(188 days)
No
The device description focuses on the material composition and physical properties of a bone graft matrix, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for use as a bone void filler and is resorbed and replaced by bone during the healing process, indicating a therapeutic function.
No
The device is described as a bone void filler and bone graft material intended for use in surgical procedures to fill bony voids or gaps. It is designed to be implanted and integrated into the bone during the healing process, not to diagnose a condition.
No
The device description clearly states it is composed of physical materials (anorganic bone mineral, bioactive glass, and type I collagen) and is a moldable bone graft matrix, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a bone void filler for surgical or traumatic bone defects. This is a therapeutic and structural application within the body.
- Device Description: The device is a moldable bone graft matrix composed of materials intended to be implanted into the body to promote bone healing.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to diagnose or monitor medical conditions. This device is implanted within the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and 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.
For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Product codes (comma separated list FDA assigned to the subject device)
MQV
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 Achilles tendon.
The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, pelvis, and 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)
Biocompatibility Testing: Additional biocompatibility data was not required to determine substantial equivalence. There are no changes to the product and the performance data remains the same as that submitted for the original submission (K182074).
Sterilization, Pyrogen, Endotoxin, Packaging and Shelf Life Testing: Sterilization validation, pyrogen testing, packaging validation and shelf life testing were completed under the original submission. K182074, and there have been no changes to the product since the original submission. Each lot of finished devices is tested for bacterial endotoxin for lot release.
Bench Testing: Bench testing was not required to determine substantial equivalence. The technological characteristics remains the same as that submitted for the original submission.
Animal Testing: The performance of the device in a rabbit femoral condyle critical-sized defect model was compared to the performance of the reference device, SIGNAFUSE bioactive bone graft. The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use.
Clinical Studies: Clinical performance data was not required to determine substantial equivalence.
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.
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
§ 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
December 20, 2022
Image /page/0/Picture/1 description: The image shows the logo for 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.
Collagen Matrix, Inc. Peggy Hansen SVP, Regulatory and Clinical Affairs 15 Thornton Road Oakland. New Jersey 07436
Re: K221735
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: MQV Dated: November 21, 2022 Received: November 22, 2022
Dear Peggy Hansen:
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 (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/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 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 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.
Laura C. Rose -S
Laura C. Rose, 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
2
Indications for Use
510(k) Number (if known) K221375
Device Name
Mineral Collagen Composite Bioactive Moldable
Indications for Use (Describe)
Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and 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.
For spine application Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
| 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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3
510(k) SUMMARY
| 1. | Applicant Information | |||
|---|---|---|---|---|
| Applicant Name: | ||||
| Address: | ||||
| Telephone: | ||||
| Fax: | Collagen Matrix, Inc. | |||
| 15 Thornton Road | ||||
| Oakland, New Jersey 07436 | ||||
| (201) 405-1477 | ||||
| (201) 405-1355 | ||||
| Contact Person: | Peggy Hansen | |||
| Sr. Vice President, Regulatory and Clinical Affairs | ||||
| phansen@collagenmatrix.com | ||||
| Date Prepared: | July 18, 2022 | |||
| 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: | Mineral Collagen Composite Bioactive Moldable | |||
| Collagen Matrix, Inc. | ||||
| K182074 | ||||
| Reference Device: | SIGNAFUSE PUTTY Bioactive Bone Graft | |||
| Bioventus, Inc. | ||||
| K132071 |
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 Achilles tendon.
The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only.
5. Intended Use
Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or qaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and 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.
For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
6. Summary/Comparison of Technical Characteristics
This submission expands the indications for use of Mineral Collagen Composite Bioactive Moldable for use in the extremities and pelvis. The subject device has equivalent technological characteristics as the cited legally marketed predicate Mineral Collagen Composite Bioactive Moldable (K182074) device.
| Feature | Mineral Collagen Composite
Bioactive Moldable Bone
Graft Matrix
(This submission) | Mineral Collagen Composite
Bioactive Moldable Bone
Graft Matrix
(K182074) | Bioactive Bone Graft Putty
SIGNAFUSE PUTTY
Reference Device
(K132071) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Mineral Collagen Composite
Bioactive Moldable is
intended for use as a bone
void filler for voids or gaps,
that are not intrinsic to the
stability of the bony structure.
The device is to be gently
packed into bony voids or
gaps of the skeletal system
(i.e., the extremities, pelvis,
and 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.
For spine applications,
Mineral Collagen Composite
Bioactive Moldable is
combined with either
autogenous bone marrow or
autograft with saline and can | 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. | Bioactive Bone Graft Putty is
a bone void filler device
intended for use in bony voids
or gaps that are not intrinsic
to the stability of the bony
structure. These defects may
be surgically created osseous
defects or osseous defects
created from traumatic injury
to the bone. Bioactive Bone
Graft Putty is indicated to be
packed gently into bony voids
or gaps of the skeletal system
(i.e., extremities, pelvis and
posterolateral spine fusion
procedures).
Bioactive Bone Graft Putty
can also be used with
autograft as a bone graft
extender in the posterolateral
spine. The device provides a
bone void filler that is
resorbed and replaced with
host bone during the healing
process. |
5
| Feature | Mineral Collagen Composite
Bioactive Moldable Bone
Graft Matrix
(This submission) | Mineral Collagen Composite
Bioactive Moldable Bone
Graft Matrix
(K182074) | Bioactive Bone Graft Putty
SIGNAFUSE PUTTY
Reference Device
(K132071) |
|-------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| | also be used with autograft as
a bone graft extender. | | |
| Physical Form | Strip or Cylindrical matrix
(moldable upon hydration) | Strip or Cylindrical matrix
(moldable upon hydration) | Putty preloaded into a syringe
applicator or Strip (moldable) |
| 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 | • Calcium phosphate
(anorganic bone mineral)
• Bioactive glass
• Type I bovine collagen | • Calcium phosphate
(60%HA:40%TCP)
• Bioactive glass
• Alkylene oxide polymer |
| Product Sizes | 2.5 cc – 40 cc | 2.5 cc – 40 cc | 2.5 cc – 10 cc |
| Biocompatibility | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 | Biocompatible
ISO 10993 |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| | Gamma irradiation, ISO11137 | Gamma irradiation, ISO11137 | Gamma irradiation, ISO11137 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/
Reuse | Single use only | Single use only | Single use only |
7. Performance Data
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 following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
Additional biocompatibility data was not required to determine substantial equivalence. There are no changes to the product and the performance data remains the same as that submitted for the original submission (K182074).
Sterilization, Pyrogen, Endotoxin, Packaging and Shelf Life Testing
Sterilization validation, pyrogen testing, packaging validation and shelf life testing were completed under the original submission. K182074, and there have been no changes to the product since the original submission. Each lot of finished devices is tested for bacterial endotoxin for lot release.
Bench Testing
Bench testing was not required to determine substantial equivalence. The technological characteristics remains the same as that submitted for the original submission.
Animal Testing
The performance of the device in a rabbit femoral condyle critical-sized defect model was compared to the performance of the reference device, SIGNAFUSE bioactive bone graft. The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
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8. Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate and reference devices.