(223 days)
K03-3815, K97-4399
Not Found
No
The document describes a bone graft material and its manufacturing process, with no mention of AI or ML technology.
Yes.
The device is used for augmenting or reconstructive treatment of various defects in bone and tissue, indicating a therapeutic purpose.
No
The device, BIO-OSS COLLAGEN®, is described as a combination of natural bone mineral granules and collagen fibers used for reconstructive treatments and filling defects. Its intended uses are therapeutic (augmentation, filling), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is a combination of bone mineral granules and collagen fibers in a block form, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone grafting and tissue regeneration in the oral and maxillofacial area. These are therapeutic and reconstructive applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a combination of bone mineral granules and collagen fibers in a block form. This is a material intended for implantation or placement within the body, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, based on the provided text, BIO-OSS COLLAGEN® is a medical device used for surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
BIO-OSS COLLAGEN® is a combination of purified cancellous natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by y-irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal, maxillary sinus, peri-implant
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The revised alkaline treatment was found to be efficient in inactivating the three viruses tested - Pseudorabies Virus (PRV), Reovirus type 3 (Reo 3) and Porcine Parovirus (PPV). Viral inactivation was found to clear the product of PRV and PPV, and viral inactivation and removal (by rinsing) of physical viral particles were shown to clear the product of Reo 3. (The acidic treatment was similarly found to be efficient at clearing the three viruses).
Using collagen MGR prepared with the revised alkalinization step, four lots of product were manufactured and tested for compliance with the final release specifications for the product. All tests were found to be within limits and the revised process, hence, the change in the alkalinization step did not affect the safety, efficacy or quality of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K03-3815, K97-4399
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
BIO-OSS COLLAGEN®
1. SPONSOR
MAR 1 8 2010
Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND
Contact Person: Peter S. Reichertz, (202) 772-5333, preichertz@sheppardmullin.com Date Prepared: March 12, 2010
2. DEVICE NAME
| Proprietary Name | BIO-OSS COLLAGEN® |
|---|---|
| Common/Usual Name: | Natural Bone Grafting Material Plus Collagen |
| Classification Name: | Bone grafting material, animal source (NPM) |
3. PREDICATE DEVICES
BIO-OSS COLLAGEN® (K03-3815 and K97-4399), 21 C.F.R. § 872.3930
INTENDED USE 4.
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy
Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
DEVICE DESCRIPTION 5.
BIO-OSS COLLAGEN® is a combination of purified cancellous natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by y-irradiation.
1
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The only change is in one step of the alkalinization process of the previously cleared product. The change involved is a reduction in the amount by molar concentration of the alkaline treatment coupled with a change in a length (in hours) of the compounding alkalization step. No other modification or technical changes were made. The rest of the manufacturing process is identical to that reviewed in prior 510(k) notifications for this product (K974399 and K033815). Importantly, the principal virus inactivation step does not change.
To substantiate that the change in the alkalinization step does not affect the safety or efficacy of the product, the Company commissioned an evaluation of the revised manufacturing process on the viral safety level in the collagen MGR portion of the product and revalidated the manufacturing process using the slightly revised alkalinization step.
The revised alkaline treatment was found to be efficient in inactivating the three viruses tested - Pseudorabies Virus (PRV), Reovirus type 3 (Reo 3) and Porcine Parovirus (PPV). Viral inactivation was found to clear the product of PRV and PPV, and viral inactivation and removal (by rinsing) of physical viral particles were shown to clear the product of Reo 3. (The acidic treatment was similarly found to be efficient at clearing the three viruses).
Using collagen MGR prepared with the revised alkalinization step, four lots of product were manufactured and tested for compliance with the final release specifications for the product. All tests were found to be within limits and the revised process, hence, the change in the alkalinization step did not affect the safety, efficacy or quality of the product.
As the alkalinization step has been validated to demonstrate adequate viral inactivation (and clearance), and the quality of the product has not otherwise changed, the BIO-OSS COLLAGEN® product manufactured in accordance with the revised alkalinization step is substantially equivalent to the previously cleared product.
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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 features a stylized depiction of an eagle or bird-like figure with three distinct, curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 8 2010
Ed. Geistlich Soehne Ag Für Chemische Industrie C/O Mr. Peter S. Reichertz Official Correspondent Sheppard Mullin Richter & Hampton LLP 1300 I Street, N.W., 11th Floor East Washington, DC 20005
Re: K092428
Trade/Device Name: BIO-OSS COLLAGEN® Regulation Number: 21CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: March 12, 2010 Received: March 15, 2010
Dear Mr. Reichertz:
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- Mr. Reichertz
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
BIO-OSS COLLAGEN®
Indications for Use:
Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects
Filling of defects after root resection, apicoectomy, and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of maxillary sinus floor
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
RBBetz DDS for Dr. K.P. Muly
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092428
W02-EAST:9PSR1\200227513.1