(89 days)
Not Found
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics strongly indicate the absence of AI/ML technology.
No.
The device is a surgical implant (peg and sleeve) and associated instruments used during a procedure, not a device that provides therapy.
No
Explanation: The device description indicates that it is a surgical implant system (pegs and sleeve) and associated surgical instruments, not a device used to diagnose a medical condition.
No
The device description explicitly details physical components made of HDPE and associated manual surgical instruments, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs are specifically intended for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a surgical implant (pegs and sleeve) and associated surgical instruments used for a procedure related to the eye. This is consistent with a surgical device, not a device used for in vitro testing of samples.
- Anatomical Site: The device is used on the "eye," which is an anatomical site for surgical intervention, not typically where samples for IVD testing are collected.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
The device described is a surgical implant system used in ophthalmology or oculoplastic surgery, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The MEDPOR® Ocular Peg and Sleeve and Accessories consist of two HDPE (High Density Polyethylene) Pegs, and an HDPE Sleeve with the necessary associated manual surgical instruments. The pegs and sleeve will be sold as a package, supplied sterile. All other components will be supplied separately, non-sterile.
The associated surgical instruments include an Ocular Implant Clamp for holding the implant during the procedure, a sleeve driver for screwing the sleeve into the implant, and three drill bits for drilling the hole for the peg or peg and sleeve. The ocular implant clamp, sleeve driver and drill bit(s) are each a manual ophthalmic surgical instrument as defined by 21 CFR 886.4350, and as such are exempt from premarket notification procedures. They are presented here with brief descriptions so that a complete understanding of the device (the pegs and sleeve), and its use, will be provided.
The pegs are intended for single patient use. The pegs are composed of HDPE (High Density Polyethylene), identical to the HDPE used to manufacture the MEDPOR® Implant. Two peg styles will be available; a flat head peg for use immediately after the hole is drilled until the prosthetic eve is modified to accept the round head peg, and the round head peg. The shank diameter in both pegs is 1.8mm. The domed head is 2.5mm in diameter. The domed head of the peg is designed to fit in a socket made in the back of a custom ocular prosthesis. The ocular prosthesis is an external custom device made by a professional ocularist.
The ocular pegs are supplied sterile. They are sterilized by contract sterilizer in Ethylene Oxide gas. Sterilizer cycles have been validated, and are periodically revalidated, according to AMMI accepted practices and guidelines. Product is released based on bio-indicator assurance that a sterility assurance level of 10 to the minus 6 power has been achieved.
The sleeve is manufactured of the same HDPE (High Density Polyethylene). The sleeve is designed to mate with the shaft of the peg. The sleeve is supplied sterile and is intended for single patient use. They are sterilized by contract sterilizer in Ethylene Oxide gas. Sterilizer cvcles have been validated, and are periodically re-validated, according to AMMI accepted practices and quidelines. Product is released based on bio-indicator assurance that a sterility assurance level of 10 tc the minus 6 power has been achieved.
The sleeve driver is a manual instrument for screwing the sleeve into the hole drilled into the MEDPOR implant. The sleeve driver is 316 stainless steel, and will be sold non-sterile.
The drill bits are surgical stainless steel, twist drill bits to be used for drilling the holes for the peg or sleeve. Three drill bits will be available. A 1.2mm drill bit for drilling a pilot hole, a 2.3mm drill bit for drilling the hole for the peg without the sleeve, and a 3.1mm bit for drilling the hole for the sleeve. The drill bits are supplied non-sterile, and are intended to be re-usable.
The ocular clamps are manufactured of surgical stainless steel and are intended to be reusable. The ocular clamp is used to hold the ocular eye sphere implant immobile during the drilling of the hole for the peg or sleeve. Two sizes will be available, a pediatric and an adult size. The ocular clamps are supplied non-sterile, and are intended to be reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologist or oculoplastic surgeon, ocularist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Porex Surgical Inc. The logo consists of a square with a black and white checkered pattern on the left, and the words "POREX SURGICAL INC." on the right. The checkered pattern has a circular opening in the center.
4715 Roosevelt Highway, College Park, Georgia 30349 USA (770) 969-8145 · · (800) 521-7321 · · Fax: (770) 969-8045
510(k) SUMMARY
MAY 2 9 1996
Manufacturer and Submitter
Porex Surgical. Inc. 4715 Roosevelt Highway College Park, GA 30349
Tel: (770) 969-8145 Fax: (770) 969-8045
Contact: Howard Mercer, Ph.D.
Date: February 28, 1996
Trade Name MEDPOR® Ocular Peg System and Accessories Classification Name: Device is not classified
Substantially equivalent to: A: The ocular pegging system offered in conjunction with the porous hydroxyapatite sphere implant distributed by Integrated Orbita Implants
B: The MEDPOR® Ocular Screw and Accessories
Device description:
The MEDPOR® Ocular Peg and Sleeve and Accessories consist of two HDPE (High Density Polyethylene) Pegs, and an HDPE Sleeve with the necessary associated manual surgical instruments. The pegs and sleeve will be sold as a package, supplied sterile. All other components will be supplied separately, non-sterile.
The associated surgical instruments include an Ocular Implant Clamp for holding the implant during the procedure, a sleeve driver for screwing the sleeve into the implant, and three drill bits for drilling the hole for the peg or peg and sleeve. The ocular implant clamp, sleeve driver and drill bit(s) are each a manual ophthalmic surgical instrument as defined by 21 CFR 886.4350, and as such are exempt from premarket notification procedures. They are presented here with brief descriptions so that a complete understanding of the device (the pegs and sleeve), and its use, will be provided.
