(107 days)
Not Found
No
The device description and performance studies focus on mechanical coupling using magnets and a screw, with no mention of AI or ML.
No
The device is used to improve the motility of a prosthetic eye by providing a coupling mechanism, rather than treating a disease or condition.
No
The device is designed to improve prosthetic eye motility by coupling an ocular implant to a prosthetic eye, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components: a titanium nitride coated stainless steel screw and magnets. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The MEDPOR ATTRACTOR Magnetic Coupling System is a physical device designed to be implanted and used to improve the movement of a prosthetic eye. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states it's for coupling an ocular implant to a prosthetic eye to improve motility. This is a mechanical function, not a diagnostic one.
The information provided describes a surgical implant and a component for a prosthetic eye, both of which are medical devices, but not IVDs.
N/A
Intended Use / Indications for 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.
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 for prosthesis motility. Not all patients will benefit from the use of the MEDPOR Attractor Magnetic Coupling System. Consider all factors affecting potential prosthesis motility when contemplating use of the MEDPOR Attractor Magnetic Coupling System.
Product codes
HPZ
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular / orbit
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
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
§ 886.3320 Eye sphere implant.
(a)
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.(b)
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.
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: (678) 479-1610 Fax: (678) 423-1437
Contact: Howard Mercer e-mail: howard.mercer@porex.com
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