(57 days)
Not Found
No
The summary describes a customized implant made from a specific material based on CT scan data, but there is no mention of AI or ML being used in the design or manufacturing process. The customization appears to be based on the anatomical data directly, not through an AI/ML algorithm.
No
The device is described as an implant for augmentation or restoration of bony contour, which is a structural and supportive function, not a therapeutic one that treats or cures a disease.
No
The device is described as a "Customized Surgical Implant" intended for augmentation or restoration of bony contour, which indicates a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description explicitly states the device is made from a physical material (porous high-density polyethylene) and is a physical implant, 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 the "augmentation or restoration of bony contour in craniofacial defects." This describes a surgical implant used directly on the patient's body to modify its structure.
- Device Description: The description details a physical implant made of a specific material (pHDPE) that integrates with body tissue. This is characteristic of a medical device used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens.
Therefore, the MEDPOR Customized Surgical Implant is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Product codes
JOF, GWO
Device Description
MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.
MEDPOR Customized Surgical Implant shapes can be created from CT scan data, a physical model, drawing or other information provided by a physician. MEDPOR Customized Surgical Implant shapes have the same intended use, are manufactured from the same material, can be trimmed with a blace in the sterile field, will accept plates and screws and are packaged the same as other MEDPOR Preformed Cranial and Facial Implants. MEDPOR Customized Surgical Implants are sterilized with Ethylene Oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan data
Anatomical Site
craniofacial defects
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
083621
Image /page/0/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, sans-serif font. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in a smaller, sans-serif font. The logo is black and white.
-3 2009
510(k) SUMMARY
Date of Summary: January 30, 2009
Manufacturer and Submitter:
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 479-4495
Contact: Mrs. Jerri Mann E-mail: jerri.mann@porex.com
Trade Name: MEDPOR® Customized Surgical Implant
Class: II 21 CFR 874.3620 Ear, nose, and throat synthetic polymer material.
Product Code: JOF
Subsequent Product Code: GWO
Substantially equivalent to: MEDPOR Surgical Implant Material; Preformed Cranial &
Facial Implants, K022480 Facial Implants, K922489
Device Description:
MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.
Indications for Use:
The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
1
Image /page/1/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 text "SURGICAL PRODUCTS GROUP" in smaller, thinner letters. The logo is simple and professional.
17
Technological Characteristics:
MEDPOR Customized Surgical Implant shapes can be created from CT scan data, a physical model, drawing or other information provided by a physician. MEDPOR Customized Surgical Implant shapes have the same intended use, are manufactured from the same material, can be trimmed with a blace in the sterile field, will accept plates and screws and are packaged the same as other MEDPOR Preformed Cranial and Facial Implants. MEDPOR Customized Surgical Implants are sterilized with Ethylene Oxide.
Substantial Equivalence:
MEDPOR Customized Surgical Implans are substantially equivalent to the predicate device MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implans. The comparison table below details the similarities between MEDPOR Customized Surgical Implants and the predicate device:
| Characteristic | MEDPOR Surgical Implant | MEDPOR Customized
Surgical Implant | SE
Y/N |
|----------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------|
| Intended Use | For augmentation or restoration of bony
contour in craniofacial defects. | For augmentation or restoration of bony
contour in craniofacial defects. | Y |
| Materials | A linear, high-density polyethylene
biomaterial | A linear, high-density polyethylene
biomaterial | Y |
| Manufacturing Process | Preformed Shapes | Patient Specific Preformed Shapes | Y |
| Size Ranges/Specifications | Refer to Product Catalog | Customized according to a signed
prescription form | Y |
| Shapes | Refer to Product Catalog | Customized according to a signed
prescription form | Y |
| Packaging | Double peel pouched and put in a
Clamshell or shelf box | Double peel pouched and put in a
Clamshell or shelf box | Y |
| Sterile/Non-Sterile | Sterile | Sterile | Y |
| Sterilization Method | EO Gas | EO Gas | Y |
| Non-Pyrogenic Claim | YES | NO | N |
2
| Shelf-Life | 10 years | 10 years | Y |
|---|---|---|---|
| Biocompatibility | Yes | Yes | Y |
| Prescription Device | Yes - Sale by or on the order of a physician | Yes - Sale by or on the order of a physician | Y |
| Labeling | MEDPOR Surgical Implants including TITAN!™ and BARRIER™ Implant Instructions For Use | MEDPOR CUSTOMIZED Surgical Implants | Y - Different only in that the labeling removes NON-PYROGENIC claim and has the statement "not tested for endotoxin". |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Porex Surgical, Inc. c/o Jerri L. Mann Regulatory Compliance Manager 15 Dart Road Newman. GA 30265-1017
FEB - 3 2009
Re: K083621
Trade/Device Name: MEDPOR® Customized Surgical Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: JOF, GWO Dated: December 3, 2008 Received: December 16, 2008
Dear Ms. Mann:
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. Iisting 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.
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Epolins, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K083621
Indications for Use
510(k) Number (if known):
Device Name: MEDPOR® Customized Surgical Implant
Indications for Use: The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amaloui
(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic and Ear,
Throat Throat Devices Division of Ophicial
Nose and Throat Devices
Nose and
510(k) Number k08362