(216 days)
Not Found
No
The summary describes a bioceramic bone substitute and its intended use and performance in animal studies. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML.
Yes
Explanation: The device is intended to treat osseous defects and aid in the healing process by filling bone voids and promoting new bone formation, which qualifies it as therapeutic.
No
Explanation: The device is a resorbable bone substitute used to fill voids or gaps in the skeletal system, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "bioceramic medical device" and a "resorbable implant," indicating it is a physical material intended for implantation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Osteocera's Function: Osteocera Resorbable Bone Substitute is an implantable device used to fill bone voids within the body. It is a physical material that is placed directly into a surgical or traumatic defect.
- Intended Use: The intended use clearly states it's a "bone void filler for voids or gaps of the skeletal system." This is a therapeutic and structural function, not a diagnostic one.
The provided information describes a surgical implant used for bone repair, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
Osteocera Resorbable Bone Substitute is a bioceramic medical device that consists of over 95% beta-tricalcium phosphate (ß-TCP). Osteocera is a resorbable implant intended to fill bony voids or gaps that are caused by trauma or surgery and are not intrinsic to the skeletal stability. The interconnected porous structure of Osteocera provides a matrix for bone ingrowth. Osteocera Resorbable Bone Substitute is for single use only and is supplied sterile in sticks and granules with various sizes and package volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis)
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 following performance data were provided in support of the substantial equivalence.
Biocompatibility testing
ISO 10993 standards and the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' " were applied to evaluate the biocompatibility of Osteocera Resorbable Bone Substitute. Osteocera is considered biologically safe based on the device characterization and biocompatibility testing data regarding cytotoxicity, sensitization, acute systemic toxicity, subchronic toxicity, genotoxicity, pyrogenicity and hemocompatibility.
Animal testing
The performance of Osteocera in the extremities and posterolateral spine indications was studied in the distal femur and the posterolateral spine of New Zealand white rabbit, respectively. Skeletally matured animals were used in these studies. Evaluation was carried out at three time points: 4, 12 and 24 weeks post-implantation. In the distal femur implantation study, critical sized defects were created in 18 animals. Radiographic, histological, and histomorphometric analyses were performed at each time point to observe implant resorption and new bone formation over time. In the posterolateral spine study, bone grafts were placed between the transverse processes in the paraspinal bed of 36 animals. Manual palpation, posteroanterior radiographic, histological and histomorphometric data were collected. The animal studies demonstrated that Osteocera is as safe and effective as the predicate device in the indications.
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.
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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October 24, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wiltrom Corporation Limited Yi-Chun Su Director 1F, No. 26, Section 2, Shengyi Road Zhubei City, Hsinchu County 30261 Taiwan (Republic of China)
Re: K180758
Trade/Device Name: Osteocera Resorbable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 14, 2018 Received: September 17, 2018
Dear Yi-Chun Su:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180758
Device Name
Osteocera Resorbable Bone Substitute
Indications for Use (Describe)
Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Wittrom, a health partner. The word "wittrom" is written in a bold, sans-serif font, with the "i" dotted with a circle. Below the word "wittrom" is the tagline "Your Health Partner" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
| I. Submitter | Wiltrom Corporation Limited
No. 221, Sec. 1, Chung Hsing Rd.
Chutung, Hsinchu County 31053
Taiwan |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Yi-Chun Su, Director
1F, No. 26, Sec. 2, Shengyi Rd.
Zhubei City, Hsinchu County 30261
Taiwan
TEL: +886-3-6107168
FAX: +886-3-6580006 |
| Date Prepared | March 12, 2018 |
III. Predicate Device Synthes (USA) chronOS (K043045)
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Image /page/4/Picture/0 description: The image shows the logo for Wittrom. The logo is black and consists of the word "wittrom" in a bold, sans-serif font. Above the "i" is a black dot. Below the word "wittrom" is the phrase "Your Health Partner" in a smaller, sans-serif font.
IV. Device Description
Osteocera Resorbable Bone Substitute is a bioceramic medical device that consists of over 95% beta-tricalcium phosphate (ß-TCP). Osteocera is a resorbable implant intended to fill bony voids or gaps that are caused by trauma or surgery and are not intrinsic to the skeletal stability. The interconnected porous structure of Osteocera provides a matrix for bone ingrowth. Osteocera Resorbable Bone Substitute is for single use only and is supplied sterile in sticks and granules with various sizes and package volumes.
V. Indication for Use
Osteocera Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. Osteocera Resorbable Bone Substitute is indicated for use in the treatment of osseous defects created surgically or through traumatic injury. Following placement into the bony void, Osteocera Resorbable Bone Substitute resorbs and is replaced with bone during the healing process.
