Porous Biologic Scaffold

{0}------------------------------------------------ March 21, 2025 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Ventris Medical % Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group 38 True Harbour Way West Islip. New York 11795 Re: K250556 Trade/Device Name: Porous Biologic Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV. MBP Dated: February 25, 2025 Received: February 25, 2025 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" {1}------------------------------------------------ (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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). {2}------------------------------------------------ Sincerely, JESSE MUIR Digitally signed by JESSE MUIR JESSE MUIR -S Date: 2025.03.21 -5 09:49:22 -04'00' 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 Enclosure {3}------------------------------------------------ | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K250556 | |----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Please provide the device trade name(s). | Porous Biologic Scaffold | | Please provide your Indications for Use below. | <p>Porous Biologic Scaffold 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. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Porous Biologic Scaffold must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.</p> | | Please select the types of uses (select one or both, as applicable). | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ventris" in white font on a black background. To the right of the word is a stylized flower-like design with different shades of blue and green. The word "ventris" is written in a bold, sans-serif font. The flower design has six petals, each with a slightly different shape and color. # 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 25, 2025 # Device | Trade Name | Porous Biologic Scaffold | |----------------|-----------------------------------------------------------------| | Common Name | Bone void filler | | Regulation | 21 CFR 888.3045 Resorbable calcium salt bone void filler device | | Classification | Class II | | Product Code | MQV, MBP | | Panel | Orthopedic | # Predicates | Primary Predicate | NuVasive - Attrax Putty (K203714) | |---------------------|------------------------------------------------------| | Secondary Predicate | Prosidyan - Fibergraft™ BG Putty (K222276) | | Reference Device | Ventris Medical - Porous Biologic Scaffold (K240765) | #### Device Description Porous Biologic Scaffold is a resorbable bone void filler that is available in two versions: Version 1 is comprised of a porous collagen mesh that is either prefilled or separately packaged with human demineralized allograft bone matrix. In the prefilled format, the demineralized bone matrix is completely enclosed inside the collagen mesh. In the separately packaged format, an open-ended collagen mesh bag is supplied with separately packaged demineralized bone matrix and is filled and sewn closed with absorbable suture by the clinician. Version 1 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation. {5}------------------------------------------------ Image /page/5/Picture/0 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 four-leaf clover design with each leaf a different shade of blue and green. Version 2 is comprised of a porous resorbable collagen mesh bag either prefilled or separately packaged with activated biphasic ceramic granules. In the prefilled format, the biphasic granules are completely enclosed inside the collagen mesh. In the separately packaged format, an openended collagen mesh bag is supplied with separately packaged biphasic granules and is filled and sewn closed with absorbable suture by the clinician. Version 2 of the Porous Biologic Scaffold may be hydrated with blood, saline, or bone marrow aspirate, and is combined with autograft bone prior to implantation. Both formats of the Porous Biologic Scaffold are supplied terminally sterile and are available in sizes of 18 x 50 mm, 18 x 100 mm, 24 x 50 mm, and 24 x 100 mm. # Indications for Use Statement Porous Biologic Scaffold 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. Porous Biologic Scaffold is indicated to be packed gently into bony voids or gaps of the pelvis, intervertebral disc space, and posterolateral spine and is used combined with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures. Porous Biologic Scaffold 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 K240765, 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. #### Summarv 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.