(182 days)
No
The summary describes a bone graft substitute material and its biological properties, with no mention of AI or ML technology.
Yes
The device is a bone graft substitute intended to facilitate the healing process by providing an osteoconductive scaffold and being replaced by host bone, which directly addresses a medical condition (osseous defects).
No
The device is a bone graft substitute, intended for filling bony voids and guiding bone regeneration, not for diagnosing medical conditions.
No
The device description clearly states it is a physical bone graft substitute made of mineral granules, bioactive glass, and collagen matrix, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SIGNAFUSE Bioactive Bone Graft is a bone graft substitute for filling bony voids or gaps in the skeletal system. It is used in vivo (within the body) to facilitate bone healing.
- Device Description: The description details the composition of the bone graft material and how it is used in vivo to provide an osteoconductive scaffold.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is implanted in vivo to promote bone regeneration.
N/A
Intended Use / Indications for Use
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
Product codes
MQV
Device Description
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 4555 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
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... osseous defects of the extremities, pelvis and posterolateral spine.
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)
SIGNAFUSE Bioactive Bone Graft was evaluated in a posterolateral spine fusion rabbit model in comparison to the MCP Bone Putty predicate device, as well as a control group. The model and method used was identical to the testing performed in K160446 to gain clearance for MCP Bone Putty. Results confirm the biological safety and normal osteoconductive healing characteristics associated with the SIGNAFUSE Bioactive Bone Graft and demonstrate substantially equivalent in vivo performance to the primary predicate MCP Bone Putty (K160446, 11/7/2016) in an established posterolateral spine fusion rabbit defect model (Boden, ASTM F2307-17).
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
§ 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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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Bioventus % Christine Scifert Exec VP MRC-X, LLC 6075 Poplar Ave Memphis, Tennessee 38119
Re: K193513
Trade/Device Name: SIGNAFUSE Bioactive Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: May 20, 2020 Received: May 22, 2020
Dear Ms. Scifert:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
June 18, 2020
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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 (QS) 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 mediation-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,
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193513
Device Name SIGNAFUSE Bioactive Bone Graft
Indications for Use (Describe)
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host 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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510(k) Summary
SIGNAFUSE Bioactive Bone Graft December 16, 2019
| Company: | Bioventus
4721 Emperor Blvd, Suite 100
Durham, NC 27700
USA |
|--------------------|----------------------------------------------------------------------|
| Primary Contact: | Christine Scifert, Exec VP of MRC-X, LLC |
| Company Contact: | Kim Patterson Kelly, Senior Director, Regulatory & Clinical Affairs |
| Trade Name: | SIGNAFUSE Bioactive Bone Graft |
| Common Name: | Filler, Bone Void, Calcium Compound |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3045 (Resorbable calcium salt bone void filler device) |
| Panel: | Orthopedic |
| Product Code: | MOV |
Device Description:
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 4555 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Indications for Use:
SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.
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Substantial Equivalence:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate:
-
MCP Bone Putty, Bioventus, K160446 (S.E 11/7/2016)
Secondary Predicate: -
Interface Bone Void Filler, Bioventus, K112857 (S.E 12/13/2011)
The subject device is for filling of bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure, like the predicate devices. The subject device is identical in indications and principle of operation to both predicate devices. The subject device contains the same materials used in the predicate devices, but the materials are present in different ratios than in the predicate devices. However, the overall collagen to particulate ratio remains the same between the subject device and the MCP Bone Putty. The geometrical differences between the subject device and the MCP Bone Putty result in more choices of graft volume to allow treatment of different size defects, but do not change the ratio of components within the device.
Performance Testing:
SIGNAFUSE Bioactive Bone Graft is a change to the manufacturer's (Bioventus) own predicate device, MCP Bone Putty (K160446, S.E 11/7/2016) to add bioactive glass (Interface Bone Void Filler, K112857, S.E. 12/13/2011) to the formulation. The SIGNAFUSE Bioactive Bone Graft formulation has been fully characterized to meet the current MCP Bone Putty specifications other than strip dimensions and HA/B-TCP content.
SIGNAFUSE Bioactive Bone Graft has met the ISO 10993 biocompatibility requirements and ANSI/AAMI ST72 bacterial endotoxin requirements relevant to bone void filler devices. The controls on sourcing, collection, and handling of the bovine collagen raw materials used in the manufacture of the SIGNAFUSE are identical to MCP Bone Putty and meet requirements of ISO 22442-2 and ISO 22442-3.
SIGNAFUSE Bioactive Bone Graft is terminally sterilized via gamma irradiation and validated to a sterilityassurance level (SAL) of 10 • according to ANSI/AMMI/ISO 11137-2 (Method VDwax) with a shelf-life of 3 years.
To ensure that the device still functions as intended, SIGNAFUSE Bioactive Bone Graft was evaluated in a posterolateral spine fusion rabbit model in comparison to the MCP Bone Putty predicate device, as well as a control group. The model and method used was identical to the testing performed in K160446 to gain clearance for MCP Bone Putty. Results confirm the biological safety and normal osteoconductive healing characteristics associated with the SIGNAFUSE Bioactive Bone Graft and demonstrate substantially equivalent in vivo performance to the primary predicate MCP Bone Putty (K160446, 11/7/2016) in an established posterolateral spine fusion rabbit defect model (Boden, ASTM F2307-17).
Conclusion:
Performance testing and technological comparisons presented in this 510(k) indicate SIGNAFUSE Bioactive Bone Graft is substantially equivalent to the predicate devices.