(39 days)
No
The description focuses on the material composition and intended use as a bone graft substitute, with no mention of AI/ML capabilities or data processing.
Yes
The device is a bone graft substitute and bone void filler intended to facilitate bone healing and replacement, which are therapeutic actions.
No
Explanation: The provided text describes "SIGNAFUSE Bioactive Strip (SBS)" and "SIGNAFUSE Putty" as bone graft substitutes and bone void fillers intended for use in the skeletal system. Their purpose is to fill bony voids or gaps and get replaced by host bone, not to diagnose medical conditions.
No
The device description clearly states that the device is a "bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix" or "comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier." These are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "bone graft substitute" and "bone void filler" for use in bony voids or gaps of the skeletal system. This describes a device that is implanted or applied directly to the body to aid in bone healing.
- Device Description: The description details the composition of the device (mineral granules, bioactive glass, collagen matrix, polymer carrier) and its function as a "single use implants in contact with bone". This further reinforces its role as a therapeutic or structural device used within the body.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) to facilitate bone repair.
N/A
Intended Use / Indications for Use
- SIGNAFUSE Bioactive Strip (SBS)
SIGNAFUSE Bioactive Strip (SBS) 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 Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.
SIGNAFUSE Putty
SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.
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 (extremities, pelvis, posterolateral spine, and intervertebral disc space)
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 devices' performance in the intervertebral body space was supported by a clinical rationale of bone grafting materials in the intervertebral space.
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.
NuVasive - Attrax Putty (K203714), Prosidyan - Fibergraff™ BG Putty (K222276)
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.
Bioventus - SIGNAFUSE Bioactive Bone Graft (K193513), Bioventus -Bioactive Bone Graft Putty (K132071)
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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December 5, 2023
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Bioventus LLC % Scott Bruder Founder & CEO Bruder Consulting & Venture Group 268 Glen Place Franklin Lakes, New Jersey 07417
Re: K233490
Trade/Device Name: SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: October 26, 2023 Received: October 27, 2023
Dear Scott Bruder:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Digitally signed by Je Jesse Muir -S Date: 2023.12.05 12:56:54
Jesse Muir, Ph.D. 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
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Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty
Indications for Use (Describe)
- SIGNAFUSE Bioactive Strip (SBS)
SIGNAFUSE Bioactive Strip (SBS) 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 Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.
SIGNAFUSE Putty
SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the logo for Bioventus. The logo consists of a circular, interwoven design in shades of orange and purple, followed by the word "bioventus" in a purple sans-serif font. A registered trademark symbol is located to the upper right of the word.
510(k) Summary
Submitter
Kellie Stefaniak Vice President, Global Regulatory & Quality Bioventus LLC 4721 Emperor Blvd. Suite 100 Durham, NC 27703
Correspondent
Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group Scott(@BruderConsulting.com 201.874.9701
Date Prepared
December 1, 2023
Device
| Trade Name | SIGNAFUSE Bioactive Strip (SBS)
SIGNAFUSE Putty |
|----------------|-----------------------------------------------------------------|
| Common Name | Bone void filler |
| Regulation | 21 CFR 888.3045 Resorbable calcium salt bone void filler device |
| Classification | Class II |
| Product Code | MQV |
| Panel | Orthopedic |
Predicates
Primary Predicate Secondary Predicate Reference Devices
NuVasive - Attrax Putty (K203714) Prosidyan - Fibergraff™ BG Putty (K222276) Bioventus - SIGNAFUSE Bioactive Bone Graft (K193513) Bioventus -Bioactive Bone Graft Putty (K132071)
Device Description
SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.
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Image /page/5/Picture/0 description: The image shows the Bioventus logo, which consists of a stylized symbol of three interlocking rings in shades of purple and orange, followed by the word "bioventus" in a bold, sans-serif font, also in purple. A registered trademark symbol is present to the right of the word. Below the logo, the words "Indications for Use Statement" are written in a bold, serif font.
SIGNAFUSE Bioactive Strip (SBS)
SIGNAFUSE Bioactive Strip (SBS) 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 Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.
SIGNAFUSE Putty
SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graft extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Substantial Equivalence
The intended use is the same for subject and predicate devices. The subject device and predicates are all indicated for use as bone void fillers in the intervertebral body space.
There are differences in the device's material composition, but these do not raise different questions of safety and effectiveness. The effect of differences in material composition is addressed in clinical rationale.
Performance
The subject devices have been previously cleared under K193513 (SIGNAFUSE Bioactive Strip (SBS)) and K132071 (SIGNAFUSE Putty), which serve as Reference Devices. These submissions are leveraged to support the device's sterility, shelf-life, endotoxin, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices. The devices' performance in the intervertebral body space was supported by a clinical rationale of bone grafting materials in the intervertebral space.
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Image /page/6/Picture/0 description: The image shows the logo for Bioventus. The logo consists of a circular graphic on the left, made up of three intertwined strands in shades of purple and orange. To the right of the graphic is the word "bioventus" in purple, with a registered trademark symbol after the "s".
Summary
The subject device and predicates have the same intended use, and the same specific indications for use in the intervertebral body space. Any differences in technological characteristics between the subject device and predicate do not raise different questions of safety and effectiveness. Based on the clinical rationale, the device is substantially equivalent to the predicates.