(157 days)
The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.
The provided document describes the OsteoSymbionics Temporal Implant, a pre-formed silicone elastomer implant intended to fill soft-tissue defects in the temporal region of the cranium.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|---|
| Material Characteristics | Comparable chemical characteristics to predicate devices. | "comparable chemical characteristics as the Implatech device (based upon literature comparison)" |
| Physical Properties | Adequate tensile strength. | Tested (tensile) |
| Adequate durometer (hardness). | Tested (durometer) | |
| Adequate tear strength. | Tested (tear strength) | |
| Biocompatibility | Non-cytotoxic. | "augmented with an agar overlay cytotoxicity study" |
| Sterility | Low bioburden to support sterilization claims. | "Bioburden testing was conducted to support the sterilization testing." |
| Low endotoxin levels. | "LAL testing demonstrated less than 0.005EU/ml." | |
| Shelf-Life | Supported by aging data/history. | "Shelf-life aging labeling claims are supported by product use history." |
Critique: The "acceptance criteria" are not explicitly stated as quantitative targets in the provided text. Instead, the document describes the types of tests performed to demonstrate that the device is "substantially equivalent" to predicate devices. For most criteria, the performance is described as "tested" or "comparable," without specific numerical values.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on sample sizes for specific tests (e.g., number of units tested for tensile strength, number of cultures for bioburden). It also does not mention the country of origin of the data or whether the data was retrospective or prospective, as the testing described is primarily laboratory-based product characterization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The "test set" here refers to the physical device and its material properties, not a set of clinical cases requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, the "test set" is related to product characteristics, not clinical assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The summary describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Clinical studies comparing human reader performance with and without AI assistance are not part of this type of submission for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the OsteoSymbionics Temporal Implant. This is a physical medical device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
For the material and physical property testing, the "ground truth" would be established by standardized laboratory methods and industry specifications for implantable-grade materials. For biocompatibility, it's established by recognized cytotoxic assays. For sterility, it's based on microbiological testing standards. The comparison for chemical characteristics relies on literature comparison to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical implant, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no training set for this type of device.
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SECTION 5 510(K) SUMMARY
Submitted on behalf of:
SEP 2 2 2011
Company Name: Ms. Cynthia Brogan, President OsteoSymbionics, LLC 1768 East 25th Street Cleveland, Ohio 44114 Registration No: 3007223102 Phone: (216) 881-8500 e-mail: cb@osteosymbionics.com
Submitted by:
Elaine Duncan, M.S.M.E., RAC
President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: Fax:
715-549-6035 715-549-5380
CONTACT PERSON: DATE PREPARED:
Elaine Duncan September 12, 2011
Trade or Proprietary Name: Common Name: Classification Name: Classification
OsteoSymbionics Temporal Implant Temporal Implant Implant, Temporal (ProCode): MNF
SUBSTANTIALLY EQUIVALENT TO:
The OsteoSymbionics Temporal Implants (made from silicone elastomer technology) are substantially equivalent to the following legally marketed predicate devices: Inc., Implantech Temporal Implant - K943644 (made from silicone elastomer) and Porex Surgical, Inc., Medpor Pterional Surgical Implant - K002568, made from porous polyethylene.
DESCRIPTION of the DEVICE:
The OsteoSymbionics Temporal Implants are pre-formed implantable prosthetic implants intended to fill soft-tissue defects in a patient's cranial/craniofacial temporal region. The implants are composed of longterm implantable-grade solid silicone elastomer. The implants are available in left and right, and come in two different sizes, small and medium. The devices are provided sterile, and are attached to native tissue with commercially available suture materials.
INDICATIONS FOR USE:
The OsteoSymbionics ST Temporalis Implant is Indicated to correct temporal hollowing in patients who have had surgery involving the pterional / Lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniotomy. The OsteoSymbionics St Temporalis Implant augments the space normally occupied by the temporalis muscle. The Implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
SUMMARY of TESTING:
The non-clinical safety and effectiveness data established that the OsteoSymbionics Temporal Implant has comparable chemical characteristics as the Implatech device (based upon literature comparison). Physical property testing included tensile, durometer and tear strength of materials representing the manufacturing and sterilization parameters. Biocompatibility data from the MAF was augmented with an agar overlay cytotoxicity study. Bioburden testing was conducted to support the sterilization testing. LAL testing demonstrated less than 0.005EU/ml. Shelf-life aging labeling claims are supported by product use history.
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Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G605 Silver Spring, MD 20993-0002
OsteoSymbionics. LLC % Paladin Medical, Inc. Elaine Duncan. MS, ME. RAC P.O. Box 560 Stillwater, Minnesota 55082
SEP 2 2 2011
Re: K111069
Trade/Device Name: OsteoSymbionics ST Temporalis Implant Regulation Number: 21 CFR 878.3550 Regulation Name: Chin prosthesis Regulatory Class: II Product Code: MNF Dated: September 12, 2011 Received: September 14, 2011
Dear Ms. Duncan:
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.
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
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Page 2 - Elaine Duncan, MS, ME, RAC
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.lda.gov/AboutFDA/CemersOfTices/CDRHOffices/ucm115809.html 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/ReportalProblem/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 tollofreen mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Erint Keith
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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Kiii069
Indications for Use
510(k) Number (if known):
Device Name:
The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).
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
Daniel Krane for MXM
(Division Sign Off)
(Division Sim Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K111069
Page 1 of 1
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.