(186 days)
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.
This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.
However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.
| Category | Acceptance Criteria (typically from established standards or predicate performance) | Reported Device Performance (FCI Gold/Platinum Eyelid Implants) |
|---|---|---|
| MRI Safety | Device is "MR Conditional" under specified conditions (e.g., static field ≤ 3T, spatial gradient ≤ 4000 Gauss/cm, SAR ≤ 4 W/kg for 15 min). | MR Conditional: meets these conditions. |
| MRI-Related Force | Negligible deflection/torque in a 3T MR system. (e.g., 2° deflection or "0" on a 0-4 torque scale). Adherence to ASTM F2052-06. | Gold: 2° deflection, Torque "0". Platinum: 2° deflection, Torque "0". |
| MRI-Related Heating | Maximum temperature rise ≤ acceptable limits (e.g., usually <5°C for implants during 15 min scan). Adherence to ASTM F2182-11a. | Gold (2.8g): Max temperature rise of +2.0°C after 15 min. Platinum (2.8g): Max temperature rise of +2.3°C after 15 min. |
| MRI-Related Artifact | Image artifact extension to be reported. Adherence to ASTM F2119-07. | Gold (2.8g): Artifact extends ~5mm from device with gradient echo, 3T MR. Platinum (2.8g): Artifact extends ~10mm from device with gradient echo, 3T MR. |
| Biocompatibility | Meets requirements of ISO 10993 standards (e.g., no cytotoxicity, acceptable leachable levels, etc.). | Established through review of existing data, chemical characterization (leachable test), and cytotoxicity testing per ISO 10993-1, -5, -18. (Results implied as favorable for clearance). |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶. Ethylene Oxide (EO) residuals within acceptable limits. Meets ISO 11135-1:2007. Bioburden specification. | SAL 10⁻⁶ achieved via Ethylene Oxide sterilization. EO Residuals: EO 4.0µg/device, ECH 5.8 µg/device. Bioburden: < 100 CFU/device. |
| Shelf-Life | Functional performance maintained, and package integrity preserved over the claimed shelf life (e.g., 5 years) following accelerated aging. Adherence to ASTM standards for package integrity. | 5 years established via accelerated aging. Functional performance (dimensional, visual inspection) verified. Package integrity (visual, peel, dye, bubble leak) confirmed per ASTM F1929, F1886, F88/F88M, F2096. |
2. Sample Size for Test Set and Data Provenance
- MRI Safety: The testing was conducted using the largest sizes available in the market (2.8g) for both Gold and Platinum Eyelid Weight Implants. While the specific number of individual implants tested for each condition (force, heating, artifact) is not explicitly stated, it implies at least one sample of each type and weight was used for the respective tests. The provenance of the data is from non-clinical laboratory testing specific to the device.
- Biocompatibility: Not directly referenced as a "test set" in the traditional sense for diagnostic performance. It involved chemical characterization and cytotoxicity testing. The sample size for these tests (e.g., number of replicates, specimens) is not specified but would follow the requirements of the ISO 10993 standards. Data provenance is from laboratory testing.
- Sterility and Shelf-Life: The testing involved validation protocols based on standards like ISO 11135-1 and ASTM standards for package integrity. The sample sizes for these validation activities are not explicitly detailed but are typically defined by the respective standards (e.g., for bioburden, sterility validation, accelerated aging studies). Data provenance is from laboratory testing (in-house or contract sterilizer).
3. Number of Experts and Qualifications for Ground Truth
This document does not pertain to the diagnostic performance of an AI/ML device or a device requiring expert interpretation for its primary function. Therefore, there were no "experts used to establish ground truth" in the context of clinical outcomes or diagnostic accuracy. The ground truth for the non-clinical tests is based on objective measurements and adherence to established engineering and material science standards and protocols.
4. Adjudication Method
Not applicable, as this is not a study requiring human adjudication of clinical or diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is not a study assessing human reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable, as this is a physical medical implant, not an AI/ML algorithm.
7. Type of Ground Truth Used
The ground truth for the non-clinical tests described is based on:
- Objective Measurements: For MRI safety (deflection angles, temperature changes, artifact dimensions), sterility (SAL, residual levels), and shelf-life (dimensional stability, package integrity).
- Established Standards and Protocols: Adherence to international standards (ISO, ASTM) for methods, acceptance criteria, and measurement techniques.
- Material Characterization: For biocompatibility, the ground truth is based on the chemical composition of the materials and their known biological responses, validated by specific in-vitro tests (cytotoxicity, leachable tests).
8. Sample Size for Training Set
Not applicable, as this is not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as this is not an AI/ML algorithm requiring a training set.
