(125 days)
Not Found
No
The device is a passive implant that uses gravity for its function. There is no mention of any computational or learning components.
Yes
The device is designed for the "gravity-assisted treatment of protracted or permanent lagophthalmos," which indicates a therapeutic purpose to alleviate a medical condition.
No
Explanation: The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the treatment of lagophthalmos by providing gravitational assistance for eyelid closure. They are therapeutic devices, not diagnostic ones, as they do not identify or analyze a medical condition but rather treat it.
No
The device is a physical implant made of gold or platinum, surgically placed in the eyelid. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. Their function is purely mechanical – to provide weight to assist in closing the eyelid. They do not analyze or test any biological samples.
- Intended Use: The intended use is the "gravity-assisted treatment of protracted or permanent lagophthalmos," which is a physical condition. It does not involve any diagnostic testing.
The information provided clearly describes a surgically implanted medical device used for a physical treatment, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed 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)
MML
Device Description
MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis.
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
Contour™ Eyelid Weight Implants feature a proprietary three-dimensional design that conforms to the curvature of the ocular globe. They are sized according to weight from 0.6g to 2.8g. They all have suture holes to assist in implantation.
MedDev's ThinProfile™ Eyelid Weight Implants are thinner than the Contour™ implants. The ThinProfile's reduced thickness provides improved eyelid cosmesis while providing the same effectiveness as our proven Contour™ implant. The ThinProfile™ Eyelid Weight Implant features a proprietary three-dimensional curvature. They are sized according to weight from 0.6g to 1.8g. They all have suture holes to assist in implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
This premarket notification is being submitted to provide FDA clearance for MR conditional labeling and to demonstrate compliance with the new Special Controls for implantable eyelid weights. No other changes from the predicate to the application device are being made. As a result only biocompatibility, sterility, shelf-life and MR compatibility data are necessary to demonstrate substantial equivalence.
i. 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 Contour™ Eyelid Weight Implants in the largest available sizes of 2.8g.
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 Contour™ Eyelid Weight Implants), 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 Contour™ 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 4second intervals. The resulting maximum measured temperature change for the 2.8g Gold Contour™ Eyelid Weight Implant was +2.0° C. For the 2.8g Platinum Contour™ 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 Contour™ 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 Contour™ 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 Contour™ 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.
ii. Biocompatibility
Biocompatibility of the Gold and Platinum Contour™ and ThinProfile™ Eyelid Weight 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 Cytotoxicity MEM Elution test along with a Chemical Characterization of Materials (leachable test). The Cytotoxicity MEM Elution testing was conducted in accordance with:
- ISO 10993-1:2003 "Biological evaluation of medical devices -- Part 1: Evaluation ● and testing"
- ISO 10993-5:1999 "Biological evaluation of medical devices -- Part 5: Tests for ● in vitro cytotoxicity"
- ISO 10993-12:2007 "Biological evaluation of medical devices -- Part 12: Sample ● preparation and reference materials"
- United States Pharmacopeia 32 & National Formulary 27. 2009. Biological Reactivity Tests, In Vitro
- United States Pharmacopeia 32 & National Formulary 27. 2009. The Biocompatibility of Materials Used in Drug containers, Medical Devices, and Implants
- Nelson Labs SOP STP0032 R4 (2009) MEM Elution .
The leachable test and the inductively-coupled plasma atomic emission spectrometer (ICP-AES) analysis were conducted in accordance with:
- ANSI/AAMI/ISO 10993-12:2012 "Biological evaluation of medical devices -Part 12: Sample preparation and reference materials"
- ANSI/AAMI/ISO 10993-17:2012 "Biological evaluation of medical devices -Part 17: Establishment of allowable limits for leachable substances"
- ANSI/AAMI BE83:2006 (R2011). Part 18: "Chemical characterization of ● materials"
- Nelson Labs SOP STP0181 R2 (2015)– Chemical Characterization of Materials ●
- ASTM E1097-12 "Standard Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry"
- . METL SOP QA manual 11.0-CHE1/ CHE11
The final report concludes that the MedDev Eyelid Weight Implants are biocompatible as defined by ISO 10993-1:2009.
