(138 days)
Not Found
Not Found
No
The summary describes a physical implant made of biomaterials and titanium mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an implant used for reconstruction and repair, not for treating a disease or condition.
No
The device is described as an implant used for reconstruction, not for identifying or diagnosing a medical condition.
No
The device description clearly states it is a physical implant made of biomaterial and titanium mesh, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a physical implant used for surgical reconstruction and repair of craniofacial structures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
Product codes
FTM, FTL
Device Description
This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial
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)
MEDPOR® Surgical Implant Material A., MEDPOR® Barrier Implants, MEDPOR® Barrier Channel Implants ்., Other titanium bone meshes currently marketed D.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
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JUN 3 0 2004
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. The logo is simple and professional.
510(k) SUMMARY (Amended May 19, 2004)
Manufacturer and Submitter
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
Contact: Greg Swords e-mail: greg.swords@porex.com
Date: February 9, 2004
Trade Name: MEDPOR Craniofacial Implants with Embedded Titanium Mesh
Class II Device 510(k) Number K040364 - - - #FF
Substantially equivalent to:
- MEDPOR® Surgical Implant Material A.
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- MEDPOR® Barrier Implants
MEDPOR® Barrier Implants
MEDPOR® Barrier Channel Implants ். - Other titanium bone meshes currently marketed D.
Device description:
This device is a MEDPOR/titanium mesh craniofacial implant available in three configurations: (1) A titanium mesh encapsulated within a thin coating of solid high density polyethylene. (2) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet with a nonporous barrier on one side. (3) A titanium mesh encapsulated within a MEDPOR Biomaterial porous polyethylene sheet.
Indications for Use.
MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
1
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three lines extending from its head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2004
Mr. Greg Swords VP, Technology and Development Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265-1017
Re: K040364
Trade/Device Name: MEDPOR® Craniofacial Implants with Embedded Titanium Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, FTL Dated: February 9, 2004 Received: February 13, 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
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Page 2 – Mr. Greg Swords
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. 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) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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 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.
INDICATION FOR USE (Amended May 19, 2004)
Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
510(k) Number: K 040364
Device Name: MEDPOR Craniofacial Implants with Embedded Titanium Mesh
Indications for Use:
MEDPOR Biomaterial with Embedded Titanium Mesh Implants are intended for non-weight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K040364 |
|---|---|
| Prescription Use: | X |
| OR | |
| Over the Counter Use: |