(20 days)
No
The 510(k) summary describes a synthetic bone void filler and its intended use. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The submission focuses on expanding the indications for a previously cleared device and references performance studies related to bone grafting materials.
Yes
The device is a bone void filler that aids in the healing process by being resorbed and replaced with host bone, which indicates a therapeutic rather than diagnostic purpose.
No
The device is a bone void filler, intended to treat osseous defects and aid in bone healing, not to diagnose a condition.
No
The device description clearly states it is a "Synthetic Bone Putty composed of biphasic ceramic granules in an alkylene oxide polymer carrier," indicating it is a physical material, not software.
No, 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 void filler intended for use in osseous defects of the skeletal system." It is used in the body to fill gaps in bone, not to perform tests on samples taken from the body.
- Device Description: The description details the composition of the putty and its function as a filler. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostics.
- Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific substances or markers
- Diagnostic or screening purposes based on laboratory testing
This device is a medical device used for surgical implantation and bone regeneration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Product codes
MQV
Device Description
Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, posterolateral spine, or 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 subject device has been previously cleared under K221644, which serves as a Reference Device. This submission is leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, 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 device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
March 7, 2024
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Ventris Medical % Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group 268 Glen Place Franklin Lakes, New Jersey 07417
Re: K240458
Trade/Device Name: Synthetic Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: February 16, 2024 Received: February 16, 2024
Dear Dr. 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" (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).
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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 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,
Sara S. Thompson -S
For
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
510(k) Number (if known) K240458
Device Name Synthetic Bone Putty
Indications for Use (Describe)
Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
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
Submitter
John Brunelle, PhD Chief Operating Officer Ventris Medical 1201 Dove Street, Suite 470 Newport Beach, CA 92660
Correspondent
Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group Scott(@BruderConsulting.com 201.874.9701
Date Prepared
February 16, 2024
Device
| Trade Name | Synthetic Bone 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 Device
NuVasive - Attrax Putty (K203714) Prosidyan - Fibergraft™ BG Putty (K222276) Ventris Medical - Synthetic Bone Putty (K221644)
Device Description
Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine.
Indications for Use Statement
Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host
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Image /page/5/Picture/1 description: The image shows the Ventris logo. The word "ventris" is written in white, sans-serif font on a black background. To the right of the word is a stylized flower with four petals in shades of blue and green.
bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Substantial Equivalence
The intended use is the same for subject and predicate devices. There are differences in the device's material composition. but this does not raise different questions of safety and effectiveness. The effect of differences in material composition is addressed in the prior functional animal model performance.
Performance
The subject device has been previously cleared under K221644, which serves as a Reference Device. This submission is leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, 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 device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies.
Summary
The subject device and predicates have the same intended use, and the same specific indications for use in the intervertebral body spine. Any differences in technological characteristics between the subject device and predicate do not raise different questions of safety and effectiveness. Based on the clinical analysis, the device is substantially equivalent to the predicates.