K Number
K233203
Device Name
Soft Tissue Augmentation Resorbable Matrix
Date Cleared
2024-05-01

(216 days)

Product Code
Regulation Number
872.3930
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue. STAR Matrix is indicated for: - Covering of implants placed in immediate or delayed extraction sockets; - Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.
Device Description
The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.
More Information

K210280 Geistlich Mucograft®, Geistlich Mucograft Seal®

K110600 Collagen Dental Membrane - Porcine Type I Collagen, K202183 Porcine Mineral Collagen Composite

No
The device description and performance studies focus on the material properties and biological performance of a collagen matrix, with no mention of AI or ML.

Yes

The device aids in localized gingival augmentation and the covering of implants, directly working to correct or modify a body structure or function.

No
Explanation: The device is a resorbable matrix intended for tissue augmentation and support, not for diagnosing a condition.

No

The device description clearly states it is a physical, resorbable membrane made from collagen fibers, intended for surgical implantation. It is a hardware 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 to "support localized gingival augmentation to increase keratinized tissue" and for "covering of implants" and "localized gingival augmentation around teeth and implants." This describes a device used in vivo (within the body) for tissue repair and augmentation.
  • Device Description: The description details a resorbable membrane made from collagen for use in surgical procedures. This is consistent with a surgical implant or tissue regeneration device, not a diagnostic test performed in vitro (outside the body).
  • Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue. There is no mention of reagents, assays, or analytical procedures.

In summary, the STAR Matrix is a surgical device intended for implantation and tissue support within the body, not a diagnostic test performed on samples outside the body.

N/A

Intended Use / Indications for Use

The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

  • Covering of implants placed in immediate or delayed extraction sockets;
  • Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

Product codes (comma separated list FDA assigned to the subject device)

NPL

Device Description

The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Localized gingival augmentation around teeth and implants, alveolar ridge.

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)

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 device.

Viral inactivation
Performed in accordance with ISO 22442-3.

Biocompatibility Testing
Conducted in accordance with the testing matrix of ISO 10993-1: Cytotoxicity, ISO 10993-5 Genotoxicity, ISO 10993-3 and ISO 10993-12 Muscle Implantation, ISO 10993-6 Implantation Assessment in Canine Study, ISO 10993-6 Intracutaneous Reactivity, ISO 10993-10 Acute System Toxicity, ISO 10993-11 Genotoxicity ISO 10993-12 Pyrogenicity ISO 10993-11.
A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment concluded that the amount of formaldehyde residual for single product use has been addressed and is within acceptable limits.

Bench Testing
Purified Collagen Characterization Testing: Hydroxyproline Content, Amino Sugar Content, Lipid Content. SDS page for purified porcine collagen, from reference device K110600, was leveraged. Heavy Metals testing was leveraged from reference device K202183.
Product Characterization Testing: Suture Pull-out Strength, Thermal Transition Temperature, Density.

Animal Testing
The performance of the device was compared to that of the predicate device, Geistlich Mucograft® in a canine model, and evaluated by gross pathology and histological assessments. Critical soft tissue periodontal defects were made at the alveolar ridge, where devices were then implanted. Measurements of the defects were taken at baseline, 4 weeks, and 12 weeks, which included anterior, central, and posterior measurements of the keratinized and soft tissue thickness. Measurement and assessment of the keratinized tissue length in the defect site was made at each termination time point.
Conclusion: The study indicates the positive healing performance of the device as compared to the predicate, with noticeable return to native structures and complete resorption of the device with no unresolved adverse effects. The results demonstrate performance substantially equivalent to the predicate device with regards to the indications for use.

Clinical Studies
Clinical performance data was not required to determine substantial equivalence.

Sterilization / Shelf Life
The device is provided sterile in following with ISO 11737. Sterilization for the subject device is based off of and leveraged from reference device K110600.
Shelf life program developed taking into consideration ISO 11607, ASTM D4169, ASTM F-1886-09, ASTM F-88/F88-M15, and ISTA 3A. The shelf life is 26 months.

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.

K210280 Geistlich Mucograft®, Geistlich Mucograft Seal®

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.

K110600 Collagen Dental Membrane - Porcine Type I Collagen, K202183 Porcine Mineral Collagen Composite

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.

