(120 days)
No
The device description and performance studies focus on the material composition and physical properties of a synthetic bone graft substitute, with no mention of AI or ML technologies.
Yes
The device is a bone grafting material intended to fill, augment, or reconstruct periodontal or oral/maxillofacial defects, which constitutes a therapeutic action to treat or alleviate a condition.
No
Explanation: The device is a bone grafting material for filling and reconstructing defects, not for diagnosing medical conditions. It is a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a synthetic osteoconductive bone graft substitute composed of physical materials (hydroxyapatite and beta-tricalcium phosphate) and is supplied as irregular shaped particles. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The device is a synthetic bone graft substitute. It is a material implanted into the body to aid in bone regeneration.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility and material properties, which are relevant for an implantable device, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a therapeutic/reconstructive purpose.
N/A
Intended Use / Indications for Use
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
Product codes
LYC
Device Description
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Periodontal, oral/maxillofacial defects
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)
Biocompatibility testing on the proposed OSTEON II has been completed. Requirements for biological evaluation of the proposed device were based on the Blue Book memorandum G95-1 issued on May 1, 1995, Use of International Standard ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing ." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:
-ISO Cytotoxicity -ISO Pyrogencity -ISO Intracutaneous reactivity -ISO Ames
-ISO Systemic toxicity -ISO Sensitization · . -ISO Implantation -ISO Micro-nucleus
The proposed OSTEON II was evaluated using the following performance bench testing to confirm the performance characteristics:
-Ca/P ratio
-Porosity
-Density
-Crystalline Phase Compositions
-Water Solubility Test
-Crystallinity Value
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 1 7 2012
CEMOZZ
510(k) Summary
12/26/2011
1. Company
| Submitter | |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | 1F Gyeonggi R&DB center, 906-5 Iui-dong, Suwon-si, Yeongtong-gu, |
| Gyeonggi-do, 433-270, Korea | |
| Phone/Fax | +82-31-888-5100/ +82-31-888-5105 |
| Contact person | Sungwon Lee / QA |
| swlee@genoss.com | |
| Summary Date | September 14, 2011 |
2. Device Name
Proprietary name: OSTEON II Common name: . Bone grafting material Classification name: Bone grafting material, Synthetic
3. Predicated Device
K062834 OSTEON
4. Description
This product is a synthetic osteoconductive bone graft substitute composed of hydroxyapatite (HA) and beta-tricalcium phosphate (B-TCP). This product presents an interconnected porous structure, similar to that of human cancellous bone. This product is available as irregular shaped particles of size 0.2~2.0 mm. It is supplied sterile by gamma irradiation.
510(k) Summary
Page 1 of 3
1
ભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના
5. Indication for use
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects.
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
6. Technological Characteristics
OSTEON II has the similar technological characteristics as the predicate device; main material, indication for use and design. Technological characteristics of OSTEON II, OSTEON are as following
| Material | Device name | ||
|---|---|---|---|
| 1 | Hydroxyapatite(HA) | OSTEON | OSTEON II |
| 2 | Beta-tricalciumphosphate(β-TCP) | 55~75wt% | 25~45wt% |
| Particles of size | 25~45wt% | 55~75wt% | |
| 0.3~2.0 mm | 0.2~2.0mm | ||
| Indication for use | OSTEON (II) is intended for use as a bone grafting | ||
| material to fill, augment or reconstruct periodontal or | |||
| oral/maxillofacial defects. |
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities | OSTEON (II) is intended for use as a bone grafting
material to fill, augment or reconstruct periodontal or
oral/maxillofacial defects. - Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities |
| | Sterilization | Gamma Irradiation | Gamma Irradiation |
510(k) Summary
Page 2 of 3
2
GENOSS
7. Performance Data
Biocompatibility testing on the proposed OSTEON II has been completed. Requirements for biological evaluation of the proposed device were based on the Blue Book memorandum G95-1 issued on May 1, 1995, Use of International Standard ISO10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing ." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological bone and tissues with its intended use. The following biocompatibility tests were completed:
-ISO Cytotoxicity -ISO Pyrogencity -ISO Intracutaneous reactivity -ISO Ames
-ISO Systemic toxicity -ISO Sensitization · . -ISO Implantation -ISO Micro-nucleus
The proposed OSTEON II was evaluated using the following performance bench testing to confirm the performance characteristics:
| -Ca/P ratio | -Crystalline Phase Compositions |
|---|---|
| -Porosity | -Water Solubility Test |
| -Density | -Crystallinity Value |
All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the OSTEON II met the established specifications necessary for consistent performance according to its intended use.
7. Conclusion
Based on the information provided in this premarket notification of GENOSS Co., Ltd. Concludes that OSTEON II is substantially equivalent to predicate devices
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Sungwon Lee Quality Assurance Assistant Manager Genoss Company, Limited 1F Gyeonggi R&DB Center 906-5 Iui-Dong Suwon-Si, Yeongtong-Gu, Gyeonggi-Do Republic of Korea 443-270
JAN 1 7 2012
Re: K112716
Trade/Device Name: OSTEON II Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 4, 2012 Received: January 5, 2012
Dear Mr. Lee:
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.
4
Page 2 - Mr. Lee
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/CDRHQffices /ucm 115809.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.goy/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,
Wh 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
5
CEMOZZ
Indication for use
| 510(k) Number: | |
|---|---|
| -- | ---------------- |
Device Name: OSTEON II
Indication for use:
OSTEON II is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or oral/maxillofacial defects
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
イ Prescription Use __ (Part 21 CFR 801 Subpart D)
Indication for use
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)
Wh
(Division Sign-Uff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K112716