(18 days)
No
The summary describes a physical contact lens made of PMMA for fundus examination and therapy. There is no mention of software, image processing, AI, or ML.
Yes
The device description and intended use explicitly state that the device is used for "therapy of intraocular abnormalities."
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "diagnostic contact lenses for eye fundus examinations." The "Device Description" also refers to the device as a "diagnostic and therapeutic contact lens system used for eye fundus examination."
No
The device description explicitly states it is a "contact lens system" made from PMMA, which is a physical material. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "diagnostic contact lens system for eye fundus examinations and use in the therapy of intraocular abnormalities." It is a physical lens used directly on the eye for examination and treatment.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the body. Its function is based on direct interaction with the eye.
Therefore, this device falls under the category of a medical device used for direct examination and therapy, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
Product codes
HJK
Device Description
The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye fundus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.
0
Volk Optical, Inc.
510(k) SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
11:10 PM
March 7, 2005 Date:
Volk Optical, Inc. Submitter: 7893 Enterprise Drive Mentor, Ohio 44060 (440) 942-6161
Contact Person:
Michaeleen Dom
:
Official Correspondent:
Richard E. Lippman, O.D., F.A.A.O. Vice President Ophthalmic Product Regulatory Affairs R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 (240) 683-3738
Device Name:
| Trade Name: | Volk Disposable Vitrectomy Lenses |
|---|---|
| Common Name: | Vitrectomy contact lens |
| Classification Name: | Lens, Contact- Diagnostic |
| Device Classification: | 21 CFR 886.1385 |
| Class II | |
| Product Code: | HJK |
Device Description:
The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.
Intended Use:
The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
Substantial Equivalence:
The Volk Disposable Vitrectomy Lenses are substantially equivalent in design, material, classification, and intended use to vitrectomy lenses cleared for marketing by Ocular Instruments, Inc. (K012096), and Volk Optical, Inc. (K943125). See chart below.
1
Volk Optical, Inc.
| Comparison | Volk Contact &
Laser Diagnostic
Lenses (current
application) | Volk Quadraspheric
Fundus Lens
(K943125) | Ocular Disposable
Vitrectomy Lenses
(K012096) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indication for
Use | Diagnostic contact
lens for eye fundus
examinations and
use in the therapy of
intraocular
abnormalities | Diagnostic contact
lens for eye fundus
examinations and
use in the therapy of
intraocular
abnormalities | Visualizastion of the
ocular fundus, vitreous
and retinal structures
during vitrectomy
surgeries. |
| Design | Various designs
include the flat, wide
field and 30° prism. | Various designs
include the flat, wide
field and 30° prism | Various designs include
the flat, wide field and
30° prism. |
| Materials | PMMA | PMMA | PMMA |
| Sterility | EO Sterilized | Non-sterile | EO Sterilized |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle.
Public Health Service
MAR 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Volk Optical, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Official Correspondent for Volk Optical, Inc. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Rd., Suite 30 Rockville, MD 20850
Re: K050623
Trade/Device Name: Volk Disposable Vitrectomy lenses Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) diagnostic contact lens Regulatory Class: Class II Product Code: HJK Dated: March 9, 2005 Received: March 10, 2005
Dear Dr. Lippman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
3
Page 2 - Richard E. Lippman, O.D., F.A.A.O.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known)
.
- Sales and the same
. . .
Device Name:
Volk Disposable Vitrectomy Lenses
Indications for Use:
The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
X Prescription Use (Part 21 CFR 801 Subpart D)
: 2 .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.C. Brown, Ph.D.
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K050623 510(k) Number.