(211 days)
Xenograft Bovine Bone Particulate is intended for use in dental surgery.
The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.
This document is a 510(k) premarket notification for a medical device, the "Xenograft Bovine Bone Particulate." It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for a new, novel device. Therefore, much of the requested information (like sample sizes for test/training sets, expert details for ground truth, MRMC studies, standalone performance, etc.) is not directly applicable or available in this type of submission.
However, I can extract the acceptance criteria related to the device's characteristics and the non-clinical performance testing conducted to demonstrate that the device meets its requirements and specifications, thereby supporting its substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table for novel device performance metrics. Instead, it demonstrates that the subject device's characteristics and performance are "substantially equivalent" to a predicate device and meet recognized industry standards. The "performance" here refers to demonstrating these equivalences and adherence to standards.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance |
|---|---|---|
| Physical Form | Ground bone particulate in a dappen dish | Ground bone particulate in a dappen dish |
| Color | White to off-white | White to off-white |
| Material composition | Anorganic bovine bone mineral | Anorganic bovine bone mineral |
| Source of bone | Bovine | Bovine |
| Physical morphology | Trabecular, interconnected macro and micro pores | Trabecular, interconnected macro and micro pores |
| Crystallinity | 83-98% (same as predicate) | 83-98% |
| Calcium Phosphate (Ca/P) Ratio | 2.3-2.5 (same as predicate) | 2.3-2.5 |
| Resorption Time | > 6 months (same as predicate) | > 6 months |
| Performance (general) | Bone formation (same as predicate) | Bone formation |
| Apparent Density | Meets ASTM F1581 requirements | Meets ASTM F1581 |
| Ca/P Ratio (specific testing) | Meets ASTM F1581 requirements | Meets ASTM F1581 |
| Crystallinity (specific testing) | Meets ASTM F1581 requirements | Meets ASTM F1581 |
| Protein Content | Meets ASTM F1581 requirements | Meets ASTM F1581 |
| Heavy Metal | Meets ASTM F1581 requirements | Meets ASTM F1581 |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Genotoxicity, Acute/Subchronic Toxicity, Implantation, Pyrogenicity) | Complies with ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP <85> | All tests indicated patient contact materials were biocompatible. |
| Sterility Assurance Level (SAL) | 10^-6 (per ANSI/AAMI/ISO 11137 series) | Achieved a SAL of 10^-6 |
| In-Vivo Performance (New bone formation, residual graft, tissue reaction) | Substantially equivalent to predicate device (Collagen Matrix OsteoGuide™ Anorganic Bone Mineral) | Performance of subject and predicate devices was substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions an "in-vivo performance" study conducted in a "beagle mandibular intraoral critical size defect model." However, the specific number of beagles or defects used in this model is not specified in the provided text.
- Data Provenance: The in-vivo study appears to be an experimental animal study (beagle model) conducted for the purpose of this submission. The country of origin is not stated but typically these studies are conducted in a controlled lab environment. It is a prospective study for the purpose of demonstrating equivalence, as it was designed and executed to compare the subject device against the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The ground truth for the in-vivo study was assessed by histomorphometry and histopathology. The document does not specify the number of experts (e.g., pathologists, histomorphometrists) or their qualifications.
4. Adjudication method for the test set
- The document does not specify an adjudication method for the histomorphometry and histopathology assessments. It's likely standard laboratory practice was followed, but no details are given.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a physical medical device (bone graft particulate), not an AI or imaging diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vivo performance study, the ground truth was established through histomorphometry and histopathology assessments of new bone formation, residual graft material, and tissue reaction in beagles. This is a form of pathology/histological assessment.
8. The sample size for the training set
- This question is not applicable as the device is not an AI/ML model that requires a training set. The "training" here would refer to the manufacturing and quality control processes to ensure the consistency of the particulate.
9. How the ground truth for the training set was established
- This question is not applicable as the device is not an AI/ML model. The "ground truth" for manufacturing would be established through adherence to Good Manufacturing Practices (GMP) and compliance with specified material and sterility standards.
{0}------------------------------------------------
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2024
Collagen Solutions, LLC % Richelle Helman Senior Director, Regulatory MEDIcept Inc. 200 Homer Avenue Ashland, Massachusetts 01721
Re: K240133
Trade/Device Name: Xenograft Bovine Bone Particulate Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: January 16, 2024 Received: July 22, 2024
Dear Richelle Helman:
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.
{1}------------------------------------------------
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).
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 QS 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.
