(115 days)
No
The device description focuses on the material composition and biological function of a bone grafting material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
OsOpia is a bone grafting material used for the specific treatment of extraction sockets and maxillary sinus augmentation procedures, which aims to repair bony defects and induce bone regeneration. This constitutes a therapeutic use as it treats a medical condition.
No
Explanation: OsOpia is a bone grafting material used for the repair of bony defects, specifically in extraction sockets and maxillary sinus augmentation procedures. It is a regenerative material, not a diagnostic one.
No
The device description clearly states it is a synthetic bone grafting material in granular form, which is a physical substance, not software.
Based on the provided information, OsOpia is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: OsOpia is a bone grafting material intended for use in specific surgical procedures (extraction sockets and maxillary sinus augmentation). It is implanted into the body to aid in bone regeneration.
- Device Description: It is described as a synthetic, resorbable material for the repair of bony defects.
- Mechanism of Action: It induces and guides bone regeneration and is replaced by bone during the natural remodeling process.
- Lack of Diagnostic Function: There is no mention of OsOpia being used to test samples from the human body (like blood, urine, tissue) to provide information about a person's health status, disease, or condition.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body. OsOpia is used in vivo (inside the body) as an implantable material.
N/A
Intended Use / Indications for Use
OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and =96% in the clinical studies. The human studies demonstrate the performance of OsOpia for socket extraction and maxillary sinus augmentation indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Implant survival rate: >=96%
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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October 2, 2020
RevisiOs BV % Kathy Remsen Principal Consultant MRC Global 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112
Re: K201546
Trade/Device Name: OsOpia Synthetic Bone Void Filler Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: July 14, 2020 Received: July 15, 2020
Dear Kathy Remsen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201546
Device Name OsOpia Synthetic Bone Void Filler
Indications for Use (Describe)
OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
OsOpia Synthetic Bone Void Filler October 1, 2020
| Company: | RevisiOs BV
Professor Bronkhorstlaan 10, building 48
3723 MB Bilthoven
The Netherlands |
|--------------------|-------------------------------------------------------------------------------------------------|
| Primary Contact: | Kathy Remsen
Phone: 901-606-4856 |
| Company Contact: | Hen Baron
+31-30-740450
hen.baron@kurosbio.com |
| Trade Name: | OsOpia Synthetic Bone Void Filler |
| Common Name: | Bone Grafting Material, Synthetic |
| Classification: | II |
| Regulation Number: | 872.3930 |
| Panel: | Dental |
| Product Code(s): | LYC |
Device Description:
OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and 90%
HA 90%
HA using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established FDA guidelines.
Bench testing
Material characterization was performed in accordance with ASTM F1088 and included the following:
- · chemical composition was analyzed by x-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR)
- · trace elemental analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/MS),
- · dissolution was performed to evaluate the in vitro calcium release rate, and
- · porosity was measured by mercury intrusion porosimetry.
The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject OsOpia and predicate/reference devices.
Animal Studies
6
The performance of OsOpia was evaluated in a sheep model for an intraoral maxillary sinus floor augmentation surgery. The results of the study demonstrated that the performance of the subject device was suitable as a bone grafting material for maxillary sinus augmentation.
Clinical Data
Six clinical studies using OsOpia in adult patients were used to support the substantial equivalence. All of the studies were prospective studies. One study was randomized. The other studies were single-arm. Overall, 90 patients were evaluated. No serious adverse events were reported for OsOpia. Two studies evaluated bone histology at 5-6 months post implantation with OsOpia demonstrating equal or greater new bone formation than the control. Four of the studies evaluated implant placement survival. The implant survival rate was ≥96% in the clinical studies. The human studies demonstrate the performance of OsOpia for socket extraction and maxillary sinus augmentation indications.
Conclusion
Based on pre-clinical and clinical data, the bench testing results and the comparison to the predicate and reference devices, the subject device is determined to be substantially equivalent to the predicate device.