(100 days)
Not Found
No
The summary describes contact lenses and a contact lens solution, with performance studies focused on shelf-life and bioburden. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a contact lens used for vision correction, which falls under refractive error management rather than therapeutic treatment of a disease or condition.
No
The device is a contact lens indicated for the correction of refractive ametropia and visual acuity, not for diagnosing medical conditions.
No
The device description explicitly states the device is composed of "silicone acrylate or fluoro silicone acrylate copolymers," which are physical materials forming contact lenses, not software. The submission also describes a physical solution.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: This device is a contact lens, which is a medical device placed directly on the eye to correct vision. It does not analyze any biological samples.
- Intended Use: The intended use clearly states the correction of refractive errors and visual acuity, not the diagnosis of a disease or condition through the analysis of biological specimens.
The information provided describes a contact lens and its associated solution, which are external medical devices, not IVDs.
N/A
Intended Use / Indications for Use
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.
BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia, hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.
BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).
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)
Performance Testing- Microbiology:
Shelf-Life Testing: Determination of shelf-life for the recommended period of 30 days for storage of Boston fluorcsilicone acrylate (FSA) and silicone acrylate (SA) classes of gas permeable lenses as stored in Boston SIMPLUS® Multi-Action Solution was conducted. The representative FSA lens was the Boston Equalens II RGP Contact Lens. The representative SA lens was the BOSTON IV RGP Contact Lens. Testing demonstrated stability as to physical and optical properties in accordance with testing conducted under ISO 11987: 1997 Ophthalmic Optics- Determination of Shelf-life; WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a wet packaging shelf-life of 30 days for SA and FSA GP lenses.
Bioburden Testing: Testing was conducted in accordance with internal procedures to compare bioburden levels of examples of SA and FSA lenses at day 30 as stored at ambient temperatures. Results indicated that bioburden levels were below the required minimum cfu values (
§ 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
FEB 21 _ 12
Bausch&Lomb
510(k) Summary Statement BOSTON RGP Lenses Wet Shipped in Boston SIMPLUS® Multi-Action Solution and Stored for up to 30 Days
| Applicant's Name and Address | Bausch & Lomb, Inc.
1400 North Goodman Street
Rochester, NY 14609 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Debra Ketchum
Manager, Regulatory Affairs
Bausch & Lomb, Inc.
1400 North Goodman Street
Rochester, NY 14609
(585) 338-8638
Debra_Ketchum@bausch.com |
| 1. Identification of device | |
Common Name: flouro silicone acrylate and silicone acrylate rigid gas permeable contact lens materials BOSTON Contact Lens Materials Trade Name: Classification Name: Rigid Gas Permeable (hydrophobic) Contact Lens Material Device classification: Class II 886.5916 Pro Code: HQD
2. Description of device
BOSTON RGP Contact Lenses are composed of silicone acrylate or fluoro silicone acrylate copolymers wet shipped in Boston SIMPLUS® Multi-Action Solution and stored up to 30 days.
BOSTON SIMPLUS® Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).
3. Intended use
BOSTON XO (hexafocon A), BOSTON EO (enflufocon B), BOSTON ES (enflufocon A), BOSTON 7 (satafocon A), and BOSTON RXD (itabisfluorofocon A RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyocia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfecting system only.
BOSTON IV (itafocon B), BOSTON II (itafocon A) RGP Contact Lenses are indicated for daily wear for the correction of visual acuity for non-aphakic persons with myopia,
1
hyperopia, or keratoconus and for the correction of corneal astigmatism up to 4.00 diopters. The lens is disinfected using a chemical (not heat) disinfection system recommended in the labeling.
4. Substantial Equivalence
| 510(k) | Clearance Date | Device Description |
|---|---|---|
| K002025 | 10/31/2000 | BOSTON RGP Lenses Wet |
| Shipped in Boston Advance | ||
| Comfort Formula Conditioning | ||
| Solution and Stored for Up to | ||
| 30 Days |
BOSTON RGP Lenses Wet Shipped in Boston Advance Comfort Formula Conditioning Solution and Stored for up to 30 Days has been selected as the predicate device for the Bausch & Lomb BOSTON RGP Lenses to be labeled and stored in BOSTON SIMPLUS® Multi-Action Solution for up to 30 days in which the predicate and substantially equivalent clearance was made under K002025 on 10/31/2000. All identified BOSTON RGP contact lenses are included for labeling with wet storage using BOSTON SIMPLUS® Multi-Action Solution and there is no change in indication for use, nor a change in manufacturing.
5. Safety and Perfomance Testing:
Performance Testing- Microbiology:
Shelf-Life Testing: Determination of shelf-life for the recommended period of 30 days for storage of Boston fluorcsilicone acrylate (FSA) and silicone acrylate (SA) classes of gas permeable lenses as stored in Boston SIMPLUS® Multi-Action Solution was conducted. The representative FSA lens was the Boston Equalens II RGP Contact Lens. The representative SA lens was the BOSTON IV RGP Contact Lens. Testing demonstrated stability as to physical and optical properties in accordance with testing conducted under ISO 11987: 1997 Ophthalmic Optics- Determination of Shelf-life; WI0523 GP Lens Wet Packaging Qualification Procedures. Results support a wet packaging shelf-life of 30 days for SA and FSA GP lenses.
Bioburden Testing: Testing was conducted in accordance with internal procedures to compare bioburden levels of examples of SA and FSA lenses at day 30 as stored at ambient temperatures. Results indicated that bioburden levels were below the required minimum cfu values (