(186 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of the implant, with no mention of AI or ML.
Yes
The device is intended for the treatment of protracted or permanent lagophthalmos resulting from facial paralysis, indicating a therapeutic purpose.
No
Explanation: The device description states that the Gold and Platinum Tapered Weight Eyelid Implants are "implantable devices for the gravity-assisted treatment of lagophthalmos by the addition of weight to the upper eyelid." This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "implantable device" made of gold or platinum, which are physical materials, not software. The performance studies also focus on physical properties like MR compatibility, biocompatibility, sterilization, and shelf life, further indicating a hardware device.
No, 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 for diagnosis, monitoring, or screening.
- Device Function: The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices that physically add weight to the eyelid to treat a condition (lagophthalmos). They do not analyze any biological samples.
- Intended Use: The intended use clearly states it's for the "gravity-assisted treatment" of lagophthalmos, which is a mechanical function, not a diagnostic one.
The device description and intended use clearly indicate it's a therapeutic implant, not a diagnostic tool.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NCB
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper eyelid
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)
MRI Safety Review:
- MRI Related force testing: 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). Showed a 2° deflection for both the gold and platinum samples. Torque testing showed a result of 0 (no torque) for the 2.8g Gold and Platinum Eyelid Weight Implants.
- MRI Related Heating evaluation: Conducted using methods outlined in ASTM F2182-11a. 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.
- MRI Related artifact testing: Conducted using methods outlined in ASTM F2119-07. 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.
Biocompatibility: Established by a review of existing data and test results in accordance with ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-18:2020. Included chemical characterization (leachable test) and cytotoxicity testing.
Sterility and Shelf-life:
- Sterilization: Ethylene Oxide (EO) sterilization in accordance with ISO 11135-1:2007. Sterility Assurance Level of 10-6.
- Shelf life: Established at five years based on accelerated aging. Functional performance (dimensional and visual inspection) verified. Package integrity testing conducted in accordance with ASTM F1929-15:2015, ASTM F1886-16:2017, ASTM F88/F88M15:2016, and ASTM F2096-11: 2019.
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.
K011740, K983607, K000127, K170591, K011115
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
§ 886.5700 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.
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 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
1
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
2
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 Armand
75015 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 Implants
Platinum 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)
4
- 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 Tapered | |||
| Weight Eyelid Implants | MedDev Corporation | ||
| Contour™ and | |||
| ThinProfile™ Eyelid Weight | |||
| Implants | |||
| (K150986) | |||
| Similarities | |||
| Intended use | Gravity-assisted treatment | ||
| for lagophthalmos | Gravity-assisted treatment | ||
| for lagophthalmos | Identical | ||
| Indications for | |||
| use | GOLD AND PLATINUM | ||
| EYELID WEIGHT | |||
| IMPLANTS are intended | |||
| for the gravity assisted | |||
| treatment of lagophthalmos, | |||
| usually resulting from | |||
| facial paralysis. | MedDev Contour™ and | ||
| ThinProfile™ Eyelid Weight | |||
| Implants are designed for the | |||
| gravity-assisted treatment of | |||
| protracted or permanent | |||
| lagophthalmos, usually | |||
| resulting from facial | |||
| paralysis. | Identical | ||
| Type of | |||
| device | Gold or platinum eyelid | ||
| weight | Gold or platinum eyelid | ||
| weight | 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:
6
| Aspect | Subject Device | Primary Predicate | Comments |
|---|---|---|---|
| Gold and Platinum Tapered | |||
| Weight Eyelid Implants | MedDev Corporation | ||
| ContourTM and | |||
| ThinProfileTM Eyelid Weight | |||
| Implants | |||
| (K150986) | |||
| 99.99% Purity Platinum | 99.99% Purity Platinum | Identical | |
| Sizes | Available in 7 sizes, 0.6 g | ||
| to 1.8 g, in 0.2 g | |||
| increments. | Available in 7 sizes, 0.6 g to | ||
| 1.8 g, in 0.2 g increments. |
Contour is also available in
larger sizes (2.0-2.8 g). | Identical for
standard sizes. |
| MR
Compatibility | MR Conditional | MR Conditional | Identical |
| Single-Use
Only | Yes | Yes | Identical |
| Differences | | | |
| Sterile unit
package | Packaged in double PETG
blister with Tyvek lid. | Packaged in double pouch
with Tyvek and PET lidding. | Different
packaging
configuration,
similar materials. |
| Sterilization
method | Ethylene Oxide | Moist Heat | Different,
both methods
sterilize to SAL
of 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.
7
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
8
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 vitro |
| cytotoxicity | |
| ISO 10993-18:2020 | Biological evaluation of medical devices -- Part 18: Chemical |
| Characterization of Medical Device Materials in a Risk Management | |
| Process |
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 | STERLAB |
| 2720 chemin Saint Bernard | |
| Vallauris, France 06224 | |
| Establishment Registration Number: 1000286794 | |
| Sterilization Chamber and Cycle | FCI products are sterilized in STERLAB's fixed cell N°6 with |
| cycle C6-S073 dedicated to FCI products. | |
| Maximum Levels of Sterilant (EO) Residuals | Ethylene Oxide (EO) 4.0µg/device |
| Ethylene chlorohydrin (ECH) 5.8 µg /device | |
| Bioburden Specification |