(303 days)
Not Found
No
The device description and intended use describe a passive optical device for viewing ocular structures. There is no mention of image processing, AI, ML, or any computational analysis of the images. The performance studies are limited to biocompatibility testing.
No
The device is used for visualization during surgical procedures or consultation, not for treating a disease or condition.
No
Explanation: The device is described as a "passive device that is used to view the fundus of the eye". Its intended use is for "visualizations" and it facilitates viewing ocular structures during surgical procedures or consultation. It does not state that it analyzes, interprets, or outputs diagnostic findings based on the visualizations.
No
The device description explicitly states it is comprised of physical components: an endocular viewing lens and/or a cornea support. These are hardware components, not software.
Based on the provided information, 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, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "passive device that is used to view the fundus of the eye by placing it on the cornea." It is used for direct visualization of structures within the eye during surgical procedures or consultation.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device is used for direct observation of the living eye.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics. It is an ophthalmic surgical/examination tool.
N/A
Intended Use / Indications for Use
The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
Product codes (comma separated list FDA assigned to the subject device)
HJK
Device Description
The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retina, vireous humor, lens, iris, anterior chamber, ocular structures, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Test Summary: The following tests were performed:
- ISO 10993-5 In vitro cytotoxicity
- ISO 10993-10 Irritation
- ISO 10993-10 Sensitization
Clinical Test Summary: No clinical studies were performed
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.
K012096, K050623, K151961, K140368, K142715
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue.
October 25, 2018
PHAKOS % J. D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K173944
Trade/Device Name: Endocular Viewing Lenses and Silicone Ring Regulation Number: 21 CFR 886.1385 Regulation Name: Polymethylmethacrylate (PMMA) Diagnostic Contact Lens Regulatory Class: Class II Product Code: HJK Dated: September 19, 2018 Received: September 25, 2018
Dear J. D. Webb:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "J. Angelo Green" in a large, bold font. The text is black and appears to be centered on a white background. The name is likely that of a person, and the image may be a title or heading.
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
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Indications for Use
510(k) Number (if known) K173944
Device Name ENDOCULAR VIEWING LENSES AND SILICONE RING
Indications for Use (Describe)
The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201.326(a) and D) Over-The-Counter Use (21 CFR 201.326(c)) |
|---|---|
| Prescription Use (Part 21 CFR 201.326(a) and D) Over-The-Counter Use (21 CFR 201.326(c)) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: ENDOCULAR VIEWING LENSES AND SILICONE RING
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | October 22, 2018 |
|---|---|
| Submitted By | PHAKOS |
| 62 Rue Kléber | |
| 93100 Montreuil | |
| FRANCE | |
| Primary Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 512-388- | |
| 0199 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Endocular Viewing Lenses and Silicone Ring |
| Common Name | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Classification Name | Polymethylmethacrylate (PMMA) diagnostic contact lens |
| Class | ll |
| Product Code | HJK |
| CFR Section | 21 CFR section 886.1385 |
| Device Panel | Ophthalmic |
| Primary Predicate | |
| Device | Disposable Vitrectomy Lens, OCULAR Instruments, Inc. (K012096) |
| Secondary Predicate | |
| Devices | Disposable Vitrectomy Lens, VOLK Optical, Inc. (K050623/ K151961) |
| Family of Vitrectomy Lenses, SENSOR Medical Technology LLC (K140368/ K142715) | |
| Device Description | The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices |
| comprised of an endocular viewing lens and/or of a cornea support that allows for | |
| stabilization of this lens on the eye. This range allows one to view the retina, the vitreous | |
| humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular | |
| structures during surgical procedures or consultation. | |
| Materials | Conventional lens: |
| PMMA polymethyl methacrylate | |
| High Resolution lens: | |
| OKP4 Polyester Optical Plastic | |
| Flexible removable | |
| ring: | |
| MED 4035 silicone | |
| Silicone ring (alone): | |
| MED 4035 silicone | |
| Intended Use | The endocular viewing lens is a passive device that is used to view the fundus of the eye |
| by placing it on the cornea. |
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K173944
| Substantial
Equivalence Claimed
to Predicate Devices | The Endocular Viewing Lenses and Silicone Ring is substantially equivalent to the
predicate devices in terms of intended use, design, materials used, mechanical safety
and performances. | | | | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indications for Use | The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations
of the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as
well as other ocular structures during surgical procedures or consultation. | | | | |
| | Device | PHAKOS | OCULAR | VOLK | SENSOR |
| Summary of the
Technological
Characteristics
Compared to
Predicate | Intended Use | The endocular
viewing lens is
a passive
device that is
used to view
the fundus of
the eye by
placing it on the
cornea. | Allow
visualization of
the ocular
fundus,
vitreous, and
retinal
structures
during
vitrectomy
surgery. | For use as
diagnostic
lenses for eye
fundus
examinations
and use in the
therapy of
intraocular
abnormalities. | Used in the
examination of
the eye
fundus, retina
and irido-
corneal and
vitreous
bodies |
| | Type of
Lenses | - Vitrectomy
- Gonioprism
- Panoramic
Wide Field - 3-prism
- Capsulotomy
- Silicone Ring | - Vitrectomy
- Gonioprism
- Panoramic
Wide Field - 3-prism
- Capsulotomy
- Silicone Ring | - Vitrectomy
- Gonioprism
- Panoramic
Wide Field - 3-prism
- Capsulotomy | - Vitrectomy
- Gonioprism
- Panoramic
Wide Field - 3-prism
- Capsulotomy
- Silicone Ring |
| | Comparison of
Lenses | - All of the systems include the full range of Vitrectomy Lens, with the
exception of the SENSOR not having a Wide-Angle Lens. The
SENSOR has no HR Vitrectomy Lens - All of the systems include Gonioprism Lens.
- All systems include a Panoramic Wide Field Lens. All of the systems
include 3-prism Lens. - All systems include a Capsulotomy Lens. | | | |
| | Material | - PMMA - OKP 4
(acrylic) - silicone | - PMMA
- Acrylic
- Glass
- Quartz | - PMMA
- Acrylic
- Glass | - PMMA |
| Non-clinical Test
Summary | The following tests were performed: - ISO 10993-5 In vitro cytotoxicity
- ISO 10993-10 Irritation
- ISO 10993-10 Sensitization | | | | |
| Clinical Test
Summary | No clinical studies were performed | | | | |
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| Conclusions: | PHAKOS considers the Endocular Viewing Lenses and Silicone Ring to be equivalent to |
|---|---|
| Non- | the predicate devices listed above. This conclusion is based upon the devices' similarities |
| clinical and Clinical | in principles of operation, technology, materials and indications for use |