(208 days)
CERASORB® Plus is recommended for:
- · Defects after extirpation of bone cysts
- · Augmentation of the atrophied jaw ridge
- · Sinus lift or sinus base elevation respectively
- · Filling alveolar defects after tooth extraction for jaw ridge support
- · Filling extraction defects to create an implant site
- · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects
- · Defects after operative removal of retained teeth or corrective osteotomes
CERASORB® Plus is a sterile, synthetic, porous and biocompatible ceramic matrix roundish and polygonal crushed shaped morsels. This modification consists of purephase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® Plus mixture of granules with porosity of 35% and of 65%).
CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic.
In contact with vital bone the CERASORB® Plus granules, morsels or granulate is reabsorbed and gradually replaced by new bone.
CERASORB® Plus is provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the vears. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size.
The provided document is a 510(k) summary for CERASORB® Plus, a bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format typically expected for medical device performance evaluation.
Instead, the submission relies on the concept of substantial equivalence to predicate devices (CERASORB® DENTAL and CERASORB® M DENTAL) which have already established safety and effectiveness. The “study” proving the device meets criteria is primarily the comparison to these predicate devices and the existing knowledge on Beta-Tricalcium Phosphate (В-ТСР).
Here's an attempt to extract and synthesize the information based on your request, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., minimum tensile strength, specific resorption rate) are not explicitly stated within the provided text, they cannot be presented in a table. The primary "acceptance criteria" appear to be:
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Material Composition & Purity: Pure-phase Beta-Tricalcium Phosphate (В-ТСР) with high purity, compliant with ASTM F 1088-04. | CERASORB® Plus consists of "pure-phase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04." |
| Biocompatibility: Non-toxic, not allergenic. | "Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic." The use of Beta-Tricalcium Phosphate in vivo is "non-toxic, biocompatible." |
| Resorbability & Bone Regeneration (Osteoconductivity): Resorbed over time and replaced by new vital bone. | "In contact with vital bone the CERASORB® Plus granules... is reabsorbed and gradually replaced by new bone." "The material is... osteoconductive and resorbable." |
| Effectiveness for Intended Uses: Performs well for specific dental/maxillofacial defects. (Implicit: equivalent to predicate devices already proven effective). | "These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use." |
| Manufacturing Quality: Ensures batch-to-batch conformity and reproducibility. | "CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility." |
| Sterility: Provided sterile. | "Provided in double sterile packages (sterilization via gamma irradiation)." |
Study Proving Acceptance Criteria:
The primary "study" or basis for proving these criteria is the claim of substantial equivalence to previously cleared/approved predicate devices (CERASORB® DENTAL PMA800035/ K051443 and CERASORB® M DENTAL K051443) and the established scientific understanding and historical use of Beta-Tricalcium Phosphate.
The document states: "The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the years. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size."
2. Sample Size Used for the Test Set and Data Provenance
- The document does not describe a specific "test set" or clinical study with a defined sample size for CERASORB® Plus.
- Instead, it leverages existing literature and studies on Beta-Tricalcium Phosphate and the predicate devices. The "data provenance" mentioned is the general body of "numerous animal and human studies over the years" related to В-ТСР and the predicate devices, implying retrospective analysis of existing data. No specific country of origin is mentioned for these historical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided as there isn't a new clinical study described for CERASORB® Plus with a ground truth established by a panel of experts.
- The "ground truth" for the safety and efficacy of Beta-Tricalcium Phosphate is implicitly established by the collective scientific and medical community's acceptance of the material through "numerous animal and human studies."
4. Adjudication Method for the Test Set
- An adjudication method is not applicable as there is no specific new test set or clinical study described in this 510(k) summary for CERASORB® Plus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically for evaluating diagnostic imaging systems or AI tools. CERASORB® Plus is a physical bone void filler.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a physical bone graft material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" is based on scientific consensus and established clinical outcomes from "numerous animal and human studies" on Beta-Tricalcium Phosphate, as well as the regulatory clearance/approval of predicate devices. This falls under the category of outcomes data and expert consensus derived from years of research and clinical use of the material.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device. The "training" for the understanding of the material's properties comes from the body of scientific literature and studies mentioned.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/algorithm, this question is not relevant to the provided submission. The scientific understanding of Beta-Tricalcium Phosphate's properties (its "ground truth") was established incrementally over time through experimental research, animal studies, and human clinical observations.
