(79 days)
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.
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.
This 510(k) submission, K972661, for the Gulden Ophthalmics Eye Sphere and Conformer, is a traditional submission, not a submission for an AI/ML powered device. As such, it does not include information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications for ground truth establishment, or comparative effectiveness studies (e.g., MRMC studies) typically found in AI/ML device submissions.
The submission focuses on establishing substantial equivalence to predicate devices based on design, materials, sterilization methods, and intended use.
Here's a breakdown of the information provided, tailored to the questions where applicable, and noting where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
This information is not applicable and not provided in the 510(k) summary because this is a traditional medical device submission, not an AI/ML powered device. The "performance" assessment is based on demonstrating substantial equivalence to legally marketed predicate devices, not on quantitative performance metrics against pre-defined acceptance criteria. The key assessment here is that:
- The "sterile" eye spheres and conformers are identical to the "non-sterile" versions already sold by Gulden Ophthalmics.
- The "sterile" versions are sterilized by methods (EtO and Gamma) that are considered safe and effective and are used for similar predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The submission does not involve a "test set" in the context of evaluating an algorithm's performance on data. The assessment is based on the device's physical characteristics, materials, and manufacturing processes, and its equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. "Ground truth" in the context of expert consensus on a test set is not relevant for this type of device submission. The assessment relies on established medical device regulations and industry standards for manufacturing, materials, and sterilization.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on ground truth, which is not part of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic performance, often for AI-assisted systems, which is not the nature of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical implant/conformer, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided. The concept of "ground truth" as used in AI/ML evaluation does not apply to this device. The basis for substantial equivalence is primarily historical use and accepted safety profiles of the materials (PMMA) and the predicate devices, along with validated sterilization methods. The submission explicitly states: "Not applicable. These products have been in commercial distribution since before July 1976 and are generally regarded as safe." This indicates reliance on long-standing clinical experience and regulatory classification rather than a formal ground truth evaluation.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for this physical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no "ground truth for the training set" for this physical device.
Summary of Acceptance Criteria and Study for K972661:
Since this is not an AI/ML device, the "acceptance criteria" discussed are largely based on demonstrating substantial equivalence to already legally marketed predicate devices and adherence to established manufacturing and sterilization standards.
Acceptance Criteria & Reported Device Performance (as inferred from the 510(k) submission):
| Acceptance Criteria (Inferred) | Reported Device Performance / Justification |
|---|---|
| Material Equivalence: Material must be the same as predicate device. | Meets Criteria: Device is made of Polymethylmethacrylate (PMMA), which is the same material as the predicate devices (Gulden Ophthalmics "non-sterile" Eye Spheres/Conformers and Storz Instruments "sterile" Eye Spheres/Conformers). PMMA is "Generally Regarded as Safe" (GRAS). |
| Design Equivalence: Device design (size range, shape) must be the same as predicate device. | Meets Criteria: Eye Spheres have size range 8-22 mm, Conformers have Small, Medium, Large, identical to predicate devices. The physical dimensions and form are stated to be "exactly the same" as Gulden's "non-sterile" versions, which are supplied to Storz as predicate. |
| Intended Use Equivalence: Intended use must be same as predicate device. | Meets Criteria: Intended Use for Eye Spheres (occupy eye cavity after enucleation/evisceration) and Conformers (maintain eye shape, prevent closure/adhesion during healing) is identical to predicate devices. |
| Sterilization Efficacy & Safety: Sterilization methods must be validated to ensure sterility and not compromise device safety/function. | Meets Criteria: Sterilization is performed using Ethylene Oxide (EtO) and Gamma Radiation. Both methods are validated: - EtO: Process parameters (temperature, humidity, EO concentration, time, aeration) are specified and align with accepted practices. - Gamma Radiation: Bioburden studies (per ANSI/AAMI/ISO 11737-1-1995) are conducted, and each lot is validated by bioburden studies. Predicate device (Storz) uses EtO for sterilization. |
| Biocompatibility: Device materials must be biocompatible. | Meets Criteria: PMMA is "Generally Regarded as Safe." This indicates prior successful use in medical devices and established biocompatibility. |
Study to Prove Acceptance Criteria:
The "study" in this context is not a clinical trial or an AI algorithm validation study. Instead, it's a demonstration of substantial equivalence based primarily on:
- Direct Comparison to Predicate Devices: The submission explicitly states the new sterile devices are "exactly the same" as the "non-sterile" versions already marketed by Gulden, which are themselves predicates for the sterile versions (via Storz Instruments). This includes material, size, and intended use.
- Regulatory History and Accepted Practice: The devices (Eye Spheres and Conformers made of PMMA) have been in "commercial distribution since before July 1976 and are generally regarded as safe." This demonstrates a long history of safe and effective use.
- Sterilization Validation: The sterilization processes (EtO and Gamma Radiation) are validated according to recognized standards (e.g., ANSI/AAMI/ISO 11737-1-1995 for bioburden studies for gamma sterilization). These validations ensure that the sterilization effectively renders the device sterile without adversely affecting its material properties or safety.
In essence, the "study" is a technical and regulatory justification of equivalence to devices with a well-established history of safety and effectiveness, coupled with validated manufacturing processes for sterility.
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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 | ftlassification Number | Jase | Numberegulation 1 |
|---|---|---|---|
| ImplantHveSphere | 86HP7 | 000 9900600-332 | |
| onrormer,ophthalmicA 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.
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| 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 EquivalenceGulden OphthalmicsEye Spheres - Non SterileConformers - Non Sterile | Substantial EquivalenceStorz OphthalmicsEye Spheres - SterileConformers - Sterile | Gulden OphthalmicsEye Spheres - SterileConformers - Sterile | |
|---|---|---|---|
| Manufacturer | Gulden Ophthalmics | Manufactured for StorzInstruments by GuldenOphthalmics | 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, 20and 22 mm | Same | Same |
| Size Range - Conformers | Small, Medium, Large | Same | Same |
| Method of sterilization | None | EtO (88%) | EtO(100%) andGamma 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)
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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.
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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.
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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
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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)
Company Confidential
§ 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.