(151 days)
Not Found
No
The device description and intended use clearly describe physical implants and temporary devices made of PMMA, with no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The devices, an Eye Sphere and a Conformer, are used in a medical context to maintain the shape of the eye cavity and prevent adhesion during the healing process after surgical removal of the eye or its contents, which are therapeutic functions.
No
Explanation: The device, consisting of "Eye Spheres" and "Conformers," is a permanent or temporary implant/device used to maintain the shape of the eye cavity after surgical removal of the eye or its contents. Its purpose is structural and supportive, not to diagnose a condition or disease.
No
The device description explicitly states that the devices are physical implants and temporary devices made of polymethylmethacrylate (PMMA), which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Eye Spheres and Conformers are implants and temporary devices used to occupy the eye cavity or maintain its shape after surgery. They are physical devices placed within the body.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the eye socket.
Therefore, based on the provided information, this device falls under the category of a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)
Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process
Product codes (comma separated list FDA assigned to the subject device)
HPZ, HQN
Device Description
When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
Indicated Patient Age Range
Pediatric and Adult
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)
Not Found
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.
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
§ 886.3320 Eye sphere implant.
(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters "PES" in a stylized font, with the words "Product and Educational Services LLC" written to the right of the letters. The text is in black and the background is white.
3 2 2009
510(k) Summary
Submitter's Name
Address
Product and Educational Services LLC
Bucks County Biotechnology Center 3805 Old Easton Road Doylestown, PA 18902 Phone: (215) 230 7515 Facsimile: (215) 230 7517
Edward T. Griffith President
Date of Summary:
Contact Person
26 September 2008
Proprietary Name of Device:
None
Common/Usual Name:
Classification Name:
Eye Sphere
Conformer
Implant, Eye Sphere
Conformer, Ophthalmic
Legally Marketed Equivalent Devices:
Gulden Ophthalmics Eye Sphere and Conformer (K972661)
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Image /page/1/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters "PES" in a stylized font, with the words "Product and Educational Services LLC" to the right of the letters. The text is in black and the background is white.
Summary of Device:
When an eye is severely damaged by trauma or disease, it may be necessary to remove it surgically. The most common procedures are evisceration (removal of the contents of the eye) or enucleation (removal of the eye itself). Eye spheres are permanent implants to occupy the cavity that results from surgery. Conformers are temporary devices, which maintain the shape of the eye and prevent closure or adhesion during the healing process. When healing is complete, conformers are replaced with prosthesis. Eye Spheres and Conformers are made of polymethylmethacrylate (PMMA), a hard, clear plastic that is lightweight, inert and virtually unbreakable. Eye spheres are available in even diameters from 10mm through 22mm. Conformers are available in three sizes: small, medium, large. Conformers may be ordered with or without holes. Eye spheres and Conformers are FDA Class II products.
Intended Use:
Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)
Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process
2
Product and
Educational Services LLC
ருப்
.
.
echnological Characteristics of the Device Compared to the Predicate Devices
| Manufacturer | Gulden Ophthalmics
Eye Spheres - Non Sterile
Conformers - Non Sterile
Gulden Ophthalmics | Gulden Ophthalmics
Eye Spheres – Sterile
Conformers – Sterile
Gulden Ophthalmics | Product and Educational
Services LLC
Eye Spheres - Sterile
Conformers - Non Sterile
Product and Educational
Services LLC |
|---------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | Pre-amendment | K972661 | New |
| FDA Product Class | Class II | Class II | Class II |
| Intended Population | Pediatric and Adult | Pediatric and Adult | Pediatric and Adult |
| Material | Polymethylmethacrylate
(PMMA) | Polymethylmethacrylate
(PMMA) | Polymethylmethacrylate
(PMMA) |
| Size Range (mm) –
Eye Sphere | 10, 12, 14, 16, 18, 20, and
22 mm | 10, 12, 14, 16, 18, 20, and
22 mm | 10, 12, 14, 16, 18, 20, and
22 mm |
| Size Range –
Conformers | Small, Medium, Large
(with and without holes) | Small, Medium, Large
(with and without holes) | Small, Medium, Large
(with and without holes) |
| Method of
sterilization | None | EtO (100%) and Gamma
Sterilization | Gamma Sterilization only |
3
Image /page/3/Picture/0 description: The image shows the logo for Product and Educational Services LLC. The logo consists of the letters 'FES' in a stylized font, with the words 'Product and Educational Services LLC' to the right of the letters. The text is in a simple, sans-serif font and is black in color. The logo is simple and professional in appearance.
Non-Clinical Tests:
Product and Educational Services LLC (PES) Eye Spheres and Conformers are the same Eye Spheres and Conformers manufactured and marketed by Gulden Ophthalmics as "non sterile". The only difference is that PES will be providing the same Eye Spheres and Conformers as sterile, single use devices. Gulden Ophthalmics Eye Spheres and Conformers are "preamendment" devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Product and Educational Services, LLC PA Biotechnology Center of Bucks County Mr. Edward T. Griffith President 3805 Old Easton Road Doylestown, PA 18902
FEB 2 7 2009
Re: K082850
Trade Name: Eye Spheres and Conformers Regulation Number: 21 CFR 886.3320 Regulatory Class: II Product Code: HPZ, HQN Dated: February 12, 2009 Received: February 17, 2009
Dear Mr. Griffith:
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.
5
Page 2 -- Mr. Edward T. Griffith
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from 1 the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
M.B. Egleston, MD
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
6
Indications for Use
510(k) Number (if known): K082850
Device Name: Eye Spheres and Conformers
Indications for Use:
Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration)
Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Qoncurrence of CDRH, Office of Device Evaluation (ODE)
Z
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
KO 82850 510(k) Number
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