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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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 01, 2024

Collagen Matrix, Inc. Daniel Fernandez Regulatory Affairs Specialist 15 Thornton Rd. Oakland. New Jersey 07436

Re: K233203

Trade/Device Name: Soft Tissue Augmentation Resorbable Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: NPL Dated: April 03, 2024 Received: April 04, 2024

Dear Daniel Fernandez:

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.

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).

1

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 OS 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.

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,

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

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Enclosure

3

Indications for Use

510(k) Number (if known) K233203

Device Name

Soft Tissue Augmentation Resorbable (STAR) Matrix

Indications for Use (Describe)

The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

  • · Covering of implants placed in immediate or delayed extraction sockets;
    · Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

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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Collagen Matrix, Inc. 510(k) Summary 510(k) Submission No.:K233203 Soft Tissue Augmentation Resorbable (STAR) Matrix Page 1 of 4

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:Daniel Fernandez
Regulatory Affairs, Specialist
dfernandez@collagenmatrix.com
Date Prepared:May 01, 2024
2. Name of the Device
Device Trade Name:Soft Tissue Augmentation Resorbable (STAR) Matrix
Device Common Name(s):Collagen Dental Membrane
Device Classification Name:Barrier, animal source, intraoral
872.3930
NPL
Class II
3. Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device:Geistlich Mucograft®, Geistlich Mucograft Seal®
Geistlich Pharma AG
K210280
Reference Device(s):Collagen Dental Membrane - Porcine Type I
Collagen
Collagen Matrix, Inc.
K110600
Porcine Mineral Collagen Composite
Collagen Matrix, Inc.
K202183
4. Description of the Device

The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The

5

product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

5. Indications for Use

STAR Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

  • Covering of implants placed in immediate or delayed extraction sockets; -
  • -Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

6. Summary/Comparison of Technical Characteristics

The subject device has equivalent technological characteristics as the predicate Geistlich Mucograft® and Geistlich Mucograft Seal® (510(k) K210280) device.

| Feature | Soft Tissue
Augmentation
Resorbable (STAR)
Matrix
(Subject Device) | Geistlich Mucograft®,
Geistlich Mucograft
Seal®
(K210280)
(Predicate Device) | Collagen Dental
Membrane - Porcine
Tendon Type I Collagen
(K110600)
(Reference Device) | Device
Comparison |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indications for
Use | STAR Matrix is intended
to support localized
gingival augmentation to
increase keratinized
tissue.
STAR Matrix is indicated
for:
• Covering of
implants placed
in immediate or
delayed
extraction
sockets;
Localized
gingival
augmentation to
increase
keratinized tissue
(KT) around
teeth and
implants. | Geistlich Mucograft and
Mucograft seal are
indicated for
covering of implants
placed in immediate or
delayed extraction sockets,
localized gingival
augmentation to increase
keratinized tissue (KT)
around teeth and implants,
alveolar ridge
reconstruction for
prosthetic treatment,
and recession defects for
root coverage. | Collagen Dental
Membrane - Porcine
Tendon Type I Collagen is
intended for use in oral
surgical procedures as a
resorbable material for
placement in the area of
dental implants, bone
defect or ridge
reconstruction to aid in
wound healing. | Similar |
| Product Code
& Regulation | NPL
872.3930
Bone Grafting Material | NPL
872.3930
Bone Grafting Material | NPL
872.3930
Bone Grafting Material | Identical |
| Material Origin | Porcine | Porcine | Porcine | Similar |
| Material
Composition | Primarily Type I Porcine
collagen | Primarily Type I Porcine
collagen | Primarily Type I Porcine
collagen | Similar |
| Product Form | Smooth outer layer
Porous matrix layer | Smooth "outer" surface
Porous "inner" structure | Membrane | Identical |

