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.

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.

AI/ML Overview

The provided 510(k) summary for the "Mineral Collagen Composite Bioactive Extra Moldable" device indicates that no new acceptance criteria or specific studies proving the device meets these criteria were conducted for this submission (K231942).

Instead, the submission relies on the substantial equivalence to predicate devices (K221735 and K182074) and states that the performance data, including sterilization, pyrogenicity, biocompatibility, and animal testing results, remain the same as those previously submitted for the predicate devices. No new clinical studies were required.

Therefore, many of the requested details about acceptance criteria and study particulars for this specific submission are not explicitly provided because the device's performance is asserted to be equivalent to previously cleared devices, and thus relies on their past demonstrations of meeting acceptance criteria.

However, based on the information provided, we can infer some details:

1. Table of Acceptance Criteria and Reported Device Performance:

Since new performance criteria are not explicitly stated for this submission, the "acceptance criteria" here refer to the standards that the predicate devices met, which are then carried over to the current device due to substantial equivalence.

Performance Characteristic	Acceptance Criteria (Inferred from Predicate Devices)	Reported Device Performance (Inherited from Predicate Devices)
Sterilization	Achieves a validated Sterility Assurance Level (SAL) of 1x10^-6	Validated SAL of 1x10^-6 (No changes from predicate)
Pyrogenicity	Non-pyrogenic	Non-pyrogenic (No changes from predicate)
Biocompatibility	Meets established biocompatibility standards	Biocompatibility data remains the same as predicates (No changes from predicate)
Animal Testing	Acceptable in vivo performance in animal models (e.g., bone ingrowth, resorption)	Animal testing conducted for predicates is applicable (No new animal testing required)
Clinical Performance	Safe and effective for intended use (as demonstrated by predicates)	No new clinical performance data required due to substantial equivalence

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable for this submission as no new testing was conducted to establish acceptance criteria for K231942. The "test set" and corresponding sample sizes would have been part of the predicate device submissions (K221735 and K182074). The document states, "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)."
Data Provenance: Not specified for this submission, as it relies on previous submissions. It's not stated whether the original predicate studies were retrospective or prospective, or their country of origin.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as no new specific ground truth establishment for a test set was detailed for this submission.

4. Adjudication Method for the Test Set:

Not applicable as no new specific test set and adjudication method were detailed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was NOT done. The device is a "Resorbable Calcium Salt Bone Void Filler Device," which is a physical implant, not an AI or imaging diagnostic device that would typically involve human reader studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

No, a standalone performance study was NOT done. This is not an algorithmic or AI device.

7. Type of Ground Truth Used:

Not explicitly defined for this submission in the context of a new test set. For the predicate devices, the "ground truth" for demonstrating performance would likely involve histopathology (for bone ingrowth and resorption in animal studies), material characterization data (for biocompatibility and physical properties), and microbiological testing (for sterility).

8. Sample Size for the Training Set:

Not applicable as this is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as this is a physical medical device, not a machine learning model.

In summary, this 510(k) relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices, asserting that the change (improved moldability) does not alter the fundamental performance as previously established. Therefore, no new primary studies to define and meet acceptance criteria were conducted or reported in this specific submission.

Summary

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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

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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

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Indications for Use

Expiration
See PRA S

K231942

Device Name

Mineral Collagen Composite Bioactive Extra Moldable

Indications for Use (Describe)

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

K182074

Mineral Collagen Composite Bioactive Moldable

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

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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.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

Regulation Number and Section

§ 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.