CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)

K011740 · Meddev Corp. · MML · Jul 2, 2001 · Ophthalmic

Device Facts

• Record ID: K011740
• Device Name: CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
• Applicant: Meddev Corp.
• Product Code: MML · Ophthalmic
• Decision Date: Jul 2, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Contour Design Gold Eyelid Implants are passive, gravity-assisted ocular implants used to treat lagophthalmos. The device consists of a 99.99% pure gold weight, spherically radiused to 12.7 mm to match the eye globe curvature, featuring suture holes for attachment to the tarsus or orbital septum. The device is implanted by a surgeon during a clinical procedure. By adding weight to the upper eyelid, the implant utilizes gravity to assist in eyelid closure, protecting the eye in patients with facial paralysis. The device is supplied sterile to the end user.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and performance characteristics identical to the predicate devices, with additional validation of the sterilization process.

Technological Characteristics

Material: 99.99% pure gold. Form factor: Rectangular with tapered, smooth edges, 12.7 mm spherical radius. Sizes: 0.6g to 1.6g in 0.2g increments. Sterilization: Steam sterilization (SAL 1 x 10^-6).

Indications for Use

Indicated for patients with protracted or permanent lagophthalmos, typically secondary to facial paralysis (e.g., Bell's palsy, facial nerve injury, acoustic neuroma, parotidectomy).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MedDev Contour Design Gold Eyelid Implants (preamendment)
• Labtician Lid Load Gold Eyelid Weight Implants (K983607)

Submission Summary (Full Text)

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### CONFIDENTIAL DOCUMENT

K011740

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 .: [phone] Fax: [phone]
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 [phone] Fax [phone] 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.

- 7. 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.

| | Proposed MedDev<br>Contour Design Gold<br>Eyelid Implant | MedDev Contour<br>Design Gold Eyelid<br>Implants | Labtician Lid Load<br>Gold Eyelid Weight<br>Implants |
|---------------------|----------------------------------------------------------|--------------------------------------------------|------------------------------------------------------|
| 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please 574-4037. Numbiliary, 102 quest [phone]. 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 [phone] 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 [phone] Fax [phone] www.meddev-corp.com

## INDICATIONS FOR USE STATEMENT

- Preamendment Device 1. 510(k) Number:
- MedDev Contour Design Gold Eyelid Implants Device Name: 2.
- 3. 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.

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