{2}------------------------------------------------
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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K240133
Device Name Xenograft Bovine Bone Particulate
Indications for Use (Describe)
Xenograft Bovine Bone Particulate is intended for use in dental surgery.
The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge
-
- Filling of periodontal defects
-
- Filling of defects after root resection, apicocectomy, and cystectomy
-
- Filling of extraction sockets to enhance preservation of the alveolar ridge
-
- Elevation of maxillary sinus floor
-
- Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR)
-
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for Collagen Solutions. The logo has a graphic on the left side that consists of three overlapping wavy lines in red, green, and blue. To the right of the graphic is the text "COLLAGEN SOLUTIONS" in a dark gray sans-serif font. Below the text is the phrase "MATERIALS FOR LIFE" in a smaller, lighter gray font.
| Date: | 15-August-2024 |
|---|---|
| Company: | Collagen Solutions6455 City West PkwyEden Prairie, MN 55344Phone: (320) 510-3615 |
| Applicant Contact: | Sheila HunterVice President of Quality and Regulatory Affairs |
| Official Contact: | Richelle HelmanSenior Director, Regulatory |
| Proprietary or Trade Name: | Xenograft Bovine Bone Particulate |
| Common/Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, Animal Source |
| Regulation Number: | 21 CFR 872.3930Classification Product Code: NPM |
| Predicate Device: | K043034: Collagen Matrix OsteoGuide™ Anorganic BoneMineral |
Device Description:
The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.
Indications for Use:
Xenograft Bovine Bone Particulate is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge ●
- . Filling of periodontal defects
- Filling of defects after root resection, apicocectomy, and cystectomy
- . Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a logo for Collagen Solutions. The logo has a graphic of three overlapping sine waves in red, green, and blue. To the right of the graphic is the text "COLLAGEN SOLUTIONS" in a dark gray sans-serif font, with the words "MATERIALS FOR LIFE" in a smaller, lighter gray font underneath.
Substantial Equivalence:
The Collagen Solutions Xenograft Bovine Bone Particulate is substantially equivalent to the predicate device, the Collagen Matrix OsteoGuide™ Anorganic Bone Mineral (510(k) K043034). The table below presents the similarities and differences between the products for substantial equivalence purposes. The difference between the subject device and the predicate device does not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.
| Characteristic | Subject Device: | Predicate Device: | Substantial |
|---|---|---|---|
| Collagen SolutionsXenograft Bovine BoneParticulate | Collagen Matrix, Inc.OsteoGuide AnorganicBone Mineral [510(k)K043034] | Equivalence | |
| Indications for Use | Xenograft Bovine BoneParticulate is intended foruse in dental surgery.The products may beused in surgicalprocedures such as:* Augmentation orreconstructive treatmentof alveolar ridge* Filling of periodontaldefects* Filling of defects afterroot resection,apicocectomy, andcystectomy* Filling of extractionsockets to enhancepreservation of thealveolar ridge* Elevation of maxillarysinus floor* Filling of periodontaldefects in conjunctionwith products intendedfor Guided BoneRegeneration (GBR)* Filling of peri-implantdefects in conjunctionwith products intendedfor Guided BoneRegeneration (GBR) | Natural Anorganic BoneGraft Substitutes areintended for use indental surgery.The products may beused in surgicalprocedures such as:* Augmentation orreconstructive treatmentof alveolar ridge* Filling of periodontaldefects* Filling of defects afterroot resection,apicocectomy, andcystectomy* Filling of extractionsockets to enhancepreservation of thealveolar ridge* Elevation of maxillarysinus floor* Filling of periodontaldefects in conjunctionwith products intendedfor Guided TissueRegeneration (GTR) andGuided BoneRegeneration (GBR)* Filling of peri-implantdefects in conjunctionwith products intendedfor Guided BoneRegeneration | SAME |
| Physical Form | Ground bone particulatein a dappen dish | Ground bone particulatein a dappen dish | SAME |
| Color | White to off-white | White to off-white | SAME |
| Material composition | Anorganic bovine bonemineral | Anorganic bovine bonemineral | SAME |
| Characteristic | Subject Device:Collagen SolutionsXenograft Bovine BoneParticulate | Predicate Device:Collagen Matrix, Inc.OsteoGuide AnorganicBone Mineral [510(k)K043034] | SubstantialEquivalence |
