes.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not involve the analysis of such specimens.
The information provided describes a medical device that is placed on the eye for vision correction, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The BOSTON XO contact lens material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfection system only.
Product codes
86 HQD
Device Description
The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer.
The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A 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
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the BOSTON XO contact lens material. The results of all testing demonstrated that the safety and effectiveness of the BOSTON XO is equivalent to the currently marketed BOSTON ES contact 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.
Shelf Life: The BOSTON XO (hexafocon A) is a hydrophobic rigid gas permeable contact lens material with
§ 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) SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BOSTON XO
1. SUBMITTER INFORMATION:
Polymer Technology Global Vision Care 1400 N. Goodman Street Rochester, New York 14603-0450
2. CONTACT PERSON:
| Manager, Regulatory Affairs | |
|---|---|
| Address: | 1400 North Goodman Street |
| P.O. Box 450 | |
| Rochester, New York 14603-0450 | |
| Telephone No.: | (716) 338-8638 |
| Fax No.: | (716) 338-0702 |
| E-mail Address: | dketchum@bausch.com |
Debra Ketchum
3. DEVICE IDENTIFICATION:
| Classification Name: | Rigid Gas Permeable (hydrophobic) Contact
Lens Material |
|----------------------|-----------------------------------------------------------------------|
| Proprietary Name: | BOSTON XO (hexafocon A) Contact Lens
Material |
| Common Name: | fluoro silicone acrylate rigid gas permeable
contact lens material |
4. PREDICATE DEVICE:
BOSTON ES (enflufocon A) has been selected as the predicate device for BOSTON XO (hexafocon A).
5. DESCRIPTION OF THE DEVICE:
The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer.
The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).
1
6. INDICATIONS FOR USE:
The BOSTON XO contact lens material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic 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 XO contact lens material. The results of all testing demonstrated that the safety and effectiveness of the BOSTON XO is equivalent to the currently marketed BOSTON ES contact 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 XO (hexafocon A) is a hydrophobic rigid gas permeable contact lens material with