(232 days)
Not Found
No
The device description and performance studies focus on the material composition and biological properties of the bone graft matrix, with no mention of AI or ML technology.
Yes
The device is described as a "Bone Graft Matrix" indicated for filling "bony voids or gaps" in the skeletal system, and it "resorbs and is replaced with bone during the healing process," serving to heal and replace damaged tissue.
No
This device is a bone graft matrix used to fill bony voids or gaps and is replaced by bone during the healing process. Its function is to facilitate healing and structural support, not to diagnose conditions.
No
The device description clearly states it is a physical bone graft matrix composed of anorganic bone mineral, bioactive glass, and type I collagen, which are all physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for filling bony voids or gaps in the skeletal system and as a bone graft extender. This is a therapeutic use, directly applied to the patient's body to aid in bone healing.
- Device Description: The description details the composition of the bone graft matrix, which is implanted into 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 outside the body to analyze samples and provide diagnostic information. This device is implanted within the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
Product codes
MOV
Device Description
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
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 (i.e., posterolateral spine)
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)
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The performance of the device in posterolateral spine fusion rabbit model was compared to the performance of the predicate device, Vitoss BA and to the performance of the Autograft control. The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender.
The materials are safe and biocompatible as demonstrated through ISO 10993 Biological Evaluation of medical Devices. The device is considered bioactive based on in vitro testing, that show apatite laver formation on the surface of the bioactive glass particles following immersion in simulated body fluid (SBF). In vitro characterization studies included evaluation of physical properties such as density, mineral content, absorbency and an evaluation of physicochemical properties such as pH. The characterization test results of the subject device were equivalent to those of the predicate devices. Viral inactivation studies were performed to ensure the viral safety of the product.
Material-mediated pyrogenicity testing was performed on the finished device in accordance with USP. Bacterial endotoxin testing performed using the limulus amebocyte lysate (LAL) method showed that the device meets the endotoxin limits in accordance with ANSI/AAMI ST72:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 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 are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
March 21, 2019
Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K182074
Trade/Device Name: Mineral Collagen Composite Bioactive Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: February 18, 2019 Received: February 19, 2019
Dear Ms. Zuclich:
We have reviewed vour 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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K182074
Device Name
Mineral Collagen Composite Bioactive Moldable
Indications for Use (Describe)
Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) SUMMARY
| 1. | Applicant Information | ||
|---|---|---|---|
| Applicant Name: | Collagen Matrix, Inc. | ||
| Address: | 15 Thornton Road | ||
| Oakland, New Jersey 07436 | |||
| Telephone: | (201) 405-1477 | ||
| Fax: | (201) 405-1355 | ||
| Contact Person: | Gloria Zuclich | ||
| Director of Regulatory Affairs | |||
| gzuclich@collagenmatrix.com | |||
| Date Prepared: | March 19, 2019 | ||
| 2. | Name of the Device | ||
| Device Trade Name: | Mineral Collagen Composite Bioactive Moldable | ||
| Device Common Name(s): | Bone Void Filler | ||
| Bone Graft Matrix | |||
| Bone Graft Substitute | |||
| Device Classification Name: | Filler, Bone Void, Calcium Compound | ||
| 888.3045 | |||
| MQV | |||
| Class II | |||
| 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | ||
| Primary Predicate Device: | Vitoss® Bioactive Foam Bone Graft Substitute | ||
| Orthovita, Inc. | |||
| K083033 | |||
| Predicate Device: | MASTERGRAFT® Strip/Putty | ||
| Medtronic Sofamor Danek USA, Inc. | |||
| K140375 |
4. Description of the Device
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of
4
anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine deep flexor Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
5. Intended Use
Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender.
The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
6. Summary/Comparison of Technical Characteristics
| Feature | Mineral Collagen
Composite Bioactive
Bone Graft Matrix
(This submission) | VITOSS Bioactive Foam
Bone Graft Substitute*
K083033 | MASTERGRAFT Strip/Putty
K140375 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Mineral Collagen Composite
Bioactive Moldable
combined with either
autogenous bone marrow or
autograft with saline is
indicated for bony voids or
gaps, that are not intrinsic to
the stability of the bony
structure; Mineral Collagen
Composite Bioactive
Moldable can also be used
with autograft as a bone
graft extender.
