(33 days)
No
The summary describes a family of contact lenses for eye examination and therapy, focusing on optical design and sterilization. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device description states it is used for "therapy of intraocular abnormalities."
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for use as diagnostic lenses for eye fundus examinations."
No
The device description clearly states it is a family of diagnostic and therapeutic contact lenses, which are physical hardware components.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. This involves direct interaction with the eye and visualization of internal structures.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples taken from the patient. The device is a tool for direct observation and therapeutic intervention.
Therefore, the Volk Single-Use Contact Laser and Diagnostic Lenses fall under the category of medical devices used for diagnosis and therapy, but not specifically as in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
Product codes (comma separated list FDA assigned to the subject device)
HJK
Device Description
The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.
The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.
The lenses are provided sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye fundus, intraocular
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 standards for diagnostic contact lenses have not been issued. However, sterilization validation testing was performed, which demonstrated that the Volk Disposable Contact Laser and Diagnostic Lenses met the sterilization requirements specified in the validation protocol. Additionally, shelf life testing was performed, which confirmed a five (5) year shelf life.
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.
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
§ 886.1385 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2015
Volk Optical Inc. Ms. Meghan M. Leonard Quality and Regulatory Manager for Volk Optical Inc. 7893 Enterprise Drive Mentor, Ohio 44060
Re: K151961
Trade/Device Name: Volk Disposable Contact Laser and Diagnostic Lens Regulation Number: 21 CFR 886.1385 Regulation Name: Lens, Contact, Polymethylmethacrylate (PMMA), Diagnostic Regulatory Class: Class II Product Code: HJK Dated: July 17, 2015 Received: July 20, 2015
Dear Ms. Leonard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"
(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -A
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Volk Disposable Contact Laser and Diagnostic Lens
Indications for Use (Describe)
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Volk, a company that specializes in aspheric optics. The logo features the company name in a stylized font, with the tagline "the leader in aspheric optics" underneath. Below the logo is the text "A HALMA COMPANY", indicating that Volk is a subsidiary of Halma plc.
ATTACHMENT 6 510(K) SUMMARY
510(k) Owner
Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 Phone: (440) 942-6161 Contact: Meghan M. Leonard
Submission Correspondent
Meghan M. Leonard Ouality Assurance and Regulatory Affairs Manager Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 Phone: (440) 510-0745 Fax: (440) 510-0845 Email: meghan.leonard@volk.com
Date Prepared: July 15, 2015 (revised July 29, 2015)
Trade Name of Device
Volk Disposable Contact Laser and Diagnostic Lens
Common or Usual Name
Polymethylmethacrylate (PMMA) diagnostic contact lens
Classification Name and Regulation
Lens, Contact, Polymethylmethacrylate, Diagnostic 21 CFR 886.1385, HJK Ophthalmic Review Panel
Predicate Device
Quadraspheric Diagnostic Fundus Lens (K943125, Cleared on September 2, 1994)
4
Image /page/4/Picture/0 description: The image shows the logo for Volk, a company that specializes in aspheric optics. The logo features the word "VOLK" in large, stylized blue letters, with the tagline "the leader in aspheric optics" underneath. Below the main logo is the text "A HALMA COMPANY", indicating that Volk is part of the Halma group of companies.
Device Description
The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens.
The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use.
The lenses are provided sterile for single use.
Intended Use / Indications for Use
The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
Substantial Equivalence
The family of Volk Disposable Contact Laser and Diagnostic Lenses are equivalent to other diagnostic contact lenses as described in 21 CFR Part 886.1385. The principal difference is the packaging and sterilization of the lenses within a sterile pouch. The device modification is being made as a result of a device improvement or enhancement.
The family of Volk Disposable Contact Laser and Diagnostic Lenses are substantially equivalent in design, material, classification, and intended use to the Volk Quadraspheric Fundus Lens (K943125) cleared on 9/2/1994, the Volk Contact Laser & Diagnostic Lenses (K023221) cleared on 10/11/2002, and the Volk Disposable Vitrectomy Lens (K050623) cleared on 5/28/2005, as seen in the chart below.
| Comparison | Volk Disposable
Contact Laser and
Diagnostic Lenses
(current
application) | Volk
Quadraspheric
Fundus Lens
(K943125) | Contact Laser &
Diagnostic Lenses
(K023221) | Volk Disposable
Vitrectomy Lenses
(K050623) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated
Use | The Volk Single-
Use Contact Laser
and Diagnostic
Lenses (Direct
Contact) are
indicated for use as
diagnostic lenses
for eye fundus
examinations and
use in the therapy of
intraocular
abnormalities. | The device is
indicated for use as
a diagnostic contact
lens for eye fundus
examinations and
use in the therapy of
intraocular
abnormalities. | The device is
indicated for use as a
diagnostic contact
lens for eye fundus
examinations and
use in the therapy of
intraocular
abnormalities. | 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. |
5
| Comparison | Volk Disposable
Contact Laser and
Diagnostic Lenses
(current
application) | Volk
Quadraspheric
Fundus Lens
(K943125) | Contact Laser &
Diagnostic Lenses
(K023221) | Volk Disposable
Vitrectomy Lenses
(K050623) |
|---------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Design | Various, including
designs for
iridotomy and
capsulotomy. | Various, including
the quadraspheric
and other designs
representing a range
of magnification and
field of view. | Various, including
designs for
iridotomy,
capsulotomy, and
fundus. | Various designs
include the flat, mid
field, wide field,
and 15°, 30°, and
45° prisms. |
| Contact
Material | PMMA | PMMA and glass | Thermoset
polyesterurethane
and glass | PMMA |
| Packaging | Single lens
packaged sterile in
sterilization pouch | Single lens
packaged in a non-
sterilizable case | Single lens packaged
in a non-sterilizable
case | Single lens
packaged sterile in
sterilization pouch |
| Sterility | EO Sterilized | Non-sterile | Non-sterile | EO Sterilized |
Performance Data
Performance standards for diagnostic contact lenses have not been issued. However, sterilization validation testing was performed, which demonstrated that the Volk Disposable Contact Laser and Diagnostic Lenses met the sterilization requirements specified in the validation protocol. Additionally, shelf life testing was performed, which confirmed a five (5) year shelf life.