(107 days)
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 occular implant to the prosthetic eye.
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
The provided text describes a 510(k) premarket notification for the MEDPOR Attractor Magnetic Coupling System. It includes information about the device, its indications for use, and a study conducted to demonstrate its performance. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Improved prosthesis motility | Significant improvement in lateral excursion motility (P<0.0001 with strongest magnet, P=0.02 with second strongest magnet) |
| Adequate coupling force between implant and prosthesis | Magnets powerful enough to provide coupling force between implant and prosthetic eye |
| Maintenance of prosthesis position/security (implied by coupling) | Magnets designed to remain entirely within the posterior of the prosthesis and provide a coupling force. |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. The "Technological Characteristics" section and the study results imply that improved motility and effective coupling were the desired outcomes for the device to be considered beneficial. The statistical significance values (P<0.0001, P=0.02) serve as the "reported device performance" against the implied criterion of improved motility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The study was conducted on one anophthalmic patient.
- Data Provenance: Not explicitly stated, but given the manufacturer (Porex Surgical, Inc., Newnan, GA) and the FDA submission, it's highly probable the data is from the USA. The study appears to be prospective as it involved an intervention (placement of magnets) and subsequent measurement.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish a "ground truth" for the motility measurements. The measurements were quantitative and objective (lateral excursion motility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study involved objective measurements of motility, not subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical implant system, not an AI or diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the effectiveness of the device was measured prosthesis motility (lateral excursion). This is a direct, objective physiological measurement.
8. The sample size for the training set
Not applicable. This device is not an AI or machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI or machine learning algorithm requiring a training set.
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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
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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.
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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.
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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
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Page 3 - Mr. Swords
INDICATION FOR USE
Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
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
§ 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.