(162 days)
BioResorb® is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.
BioResorb® Macro Pore ß tricalcium phosphate is a synthetic, resorbable bone void filling material.
The provided text describes a 510(k) submission for the BioResorb® Macro Pore device and does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics for areas like sensitivity, specificity, or AUC, which are typically found in AI/diagnostic device submissions.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on composition, intended use, and technological characteristics, as well as prior marketing history and adherence to safety standards.
Therefore, the requested table and many of the detailed questions about performance studies (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance) cannot be answered from the provided text, as this type of information is generally not included in a substantial equivalence claim for a material like a bone void filler where performance is largely defined by material properties and established clinical use.
Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | The proposed BioResorb® Macro Pore and the predicate device Cerasorb® are of identical composition (both ß-tricalcium phosphate). BioResorb® is a ceramics powder of phase-three ß-TCP, manufactured from pure laboratory chemicals. |
| Intended Use Equivalence | BioResorb® Macro Pore's intended use (bone void filler in guided tissue regeneration, sinus lifts, ridge maintenance, alveolar socket preservation or ridge augmentation, and treatment of osseous defects) is the same as the predicate device. |
| Technological Characteristics Equivalence | The technological characteristics of the materials used are exact to the predicate device. |
| Safety - Heavy Metal Content (per ASTM 1088) | The contents of heavy metal according to ASTM 1088 (Standard specification for beta-TCP for implant surgery) are far below the permissible levels. |
| Safety & Effectiveness - Prior Use History | BioResorb® has been used and marketed in Germany since 1988 with no adverse events. The safety and effectiveness of this material ß-TCP in this application has been established (through this prior use history and general understanding of ß-TCP for this application, rather than a specific clinical trial described here). |
| Substantial Equivalence to Predicate Device (Overall Claim) | The proposed BioResorb® Macro Pore device is substantially equivalent to the listed predicate device (Curasan Cersorb® Ortho, K014156) based on identical composition, same intended use, and exact technological characteristics. FDA concurred with this assessment in the 510(k) clearance letter dated July 15, 2005 (and corrected Sep 13, 2007). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on a comparison to a predicate device and established knowledge of ß-TCP, rather than a specific clinical "test set" in the sense of a new performance study with human subjects or imaging data. The mention of marketing in Germany since 1988 with no adverse events refers to real-world usage, but no structured "test set" definition is given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The assessment relies on material science comparisons, regulatory standards (ASTM 1088), and a history of safe market use, not expert-adjudicated ground truth derived from a specific test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable in this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. This is not an AI/diagnostic imaging device, so MRMC studies are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's safety and effectiveness is established through:
- Material composition analysis: Verifying ß-TCP composition and purity.
- Adherence to recognized standards: Meeting ASTM 1088 for heavy metal content.
- Historical clinical use/Outcomes data (adverse events): The statement that "BioResorb® has been used and marketed in Germany since 1988 with no adverse events" serves as an implicit form of real-world outcomes data demonstrating safety.
- Substantial Equivalence: The primary ground for clearance is substantial equivalence to a legally marketed predicate device, whose safety and effectiveness are already established.
8. The sample size for the training set
This information is not provided. Not applicable in this type of submission.
9. How the ground truth for the training set was established
This information is not provided. Not applicable in this type of submission.
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Section 2: 510(K) Summary of Safety and Effectiveness BioResorb® Macro Pore
JUL 1 5 2005
A. Submitters Information
| Name: | Oraltronics Dental Implant Technology GmbH. |
|---|---|
| Address: | Herrlichkeit 4Bremen, DE 28199 |
| Telephone: | 49-421-4-39390 |
| Fax: | 49-421-4-43936 |
| Contact Person: | Dr. Greggory Cox |
| Date of Submission: | January 28, 2005 |
B. Device Name
BioResorb® Macro Pore
C. Predicate Device
Curasan Cersorb® Ortho, K014156, Curasan AG, Lindstrasse 4, Kleinostheim, Germany
D. Device Description
BioResorb® Macro Pore ß tricalcium phosphate is a synthetic, resorbable bone void filling material.
E. Intended Use
BioResorb® Macro Pore is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.
F. Technological Characteristics
The proposed BioResorb® Macro Pore and the predicate device Cerasorb® are of identical composition and are intended for the same use. The technological characteristics of the materials used are exact to the predicate device.
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G. Performance Data
BioResorb® is a ceramics powder of phase-three ß-TCP. It is manufactured from pure laboratory chemicals. The contents of heavy metal according to ASTM 1088 (Standard specification for beta-TCP for implant surgery) are far below the permissible levels. BioResorb® has been used and marketed in Germany since 1988 with no adverse events. The safety and effectiveness of this material ß-TCP in this application has been established.
The proposed BioResorb® Macro Pore device is substantially equivalent to the listed predicate device.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The logo is presented in black and white.
Public Health Service
SEP 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oraltronics Dental Implant Technology GmbH C/O Mr. Chad Bartee Osteogenics Biomedical, Incorporated 3234 64th Street Lubbock, Texas 79413
Re: K050260
Trade/Device Name: BioResorb® Macro Pore Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 6, 2005 Received: July 7, 2005
Dear Mr. Bartee:
This letter corrects our substantially equivalent letter of July 15, 2005.
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 (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.
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.
{3}------------------------------------------------
Page 2 - Mr. Bartee
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA Sissuance on a substanted of a complies with other requirements mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seggtreat of the Act of ally rederal statues and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, including arguited You must comply with an the Fee brequirement) art 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Part 801); and i and listing (21 CFR Fall 807), lacemig (21 CFR are 600); }
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (20) regisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section I his letter will anow you to continue manoming your dence of your device to 310(K) premaiket nonfleation: "The PDF in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specifice of Compliance at (240) 276-0115 please contact the Office of Comphanis.html#OC for OC organization structure). Also, please (http://www.ida.gov/currorganishranding by reference to premarket notification" (21 CFR)
note the regulation entitled, "Misbranding by reference to premarket ikilities under note the regulation childed, "Miberananing of information on your responsibilities under the Part 807.97). 1 ou may obtain other general international and Consumer Assistance at its Act from the DrAbion 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qur
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (K) Submission BioResorb® Macro Pore
510(k) Number (if known): 050260
Device Name:__BioResorb® Macro Pore
Indications for Use:
BioResorb® is to be used as a bone void filler device used in guided tissue DIOKESOFUL Is to be assure a commenance, alveolar socket preservation or ridge augmentation, and the treatment of osseous defects.
Prescription Use __ X_ (Per 21 CFR 801.109) OR
Over-the-Counter Usc (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)
Robert S. Betz DDS for Dr. Susan Runner
eral Hospital. Infection
510(k) Number
Oraltronics Dental Implant Technology GmbH BioResorb® Macro Pore 510 (K)
8
§ 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.