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K 120152
CERASORB® PLUS
Abbreviated 510 (K) Summary
RIEMSER
ITEM
Abbreviated 510 (k) Summary:
CERASORB® Plus Date Prepared: 1 December 2011
AUG 1 3 2012
10,3
SUBMISSION INFORMATION 1.
| Name and Address of the Sponsor: | Riemser Arzneimittel AGAn der Wiek 717493 GreifswaldGermany |
|---|---|
| ---------------------------------- | ------------------------------------------------------------------------- |
Contact person:
Christoph Wahl Regulatory affairs dental medical devices/ Product Group Responsible Tel : +49 - 38351-76667 Fax: +49 - 38351-7688694 E - Mail: wahl@RIEMSER.de
Registered U. S. Agent:
James M. Clinton 5105 Fairoaks Rd. Durham, NC 27712, USA Phone: 919 - 247-0479, fax: 919 - 287-2551 E - Mail: clintonim(wearthiink.net
2. DEVICE IDENTIFICATION
| Proprietary Name: | CERASORB® Plus |
|---|---|
| Common Name: | Bone Void Filler, Synthetic |
| Classification Name: | Bone Grafting Material, Synthetic |
| Classification: | Class II, Special Controls. |
| Classification regulation Number: | 21CFR 872.3930 |
| Product Code: | LYC |
PREDICATE DEVICES 3.
CERASORB® DENTAL: PMA800035/ K051443
Revised 20 Jun 2012
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CERASORB® PLUS
Abbreviated 510 (K) Summary
TEM 6
CERASORB® M DENTAL: K051443
INTENDED USE 4.
CERASORB® Plus is recommended for:
- · Defects after extirpation of bone cysts
- · Augmentation of the atrophied jaw ridge
- · Sinus lift or sinus base elevation respectively
- · Filling alveolar defects after tooth extraction for jaw ridge support
- · Filling extraction defects to create an implant site
- · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects
- · Defects after operative removal of retained teeth or corrective osteotomes
5. DESCRIPTION OF THE DEVICE
CERASORB® Plus is a sterile, synthetic, porous and biocompatible ceramic matrix roundish and polygonal crushed shaped morsels. This modification consists of purephase Beta-Tricalcium Phosphate with a phase purity of ≥ 99% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a network of large, smoothly interconnected pores providing different porosities (CERASORB® Plus mixture of granules with porosity of 35% and of 65%).
CERASORB® Plus is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature CERASORB® Plus does not pose any risk of potential allergic reactions and are neither locally nor systemically toxic.
In contact with vital bone the CERASORB® Plus granules, morsels or granulate is reabsorbed and gradually replaced by new bone.
CERASORB® Plus is provided in double sterile packages (sterilization via gamma irradiation) and are for single-use only.
The use of Beta-Tricalcium Phosphate in vivo is well known and has been studied and evaluated in numerous animal and human studies over the vears. These studies indicate overall excellent performance, biocompatibility, resorption and bone regeneration with CERASORB® derived thereof the performance of CERASORB® Plus in the areas of its intended use and have proven that the material is non-toxic, biocompatible, resorbable while in contact with vital bone over time is replaced by new bone at the defect size.
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CERASORB® PLUS
Abbreviated 510 (K) Summary
TEM 6
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
CERASORB® Plus is are substantially equivalent to a number of currently marketed and approved/cleared bone void fillers for defects in the oral/maxillofacial and dental region, such as CERASORB® DENTAL (formally regulated as a PMA800035/ K051443) and CERASORB® M DENTAL (K051443)
Although the manufacturing process of the material is different (Beta-Tricalcium Phosphate in different porosities and morsel sizes), the intended use, recommended indications for use, target population, anatomical site, and performance data for CERASORB® Plus and the predicate devices are essentially similar. Also, all materials are resorbable and biocompatible. In contact with vital bone any of the bone grafting materials is reabsorbed and gradually replaced by new bone.
Information provided in this submission proves the effectiveness and safety of CERASORB® Plus design.
STATEMENT OF TECHNOLOGICAL COMPARISON 7.
The CERASORB® Plus modification consist of pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-04. The material is of interconnecting porosity, osteoconductive and resorbable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Riemser Arzneimittel AG C/O Mr. James Clinton Quality And Regulatory Consulting, Limited Liability Company 5105 Fairoaks Road Durham, North Carolina 27712
AUG 1 3 2012
Re: K120152
Trade/Device Name: CERASORB® Plus Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: June 26, 2012 Received: July 02, 2012
Dear Mr. Clinton:
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 Eederal Register.
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Page 2- Ms. Clinton
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Rumm
Anthony D. Watson, B.S., M.S., M.B.A. Director Director of Anesthesiology, General Hospital, 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: K120152
CERASORB® Plus Device Name:
Indications for Use:
CERASORB® Plus is recommended for
- · Defects after extirpation of bone cysts
- · Augmentation of the atrophied jaw ridge
- · Sinus lift or sinus base elevation respectively
- · Filling alveolar defects after tooth extraction for jaw ridge support
- · Filling extraction defects to create an implant site
- · Filling of two or multi-walled infrabony pockets, and bifurcation and trifurcation defects
- · Defects after operative removal of retained teeth or corrective osteotomes
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susem Reuryer
، Division Sign-Off) ivision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K-20-152
§ 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.