MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM

K040851 · Porex Surgical, Inc. · HPZ · Jul 16, 2004 · Ophthalmic

Device Facts

• Record ID: K040851
• Device Name: MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
• Applicant: Porex Surgical, Inc.
• Product Code: HPZ · Ophthalmic
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.3320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, and wish to gain improved prosthetic eye motility by coupling the ocular implant to the prosthetic eye.

Device Story

System improves prosthetic eye motility by creating magnetic coupling between an orbital implant and a prosthetic eye. Components include a titanium nitride-coated stainless steel attractor screw embedded in the anterior aspect of a MEDPOR ocular implant and magnets embedded in the posterior of the prosthetic eye. Magnetic attraction between the screw and the prosthesis magnets enables the two to move in unison. Used in anophthalmic patients following enucleation. The device is implanted by a surgeon; the coupling mechanism functions passively post-implantation. Benefits include enhanced prosthetic motility compared to uncoupled systems, dependent on adequate implant mobility and socket space.

Clinical Evidence

Clinical study on an anophthalmic patient post-enucleation. Measured prosthesis motility in lateral excursion comparing a prosthesis without magnets to the same prosthesis with three different magnet strengths. Results showed statistically significant improvements in motility with the strongest magnets (P<0.0001 and P=0.02).

Technological Characteristics

System consists of a titanium nitride-coated stainless steel attractor screw and magnets. The screw is designed for implantation into the anterior aspect of a MEDPOR ocular implant. Magnets are embedded in the posterior of an acrylic prosthetic eye. No electronic components, software, or connectivity.

Indications for Use

Indicated for patients with a MEDPOR Ocular Implant desiring improved prosthetic eye motility via magnetic coupling between the implant and the prosthesis.

Regulatory Classification

Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• MEDPOR Ocular Peg System (K971583)
• MEDPOR Ocular Screw (K960859)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 16 2004

K 040851

Image /page/0/Picture/2 description: The image shows the logo for Porex Surgical Products Group. The logo is in black and white and features the word "POREX" in large, bold letters. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

510(k) SUMMARY (Revised 7-14-04)

Manufacturer and Submitter

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: [phone] Fax: [phone]

Contact: Howard Mercer e-mail: [e-mail]

Date: February 27, 2004

Trade Name: Device Name: MEDPOR Attractor Magnetic Coupling System (MCS)

Class II Device 510(k) Number

Substantially equivalent to:

MEDPOR Ocular Peg System K971583 A. B. MEDPOR Ocular Screw K960859

Device description:

Titanium nitride coated stainless steel screw, ATTRACTOR SCREW, is designed to be placed into the MEDPOR implant, so that the head of the screw is placed at the anterior appx of the implant as it site in the orbit. The flat head of the screw is flush with the surface of the implant and is covered with the verlying tissue.

Magnets of appropriate material, shape, and size to be imbedded into the posterior of the prosthetic eye. The magnets are designed small enough to remain enlinely within the posterior of the prostinents and and any and a belgives onlike the sgrowing force between the imaterial (typically accylic) of the
prosthelic eye, and powerful enough to provide a coupling force between th

Indications for Use:

The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR : Ocular Included to be a mightelle Guping System is indicated for patients who have a MEDPOR
prosthetic eve prosthetic eye.

NOTE: Improved prosthesis motility is a function of adequate implant mobility, adequate coupling forces between the implant and the prosthesis, and adequate room in the socket coupling forces
patients will henefit for the use of the MCDDC All of the socket for prosthesis motili patients will benefit from the use of the MEDPOR Altrector Magnetic Coupling System. Consider all factors affecting potential prosiness of the MEDI ON Attractor Magnetic Coupling System. Consider all factor of Counting System. Councillion System. Councillion System Coupling System.

## Technological Characteristics:

Some physicians believe that it is necessary to mechanically couple the prosthesis to the implant in some manner to improve molily over an uncoupled prosinesis. The implant is the implant in some
notification uses mannelic force to essential the security the subject of this prem nothis and health force to accomplish the coupling between the subject of this premarket
and the even restbests. During the manufacturing of the orbital volume replacement and the eye prosthesis. During the couping between the orginal volume replacement impli

{1}------------------------------------------------

rnagnets are placed into the posterior of the prosthesis so that they are covered with a thin layer of acrylic magnals are placed into the prosterior of the progriders steel is placed in the implant so that it is flush An attractor screw made of thatlion filmos costed atamiess steel is placed on the with the sunace of the might the becomed on the min above in the screw in the implant provide a coupling force to enable the two to move in unison.

Prosthesis motility was measured on an anophthalmic palient who had undergone enucleation followed by I fosmood moting not me so here implant. The implant contained a titanium nitride coated steel screw insert placed anteriorly in the implant and the implant and insert were covered with Tenon's and conjunctive. insert pibood attionery in a prosthesis containing no magnet, and with the same prosthesis after placement of three different magnets of various strengths in the posterior surface of the prosthesis. ance placement of and in lateral excursion motility (P<0.0001 with the strongest and P=0.02 with the second strongest magnet) were measured for the prosthesis.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

JUL 16 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Porex Surgical Products Group c/o Mr. Greg Swords Vice President, Technology and Development 15 Dart Road Newnan, GA 30265-1017

Re: k040851

Trade/Device Name: MEDPOR® Attractor™ Magnetic Coupling System Regulation Number: 21 CFR 886.3320 Regulation Name: Eye Sphere Implant Regulatory Class: Class II Product Code: HPZ Dated: May 25, 2004 Received: May 27, 2004

Dear Mr. Swords:

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.

{3}------------------------------------------------

Page 2 - Mr. Swords

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. Paigi Corentthal

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

{4}------------------------------------------------

## Page 3 - Mr. Swords

## INDICATION FOR USE

Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: [phone] Fax: [phone]

510(k) Number:

Trade Name: Device Name; MEDPOR Magnetic Coupling System (MCS)

Indications for Use:

The MEDPOR ATTRACTOR Magnetic Coupling System is indicated for patients who have a MEDPOR Ocular Implant, The MEDPOR ATTRACTOR Magicale Couping Cystem is notation of the prosthelic eye.
and wish to gain improved prosthatic are motillity by coupling the occular implant to the pro

NOTE: Improved prosihesis motility is a function of adequate implant motility, atequale coupling forces belwean the NOTE: improved prosthesis nowling is a fine socket for prosthesis modility. Not all benefit from the lmplant and the prosinessis, and adding System. Onsilier all leaders affective modify Northeris motility when in the simmers motility when use of the MEDPOR ARROLET Magnetic Coupling System.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Prescription Use: X OR Over the Counter Use:
(Per 21CFR801.109)

(Division Sigh-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number. K040851