LID CHAIN EYELID WEIGHTS

K021750 · Jedmed Instrument Co. · MML · Jan 27, 2003 · Ophthalmic

Device Facts

• Record ID: K021750
• Device Name: LID CHAIN EYELID WEIGHTS
• Applicant: Jedmed Instrument Co.
• Product Code: MML · Ophthalmic
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis

Device Story

Lid Chain Eyelid Weight Implant is a passive mechanical device designed to assist eyelid closure in patients with facial nerve paralysis. The implant is surgically placed in the upper eyelid; it utilizes gravity to facilitate lid closure, compensating for the loss of muscle function. The device is intended for use by ophthalmic or plastic surgeons in a clinical or surgical setting. By restoring dynamic lid closure, the implant helps protect the ocular surface from exposure-related complications associated with lagophthalmos.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Passive eyelid implant; metallic chain construction; designed for surgical implantation in the upper eyelid to provide weight-assisted closure via gravity.

Indications for Use

Indicated for patients with paralytic lagophthalmos resulting from facial nerve paralysis requiring restoration of dynamic eyelid closure.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2003

JEDMED Instrument Company c/o Craig R. Parks Regulatory Affairs Manager 5416 Jedmed Court St. Louis, MO 63129-2221

Re: K021750

Trade/Device Name: Lid Chain Eyelid Weight Implant Regulatory Class: Unclassified Product Code: MML Dated: November 4, 2002 Received: November 5, 2002

Dear Mr. Parks:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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## Page 2 - Craig R. Parks

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A kalpi korenthal

A. Ralph Rosenthal, M.D 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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## 510(k) Number (if known): K021750

Device Name: Lid Chain Eyelid Weight

Indications for Use:

This indication for use for the 'Lid Chain Eyelid Weight Implant' is for the

"Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis"

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Duwa R. Voorhies

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

**510(k) Number** K021750

(Optional Format 3-10-98)

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