(336 days)
No
The summary describes a physical implant made of porous polyethylene for bone grafting support. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is described as an implant to stabilize, support, and provide space maintenance for bone graft materials, which is structural and supportive rather than therapeutic.
No
The device is described as an implant material to stabilize, support, and provide space maintenance for bone graft materials, not to diagnose a condition.
No
The device description clearly states it is a "semi-rigid sheet, made from... porous high-density polyethylene (pHDPE) material," indicating it 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 to "stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible and zygoma." This describes a surgical implant used in vivo (within the body) to aid in bone grafting procedures.
- Device Description: The description details a "semi-rigid sheet" made of a biocompatible material for surgical implantation.
- 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 information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the MEDPOR CONTAIN Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MEDPOR CONTAIN 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
MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
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.
K922489, K051267, K984230, K972278, K970841
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
Image /page/0/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, black letters. The logo is simple and professional.
MAR 1 9 2010
510(k) SUMMARY
Date of Summary: March 11, 2010
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® CONTAIN™ Implant
Class: II, 21 CFR 872.3930 Bone grafting material
Product Code: NPK
Substantially equivalent to:
- MEDPOR® Surgical Implant Material; Preformed Cranial & Facial Implants, K922489 2) GORE RESOLUT® ADAPT Regenerative Membrane, K051267 3) Osteo-Mesh TM-300 (Titanium Ridge Augmentation Mesh), K984230 4) Cytoplast™ Regentex Titanium 250, K972278 5) IMTEC/Titanium Mesh, K970841
Device Description:
MEDPOR CONTAIN Implant is a thin, highly porous, biocompatible semi-rigid sheet, made from the same biocompatible pure porous high-density polyethylene (pHDPE) material which allows for host tissue integration as other MEDPOR Surgical Implants. The MEDPOR CONTAIN Implant is designed to stabilize and support bone graft materials and provide space maintenance necessary for regenerative healing.
Indications for Use:
The MEDPOR CONTAIN Implant is intended to stabilize, support and provide space maintenance for bone graft materials in the maxilla, mandible, and zygoma.
ર - I
1
Technological Characteristics:
The MEDPOR CONTAIN 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 reestablish missing bone or establish new bone for support of dental implants. The MEDPOR CONTAIN Implant can be trimmed or cut to size and bent to conform to the needs of the individual patient. It may be stabilized with tacks, sutures, wires, or craniofacial screws. The MEDPOR CONTAIN Implant is manufactured from the same material, packaged, labeled and sterilized the same as all other MEDPOR Surgical Implant Material: Preformed Cranial and Facial Implants.
Substantial Equivalence:
The MEDPOR CONTAIN Implant shares indications and design principles with the following predicate devices:
| Device Name | Proposed
Device | Predicate
Device #1 | Predicate
Device #2 | Predicate
Device #3 | Predicate
Device #4 | Predicate
Device #5 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MEDPOR
CONTAIN
Implant | MEDPOR
Surgical Implant
Material;
Preformed
Cranial & Facial
Implants | GORE
RESOLUT
ADAPT
Regenerative
Membrane | Osteo-Mesh TM-
300 (Titanium
Ridge
Augmentation
Mesh) | IMTEC/Titanium
Mesh | Cytoplast
Regnetex
Titanium 250
(Titanium Ridge
Augmentation
Mesh |
| 510(k)
Number | This
Submission | K922489 | K051267 | K984230 | K970841 | K972278 |
| Intended Use | The MEDPOR
CONTAIN
Implant is
intended to
stabilize, support
and provide
space
maintenance for
bone graft
materials in the
maxilla,
mandible, and
zygoma. | For augmentation
or restoration of
bony contour in
craniofacial
defects. | For use during
the process of
guided bone
regeneration as a
bioabsorbable
membrane for
supporting:
augmentation
around
immediately
placed
endosseous
implants or
existing
endosseous
implants (e.g.,
dehiscence and
fenestration
defects,
extraction
sockets); ridge
augmentation for
later implantation
of endosseous
implants; and
sinus procedures
(e.g., sinus
window, sinus
lift). | For stabilization
and support of
bone grafts in
dento-alveolar
bony defect sites. | For the repair of
both localized
and extensive
alveolar ridge
defects,
protection for the
graft site,
membrane
support, tissue
support. | A temporarily
implantable
material (non-
resorbable) for
use as a space-
making barrier in
the treatment of
periodontal
defects. |
| Material | A linear, high-density
polyethylene
biomaterial | A linear, high-density
polyethylene
biomaterial | Synthetic
resorbable
copolymer
materials | Grade 1 Titanium | Expanded CP
Titanium | A nonporous high
density
polytetrafluoroet
hylene film
enforced with a
titanium |
2
| Design | 15mm x 30mm,
25mm x 30mm,
45mm x 30mm
sheets in 0.25mm
and 0.35mm
thicknesses and
other shapes and
sizes as well as
patient specific
customized
shapes | Preformed
shapes including
sheets, micro thin
sheets and ultra
thin sheets | Regenerative
membrane 15mm
x 20mm, 20mm x
25mm and 25mm
x 30mm | Ti nitride coated
perforated mesh
0.009 inch thick
25mm x 30mm,
and
12mm x 25mm | 34mm x 25mm
0.10mm
thickness | 0.25 mm thick
25mm x 30mm,
12mm x 25mm,
14mm x 20mm,
14mm x 24mm,
20mm x 25mm,
13mm x 19mm
and 13mm x
18mm |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Sterile/
Non-Sterile | Sterile | Sterile | Sterile | Non-Sterile | Sterile | Sterile |
| Sterilization
Method | EtO | EtO | Gamma | Autoclave | Not specified | Steam |
| Biocompatible | Yes | Yes | Yes | Yes | Yes | Yes |
.
3
Image /page/3/Picture/1 description: The image shows the seal of 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 an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jerri L. Mann Regulatory Compliance Manager Porex Surgical, Incorporated 15 Dart Road Newnan, Georgia 30265
MAR 1 9 2010
Re: K091120
Trade/Device Name: MEDPOR® CONTAIN™ Implant Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPK Dated: March 11, 2010 Received: March 12, 2010
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, 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.
4
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 /ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
1- 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
Enclosure
5
09/120 Indications for Use
510(k) Number: K091120
Device Name: MEDPOR® CONTAIN™ Implant
Indications for Use: The MEDPOR CONTAIN 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)
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: K09112
Page 1 of 1