(79 days)
No
The device description and intended use are for physical implants and temporary devices used in eye surgery, with no mention of software, data processing, or AI/ML terms.
No
The devices are used to maintain the shape of the eye or occupy the eye cavity after surgical removal, which are structural and cosmetic purposes, not therapeutic (treating a disease or condition).
No
The device, consisting of eye spheres and conformers, is described as permanent implants or temporary devices used to occupy or maintain the shape of the eye cavity after surgical removal of the eye or its contents, or during the healing process. Its purpose is structural and supportive, not to diagnose a medical condition.
No
The device description clearly states that the devices are physical implants (Eye Spheres) and temporary physical devices (Conformers), not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that these devices are implants (Eye Spheres) and temporary devices (Conformers) that are placed within the eye cavity. They are used to physically occupy space, maintain shape, and prevent adhesion during healing.
- Lack of Testing: There is no mention of any testing being performed on samples from the body. The devices themselves are the treatment/support mechanism, not a tool for diagnosis through laboratory analysis.
The intended use and device description clearly indicate that these are surgical implants and temporary support devices, not diagnostic tools that analyze biological samples.
N/A
Intended Use / Indications for Use
Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.
Product codes
86HP7, 86HON
Device Description
Eye Spheres: 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: Conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process.
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)
Assessment of non-clinical performance data for equivalence: The Gulden Ophthalmics "sterile" eye spheres and "sterile" conformers are exactly the same as the eye spheres and conformers sold as "non-sterile" by Gulden Ophthalmics. Gulden supplies Storz Instruments with Gulden's "non-sterile" eve spheres and conformers. Storz Instruments sterlizes these products with Ethylene Oxide (EtO) and distributes them as "sterile". Gulden proposes to offer for sale the same eye spheres and conformers as sterile.
Assessment of clinical performance data for equivalence: Not applicable. These products have been in commercial distribution since before July 1976 and are generally regarded as safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pre-amendment, K921106
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
OCT - 3 1997
as required per 807.92(c)
2: Submitters Name, Address:
Gulden Ophthamics, Inc 225 Cadwalader Drive Elkins Park, Pa 19027
Date submission was prepared: July 7, 1997 Establishment Registration Number: 2519410
Telephone: (215) 884-8105 Fax: (215) 884-0418 Official Correspondent: Mr. Thomas Cockley
3: Trade Name, Common Name and Classification Name:
A. Trade Name:
Eye Sphere - Sterile Conformer - Sterile B. Common Name, Classification Number, Class and Regulation Number,
(
| ommon Name | f
t
lassification Number | Jase | Number
egulation 1 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------|-----------------------|
| Implant
Hve
Sphere | 86HP7 | | 000 9900
600-332 |
| onrormer,
ophthalmic
A CONSULT LA A LA LE LE LE LE LE LE LE LE LA LA LE LA LE LA LEA LE LA LA LA LEA LE LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA LA L | 86HON | | 886,3130 |
4: Predicate Device Identification:
Eye Sphere - Non Sterile Eye Sphere - Sterile Conformers - Non Sterile Conformers - Sterile
ﺳﮯ
Gulden Ophthalmics, Elkins Park, PA Storz Instruments, St. Louis, Mo Gulden Ophthalmics, Elkins Park, PA Storz Instruments, St. Louis, Mo
Pre-amendment K921106 Pre-amendment K921106
:
5. Device Description:
:
Eye Spheres: 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: Conformers are temporary devices that maintain the shape of the eye and prevent closure or adhesion during the healing process. 1
6. Intended Use:
Eye Spheres: To occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: To maintain the shape of the eye and prevent closure or adhesion during the healing process.
1
| 7. Table of device similarities and differences to predicate device | ||
|---|---|---|
| 4 (4 ступравленные продавления при при при при приведение при полнение пристементительности по полнение пристементительности по полнением пристем в политические по политическ |
| | Substantial Equivalence
Gulden Ophthalmics
Eye Spheres - Non Sterile
Conformers - Non Sterile | Substantial Equivalence
Storz Ophthalmics
Eye Spheres - Sterile
Conformers - Sterile | Gulden Ophthalmics
Eye Spheres - Sterile
Conformers - Sterile |
|--------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Manufacturer | Gulden Ophthalmics | Manufactured for Storz
Instruments by Gulden
Ophthalmics | Gulden Ophthalmics |
| 510K Number | Pre-amendment | K921106 | New |
| FDA Product Class | Class II | Same | Same |
| Intended Population | Pediatric and Adult | Same | Same |
| Material | Polymethylmethacrylate
(PMMA) | Same | Same |
| Size Range - Eye spheres | 8, 10, 12, 14, 16, 18, 20
and 22 mm | Same | Same |
| Size Range - Conformers | Small, Medium, Large | Same | Same |
| Method of sterilization | None | EtO (88%) | EtO(100%) and
Gamma Sterilization |
-
Assessment of non-clinical performance data for equivalence: The Gulden Ophthalmics "sterile" eye spheres and "sterile" conformers are exactly the same as the eye spheres and conformers sold as "non-sterile" by Gulden Ophthalmics. Gulden supplies Storz Instruments with Gulden's "non-sterile" eve spheres and conformers. Storz Instruments sterlizes these products with Ethylene Oxide (EtO) and distributes them as "sterile". Gulden proposes to offer for sale the same eye spheres and conformers as sterile.
-
Assessment of clinical performance data for equivalence: Not applicable. These products have been in commercial distribution since before July 1976 and are generally regarded as safe.
-
Biocompatability: PMMA: Generally Regarded as Safe
Exposure Time
Post Vacuum
Aeration time
11. Sterilization:
A. ETO. 100% Ethylene Oxide 130 +5 °F / + 3 ° C Temperature Pre-Vacuum 24" - 26" inHg / 610 - 660 mmHg Relative Humidity 60 + 10 % RH Humidity Dwell Sterilant Gas EO Concentration
30 - 45 minutes Ethylene Oxide, 100% 600 + 30 mg/l 2 hours + 5 minutes 24" - 26" / 610 - 660 mmHg (2 times) Mechanical Aeration temp. 110 - 124 ° F / 43 - 51° C 48 Hours (minimum) 72 Hours (Recommended)
2
K9726le1
、
- B. Gamma Radiation
- Bioburden Studies per ANSI/AAMI/ISO 11737-1-1995, "Sterilization of Medical devicesl . Microbiological Methods-Part 1: Estimation of population of microorganisms on product" AAMI Method 1
- Gamma Sterilization at dose validated by bioburden studies 2.
- Each lot to be validated rather than routine monitoring studies. 3.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines or shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Cockley President Gulden Ophthalmics 225 Cadwalader Avenue Elkins Park, PA 19117-2097
OCT - 3 1997
Re: K972661
Trade Name: Eye Sphere and Conformer Regulatory Class: II Product Code: 86 HPZ and 86 HQN Dated: July 7, 1997 Received: July 16, 1997
Dear Mr. Cockley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Thomas Cockley
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indicated Use Statement
Eye Spheres: 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: Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process.
Danne lochner
(Division Sign-Off)
Division of Ophthalmic Devices K972661 510(k) Number _
Prescription Use. (Per 21 CFR 801.109)