(90 days)
MEDPOR® Surgical Granule Implants are intended for the augmentation or restoration of contour in the cranial facial area. They are indicated for use where a well formed pocket can be formed for containment, and where, because of the irregularity of the deformity, it is difficult to fill with other shaped implants. This material is intended exclusively for non-load bearing applications.
MEDPOR Surgical Granular Implants are 1.15±0.15 cliameter spheres of porous polye : hylene.
The provided text describes a 510(k) summary for a medical device called "MEDPOR® Surgical Granule Implants." This document details the device's description, its comparison to predicate devices, and its intended use. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as a traditional clinical study report would.
The crucial information about acceptance criteria, performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not present in the provided 510(k) summary.
A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data from a clinical trial in the way that would typically be described in response to your request.
The document states:
- "The device of this submission is identical to the previously approved MEDPOR material except for the external dimension of the sphere."
- "The device of this submission is substantially equivalent to the referenced IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers in that both are granular form, with granules being in the 1 mm range, and both are constructed of previously approved, although different, biomaterials."
This indicates that the FDA's clearance (K982040) was based on a demonstration of substantial equivalence rather than a new clinical study with specific acceptance criteria that the device had to meet. Therefore, the details requested are not available in this type of regulatory submission.
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Image /page/0/Picture/1 description: The image shows the logo for Porex Surgical Inc. The logo consists of a black and white checkered pattern on the left, followed by the company name in bold, black letters. The checkered pattern has a circular opening in the center, creating a vortex effect. The text "SURGICAL INC." is placed below "POREX" in a smaller font size.
4715 Roosevelt Highway, College Paik, Georgia 30349 USA (770) 969-8145 · (800) 521-7321 · Fax: (770) 969-8045
992240
510(k) SUMMARY
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: May 30, 1997
Trade Name: MEDPOR® Surgical Granule Implants Classification Name: Ear, Nose and Throat Synthetic Polymer Material
Substantially equivalent to: A) Other MEDPOR® implants manufactured and sold by Porex Surgical Inc. B) INTERPORE IP 200 Granular Coralline Hydroxyap:atite Bone Void Fillers Manufactured by: Interpore International 181 Technology Drive Irvine. CA 92718
Device description:
MEDPOR Surgical Granular Implants are 1.15±0.15 cliameter spheres of porous polye : hylene.
Comparison with predicate device
The device of this submission is identical to the previously approved MEDPOR material except for the external dimension of the sphere. The device of this submission is substantially eculvalent to the referenced IP 200 Granular Coralline Hydroxyapatite Bone Void Fillers in that both are granular form, with granules being in the 1 mm range, and both are constructed of previously approved, although different, biomaterials. This material is intended exclusively for non-load bearing applications.
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Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1998 SEP
Howard Mercer, Ph.D. Porex Surgical, Inc. 4715 Roosevelt Highway College Park, Georgia 30349
Re : K982040 Trade Name: MEDPOR® Surqical Granule Implants Requlatory Class: II Product Code: GXP Dated: June 9, 1998 Received: June 10, 1998
Dear Dr. Mercer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), 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 895. ਖੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Howard Mercer, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamaim.html".
Sincerely yours,
Colia M. Witton Ph.D. M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Porex Surgical Inc. The logo consists of a black and white checkered square with a circular opening on the left side. To the right of the square is the company name, "POREX SURGICAL INC.", written in bold, black letters.
INDICATION FOR USE
510(k) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
MEDPOR® Surgical Granule Implants are intended for the augmentatio 1 or restoration of contour in the cranial facial area. They are indicated for use where a well formed pocket can be formed for containment, and where, because of the irregularity of the deformity, it is difficult to fill with other shaped implants. This material is intended exclusively for non-load bearing applications.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Picoello
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982040
Prescription Use:
(Per 21 CFR 801.109_
OR
Over the Counter I Jse: _________________
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).