iii. Sterility and Shelf-life
Sterilization validation and packaging validation (shelf life) were completed in accordance with ISO 11607:2006 "Packaging for Terminally Sterilized Medical Devices" and in context of ISO 13485:2003 "Medical devices - Quality management systems"
a. Sterilization
Sterilization validation was completed in accordance with ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products-Moist heat-Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" which demonstrates that the devices could be moist heat sterilized to a Sterility Assurance Level of 106. The validation approach was based on the use of biological indicators (BI Spore Strips) in a half-cycle "overkill" method. The validation protocol includes an installation, operational, and performance qualification; and the demonstration of sterility assurance.
b. Shelf life
The shelf life testing included real time aging, distribution simulation, visual inspection, bubble leak testing, and seal strength testing. The shipping configuration and packaging integrity were tested at the completion of real-time aging of 36 months in accordance with:
- . ASTM D4169-05 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- . ASTM F1886-98 "Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection"
- ASTM F2096-04 "Standard Test Method for Detecting Gross leaks in Medical Packaging by Internal Pressurization (Bubble Test)"
- . ASTM F88-06 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
Other reviews included:
- Seal Strength Test Capability index study
- . A review of product's functionality and examination for physical damage at the completion of the packaging integrity testing
- . Testing and validation of the microbial barrier performance for Tyvek®, manufactured by DuPont™, demonstrate an effective barrier for up to five years. Testing standards used by DuPont™:
- ASTM F1608-00(2009) "Standard Test Method for Microbial Ranking of . Porous Packaging Materials (Exposure Chamber Method)"
- . ASTM F2638-12 "Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier"
The completed testing confirmed the integrity of the sterile barrier and packaging for a period of 36 months.
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
§ 886.5700 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2015
MedDev Corporation Ms. Eileen Ho 730 North Pastoria Ave. Sunnyvale, CA 94085
Re: K150986
Trade/Device Name: Contour™ Eyelid Weight Implants ThinProfile™ Eyelid Weight Implants Regulation Number: 21 CFR 886.5700 Regulation Name: Implantable Eyelid Weight Regulatory Class: Class II Product Code: MML Dated: July 8, 2015 Received: July 9, 2015
Dear Ms. Ho:
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. 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.
1
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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -A
for 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
2
Indications for Use
510(k) Number (if known) K150986
Device Name Contour Eyelid Weight Implants ThinProfile Eyelid Weight Implants
Indications for Use (Describe)
The MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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510(k) Summary
| A. Device Information: | |
|---|---|
| Category | Comments |
| Sponsor / Submitter: | MedDev Corporation |
| 730 North Pastoria Ave | |
| Sunnyvale, CA 94085 | |
| Contact: Patrick Grey, COO | |
| 408-730-9702 | |
| Pat@meddev-corp.com | |
| Correspondent Contact | |
| Information: | Eileen Ho |
| MedDev Corporation | |
| 730 North Pastoria Ave | |
| Sunnyvale, CA 94085 | |
| 408-730-9702 | |
| eho@meddev-corp.com | |
| Device Common Name: | Implantable Eyelid Weight |
| Device Classification Number: | 21 CFR 886.5700 |
| Eyelid Weight | |
| Device Classification & | |
| Product Code: | Class II |
| MML | |
| Device Proprietary Name: | Contour™ Eyelid Weight Implants |
| ThinProfile™ Eyelid Weight Implants |
A Device Information:
Predicate Device Information:
| Predicate Device: | Contour Eyelid Implant Weights |
|---|---|
| Predicate Device Manufacturer: | MedDev Corp |
| Predicate Device Common Name: | Implantable Eyelid Weights |
| Predicate Device Premarket Notification # | K011740 |
| Predicate Device Classification: | 21 CFR 886.5700 |
| Predicate Device Classification & | Class II, |
| Product Code: | MML |
B. Date Summary Prepared
05 August 2015
C. Description of Device
MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis.
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can
4
use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
Contour™ Eyelid Weight Implants
Contour" Eyelid Weight Implants feature a proprietary three-dimensional design that conforms to the curvature of the ocular globe. They are sized according to weight from 0.6g to 2.8g. They all have suture holes to assist in implantation.
ThinProfile™ Eyelid Weight Implant
MedDev's ThinProfile™ Eyelid Weight Implants are thinner than the Contour™ implants. The ThinProfile's reduced thickness provides improved eyelid cosmesis while providing the same effectiveness as our proven Contour™ implant. The ThinProfile™ Eyelid Weight Implant features a proprietary three-dimensional curvature. They are sized according to weight from 0.6g to 1.8g. They all have suture holes to assist in implantation.