VI. Comparison of Technological Characteristics with the Predicate Device
The subject device has the same intended use and technological principles as the predicate device. The devices are both ß-TCP bone substitutes with porous structure. The interconnected pores provide a scaffold for bone ingrowth, and the biodegradable ß-TCP allows replacement of the bone substitute by natural bone. The subject device has higher porosity and similar pore size distribution to that of the predicate device. The devices are to be used in non-load bearing indications and internal fixation techniques may often be recommended to stabilize the operating area. Both devices are biocompatible and are sterilized by irradiation.
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Image /page/5/Picture/0 description: The image shows the logo for Wittrom, a health partner. The word "wittrom" is written in a bold, sans-serif font, with a small circle above the "i". Below the word "wittrom" is the tagline "Your Health Partner" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's mission.
| Subject Device | Predicate Device | |
|---|---|---|
| Trade Name | Osteocera Resorbable Bone Substitute | Synthes (USA) chronOS (K043045) |
| Intended Use | To be used as bone void filler and to provide a matrix for bone ingrowth | To be used as bone void filler and to provide a matrix for bone ingrowth |
| Anatomical Site | Bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) | Bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) |
| Indications for Use | • Bony voids or gaps that are not intrinsic to the stability of the bony structure | |
| • Bony defects created surgically or through traumatic injury | • Bony voids or gaps that are not intrinsic to the stability of the bony structure | |
| • Bony defects created surgically or through traumatic injury | ||
| Composition | β-TCP conforming to ASTM F1088 | β-TCP conforming to ASTM F1088 |
| Design | • Biodegradable ceramic | |
| • Interconnected porous structure | • Biodegradable ceramic | |
| • Interconnected porous structure | ||
| Performance | • Possessing osteoconductivity to promote bone formation | |
| • Resorbing and being replaced with bone during the healing process | • Possessing osteoconductivity to promote bone formation | |
| • Resorbing and being replaced with bone during the healing process | ||
| Porosity | 75-85% | 60-70% |
| Pore Size | 300-600 μm | 100-500 μm |
| Physical Form | Stick, granules | Blocks, wedges, granules and cylinders |
| Dimension | Stick | |
| • 5 x 5 x 10 mm | ||
| • 5 x 5 x 20 mm | ||
| Granules | ||
| • 0.25-0.5 mm | ||
| • 0.5-1.0 mm | ||
| • 1.0-2.0 mm | ||
| • 2.0-3.0 mm | Block | |
| • 5 x 5 x 10 mm | ||
| • 12.5 x 12.5 x 10 mm | ||
| • 20 x 20 x 10 mm | ||
| Granules | ||
| • 0.5-0.7 mm | ||
| • 0.7-1.4 mm | ||
| • 1.4-2.8 mm | ||
| • 2.8-5.6 mm | ||
| Biocompatibility | Established | Established |
| Sterility | Sterile (SAL:10⁻⁶) | Sterile (SAL:10⁻⁶) |
| Sterilization | Gamma irradiation | Gamma irradiation |
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Image /page/6/Picture/0 description: The image shows the logo for Wittrom. The logo is black and consists of the word "wittrom" in a bold, sans-serif font. Above the "i" is a black dot. Below the word "wittrom" is the phrase "Your Health Partner" in a smaller, sans-serif font.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence.
Biocompatibility testing
ISO 10993 standards and the FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' " were applied to evaluate the biocompatibility of Osteocera Resorbable Bone Substitute. Osteocera is considered biologically safe based on the device characterization and biocompatibility testing data regarding cytotoxicity, sensitization, acute systemic toxicity, subchronic toxicity, genotoxicity, pyrogenicity and hemocompatibility.
Animal testing
The performance of Osteocera in the extremities and posterolateral spine indications was studied in the distal femur and the posterolateral spine of New Zealand white rabbit, respectively. Skeletally matured animals were used in these studies. Evaluation was carried out at three time points: 4, 12 and 24 weeks post-implantation. In the distal femur implantation study, critical sized defects were created in 18 animals. Radiographic, histological, and histomorphometric analyses were performed at each time point to observe implant resorption and new bone formation over time. In the posterolateral spine study, bone grafts were placed between the transverse processes in the paraspinal bed of 36 animals. Manual palpation, posteroanterior radiographic, histological and histomorphometric data were collected. The animal studies demonstrated that Osteocera is as safe and effective as the predicate device in the indications.
VIII. Conclusion
Osteocera Resorbable Bone Substitute has the same intended use and indications for use as the predicate device, Synthes (USA) chronOS (K043045). Based on the material, technological characteristics and non-clinical data, Osteocera Resorbable Bone Substitute is substantially equivalent to the predicate device.