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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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
June 11, 2021
FCI (France Chirurgie Instrumentation) SAS % Dennis Hahn, RAC Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati, OH 45220
Re: K203569
Trade/Device Name: Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants Regulation Number: 21 CFR 886.5700 Regulation Name: Eyelid Weight Regulatory Class: Class II Product Code: NCB Dated: April 30, 2021 Received: May 5, 2021
Dear Dennis Hahn:
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. 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.
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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LT Charles Chiang Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203569
Device Name
Gold Tapered Weight Eyelid Implant Platinum Tapered Weight Eyelid Implant
Indications for Use (Describe)
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Owner: | France Chirurgie Instrumentation SAS (FCI S.A.S.)20-22 rue Louis Armand75015 Paris, France |
|---|---|
| Telephone: +33 1 53 98 98 98 | |
| Facsimile: +33 1 53 98 98 99 | |
| Contact Person: | Dennis Hahn |
| Clinical Research Consultants, Inc. | |
| 3308 Jefferson Avenue | |
| Upper Level | |
| Cincinnati, OH 45220 | |
| Phone: (513) 961-8200 | |
| Facsimile: (513) 961-2858 | |
| E-Mail: dhahn@crc-regulatory.com |
Date: June 10, 2021
| Trade Name: | Gold Tapered Weight Eyelid ImplantsPlatinum Tapered Weight Eyelid Implants |
|---|---|
| Common name: | Implantable Eyelid Weights |
| Device Classification Regulation: | 886.5700 – Eyelid Weights |
| Classification Product Code: | NCB – Weights, Eyelid, Implantable |
Identification of a Legally Marketed Predicate Device
The FCI Gold and Platinum Tapered Weight Eyelid Implants are substantially equivalent to the Contour™ and ThinProfile™ Eyelid Weight Implants marketed by MedDev Corporation, 510(k) Premarket Notification Number: K150986, FDA Classification Product Code MML.
The following are included as reference devices for the purpose of sterilization and biocompatibility evaluation:
- Contour Gold Eyelid Weight Implants (MedDev Corporation) K011740: Labtician Lid Load Gold Eyelid Weight Implants (Labtician Ophthalmics, Inc.) K983607: Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10 K000127: (HEINZ KURZ GMBH MEDIZINTECHNIK K170591: Altomed Malhotra Platinum Segments (Altomed Limited)
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- K011115: Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 (HEINZ KURZ GMBH MEDIZINTECHNIK)
General Description
The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.
MRI Safety Information:
The Gold and Platinum Tapered Weight Eyelid Implants are "MR Conditional". A patient with this device can be safely scanned in an MR system meeting the following specific conditions:
- Static magnetic field of 3 Tesla or less; -
- Maximum spatial gradient magnetic field of 4,000 Gauss/cm (extrapolated) or less; -
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 - W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system;
- Under the scan conditions defined about, the Gold Tapered Weight Eyelid Implant is expected to produce a maximum temperature rise of 2.0℃ after 15 minutes of continuous scanning (i.e., per pulse sequence);
- Under the scan conditions defined about, the Platinum Tapered Weight Eyelid Implnt is expected to produce a maximum temperature rise of 2.3ºC after 15 minutes of continuous scanning.
Scanning in an MR system without meeting above-mentioned conditions could endanger the patient.
In non-clinical testing, the image artifact caused by the Gold and Platinum Tapered Weight Eyelid Implants extends respectively 5mm and 10mm from the device when imaged using a gradient echo pulse sequence and a 3 tesla MR system.
Indications for Use
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
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Comparison of Technological Characteristics
The FCI Gold Tapered Weight Eyelid Implants and Platinum Tapered Weight Eyelid Implants are identical, or nearly identical, in every respect to the MedDev Contour™ and ThinProfile™ Eyelid Weights except for the sterilization method. The FCI devices are sterilized by ethylene oxide, whereas the MedDev devices are sterilized by moist heat (steam). Both sterilization methods sterilize to SAL 106, and the finished devices are each provided as sterile products for permanent implantation in the eyelid for gravity-assisted treatment of lagophthalmos.
The cited reference devices [Labtician Lid Load Gold Eyelid Weight Implants (K983607), Kurz Pure Gold Upper Eyelids Implant (K000127), Altomed Malhotra Platinum Segments (K170591), and Kurz Upper Eyelid Implant- Platinum/Iridium,Models (K011115)] are all sterilized by ethylene oxide.