D. Indications for Use
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
E. Comparison to Predicate Device
The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are substantially equivalent in intended use, indications for use, technology, design, and materials as the predicate MedDev Contour™ Design Eyelid Implants (K011740).
The application and predicate devices have IDENTICAL product codes, Indications for Use, construction materials (99.99% gold or platinum) and design. They are implanted in an identical manner. They are all moist-heat sterilized and sold in sterile packaging.
The application implants have MR conditional labeling derived from the testing described below. The addition of MR conditional labeling does not raise any new questions of safety and efficacy.
The application devices meet all the requirements of the Special Controls initiated for these devices as published in the Federal Register (Vol 79, Num 76, pages 22012 - 16) on April 21, 2014.
5
| Characteristic | Predicate:
MedDev Contour™ Design
Gold Eyelid Implants
(K011740) | Application Device:
MedDev Contour™ and
ThinProfile™ Eyelid
Weight Implants | How do differences, if any,
pertain to justification of
substantial equivalence? |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Indications for Use of the
proposed Contour Design
Gold Eyelid Implants is
exactly the same as for the
original Contour Design Gold
Eyelid Implants. The broad
indication for prescribing
MedDev's Contour Design
Gold Eyelid Implants is for
the gravity-assisted treatment
of protracted or permanent
lagophthalmos, usually
resulting from facial
paralysis. Conditions, which
may damage the facial nerve,
include Bell's palsy, facial
nerve injury, trauma, tumor
invasion, and resection of
tumors, i.e. acoustic neuroma
and parotidectomy. | The MedDev Contour™ and
ThinProfile™ Eyelid Weight
Implants are designed for the
gravity-assisted treatment of
protracted or permanent
lagophthalmos, usually
resulting from facial
paralysis. | Differences in marketing
names and grammatical
construction of the statement.
These differences have no
impact on the substantial
equivalence of the
Indications for Use. |
| FDA Product Code | MML | MML | Identical |
| Operating
Principle
(Technology) | Implants provide the
additional weight needed to
close the eyelid when the
orbital musculature is
compromised by facial
paralysis. | Implants provide the
additional weight needed to
close the eyelid when the
orbital musculature is
compromised by facial
paralysis. | Identical |
| | | | |
| Characteristic | Predicate:
MedDev Contour™ Design
Gold Eyelid Implants
(K011740) | Application Device:
MedDev Contour™ and
ThinProfile™ Eyelid
Weight Implants | How do differences, if any,
pertain to justification of
substantial equivalence? |
| Design | | | |
| Contour
Model | 1.0mm thickness
12.7mm spherical radius
1.0mm diameter suture holes
0.6 to 2.8g in 0.2g increments | 1.0mm thickness
12.7mm spherical radius
1.0mm diameter suture holes
0.6 to 2.8g in 0.2g
increments | Identical |
| ThinProfile
Model | 1.0 mm thickness
12.7mm spherical radius
1.0mm diameter suture holes
Au: 0.6 to 1.6g in 0.2g
increments
Pt: 0.6 to 1.8g in 0.2g
increments | Contour™ 1.0 mm thickness
ThinProfile™ 0.65 mm
thickness
12.7mm spherical radius
1.0mm diameter suture holes
Au: 0.6 to 1.6g in 0.2g
increments
Pt: 0.6 to 1.8g in 0.2g
increments | Identical.
The ThinProfile™ Model was
considered a non-significant
change addition (per FDA
memo K97-1) to K011740 |
| Materials (body
contacting) | Pure (99.99%) Gold or
Platinum | Pure (99.99%) Gold or
Platinum | Identical |
| MRI Compatible? | Yes, but not labeled as such | Yes | This submission documents
that the predicate version of
the device was MR
compatible. Therefore the
addition of MR compatible
labeling has no bearing on
the substantial equivalence
of the predicate and
application devices. |
| Characteristic | Predicate:
MedDev Contour™ Design
Gold Eyelid Implants
(K011740) | Application Device:
MedDev Contour™ and
ThinProfile™ Eyelid
Weight Implants | How do differences, if any,
pertain to justification of
substantial equivalence? |
| Permanent or
Temporary Use? | Both | Both | Identical |
| Sterilization | Moist Heat Sterilized | Moist Heat Sterilized | Identical |
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7
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F. Summary of Supporting Data
This premarket notification is being submitted to provide FDA clearance for MR conditional labeling and to demonstrate compliance with the new Special Controls for implantable eyelid weights. No other changes from the predicate to the application device are being made. As a result only biocompatibility, sterility, shelf-life and MR compatibility data are necessary to demonstrate substantial equivalence.
i. 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 Contour™ Eyelid Weight Implants in the largest available sizes of 2.8g.
