(27 days)
The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.
MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.
Implants are made of 99.99% pure gold. They are designed in a receinigular onapo with a opners spherical radius of 12.7 mm to conform to the shape of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.
The MedDev Contour Design Gold Eyelid Implants are spherically radiused gold implants designed to conform to the curvature of the eye globe. They are used for the gravity-assisted treatment of protracted or permanent lagophthalmos, typically resulting from facial paralysis.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The submission relies on substantial equivalence to predicate devices rather than defining specific quantitative acceptance criteria or performance metrics for the device itself. The primary change in the proposed device is that it will now be supplied sterile, whereas previous MedDev Contour Design Gold Eyelid Implants were non-sterile.
The acceptance criteria for the re-submitted device are implicitly based on maintaining all other characteristics and performance features of the predicate devices. The study provided focuses on asserting that the proposed device is "the same or substantially equivalent" to the predicate devices across various attributes.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Indications for Use: Same as predicate devices | Same |
| Target Population: Same as predicate devices | Same |
| Design: Same as predicate devices | Same (rectangular shape, spherical radius, tapered, smooth edges, suture holes) |
| Materials: Same as predicate devices | Same (99.99% pure gold) |
| Performance: Same as predicate devices | Same |
| Sterility: Must be sterile | Sterile (validated steam sterilization, SAL 1 x 10-6) |
| Biocompatibility: Same as predicate devices | Same |
| Mechanical Safety: Same as predicate devices | Same |
| Anatomical Site: Same as predicate devices | Same |
| Human Factors: Same as predicate devices | Same |
| Where Used: Same as predicate devices | Same |
2. Sample Size for Test Set and Data Provenance
No specific test set or clinical study data is referenced in the provided document for the evaluation of the device's functional performance or efficacy. The submission relies on the established safety and effectiveness of its own pre-amendment non-sterile version and the cleared Labtician Lid Load™ Gold Eyelid Weight Implants (K983607).
The "study" presented is a comparison table asserting substantial equivalence. It does not involve a test set of patients or data provenance in the traditional sense of a clinical trial. The data provenance is effectively the regulatory approval of the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for the claims of equivalence lies in the established properties and regulatory acceptance of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical implant. The concept of an "algorithm only" performance study is not applicable.
7. Type of Ground Truth Used
The ground truth used for this submission is the established safety and effectiveness of the predicate devices (MedDev's own pre-amendment non-sterile Contour Design Gold Eyelid Implants and Labtician Lid Load™ Gold Eyelid Weight Implants). The primary ground truth for the new aspect of the device (sterility) is the validation of the steam sterilization process to achieve a Sterility Assurance Level (SAL) of 1 x 10-6.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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CONFIDENTIAL DOCUMENT
JUL = 2 2001
SPECIAL 510(K) SUMMARY
In accordance with CFR 807.92 the following information is submitted:
- MedDev Corporation 1. Submitter: 730 North Pastoria Avenue Tel .: (408) 730-9702 Fax: (408) 730-9732
Suzanne Brick, Operations Administrator Contact:
Registration Number: 2921577
Monday, June 18, 2001 Date of Summary:
- Contour™ Design Gold Eyelid Implants 2. Device Name:
Gold Evelid Weight Common Name:
Class II; Eyelid Weights, External Classification:
- MedDev Contour™ Design Gold Eyelid Implants, Predicated Devices: 3. preamendment devices Labtician Lid Load™ Gold Eyelid Weight Implants, 510(k) number K983607
Description of Modified Device: 4.
Description of Moullied Dovide.
MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.
MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.
Indications for Use: 5.
Indications for Use of the proposed Contour Design Gold Eyelid Implants is exactly the The Indications for 600 of the preposign Gold Eyelid Implants. The broad indication for Sume as to the onginer Design Gold Eyelid Implants is for the gravity-assisted prosombing "ModDove" - Comos.
treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
730 North Pastoria Avenue Sunnyvale, California 94085-3522 Tel 408.730.9702 Fax 408.730.9732 www.meddev-corp.com
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Conditions, which may damage the facial nerve, include Bell's palsy, facial nerve injury, Conditions, whiler may admage the natures, i.e. acoustic neuroma and parotidectorny.
-
Technical Specifications for the Device: 6.
