(84 days)
No
The 510(k) summary describes rigid gas permeable contact lenses and their materials. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is indicated for the management of irregular corneal conditions such as keratoconus and following surgery, which constitutes a therapeutic purpose.
No
The device is a contact lens used for vision correction and management of certain corneal conditions, not for diagnosing diseases. Its "Intended Use" section explicitly states it's for "correction of refractive ametropia" and "management of irregular corneal conditions," not for diagnosis.
No
The device description clearly states the device is a rigid gas permeable contact lens, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes contact lenses intended to be worn on the eye for vision correction and management of corneal conditions. They are not used to analyze specimens from the body.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.
Product codes
HOD
Device Description
The BOSTON ES (enflufocon A) and BOSTON EO (enflufocon B) are rigid gas permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.
BOSTON XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lenses may also be supplied clear (no tint).
The physical / optical properties of the lenses are:
| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|---|---|---|---|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Visible Light Transmittance | > 85% | > 85% | > 92% |
| Water Content |
§ 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
JAN 3 0 2006
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND DOSTON 20 - (Smidloodl A), DOSTON EO - (ennutocon B) AND
BOSTON XO® (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES
1. SUBMITTER INFORMATION
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609
Contact Person: Lisa Graney Manager, Global Regulatory Affairs Telephone No .: (585) 338-6612
2. DEVICE NAME
Classification Name: rigid gas permeable (hydrophobic) contact lens
Proprietary Name: BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses
3. PREDICATE DEVICES
Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufiocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premarket Notification K013646, have been selected as the predicate devices for the BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hexafocon A) Rigid Gas Permeable Contact Lenses.
DESCRIPTION OF DEVICE 4.
The BOSTON ES (enflufocon A) and BOSTON EO (enflufocon B) are rigid gas permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorher.
BOSTON XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lenses may also be supplied clear (no tint).
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses for Daily Wear
| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|---|---|---|---|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Visible Light Transmittance | > 85% | > 85% | > 92% |
| Water Content |