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 Contour™ Eyelid Weight Implants), 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 Contour™ 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 4second intervals. The resulting maximum measured temperature change for the 2.8g Gold Contour™ Eyelid Weight Implant was +2.0° C. For the 2.8g Platinum Contour™ 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 Contour™ 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 Contour™ Eyelid Weight Implant
9
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 Contour™ 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.
ii. Biocompatibility
Biocompatibility of the Gold and Platinum Contour™ and ThinProfile™ Eyelid Weight 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 Cytotoxicity MEM Elution test along with a Chemical Characterization of Materials (leachable test). The Cytotoxicity MEM Elution testing was conducted in accordance with:
- ISO 10993-1:2003 "Biological evaluation of medical devices -- Part 1: Evaluation ● and testing"
- ISO 10993-5:1999 "Biological evaluation of medical devices -- Part 5: Tests for ● in vitro cytotoxicity"
- ISO 10993-12:2007 "Biological evaluation of medical devices -- Part 12: Sample ● preparation and reference materials"
- United States Pharmacopeia 32 & National Formulary 27. 2009. Biological Reactivity Tests, In Vitro
- United States Pharmacopeia 32 & National Formulary 27. 2009. The Biocompatibility of Materials Used in Drug containers, Medical Devices, and Implants
- Nelson Labs SOP STP0032 R4 (2009) MEM Elution .
The leachable test and the inductively-coupled plasma atomic emission spectrometer (ICP-AES) analysis were conducted in accordance with:
- ANSI/AAMI/ISO 10993-12:2012 "Biological evaluation of medical devices -Part 12: Sample preparation and reference materials"
- ANSI/AAMI/ISO 10993-17:2012 "Biological evaluation of medical devices -Part 17: Establishment of allowable limits for leachable substances"
- ANSI/AAMI BE83:2006 (R2011). Part 18: "Chemical characterization of ● materials"
- Nelson Labs SOP STP0181 R2 (2015)– Chemical Characterization of Materials ●
- ASTM E1097-12 "Standard Guide for Determination of Various Elements by Direct Current Plasma Atomic Emission Spectrometry"
- . METL SOP QA manual 11.0-CHE1/ CHE11
The final report concludes that the MedDev Eyelid Weight Implants are biocompatible as defined by ISO 10993-1:2009.
10
iii. Sterility and Shelf-life
Sterilization validation and packaging validation (shelf life) were completed in accordance with ISO 11607:2006 "Packaging for Terminally Sterilized Medical Devices" and in context of ISO 13485:2003 "Medical devices - Quality management systems"
a. Sterilization
Sterilization validation was completed in accordance with ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products-Moist heat-Part1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" which demonstrates that the devices could be moist heat sterilized to a Sterility Assurance Level of 106. The validation approach was based on the use of biological indicators (BI Spore Strips) in a half-cycle "overkill" method. The validation protocol includes an installation, operational, and performance qualification; and the demonstration of sterility assurance.
b. Shelf life
The shelf life testing included real time aging, distribution simulation, visual inspection, bubble leak testing, and seal strength testing. The shipping configuration and packaging integrity were tested at the completion of real-time aging of 36 months in accordance with:
- . ASTM D4169-05 "Standard Practice for Performance Testing of Shipping Containers and Systems"
- . ASTM F1886-98 "Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection"
- ASTM F2096-04 "Standard Test Method for Detecting Gross leaks in Medical Packaging by Internal Pressurization (Bubble Test)"
- . ASTM F88-06 "Standard Test Method for Seal Strength of Flexible Barrier Materials"
Other reviews included:
- Seal Strength Test Capability index study
- . A review of product's functionality and examination for physical damage at the completion of the packaging integrity testing
- . Testing and validation of the microbial barrier performance for Tyvek®, manufactured by DuPont™, demonstrate an effective barrier for up to five years. Testing standards used by DuPont™:
- ASTM F1608-00(2009) "Standard Test Method for Microbial Ranking of . Porous Packaging Materials (Exposure Chamber Method)"
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- . ASTM F2638-12 "Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier"
The completed testing confirmed the integrity of the sterile barrier and packaging for a period of 36 months.
G. Conclusion Statement
MedDev concludes that the application and predicate Eyelid Implants are substantially equivalent.