(33 days)
No
The summary describes a bone graft material composed of minerals and collagen, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, aiding in the repair of bone defects. This function directly relates to treating a condition (bone voids) to restore health, aligning with the definition of a therapeutic device.
No
Explanation: The device is a bone void filler intended for use as a structural material, not for identifying, monitoring, or predicting diseases or health 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, intended for physical implantation. It does not describe any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "bone void filler" for surgical or traumatic bone defects. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition of the material (anorganic bone mineral, bioactive glass, type I collagen) and its function as an osteoconductive, bioactive, porous implant that is resorbed and replaced by bone. This describes a material implanted into the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for a health issue. IVDs are used in vitro (outside the body) to analyze biological samples.
The device is a medical device intended for surgical implantation to aid in bone healing, which is a completely different category from an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mineral Collagen Composite Bioactive Extra 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 Extra 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
MQV
Device Description
Mineral Collagen Composite Bioactive Extra 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 osteroconductive, 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 of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. The purified type I collagen is derived from bovine 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
skeletal system (i.e., the 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
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074).
Sterilization: There are no changes to the validated sterility assurance level (SAL 1x10-6) remains the same as documented in the primary predicate device submission (K221375) and the predicate device submission (K182074).
Pyrogenicity: The subject device is non-pyrogenic. There are no changes to the biocompatibility data remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074).
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 primary predicate device submission (K221735).
Animal Testing: Additional animal testing was not required to determine substantial equivalence. The animal testing conducted in the primary predicate device (K221735) and predicate device (K182074) is applicable for the subject device.
Clinical Studies: Clinical performance data was not required to determine substantial equivalence.
Conclusions Drawn from Non-Clinical Sites: The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to its predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
August 2, 2023
Image /page/0/Picture/1 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, 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. Victoria Augustine Regulatory Affairs Specialist 15 Thornton Rd. Oakland, New Jersey 07436
Re: K231942
Trade/Device Name: Mineral Collagen Composite Bioactive Extra Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: June 30, 2023 Received: June 30, 2023
Dear Victoria Augustine:
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
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jesse Muir -S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Expiration
See PRA S
Device Name
Mineral Collagen Composite Bioactive Extra Moldable
Indications for Use (Describe)
Mineral Collagen Composite Bioactive Extra 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 Extra 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)
The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared on: 2023-06-30
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Collagen Matrix, Inc. | |
|---|---|---|
| Applicant Address | 15 Thornton Rd. Oakland NJ 07436 United States | |
| Applicant Contact Telephone | 6462229564 | |
| Applicant Contact | Victoria Augustine | |
| Applicant Contact Email | taugustine@regenity.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Mineral Collagen Composite Bioactive Extra Moldable | |
| Common Name | Resorbable calcium salt bone void filler device | |
| Classification Name | Filler, Bone Void, Calcium Compound | |
| Regulation Number | 888.3045 | |
| Product Code | MQV | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K221735 | Mineral Collagen Composite Bioactive Moldable | MQV |
Device Description Summary
Mineral Collagen Composite Bioactive Extra 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 osteroconductive, 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.
Mineral Collagen Composite Bioactive Moldable
The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material of all organic components from bovine bone. The anorganic bone mineral meets ASTM F1581 standard specifications for the composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meeting ASTM F1538 standard specifications for malantation. The purified type I collagen is derived from bovine Achilles tendon.
The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
MQV
21 CFR 807.92(a)(4)
Mineral Collagen Composite Bioactive Extra 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 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 created from traumatic iniury to the hone The device resorbs and is replaced with hone during the healing process
4
For spine application Mineral Collagen Composite Bioactive Extra Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.
Indications for Use Comparison
The subject device has the same indications for use as the predicate device.
Technological Comparison
The subject device has the same basic design characteristics and technological characteristics (i.e., design, material, chemical composition, principle of operation) as the primary predicate device, with the same specification improves the moldability of the device compared to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance Data
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device and remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074).
Sterilization
There are no changes to the validated sterility assurance level (SAL 1x^10-6) remains the same as documented in the primary predicate device submission (K221375) and the predicate device submission (K182074).
Pyrogenicity
The subject device is non-pyrogenic. There are no changes to the biocompatibility data remains the same as that submitted for the primary predicate device (K221735) and the secondary predicate device (K182074).
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 primary predicate device submission (K221735).
Animal Testing
Additional animal testing was not required to determine substantial equivalence. The animal testing conducted in the primary predicate device (K221735) and predicate device (K182074) is applicable for the subject device.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
Conclusions Drawn from Non-Clinical Sites
The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to its predicate devices.