Ocular Pegs
The pegs are intended for single patient use. The pegs are composed of HDPE (High Density Polyethylene), identical to the HDPE used to manufacture the MEDPOR® Implant. Two peg styles will be available; a flat head peg for use immediately after the hole is drilled until the prosthetic eve is modified to accept the round head peg, and the round head peg. The shank diameter in both pegs is 1.8mm. The domed head is 2.5mm in diameter. The domed head of the peg is designed to fit in a socket made in the back of a custom ocular prosthesis. The ocular prosthesis is an external custom device made by a professional ocularist.
1
The ocular pegs are supplied sterile. They are sterilized by contract sterilizer in Ethylene Oxide gas. Sterilizer cycles have been validated, and are periodically revalidated, according to AMMI accepted practices and guidelines. Product is released based on bio-indicator assurance that a sterility assurance level of 10 to the minus 6 power has been achieved.
Sleeve
The sleeve is manufactured of the same HDPE (High Density Polyethylene). The sleeve is designed to mate with the shaft of the peg. The sleeve is supplied sterile and is intended for single patient use. They are sterilized by contract sterilizer in Ethylene Oxide gas. Sterilizer cvcles have been validated, and are periodically re-validated, according to AMMI accepted practices and quidelines. Product is released based on bio-indicator assurance that a sterility assurance level of 10 tc the minus 6 power has been achieved.
Sleeve Driver
The sleeve driver is a manual instrument for screwing the sleeve into the hole drilled into the MEDPOR implant. The sleeve driver is 316 stainless steel, and will be sold non-sterile.
Drill Bits
The drill bits are surgical stainless steel, twist drill bits to be used for drilling the holes for the peg or sleeve. Three drill bits will be available. A 1.2mm drill bit for drilling a pilot hole, a 2.3mm drill bit for drilling the hole for the peg without the sleeve, and a 3.1mm bit for drilling the hole for the sleeve. The drill bits are supplied non-sterile, and are intended to be re-usable.
Ocular Clamp
The ocular clamps are manufactured of surgical stainless steel and are intended to be reusable. The ocular clamp is used to hold the ocular eye sphere implant immobile during the drilling of the hole for the peg or sleeve. Two sizes will be available, a pediatric and an adult size. The ocular clamps are supplied non-sterile, and are intended to be reusable. Although these are hand held ophthalmic instruments and thus do not require 510(k) approval they are included here for explanatory purposes.
STERILIZATION
The MEDPOR® Ocular Pegs and Sleeve are prov ded STERILE. Resterilization is not recommended.
The Drill Bits, Sleeve Driver and Implant Clamps must be sterilized prior to use. Based on AAMI and current JCAHO standards, the Drill Bits, Sleeve Driver, and Clamps should be wrapped and sterilized using moist heat and a vacuum cycle, using the institution's sterilization policy or by the following guidelines:
Vacuum sterilize at 275 degrees F, for minimum 15 minutes, and dry for 15 minutes. An appropriate chemical process indicator should be included with the implant to assure sterility.
Flash sterilization (gravity cycle) is not recommended for routine sterilization.
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Biocompatibility
The Ocular Pegs and Sleeve are made from the sarne grade HDPE as the MEDPOR® Ocular Implants, in molds made from the same materials, using the same heat and pressure process used to make the Barrier portion of the MEDPOR® Barrier Implants. Biocompatibility of this material is well established by over ten years of animal and human clinical studies before FDA approval to market MEDPOR® Biomaterial in 1985, and over 10 years of clinical experience since then.
There are no changes in the method of sterilization, the sterilization assurance level, material of construction, quality control procedures, or packaging.
Background for Product Use
After routine enucleation or evisceration of the eye by an ophthalmologist or oculoplastic surgeon, the void is filled with a MEDPOR® Surgical Implant in the form of a sphere or in the form of a conical shape . The muscles of the eye are routinely attached to the implant or a tissue covering to provide motility to the implant after healing has taken place. The surgeon then closes the Tenon's capsule and conjunctiva around the anterior portion of the implant.
After the conjunctiva covering the implant heals and the swelling subsides, the surgeon refers the patient to an ocularist for fitting of a custom external eye prosthesis. The ocularist creates an artfully designed prosthetic eye. The prosthetic eye is made, for example, of a plastic such as polymethylmethacrylate (PMMA) and decorated to match the contra lateral real eye. The prosthesis is then worn by the patient between the healed eye globe and eye lids in a manner similar to a contact lens.
Many ophthalmologists and oculoplastic surgeons feel that simply inserting the prosthetic eye over the tissues covering the implant provides adequate motility and cosmesis. Others, however, believe enhanced motility can be achieved by a direct coupling of the orbital implant to the external prosthesis. This mechanical coupling is provided by drilling a hole in the anterior surface of the implant, and placing a peg in the hole. The domed head of the peg fits into a matching socket provided in the back of the prosthesis.
Comparison With Predicate Devices
A porous hydroxyapatite implant currently marketed by Integrated Orbital Implants (IOI) utilizes an acrylic peg placed into a drilled hole in the implant, or into a solid sleeve threaded into a drilled hole as a coupling device. The use of the MEDPOR® Ocular Peg System performs the same function as the acrylic peg, the only difference being that it is manufactured from High Density Polyethylene.
The MEDPOR® Ocular Screw, currently approved for marketing by the FDA, couples the MEDPOR® Ocular Implant to the prosthesis via the head of a titanium screw placed into a hole drilled into a well vascularized implant. The MEDPOR® Ocular Peg System performs the same function as the Medpor® Ocular Screw, the only difference being that an HDPE Peg, or Sleeve and Peg, is used in the prace of the screw.