The FCI and predicate MedDev eyelid weight implants are each manufactured from 99.99% purity gold or from 99.99% purity platinum and are available in seven different weights ranging from 0.6g to 1.8g (in 0.2 g increments). The 99.99% purity gold and platinum materials used in each device are medical grade with well characterized mechanical and biocompatibility properties.
| Aspect | Subject Device | Primary Predicate | Comments |
|---|---|---|---|
| Gold and Platinum TaperedWeight Eyelid Implants | MedDev CorporationContour™ andThinProfile™ Eyelid WeightImplants(K150986) | ||
| Similarities | |||
| Intended use | Gravity-assisted treatmentfor lagophthalmos | Gravity-assisted treatmentfor lagophthalmos | Identical |
| Indications foruse | GOLD AND PLATINUMEYELID WEIGHTIMPLANTS are intendedfor the gravity assistedtreatment of lagophthalmos,usually resulting fromfacial paralysis. | MedDev Contour™ andThinProfile™ Eyelid WeightImplants are designed for thegravity-assisted treatment ofprotracted or permanentlagophthalmos, usuallyresulting from facialparalysis. | Identical |
| Type ofdevice | Gold or platinum eyelidweight | Gold or platinum eyelidweight | Identical |
| Material | 99.99% Purity Gold | 99.99% Purity Gold | Identical |
The following table summarizes the similarities and differences between the FCI and MedDev predicate device:
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| Aspect | Subject Device | Primary Predicate | Comments |
|---|---|---|---|
| Gold and Platinum TaperedWeight Eyelid Implants | MedDev CorporationContourTM andThinProfileTM Eyelid WeightImplants(K150986) | ||
| 99.99% Purity Platinum | 99.99% Purity Platinum | Identical | |
| Sizes | Available in 7 sizes, 0.6 gto 1.8 g, in 0.2 gincrements. | Available in 7 sizes, 0.6 g to1.8 g, in 0.2 g increments.Contour is also available inlarger sizes (2.0-2.8 g). | Identical forstandard sizes. |
| MRCompatibility | MR Conditional | MR Conditional | Identical |
| Single-UseOnly | Yes | Yes | Identical |
| Differences | |||
| Sterile unitpackage | Packaged in double PETGblister with Tyvek lid. | Packaged in double pouchwith Tyvek and PET lidding. | Differentpackagingconfiguration,similar materials. |
| Sterilizationmethod | Ethylene Oxide | Moist Heat | Different,both methodssterilize to SALof 10-6. |
Special Controls
The subject devices meet all the requirements of the Special Controls for these devices as published in the Federal Register (Vol 79, Num 76, pages 22012 - 16) on April 21, 2014.
Brief Summary of Non-Clinical Tests and Results
The following summarizes the testing conducted to address MR compatibility, biocompatibility, sterilization and shelf life for the Gold and Platinum Tapered Weight Eyelid Implants.
1. MRI Safety Review
To support the claim of "MR-Conditional," the testing demonstrated that the implants are conditionally safe when exposed to a static magnetic field of 3-Tesla or less. MR safety testing was conducted with the Gold and Platinum Eyelid Weight Implants in the largest sizes available in the market of 2.8g.
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a. MRI Related force
MRI Related force testing was conducted using a method similar to ASTM F2052- 06:2006, (a 3-Tesla (T) GE Excite MRI scanner at a location where the spatial gradient is 720 gauss/cm and the field strength is 2.7 T), which showed a 2° deflection for both the gold and platinum samples. Torque testing was conducted using a test apparatus with the Eyelid Implant, (2.8g Gold and Platinum), positioned in the center of the MR system. The Eyelid Implant was directly observed for possible movement with respect to the alignment of rotation relative to the static magnetic field of the 3-Tesla MR system. The following qualitative scale of torque was applied to the results: 0 (no torque) up to +4 (very strong torque). A result for the 2.8g Gold and Platinum Eyelid Weight Implants in both the long and short axis was 0.
b. MRI Related Heating
MRI Related Heating evaluation was conducted using methods outlined in ASTM F2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging." The Eyelid Implant with thermometry probes attached was placed in the gel-filled phantom. The implant test assembly was exposed to a 3-Telsa field for 15 minutes with temperatures recorded in 4- second intervals. The resulting maximum measured temperature change for the 2.8g Gold Eyelid Weight Implant was +2.0° C. For the 2.8g Platinum Eyelid Weight Implant the maximum was +2.3° C.
c. MRI Related artifact
MRI Related artifact testing was conducted using methods outlined in ASTM F2119-07, "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants". The 2.8g Gold and Platinum Eyelid Weight Implants were tested separately. Each Eyelid Implant was subjected to a 3-Tesla MR system and pulse sequences commonly used for MR imaging. For the Gold 2.8g Eyelid Weight Implant the image artifact extends approximately 5-mm from the device when imaged using a gradient echo pulse sequence and a 3-Telsa MR system. For the Platinum 2.8g Eyelid Weight Implant the image artifact extends approximately 10-mm from the device when imaged using a gradient echo pulse sequence and a 3-Telsa MR system.
