(55 days)
No
The description focuses on the material composition and physical properties of a bone graft substitute, with no mention of AI or ML in its function or intended use.
Yes
The device is a material (Beta-tricalcium phosphate) intended to fill, augment, or reconstruct periodontal or bony defects, which are therapeutic interventions.
No
The device description and intended use indicate it is a bone void filler material used for augmentation or reconstruction of bony defects, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "white porous material composed of Beta-tricalcium phosphate(ß-TCP)", indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material intended to be implanted or used directly on or within the body to fill, augment, or reconstruct bony defects. This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a porous ceramic material (Beta-tricalcium phosphate) used for physical filling and reconstruction. This aligns with a medical device used for structural support or regeneration, not for analyzing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is entirely focused on physical reconstruction and augmentation within the body.
N/A
Intended Use / Indications for Use
It is intended to fill, augment, or reconstructive periodontal or bony defects of the oral and maxillofacial region.
- Augmentation or reconstructive treatment of the alveolar ridge. .
- Filling of infrabony periodontal defects. .
- Filling of defects after root resection, apicoectomy, and cystectomy. .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge.
- . Elevation of the 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)
LYC
Device Description
OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.150.8mm,G1:0.51.5mm,G2:1.0~3.0mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region
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)
Not Found
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.
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.
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
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|Ko8156|
510(k) SUMMARY
JUL 2 8 2008
OSferion D
May 30, 2008
1 General Information
- 트 Owner/Operator: OLYMPUS TERUMO BIOMATERIALS CORP. 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182, Japan Establishment Registration No: 3006617492
- l Official Correspondent: Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley PA18034-0610 Phone: (484) 896-5405 Facsimile: (484) 896-7128 Email: Stacy.Kluesner@olympus.com Establishment Registration No: 2429304
- Manufacturer: OLYMPUS TERUMO BIOMATERIALS CORP. (Sterilization site) Hinode Factory 34-3 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182. Japan Establishment Registration No: 3006617492
2 Device Identification
| Device Trade Name: | OSferion D |
|---|---|
| Common Name: | Bone void filler, Synthetic |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Bone grafting material, synthetic |
| Regulatory Class: | II |
| Product Code: | LYC |
| Classification panel | Dental |
1
3 Predicate Device/Reference Device Information
| Predicate Device | Reference Device | |||
|---|---|---|---|---|
| Device | ||||
| Name: | Cerasorb® | |||
| DENTAL | BioResorb® | |||
| Macro Pore | OSferion | Vitoss® Scaffold | ||
| Synthetic Cancellous | ||||
| Bone Void Filler | ||||
| Common | ||||
| Name: | Bone Void Filler, | |||
| Synthetic | Bone Void Filler, | |||
| Synthetic | Bone void filler | Bone void filler | ||
| Manufacturer: | Curasan AG | Oraltronics Dental | ||
| Implant | ||||
| Technology | ||||
| GmbH | OLYMPUS | |||
| TERUMO | ||||
| BIOMATERIALS | ||||
| CORP. | ORTHOVITA, INC. | |||
| 510(k) No. | K051443 | K050260 | K080065 | K032409 |
র্ব Device Description
OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.150.8mm,G1:0.51.5mm,G2:1.0~3.0mm).
5 Indications for Use
It is intended to fill, augment, or reconstructive periodontal or bony defects of the oral and maxillofacial region.
- Augmentation or reconstructive treatment of the alveolar ridge. .
- Filling of infrabony periodontal defects. .
- Filling of defects after root resection, apicoectomy, and cystectomy. .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge.
- . Elevation of the 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).
Comparison of Technological Characteristics હ
OSferion D is substantially equivalent to the predicate devices in indication for use, and in specifications of the material.
Information provided in this submission supports the safety and effectiveness of OSferion D compared to the predicate device.
7 Conclusion
When compared to the predicate device, this subject device "OSferion D" does not incorporate any significant changes in intended use, instruction for use, material, or design that could effect the safety or effectiveness of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Olympus Terumo Biomaterials Corporation C/O Ms. Stacy Abbatiello Kluesner, RAC Regulatory Affairs & Quality Assurance Olympus America, Incorporated 3500 Corporate Parkway P.O. Box 610 Center Valley, Pennsylvania 18034-0610
JUL 2 8 2008
Re: K081561 Trade/Device Name: OSferion D Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: June 2, 2008 Received: June 13, 2008
Dear Ms. Kluesner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Kluesner
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
VK Hommeler fender my for CL
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
4
081561
Indications for Use Statement
510(k) Number (if known) :
Device Name : OSferion D
Indications for Use :
It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- . Augmentation or reconstructive treatment of the alveolar ridge.
- . Filling of infrabony periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy. ▶
- Filling of extraction sockets to enhance preservation of the alveolar ridge. .
- Elevation of the 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).
| 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)
ucon Ranne
Page 1 of _ 1
(Division Sign-O Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: C081561
: 00012