(211 days)
Not Found
No
The device description and performance studies focus on the material properties and biological performance of a bone graft material, with no mention of AI or ML technologies.
No
The device is a xenograft bone particulate used to augment bone in dental surgery, which is a structural material, not a device for treating diseases or conditions in a therapeutic manner.
No
The device description and intended use indicate that this product is a bone graft material used in dental surgical procedures to fill defects and enhance bone formation. It is a therapeutic device, not a diagnostic one.
No
The device is a physical bone particulate material, not software. The description details its composition, physical properties, packaging, and sterilization, all indicative of a hardware/material device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures in dentistry, specifically for bone grafting and augmentation. This is a therapeutic and reconstructive purpose, not for diagnosing a condition.
- Device Description: The device is a bone mineral matrix used in surgery. It's a physical material implanted into the body to promote bone growth.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the material's composition, biocompatibility, sterilization, and in-vivo performance in promoting bone formation. These are all related to its function as a surgical implant, not a diagnostic tool.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / 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 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)
Product codes (comma separated list FDA assigned to the subject device)
NPM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, periodontal defects, defects after root resection, apicocectomy, and cystectomy, extraction sockets, maxillary sinus floor, peri-implant defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery
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)
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
- Crystallinity
- Protein Content
- Heavy metal
Biocompatibility was evaluated in accordance with ISO 10993-1 as follows:
- Cytotoxicity per ISO 10993-5
- Irritation per ISO 10993-10
- 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
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.
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.
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.
Not Found
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
§ 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.
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)
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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 Solutions |
| 6455 City West Pkwy | |
| Eden Prairie, MN 55344 | |
| Phone: (320) 510-3615 | |
| Applicant Contact: | Sheila Hunter |
| Vice President of Quality and Regulatory Affairs | |
| Official Contact: | Richelle Helman |
| Senior 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 872.3930 |
| Classification Product Code: NPM | |
| Predicate Device: | K043034: Collagen Matrix OsteoGuide™ Anorganic Bone |
| Mineral |
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 Solutions | |||
| Xenograft Bovine Bone | |||
| Particulate | Collagen Matrix, Inc. | ||
| OsteoGuide Anorganic | |||
| Bone Mineral [510(k) | |||
| K043034] | Equivalence | ||
| 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) | Natural Anorganic Bone
Graft Substitutes are
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 Tissue
Regeneration (GTR) and
Guided Bone
Regeneration (GBR) - Filling of peri-implant
defects in conjunction
with products intended
for Guided Bone
Regeneration | SAME |
| Physical Form | Ground bone particulate
in a dappen dish | Ground bone particulate
in a dappen dish | SAME |
| Color | White to off-white | White to off-white | SAME |
| Material composition | Anorganic bovine bone
mineral | Anorganic bovine bone
mineral | SAME |
| Characteristic | Subject Device:
Collagen Solutions
Xenograft Bovine Bone
Particulate | Predicate Device:
Collagen Matrix, Inc.
OsteoGuide Anorganic
Bone Mineral [510(k)
K043034] | Substantial
Equivalence |
| Size (Dimension and
weight) | Small Cancellous
Granules (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 cc
Large Cancellous (1-2
mm): 0.25g/0.85cc,
0.5g/1.7cc, 1.0g/3.4 cc,
1.2g/4.0 cc, 2.0 g/6.8 cc
Cortical Bone (0.5-1
mm):
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 Cancellous
Granules (0.25-1mm):
0.25g/0.6cc, 0.5g/1.2cc,
1.0g/2.4 cc, 2.0 g/4.7 cc
Large Cancellous (1-2
mm): 0.25g/0.85cc;
0.5g/1.7cc, 1.0g/3.4 cc;
2.0 g/6.8 cc
Cortical Bone (0.5-1
mm): 0.25g/0.4cc,
0.5g/0.8cc, 1.0g/1.6 cc,
2.0 g/3.2 cc | SIMILAR
The subject device has
one additional size in
each bone type that is
within the range of sizes
available in the predicate
device. |
| Source of bone | Bovine | Bovine | SAME |
| Physical morphology | Trabecular,
interconnected macro
and micro pores | Trabecular,
interconnected macro
and 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 F1581
ISO 10993-1 | ASTM F1581
ISO 10993-1 | SAME |
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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
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.