(98 days)
Not Found
No
The summary describes a passive implant material and does not mention any computational or analytical functions, let alone AI/ML.
Yes
The device is described as an "orbital volume replacement implant" intended for "augmentation or restoration in the craniofacial region," which falls under the definition of a therapeutic device as it is used to treat or restore function.
No
The device description and intended use indicate that the product is an implant for augmentation or restoration of the craniofacial region, not for diagnosing a condition or disease.
No
The device description clearly states it is an implant formed by blending materials, indicating a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "augmentation or restoration in the craniofacial region." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is described as "orbital volume replacement implants formed by blending Bioglass® Synthetic Bone Graft Particulate with the polyethylene." This is a physical implant material.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens outside the body.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.
Product codes
HPZ
Device Description
The devices of this submission are orbital volume replacement implants formed by blending @ Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial region
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the phrase "SURGICAL PRODUCTS GROUP" in smaller, thinner, black letters.
510(k) SUMMARY
Manufacturer and Submitter
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
Contact: Howard Mercer, Ph.D. e-mail: howard mercer@porex.com
Date: April 26, 2002
Trade Name:
MEDPOR® Plus Sphere; MEDPOR® Plus COI™ (Conical Orbital Implant); MEDPOR® Plus MCOI™ (Multi-Purpose Conical Orbital Implant); MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere); MEDPOR®Plus SST™ COI™; MEDPOR®Plus MCOI™ SST™; MEDPOR® Plus QUAD™ Motility Implant
Class II Device
Substantially equivalent to:
Orbital volume replacement implants currently cleared for marketing and to Bioglass® Synthetic Bone Graft Particulate
Device description:
The devices of this submission are orbital volume replacement implants formed by blending @ Bioglass® Synthetic Bone Graft Particulate with the polyethylene used to produce MEDPOR Surqical Implant Material.
Indications for Use:
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around a stylized eagle-like symbol. The symbol is composed of three curved lines that form the shape of a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
: *
AUG 0 5 2002
Porex Surgical Inc. c/o Howard Mercer, Ph.D. Regulatory Affairs Manager 15 Dart Road Newnan, GA 30265
Re: K021357
Trade/Device Name: MEDPOR® Plus Orbital Volume Replacement Implant Regulation Number: 886.3320 Regulation Name: Eye sphere implant Regulatory Class: II Product Code: HPZ Dated: July 29, 2002 Received: July 30, 2002
Dear Dr. Mercer:
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- Howard Mercer, Ph.D.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Ralph Rosenthal
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
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INDICATION FOR USE
Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
Image /page/3/Picture/3 description: The image is a black and white photograph. The image is blurry and out of focus. There are some dark spots in the image. The image is mostly white.
510(k) Number: K021357
Device Name: MEDPOR® Plus orbital volume replacement implants
MEDPOR® Plus Sphere; MEDPOR® Plus COI™ (Conical Orbital Implant); MEDPOR® Plus MCOI™ (Multi-Purpose Conical Orbital Implant); MEDPOR®Plus SST™ Sphere (Smooth Surface Tunnel Sphere); MEDPOR®Plus SST™ COI™; MEDPOR®Plus MCOI™ SST™; MEDPOR® Plus QUAD™ Motility Implant
Indications for Use:
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.
(PLEASE DO NOT WRITE BELOW THIS LINE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K021357 |
| Prescription Use:
| (Per 21CFR801.109 | OR | Over the Counter Use: |
|---|---|---|
| ---------------------------------------- | ---- | ----------------------- |