The device is to be gently
packed into bony voids or
gaps of the skeletal system
(i.e., posterolateral spine).
These defects may be
surgically created osseous
defects or osseous defects
created from traumatic injury
to the bone. The device
resorbs and is replaced with
bone during the healing
process. | Vitoss Bioactive Foam Bone
Graft Substitute is intended for
use as a bone void filler for
voids or gaps that are not
intrinsic to the stability of the
bony structure. Vitoss
Bioactive Foam is indicated for
use in the treatment of
surgically created osseous
defects or osseous defects
created from traumatic injury to
the bone.
Vitoss Bioactive Foam Bone
Graft Substitute is intended to
be used for filling bony voids or
gaps of the skeletal system
(i.e. the extremities, pelvis, and
spine, which includes
posterolateral fusion
procedures), and may be
combined with saline,
autogenous blood, and/or
bone marrow. Following
placement in the bony void or
gap, the scaffold resorbs and
is replaced with bone during
the healing process. | MASTERGRAFT® Putty
combined with either
autogenous bone marrow,
and/or sterile water, and/or
autograft is indicated as a
bone void filler for bony voids
or gaps that are not intrinsic to
the stability of the bony
structure. Additionally,
MASTERGRAFT® Putty can
be used with autograft as a
bone graft extender.
MASTERGRAFT® Putty is to
be gently packed into bony
voids or gaps of the skeletal
system (e.g., the posterolateral
spine, pelvis, ilium, and/or
extremities). These defects
may be surgically created
osseous defects or osseous
defects created from traumatic
injury to the bone.
MASTERGRAFT® Putty
resorbs and is replaced with
bone during the healing
process. |
| Physical Form | Strip or Cylindrical matrix
(moldable upon hydration) | Foam Pack (moldable upon
hydration) | Strip or Putty Matrix
(Putty is moldable upon) |
5
| Foam Strip | hydration) | ||
|---|---|---|---|
| Color | White to off-white | White to off-white | White to off-white |
| Material | |||
| Composition | • Calcium phosphate | ||
| (anorganic bone mineral) | |||
| • Bioactive glass | |||
| • Type I bovine collagen | • β-Tricalcium phosphate | ||
| • Bioactive glass | |||
| • Type I bovine collagen | • β-Tricalcium phosphate and | ||
| Hydroxyapatite | |||
| • Type I bovine collagen | |||
| Product Sizes | 2.5 cc – 40 cc | 1 cc – 10 cc | 0.75 cc – 43 cc |
| Biocompatibility | Biocompatible | ||
| ISO 10993 | Biocompatible | ||
| ISO 10993 | Biocompatible | ||
| ISO 10993 | |||
| Sterility | Sterile, SAL 10-6 | ||
| Gamma irradiation | |||
| ISO 11137 | Sterile, SAL 10-6 | ||
| Gamma irradiation | Sterile, SAL 10-6 | ||
| Gamma irradiation | |||
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/ | |||
| Reuse | Single use only | Single use only | Single use only |
Nonclinical Tests Submitted
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The performance of the device in posterolateral spine fusion rabbit model was compared to the performance of the predicate device, Vitoss BA and to the performance of the Autograft control. The results of the animal study demonstrate performance substantially equivalent to the predicate device Vitoss BA and performance substantially equivalent to autograft when used as an autograft extender.
The materials are safe and biocompatible as demonstrated through ISO 10993 Biological Evaluation of medical Devices. The device is considered bioactive based on in vitro testing, that show apatite laver formation on the surface of the bioactive glass particles following immersion in simulated body fluid (SBF). In vitro characterization studies included evaluation of physical properties such as density, mineral content, absorbency and an evaluation of physicochemical properties such as pH. The characterization test results of the subject device were equivalent to those of the predicate devices. Viral inactivation studies were performed to ensure the viral safety of the product.
Material-mediated pyrogenicity testing was performed on the finished device in accordance with USP. Bacterial endotoxin testing performed using the limulus amebocyte lysate (LAL) method showed that the device meets the endotoxin limits in accordance with ANSI/AAMI ST72:2011.
Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.