(189 days)
Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Specific indications (SynPOR HD Ocular Spheres):
• Ocular reconstruction
• Socket preservation
Specific indications (SynPOR HD Facial Shapes):
• Enhancement of the malar and chin
• Correction of deficiencies of the malar and chin
SynPOR HD Porous Polyethylene Three Dimensional Implants are devices intended for ocular reconstruction and socket preservation, enhancement of the midface and mandibular skeleton, and correction of deficiencies of the midface and mandible. The porous structure of the HDPE material allows for fibrovascular ingrowth.
The implants include facial shapes (chin and malar implants for aesthetic and reconstructive surgery to augment the contours of the craniofacial skeleton) and ocular spheres (for restoring the volume of an eviscerated or enucleated eye globe).
SynPOR HD Porous Polyethylene Implants are delivered sterile for single patient use and should not be resterilized.
The requested information about the acceptance criteria and the study proving the device meets them is not available in the provided text. The document is a 510(k) summary for a medical device (Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants), and it primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria or a study designed to meet them.
The text does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or the sample size for a training set.
The document states that the new device is "substantially equivalent" to predicate devices based on "indications, materials, principles of operation, dimensions, and device design," and that "none of the modifications impact safety and effectiveness." This indicates a regulatory clearance pathway that relies on comparison to existing legally marketed devices, rather than a new study with explicit acceptance criteria for novel performance claims.
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バリアママ 1۰-2
| 510(k) Summary | Page 1 of 2 |
|---|---|
| Date Prepared | August 30, 2011 |
| Submitter | SYNTHES (USA) |
| 1301 Goshen ParkwayWest Chester, PA 19380United States of America | |
| Contact | Contact: Alan T. Haleyhaley.alan@synthes.com(484) 356-9763 |
| Trade Name | Synthes SynPOR HD Porous Polyethylene Three Dimensional ImplantsSynthes SynPOR HD Facial Shape SystemSynthes SynPOR HD Ocular Spheres |
| Common Name | Porous High Density Polyethylene (HDPE) Implant |
| ClassificationName | Material, polytetrafluoroethylene vitreous carbon, for maxillofacialreconstruction, Class II, 21 CFR 878.3500 |
| Product Code | KKY |
| Predicate Devices | AOC Porous Polyethylene Surgical Implants (K080507) |
| DeviceDescription | SynPOR HD Porous Polyethylene Three Dimensional Implants aredevices intended for ocular reconstruction and socket preservation,enhancement of the midface and mandibular skeleton, and correction ofdeficiencies of the midface and mandible. The porous structure of theHDPE material allows for fibrovascular ingrowth. |
| The implants include facial shapes (chin and malar implants for aestheticand reconstructive surgery to augment the contours of the craniofacialskeleton) and ocular spheres (for restoring the volume of an evisceratedor enucleated eye globe). | |
| SynPOR HD Porous Polyethylene Implants are delivered sterile for singlepatient use and should not be resterilized. | |
| Intended Use | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implantsare intended for the augmentation or reconstruction of thecraniomaxillofacial skeleton. |
| Specific indications (SynPOR HD Ocular Spheres):• Ocular reconstruction• Socket preservation | |
| Specific indications (SynPOR HD Facial Shapes):• Enhancement of the malar and chin• Correction of deficiencies of the malar and chin |
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Page 2 of 2
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510(k) Summary
Technological Characteristics Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants. are modifications to the predicate and are therefore similar in terms of indications, materials, principles of operation, dimensions, and design. It was determined that none of the modifications impact safety and effectiveness.
Substantial Equivalence to Predicate Devices The modified devices are similar to the predicate devices identified above in terms of indications, materials, principles of operation, dimensions, and device design. The information presented in this submission supports substantial equivalence of the Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants to the predicate device. ·
(end of summary)
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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-W066-G609 Silver Spring, MD 20993-0002
NOV 1 6 2011
Synthes. Inc. % Mr. Alan T. Haley Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K111323
Trade/Device Name: Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polyetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KK Y Dated: November 11, 2011 Received: November 14, 2011
Dear Mr. Haley:
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 (för 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.
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
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Page 2 - Mr. Alan T. Haley
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/CDRHQffices/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely vours.
Erin A. Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Indications for Use Statement | |
|---|---|
| 510(k) Number (if known): | K111323 |
| Device Name: | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants |
| Indications for Use: | Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. |
| Specific indications (SynPOR HD Ocular Spheres): Ocular reconstructionSocket preservation | |
| Specific indications (SynPOR HD Facial Shapes): Enhancement of the malar and chinCorrection of deficiencies of the malar and chin | |
| Prescription Use X (Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF needed)
:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel D. Kamo de MXM
(Division Sign-Off) Division of Surgical, Orthopedic, . . and Restorative Devices
510(k) Number K111323
§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.
(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.