| Size (Dimension andweight) | Small CancellousGranules (0.25-1mm):0.25g/0.6cc, 0.5g/1.2cc,1.0g/2.4 cc, 1.25g/3.0 cc,2.0 g/4.7 ccLarge Cancellous (1-2mm): 0.25g/0.85cc,0.5g/1.7cc, 1.0g/3.4 cc,1.2g/4.0 cc, 2.0 g/6.8 ccCortical Bone (0.5-1mm):0.25g/0.4 cc, 0.5g/0.8cc,1.0g/1.6 cc, 1.25g/2.0 cc,2.0 g/3.2 cc | Small CancellousGranules (0.25-1mm):0.25g/0.6cc, 0.5g/1.2cc,1.0g/2.4 cc, 2.0 g/4.7 ccLarge Cancellous (1-2mm): 0.25g/0.85cc;0.5g/1.7cc, 1.0g/3.4 cc;2.0 g/6.8 ccCortical Bone (0.5-1mm): 0.25g/0.4cc,0.5g/0.8cc, 1.0g/1.6 cc,2.0 g/3.2 cc | SIMILARThe subject device hasone additional size ineach bone type that iswithin the range of sizesavailable in the predicatedevice. |
| Source of bone | Bovine | Bovine | SAME |
| Physical morphology | Trabecular,interconnected macroand micro pores | Trabecular,interconnected macroand micro pores | SAME |
| Crystallinity | 83-98% | 83-98% | SAME |
| Calcium Phosphate Ratio | 2.3-2.5 | 2.3-2.5 | SAME |
| Resorption Time | > 6 months | > 6 months | SAME |
| Performance | Bone formation | Bone formation | SAME |
| FDA Recognized Standards | ASTM F1581ISO 10993-1 | ASTM F1581ISO 10993-1 | SAME |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for Collagen Solutions. The logo has an abstract design on the left side with three overlapping curved lines in red, green, and blue. To the right of the design is the text "COLLAGEN SOLUTIONS" in a bold, sans-serif font. Below that is the text "MATERIALS FOR LIFE" in a smaller, lighter font.
From the comparison form above, the subject device and predicate device have the same intended use and the same operating principle for acting as a scaffold for new bone formation in dental surgery. The minor difference in the additional sizes offered does not raise different questions of safety or effectiveness.
Non-clinical performance testing: Bench / Performance Testing -
- . Bench testing was conducted in order to demonstrate that Collagen Solutions Xenograft Bovine Bone Particulates perform according to its requirements and specifications. In particular, the composition of the Collagen Solutions Xenograft Bovine Bone Particulates meets the requirements of ASTM F1581 "Standard Specification for Composition of Anorganic Bone for Surgical Implants".
- Apparent Density
- Ca/P ratio
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Collagen Solutions. The logo consists of three overlapping, wavy lines in red, green, and blue, with a series of blue circles above them. To the right of the lines, the words "COLLAGEN SOLUTIONS" are written in a bold, sans-serif font, with the words "MATERIALS FOR LIFE" written in a smaller font below.
- Crystallinity
- Protein Content
- Heavy metal
- Biocompatibility was evaluated in accordance with ISO 10993-1 as follows:
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10093-10
- Sensitization per ISO 10993-10
- Genotoxicity per ISO 10993-3
- Acute systemic toxicity per ISO 10993-11
- Subchronic toxicity per ISO 10993-11
- Implantation per ISO 10993-6
- Pyrogenicity per ISO 10993-11 and endotoxin testing (LAL, Limulus Amebocyte Lysate) per USP <85>
All tests indicated the patient contact materials were biocompatible.
- The product is radiation sterilized. Sterilization process validation was performed in . accordance with the ANSI/AAMI/ISO 11137 series demonstrating a Sterility Assurance Level (SAL) of 10-6.
The in-vivo performance of the subject device in a beagle mandibular intraoral critical size defect model was compared to that of the primary predicate device, Collagen Matrix OsteoGuide™ Anorqanic Bone Mineral. New bone formation, presence of residual graft material and tissue reaction were assessed by histomorphometry and histopathology, at 4, 12 and 24 weeks for the subject device, primary predicate device and neqative control. The results demonstrated that the performance of the subject and primary predicate devices was substantially equivalent.
The results demonstrated that the Collagen Solutions Xenograft Bovine Bone Particulates performs according to its specifications and functions as intended.
Substantial Equivalence Conclusion
Performance testing demonstrated that any risks associated with the subject device do not raise any new questions of substantial equivalence. The minor difference in sizes offered does not raise different questions of substantial equivalence based on the performance data. The use of the Collagen Solutions Xenograft Bovine Bone Particulates is substantially equivalent to the predicate device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.