6

| Feature | Soft Tissue
Augmentation
Resorbable (STAR)
Matrix
(Subject Device) | Geistlich Mucograft®,
Geistlich Mucograft
Seal®
(K210280)
(Predicate Device) | Collagen Dental
Membrane - Porcine
Tendon Type I Collagen
(K110600)
(Reference Device) | Device
Comparison |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Sizes | 1.5 x 2.0 cm
2.0 x 3.0 cm
3.0 x 4.0 cm
10 x 20 mm
15 x 15 mm
15 x 25 mm
10 x 40 mm
20 x 40 mm
15 x 45 mm
15 x 40 mm
25 x 45 mm
Diameter: 8 - 12 mm | Mucograft: 15 x 20 mm,
20 x30 mm, and 30 x 40
mm
Mucograft Seal: 8mm and
12 mm diameter | 1.5 x 2.0 cm
2.0 x 3.0 cm
3.0 x 4.0 cm | Similar; The
additional
potential
sizes of the
subject
device fall
within the
surface
area of the
largest
device. |
| Device
Thickness | Approx. 1.5 to 5 mm | Approx. 2.5 to 5 mm | 0.2 - 0.6 mm | Similar |
| Thermal
Stability | $53 \pm 8$ | $31.4 \pm 0.20$ | $57 \pm 7$ | Different |
| Suturability
(kg) | ≥ 0.065 | 0.166 ± 0.0816 | ≥ 0.065 | Similar |
| Density | 0.047 ± 0.018 | 0.054 ± 0.003 | N/A | Similar |
| Cross-linking | Crosslinked with
formaldehyde | N/A | Crosslinked with
formaldehyde | Different |
| Biocompatibility | Biocompatible
Meets ISO 10993
biocompatibility series of
testing | Biocompatible
Meets ISO 10993
biocompatibility series of
testing | Biocompatible
Meets ISO 10993
biocompatibility series of
testing | Identical |
| Sterility | Sterile using Gamma
Irradiation; SAL 10-6 | Sterile using Gamma
Irradiation | Sterile using Gamma
Irradiation; SAL 10-6 | Identical |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Identical |
| Single Use/
Reuse | Single use only | Single use only | Single use only | Identical |

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 device. The following performance data are provided in support of the substantial equivalence determination.

Viral inactivation to ensure product safety was performed in accordance with ISO 22442-3.

Biocompatibility Testing

Biocompatibility testing was conducted in accordance with the testing matrix of ISO 10993-1: Cytotoxicity, ISO 10993-5 Genotoxicity, ISO 10993-3 and ISO 10993-12 Muscle Implantation, ISO 10993-6 Implantation Assessment in Canine Study, ISO 10993-6 Intracutaneous Reactivity, ISO 10993-10 Acute System Toxicity, ISO 10993-11 Genotoxicity ISO 10993-12 Pyrogenicity ISO 10993-11

7

A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment included an evaluation of information presented in scientific literature and biocompatibility testing conducted on the subject device as well as similar devices. The results of the assessment concluded that the amount of formaldehyde residual for single product use has been addressed. The level of formaldehyde residual present in the subject device is within the acceptable limit as found in previous FDA approved Collagen Matrix, Inc devices.

Bench Testing

  • Purified Collagen Characterization Testing -
    • -Hydroxyproline Content
    • Amino Sugar Content -
    • Lipid Content -
    • -SDS page for purified porcine collagen, from reference device K110600, was leveraged in support of characterization testing.
    • -Heavy Metals testing was leveraged from reference device K202183 in support of characterization testing.

Product Characterization Testing -

  • Suture Pull-out Strength -
  • Thermal Transition Temperature -
  • Density -

Animal Testing

The performance of the device was compared to that of the predicate device. Geistlich Mucograft® in a canine model, and evaluated by gross pathology and histological assessments. Critical soft tissue periodontal defects were made at the alveolar ridge, where devices were then implanted. Measurements of the defects were taken at baseline, 4 weeks, and 12 weeks, which included anterior, central, and posterior measurements of the keratinized and soft tissue thickness. Measurement and assessment of the keratinized tissue length in the defect site was made at each termination time point. Conclusion of the study indicates the positive healing performance of the device as compared to the predicate, with noticeable return to native structures and complete resorption of the device with no unresolved adverse effects. The results demonstrate performance substantially equivalent to the predicate device with regards to the indications for use.

Clinical Studies

Clinical performance data was not required to determine substantial equivalence.

Sterilization / Shelf Life

The device is provided sterile in following with ISO 11737. Sterilization for the subject device is based off of and leveraged from reference device K110600.

The subject device shelf-life program was developed taking into consideration ISO 11607, ASTM D4169, ASTM F-1886-09, ASTM F-88/F88-M15, and ISTA 3A. The shelf life of the subject device is 26 months.

8. Conclusions Drawn from Non-clinical Studies

The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.