Technical Specifications for the Borico. Implants are made of 99.99% pure gold. They are Medbers Oonlour Doolyn Sola Lyona spherical radius of 12.7 mm to conform to the shape designed in a receinigular onapo with a opners and tapered, smooth edges. Suture holes are of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum. -
- Comparison and Substantial Equivalence:
Outhpanson and Gabotantan Ligaratoristics of the proposed Contour While Exception of Storilly, an Toolt Contour Design Gold Eyelid Implants and Labtician Design Ook Lyolid Implants are the same or substantially equivalent. The proposed Eld Coad Ook Eyelid Implants are the same implants as the predicated Contour Contour Design Oola Eyona Implants will be sold sterile. The proposed MedDev Contour Design Gold Eyelid Implants will be sterilized by steam using a validated sterilization cycle providing a Sterility Assurance Level of 1 x 10 6.
- Comparison and Substantial Equivalence:
| Proposed MedDevContour Design GoldEyelid Implant | MedDev ContourDesign Gold EyelidImplants | Labtician Lid LoadGold Eyelid WeightImplants | |
|---|---|---|---|
| Indications for Use | Same | Same | Same |
| Target Population | Same | Same | Same |
| Design | Same | Same | Same |
| Materials | Same | Same | Same |
| Performance | Same | Same | Same |
| Sterility | Sterile | Non-Sterile | Sterile |
| Biocompatibility | Same | Same | Same |
| Mechanical Safety | Same | Same | Same |
| Anatomical Site | Same | Same | Same |
| Human Factors | Same | Same | Same |
| Where Used | Same | Same | Same |
SUBSTANTIAL EQUIVALENCE COMPARISON
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a row, with the first profile being the most defined and the subsequent profiles gradually fading into the background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
JUL - 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Suzanne Brick Operations Administrator MedDev Corporation 730 North Pastoria Avenue Sunnyvale, CA 94085-
K011740 Re: Contour™ Design Gold Eyelid Implants Unclassified Product Code: MML Dated: May 31, 2001 Received: June 5, 2001 Amended: June 22, 2001
Dear Ms. Brick:
We have reviewed your Section 510(k) notification of intent to market the device referenced above We have revewed your Secuent 700x7 notically equivalent (for the indications for use stated in and we have detellimited the devices is oase allerices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been the Association Associated Ast Association Association Associated Association Asso May 26, 1976, the ellaculicit tare of the Federal Food, Drug, and Cosmetic Act (Act).
reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic A reclassified in accordance with the provisions of the general controls provisions of the Act. The You may, therefore, manet the device, subject to the games for annual registration, listing of devices, general collutors provisions of the free measonst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Prematker If your device is classified (see above) into clifted in (Existing major regulations affecting your Approval), if may be subject to sach additions, Title 21, Parts 800 to 895. A substantially device can be round in the Code of Pederal Regulance with the Current Good Manufacturing Practice equivalent detectimination assumes colinp.System Regulation (QS) for Medical Developed Developed Devel requirements, as set fortu in the Quality of techniques inspections, the Food and Drugs fegulation (FDA) will verify such asumptions. Failure to comply with the GMP regulation may Administration (FDA) will velify such assumptions further announcements concerning your result in regulatory action. In addition, I DA hist processed on the more of 10 at the Art for download device in the Federal Negister. Thease noter and sections 531 through 542 of the Act for devices does not affect any obligation you might have ander sources of other Federal laws or regulations.
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Page 2 - Ms. Suzanne Brick
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begal maintains of your device to a legally marketed noutication: "The PDF midning or rubstins for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific advice for your dorices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please 574-4037. Numbiliary, 102 quest (301) 594-4639. Also, please note the regulation entitled, Contact are Stices of Schools of Scation" (21CFR 807.97). Other general information Misolanding by receience to premaired an an an a Division of Small Manufacturers on your responsibilities and its not 200 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
David M. Whijsole
Lee A. Ralph Rosenthal, M.D.
A. Ralph Rosenthal, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CONFIDENTIAL DOCUMENT
Image /page/4/Picture/1 description: The image shows the logo for MedDev Corporation. The text "MedDev" is in a large, bold font on the top line. Below that, the word "CORPORATION" is in a smaller font.
730 North Pastoria Avenue Sunnyvale, California 94085-3522 Tel 408.730.9702 Fax 408.730.9732 www.meddev-corp.com
INDICATIONS FOR USE STATEMENT
- Preamendment Device 1. 510(k) Number:
- MedDev Contour Design Gold Eyelid Implants Device Name: 2.
-
- Indications for Use: Includions for Ose.
The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
- Indications for Use: Includions for Ose.
The intended use and indications for use of the proposed device have not changed at all.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Counter Use_
Joel P. H
(Division Sign-Off)
Division of Ophthalmic Devices
011740
510(k) Nul
§ 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.