(158 days)
Not Found
No
The summary describes a physical implant made of porous polyethylene for bone grafting support. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
Explanation: The device is intended to stabilize and support bone graft materials and provide space maintenance, which serves a structural and supportive role rather than directly treating a disease or condition. While it aids in healing, its primary function is mechanical support.
No
The device is described as an implant used to stabilize and support bone graft materials, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a physical implant made from porous high-density polyethylene (pHDPE), which is a hardware material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma." This describes a surgical implant used directly in the body during a procedure.
- Device Description: The description details a physical implant made of porous high-density polyethylene, designed to be placed surgically.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on in vitro analysis.
This device is clearly a surgical implant intended for direct use within the patient's body.
N/A
Intended Use / Indications for Use
The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Product codes (comma separated list FDA assigned to the subject device)
NPK
Device Description
The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form.
Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla, mandible and zygoma
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): 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.
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
KI02184
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, black letters.
510(k) Summary
JAN - 7 2011
Date of Summary: July 30, 2010
Manufacturer and Submitter:
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265 Tel: (678) 479-1610 Fax: (678) 479-4495
Contact: Stephanie Fullard E-mail: stephanie.fullard(@)porex.com
Trade Name: MEDPOR® CONTAIN™ CAN Implant
Descriptive Name: MEDPOR CONTAIN Implant
Classification: II, 21 CFR 872.3930 - Bone grafting material
Product Code: NPK
Predicate Device: MEDPOR CONTAIN Implant (K091120)
Device Description:
The purpose of this Special 510(k) is to add the CAN configuration to MEDPOR CONTAIN Implants. The MEDPOR CONTAIN CAN Implant is a cylinder shaped, thin walled, highly porous, implant that is closed on one end and open on the other. It is made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as MEDPOR CONTAIN Implants in sheet form.
Like the sheet configuration, the CAN is non-resorbable, allows for host integration and is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
The CAN configuration will minimize the need for the surgeon to shape the MEDPOR CONTAIN Sheet Implant, which will reduce the time required for performing the procedure and reduce the possibility of introducing contaminants or debris to the surgical site.
ર - I
1
Image /page/1/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, black letters.
Indications for Use:
The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Technological Characteristics: The MEDPOR CONTAIN CAN Implant can be used to contain, support, and maintain the space for bone graft material that is used in the maxilla, mandible or zygoma to re-establish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN CAN Implant is designed to minimize the surgeon's need to shape, trim or cut the implant to fit a patient's specific needs. It may be stabilized with tacks, sutures, wires, craniofacial screws or dental implant retention screws. The MEDPOR CONTAIN CAN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR CONTAIN Implants.
Substantial Equivalence: The MEDPOR CONTAIN CAN Implant is substantially equivalent in intended use, material, function and design principles to the MEDPOR CONTAIN Implant.
| | MEDPOR CONTAIN CAN | Predicate Device
MEDPOR CONTAIN Implant |
|------------------------|-----------------------------------------|--------------------------------------------|
| | Implant | |
| 510(k) Number | This Submission | K091120 |
| Device Classification | Class II, Code NPK | Class II, Code NPK |
| | Reg. No. 872.3930 | Reg. No. 872.3930 |
| Intended Use | The MEDPOR CONTAIN CAN | The MEDPOR CONTAIN |
| | Implant is intended to stabilize, | Implant is intended to stabilize, |
| | support and provide space | support and provide space |
| | maintenance for bone graft | maintenance for bone graft |
| | materials in the maxilla, | materials in the maxilla, |
| | mandible and zygoma. | mandible and zygoma. |
| Material | Linear high-density | Linear high-density |
| | polyethylene biomaterial | polyethylene biomaterial |
| Shape | Cylinder (Can) | Flat (Sheet) |
| Diameter (mm) | 8, 9, 10 | Not Applicable |
| Thickness (mm) | 0.40 | 0.25, 0.35, 0.45 |
| Sterility | Sterile/Ethylene Oxide | Sterile/Ethylene Oxide |
| Single Use Only | Yes | Yes |
| Packaging | Double peel pouch | Double peel pouch |
| Shelf life | 10 years | 10 years |
| Safety & Effectiveness | No changes in function and intended use | |
- Substantial Equivalence Matrix
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Stephanie Fullard Regulatory Affairs Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265
JAN - 7 2011
Re: K102184
Trade/Device Name: MEDPOR® CONTAIN™ CAN Implant Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: November 22, 2010 Received: November 24, 2010
Dear Ms. Fullard:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Ms. Fullard
Enclosure
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number: K102184
JAN - 7 2011
Device Name: MEDPOR® CONTAIN™ CAN Implant
Indications for Use: The MEDPOR CONTAIN CAN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoe
(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices
510(k) Number:
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