2. Biocompatibility
Biocompatibility of the Gold and Platinum Tapered Weight Eyelid Implants was established by a review of existing data and test results. The materials used in the implants and materials used in the manufacturing processes were reviewed for available toxicity and bioavailability data for each chemical component, and a justification for the tests conducted to evaluate all potential toxic end points was completed. Implant materials testing included a chemical characterization
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of materials (leachable test) and cytotoxicity testing. Biocompatibility testing was conducted in in accordance with:
| ISO 10993-1:2009 | Biological evaluation of medical devices – Part 1: evaluation and tests |
|---|---|
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-18:2020 | Biological evaluation of medical devices -- Part 18: ChemicalCharacterization of Medical Device Materials in a Risk ManagementProcess |
3. Sterility and Shelf-life
a. Sterilization
The Gold and Platinum Tapered Weight Eyelid Implants are distributed as a packaged, sterile device. The Gold and Platinum Tapered Weight Eyelid Implants are sterilized by ethylene oxide (EO) in the sealed packaging (double Tyvek blister). EO is an established Category A Method, in accordance with ISO 11135-1:2007 Sterilization of health care products --Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. A summary of the sterilization and sterilizer information required for 510(k) submissions for devices labeled as sterile per the FDA Guidance for Industry and Staff: Submission and Review of Sterility Information is provided below.
| Sterilization Method | Ethylene Oxide |
|---|---|
| Contract Sterilization Site | STERLAB2720 chemin Saint BernardVallauris, France 06224Establishment Registration Number: 1000286794 |
| Sterilization Chamber and Cycle | FCI products are sterilized in STERLAB's fixed cell N°6 withcycle C6-S073 dedicated to FCI products. |
| Maximum Levels of Sterilant (EO) Residuals | Ethylene Oxide (EO) 4.0µg/deviceEthylene chlorohydrin (ECH) 5.8 µg /device |
| Bioburden Specification | < 100 CFU/device |
| Validation Method | Half-cycle |
| Minimum Aeration Time | 5 Days |
| Sterility Assurance Level | 10-6 |
| FDA Recognized Standards Applied | AAMI/ANSI/ISO 10993-7 - Biological Evaluation of MedicalDevices - Part 7:Ethylene Oxide Sterilization Residuals.ISO 11135-1:2007 - Sterilization of health care products -- Ethyleneoxide -- Part 1: Requirements for development, validation and routinecontrol of a sterilization process for medical devicesISO 11138-1:2006 - Sterilization of health care products -- Biologicalindicators -- Part 1: General requirementsISO 10993-7:2008 - Biological evaluation of medical devices -- Part7: Ethylene oxide sterilization residuals |
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b. Shelf life
Shelf life of the Gold and Platinum Tapered Weight Eyelid Implants has been established at five years based on accelerated aging. The functional performances of the device (dimensional and visual inspection) have been verified through the tests conducted before and after the aging; the device transport testing was conducted in accordance with the standard ISTA 3A, and package integrity (visual integrity, peel strength, dye penetration and bubble leak test) was conducted. Package integrity testing was conducted in accordance with:
ASTM F1929-15:2015 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1886-16:2017 - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F88/F88M15:2016 - Test Method for Seal Strength of Flexible Barrier Materials
ASTM F2096-11: 2019 - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
Basis of Substantial Equivalence
The FCI Gold and Platinum Tapered Weight Eyelid Implants are substantially equivalent to the MedDev Contour™ Eyelid Weight Implants and ThinProfile™ Eyelid Weight Implants in intended use and indications for use, basic design concept, materials (gold and platinum), dimensions, and manufacturing processes, with the primary difference being that the FCI Gold and Platinum Tapered Weight Eyelid Implants are sterilized by ethylene oxide; whereas, the predicate MedDev eyelid weight implants are sterilized by moist heat (steam), both of which sterilize to SAL 106. The FCI Gold and Platinum Tapered Weight Eyelid Implants are manufactured by FCI and distributed in the U.S.A. by FCI Ophthalmics, Inc. The Contour™ Eyelid Weight Implants and ThinProfile™ Eyelid Weight Implants are manufactured and distributed in the U.S.A.by MedDev Corporation.
§ 886.5700 Eyelid weight.
(a)
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b)
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.