(436 days)
Mesothelium Dental Membrane is indicated for: simultaneous use of GBR-membrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
The device is intended for one time use.
Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.
The provided text describes the regulatory clearance (510(k)) for the "Mesothelium Dental Membrane" and establishes its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations.
The context of this document is a traditional medical device submission, focusing on material properties, intended use, and comparison to existing predicate devices. It relies on the concept of "substantial equivalence" rather than data-driven performance metrics against predefined acceptance criteria for a novel AI/ML algorithm.
Therefore, for your specific request regarding acceptance criteria and a study demonstrating performance, I must state that the provided text does not contain this information.
Here's why and what's missing:
- Acceptance Criteria & Reported Performance: The document lists "Technological Characteristics" and "Biocompatibility," "Non pyrogenic," and "Resorbable" as properties for comparison. These are characteristics, not quantitative acceptance criteria with numerical performance targets (e.g., sensitivity > X%, specificity > Y%). The "reported device performance" against such criteria is absent.
- Study Details (Sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone): None of these details are present because the submission process described here for a resorbable membrane doesn't involve the kind of performance study typical for an AI/ML diagnostic or assistive device. The "study" here is essentially the comparison table showing similar characteristics and intended use to existing devices, coupled with standard biocompatibility and material testing (which are not detailed in this summary). The ground truth for such a device would be based on established material science and biological response, not expert consensus on image interpretation or clinical outcomes of a diagnostic prediction.
- Training Set: There's no AI/ML algorithm, so there's no training set or ground truth establishment for a training set.
In summary, the provided FDA 510(k) document is for a physical medical device (a resorbable membrane) and relies on demonstrating substantial equivalence to predicate devices based on material properties and intended use. It does not present data, acceptance criteria, or study methodologies that would be relevant to evaluating an AI/ML-based medical device.
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Mesothelium Dental Membrane
JUL 1 1 2013
510(k) Summary
DSM Biomedical Submitted by: 735 Pennsylvania Drive Exton, PA 19341 USA
Lori Burns, MS, RAC Contact Person: Manager Regulatory Affairs Ph: (484) 713-2186 Fax: (484) 713-2903
July 2, 2013 Date Prepared: K121310 510(K) #:
Device:
| 'Trade Name: | Mesothelium Dental Membrane |
|---|---|
| Common/Usual Name: | Resorbable Membrane for Guided Tissue and Bone Regeneration |
| Classification Name: | Barrier, Animal Source, Dental |
| Proposed Classification: | 21 CFR 872.3930, Class II, NPL |
Device Description:
Mesothelium Dental Membrane is a barrier membrane for guided tissue and bone regencration in dental applications. It is a resorbable porcine-mesothelium-derived extracellular matrix available as a lyophilized sheet. Mesothelium Dental Membrane is available in a variety of shapes and sizes. Furthermore, the device can be casily trimmed or shaped to the appropriate size to fit the defect to be treated. The device is packaged sterile in a double-layer package.
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Intended Use:
Mesothelium Dental Membrane is indicated for:
- . simultaneous use of GBR-membrane and implants.
- augmentation around implants placed in immediate extraction sockets. .
- augmentation around implants placed in delayed extraction sockets. .
- . localized ridge augmentation for later implantation.
- alveolar ridge reconstruction for prosthetic treatment. .
- filling of bone defects after root resection, cystectomy, removal of retained teeth. .
- guided bone regeneration in dehiscence defects. .
- guided tissue regencration procedures in pcriodontal defects. .
Predicate Devices:
| Manufacturer | Device | 510(k) |
|---|---|---|
| Ed. Geistlich Soehne Ag FuerChemische Industrie | K050446 | Bio-Gide® |
| RTI Biologics | K073097 | CopiOs™ Pericardium Membrane |
Technological Characteristics:
The intended use, product design, material, function and target population of Mesothelium Dental Membrancs are substantially equivalent to the FDA cleared and legally marketed predicate devices Bio-Gide (K050446) and CopiOs Pericardium Membrane (K073097).
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
…
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| Medical Device Name | Mesothelium DentalMembrane | Bio-Gide | CopiOs PericardiumMembrane |
|---|---|---|---|
| Origin | Porcine | Porcine | Bovine |
| Device Characteristics | Extracellular matrix | Extracellular Matrix | Extracellular Matrix |
| Cell-occlusive | Cell-occlusive | Cell-occlusive | |
| Implantable | Implantable | Implantable | |
| Resorbable | Resorbable | Resorbable | |
| Intended Use | Mesothelium DentalMembrane isindicated forsimultaneous use ofGBR-membrane andimplants;augmentation aroundimplants placed inimmediate extractionssockets, augmentationaround implantsplaced in delayedextraction sockets,localized ridgeaugmentation for laterimplantation, alveolarridge reconstructionfor prosthetictreatment, filling ofbone defects after rootresection, cystectomyremoval of retainedteeth, guided boneregeneration indehiscence defects,guided tissueregenerationprocedures inperiodontal defects. | Bio-Gide is indicatedfor simultaneous useof GBR-membraneand implants;augmentation aroundimplants placed inimmediate extractionssockets, augmentationaround implantsplaced in delayedextraction sockets,localized ridgeaugmentation for laterimplantation, alveolarridge reconstructionfor prosthetictreatment, filling ofbone defects after rootresection, cystectomyremoval of retainedteeth, guided boneregeneration indehiscence defects,guided tissueregenerationprocedures inperiodontal defects. | CopiOs is intendedfor use in oral surgicalprocedures as aresorbable materialfor augmentationaround implantsplaced in immediateextraction sockets,augmentation aroundimplants placed indelayed extractionsockets; localizedridge augmentationfor later implantation;alveolar ridgereconstruction forprosthetic treatment;filling of bone defectsafter root resection,cystectomy, removalof retained teeth;guided boneregeneration indehiscence defectsand guided tissueregenerationprocedures inperiodontal defects. |
| Biocompatibility | Yes | Yes | Yes |
| Non pyrogenic | Yes | Yes | Yes |
| Resorbable | Yes | Yes | Yes |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(066-G609 Silver Spring, MD 20993-0002
July 11, 2013
DSM Biomedical C/O Ms. Lori Burns, MS. RAC Manager, Regulatory Affairs 735 Pennsylvania Drive EXTON PA 19341
Re: K121310
Trade/Device Name: Mesothelium Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 2, 2013 Received: July 5, 2013
Dear Ms. Burns:
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.
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Page 2 - Ms. Burns
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 CFF Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 yours,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K121310
Device Name: Mesothelium Dental Membrane
Indications for Use: Mesothelium Dental Membrane is indicated for: simultaneous use of GBRmembrane and implants, augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
The device is intended for one time use.
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)
Mary S. Runner -S
Susan Run DDS, MA 2013.07.11
11:29:45-04'00'
Page __ of
(Division Sign-Off) (Division Sign-On)
Division of Anesthestology, General Hospital Unfection Control, Dental Devices
s10(k) Number: K121510
Page 60
§ 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.